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href="https://microbe-investigations.com/jisl1902/"> <span class="elementor-icon-list-text">JISL1902</span> </a> </li> <li class="elementor-icon-list-item"> <a href="https://microbe-investigations.com/iso-20743/"> <span class="elementor-icon-list-text">ISO 20743</span> </a> </li> <li class="elementor-icon-list-item"> <a href="https://microbe-investigations.com/aatcc-147/"> <span class="elementor-icon-list-text">AATCC 147 </span> </a> </li> <li class="elementor-icon-list-item"> <a href="https://microbe-investigations.com/iso-20645/"> <span class="elementor-icon-list-text">ISO 20645</span> </a> </li> </ul> </div> </div> </div> </div> <div class="elementor-column elementor-col-25 elementor-inner-column elementor-element elementor-element-da15636" data-id="da15636" data-element_type="column"> <div class="elementor-widget-wrap elementor-element-populated"> <div class="elementor-element elementor-element-57ca362 elementor-widget elementor-widget-heading" data-id="57ca362" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <p class="elementor-heading-title elementor-size-default">Plastics/Coatings</p> </div> </div> <div class="elementor-element elementor-element-75e3d04 elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list" data-id="75e3d04" data-element_type="widget" data-widget_type="icon-list.default"> <div class="elementor-widget-container"> <ul class="elementor-icon-list-items"> <li class="elementor-icon-list-item"> <a href="https://microbe-investigations.com/jisz2801/"> <span class="elementor-icon-list-text">JISZ2801</span> </a> </li> <li class="elementor-icon-list-item"> <a href="https://microbe-investigations.com/iso-22196/"> <span class="elementor-icon-list-text">ISO 22196 </span> </a> </li> <li class="elementor-icon-list-item"> <a href="https://microbe-investigations.com/astm-e2180/"> <span class="elementor-icon-list-text">ASTM E2180</span> </a> </li> <li class="elementor-icon-list-item"> <a href="https://microbe-investigations.com/astm-e3031/"> <span class="elementor-icon-list-text">ASTM E3031</span> </a> </li> <li class="elementor-icon-list-item"> <a href="https://microbe-investigations.com/astm-g22/"> <span class="elementor-icon-list-text">ASTM G22</span> </a> </li> <li class="elementor-icon-list-item"> <a href="https://microbe-investigations.com/astm-d2574/"> <span class="elementor-icon-list-text">ASTM D2574</span> </a> </li> </ul> </div> </div> </div> </div> <div class="elementor-column elementor-col-25 elementor-inner-column elementor-element elementor-element-f204eab" data-id="f204eab" data-element_type="column"> <div class="elementor-widget-wrap elementor-element-populated"> <div class="elementor-element elementor-element-a01b6ae elementor-widget elementor-widget-heading" data-id="a01b6ae" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <p class="elementor-heading-title elementor-size-default">Disinfectants</p> </div> </div> <div class="elementor-element elementor-element-bb48694 elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list" data-id="bb48694" data-element_type="widget" data-widget_type="icon-list.default"> <div class="elementor-widget-container"> <ul class="elementor-icon-list-items"> <li class="elementor-icon-list-item"> <a href="https://microbe-investigations.com/en-1276/"> <span class="elementor-icon-list-text">EN 1276</span> </a> </li> <li class="elementor-icon-list-item"> <a href="https://microbe-investigations.com/en-16615/"> <span class="elementor-icon-list-text">EN 16615</span> </a> </li> <li class="elementor-icon-list-item"> <a href="https://microbe-investigations.com/en-13697/"> <span class="elementor-icon-list-text">EN 13697</span> </a> </li> <li class="elementor-icon-list-item"> <a href="https://microbe-investigations.com/en-13727/"> <span class="elementor-icon-list-text"> EN 13727</span> </a> </li> <li class="elementor-icon-list-item"> <a href="https://microbe-investigations.com/pas-2424/"> <span class="elementor-icon-list-text">PAS 2424</span> </a> </li> <li class="elementor-icon-list-item"> <a href="https://microbe-investigations.com/aoac-use-dilution-test-955-14-955-15-964-02/"> <span class="elementor-icon-list-text">AOAC Use Dilution Test</span> </a> </li> </ul> </div> </div> </div> </div> <div class="elementor-column elementor-col-25 elementor-inner-column elementor-element elementor-element-56cfd2c" data-id="56cfd2c" data-element_type="column"> <div class="elementor-widget-wrap elementor-element-populated"> <div class="elementor-element elementor-element-6220f57 elementor-hidden-desktop elementor-hidden-tablet elementor-widget elementor-widget-heading" data-id="6220f57" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <p class="elementor-heading-title elementor-size-default">Others</p> </div> </div> <div class="elementor-element elementor-element-8ceecdd elementor-widget__width-auto elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list" data-id="8ceecdd" data-element_type="widget" data-widget_type="icon-list.default"> <div class="elementor-widget-container"> <ul class="elementor-icon-list-items"> <li class="elementor-icon-list-item"> <a href="https://microbe-investigations.com/minimum-inhibitory-concentration-test/"> <span class="elementor-icon-list-text">Minimum Inhibitory Concentration</span> </a> </li> <li class="elementor-icon-list-item"> <a href="https://microbe-investigations.com/minimum-bactericidal-concentration-mbc-test/"> <span class="elementor-icon-list-text">Minimum Bactericidal Concentration </span> </a> </li> <li class="elementor-icon-list-item"> <a href="https://microbe-investigations.com/zone-of-inhibition-test/"> <span class="elementor-icon-list-text">Zone of Inhibition</span> </a> </li> <li class="elementor-icon-list-item"> <a href="https://microbe-investigations.com/aerobic-plate-count-test/"> <span class="elementor-icon-list-text">Aerobic Plate Count</span> </a> </li> <li class="elementor-icon-list-item"> <a href="https://microbe-investigations.com/astm-d7907-14/"> <span class="elementor-icon-list-text">ASTM D7907-14</span> </a> </li> <li class="elementor-icon-list-item"> <a href="https://microbe-investigations.com/astm-g29/"> <span class="elementor-icon-list-text">ASTM G29</span> </a> </li> <li class="elementor-icon-list-item"> <a href="https://microbe-investigations.com/astm-e2362/"> <span class="elementor-icon-list-text">ASTM E2362</span> </a> </li> </ul> </div> </div> <div class="elementor-element elementor-element-541dedd elementor-widget__width-auto elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list" data-id="541dedd" data-element_type="widget" data-widget_type="icon-list.default"> <div class="elementor-widget-container"> <ul class="elementor-icon-list-items"> <li class="elementor-icon-list-item"> <a href="https://microbe-investigations.com/iso846/"> <span class="elementor-icon-list-text">ISO 846</span> </a> </li> <li class="elementor-icon-list-item"> <a href="https://microbe-investigations.com/iso-11930/"> <span class="elementor-icon-list-text">ISO 11930</span> </a> </li> <li class="elementor-icon-list-item"> <a href="https://microbe-investigations.com/usp-51-antimicrobial-effectiveness-test/"> <span class="elementor-icon-list-text">USP 51</span> </a> </li> <li class="elementor-icon-list-item"> <a href="https://microbe-investigations.com/usp-60-test-for-burkholderia-cepacia-complex/"> <span class="elementor-icon-list-text">USP 60</span> </a> </li> <li class="elementor-icon-list-item"> <a href="https://microbe-investigations.com/usp-61-microbial-enumeration-test/"> <span class="elementor-icon-list-text">USP 61</span> </a> </li> <li class="elementor-icon-list-item"> <a href="https://microbe-investigations.com/usp-62-test/"> <span class="elementor-icon-list-text">USP 62</span> </a> </li> <li class="elementor-icon-list-item"> <a href="https://microbe-investigations.com/usp-71-sterility-testing/"> <span class="elementor-icon-list-text">USP 71</span> </a> </li> </ul> </div> </div> <div class="elementor-element elementor-element-33984f0 elementor-widget__width-auto elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list" data-id="33984f0" data-element_type="widget" data-widget_type="icon-list.default"> <div class="elementor-widget-container"> <ul class="elementor-icon-list-items"> <li class="elementor-icon-list-item"> <a href="https://microbe-investigations.com/usp-85-bacterial-endotoxin-test/"> <span class="elementor-icon-list-text">USP 85</span> </a> </li> <li class="elementor-icon-list-item"> <a href="https://microbe-investigations.com/usp-1111/"> <span class="elementor-icon-list-text">USP 1111</span> </a> </li> </ul> </div> </div> </div> </div> </div> </section> <section class="elementor-section elementor-inner-section elementor-element elementor-element-017db13 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="017db13" data-element_type="section"> <div class="elementor-container elementor-column-gap-default"> <div class="elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-97b89ac" data-id="97b89ac" data-element_type="column"> <div class="elementor-widget-wrap elementor-element-populated"> <div class="elementor-element elementor-element-d3f0f58 elementor-widget elementor-widget-heading" data-id="d3f0f58" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <p class="elementor-heading-title elementor-size-default"><a href="https://microbe-investigations.com/antiviral/">Antiviral</a></p> </div> </div> <div class="elementor-element elementor-element-717dda1 elementor-widget-divider--view-line elementor-widget elementor-widget-divider" data-id="717dda1" data-element_type="widget" data-widget_type="divider.default"> <div class="elementor-widget-container"> <div class="elementor-divider"> <span class="elementor-divider-separator"> </span> </div> </div> </div> </div> </div> <div class="elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-73a7ecf elementor-hidden-mobile" data-id="73a7ecf" data-element_type="column"> <div class="elementor-widget-wrap elementor-element-populated"> <div class="elementor-element elementor-element-8c45e3d elementor-widget elementor-widget-heading" data-id="8c45e3d" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <p class="elementor-heading-title elementor-size-default"><a href="https://microbe-investigations.com/entomology-chemistry/">Entomology & Chemistry</a></p> </div> </div> <div class="elementor-element elementor-element-2c1986f elementor-widget-divider--view-line elementor-widget elementor-widget-divider" data-id="2c1986f" data-element_type="widget" data-widget_type="divider.default"> <div class="elementor-widget-container"> <div class="elementor-divider"> <span class="elementor-divider-separator"> </span> </div> </div> </div> </div> </div> </div> </section> <section class="elementor-section elementor-inner-section elementor-element elementor-element-986e028 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="986e028" data-element_type="section"> <div class="elementor-container elementor-column-gap-default"> <div class="elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-a239553" data-id="a239553" data-element_type="column"> <div class="elementor-widget-wrap elementor-element-populated"> <section class="elementor-section elementor-inner-section elementor-element elementor-element-29a04c0 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="29a04c0" data-element_type="section"> <div class="elementor-container elementor-column-gap-default"> <div class="elementor-column elementor-col-33 elementor-inner-column elementor-element elementor-element-82cf80d" data-id="82cf80d" data-element_type="column"> <div class="elementor-widget-wrap elementor-element-populated"> <div class="elementor-element elementor-element-3665773 elementor-widget elementor-widget-heading" data-id="3665773" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <p class="elementor-heading-title elementor-size-default">Textiles</p> </div> </div> <div class="elementor-element elementor-element-9b7c505 elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list" data-id="9b7c505" data-element_type="widget" data-widget_type="icon-list.default"> <div class="elementor-widget-container"> <ul class="elementor-icon-list-items"> <li class="elementor-icon-list-item"> <a href="https://microbe-investigations.com/iso18184/"> <span class="elementor-icon-list-text">ISO18184</span> </a> </li> <li class="elementor-icon-list-item"> <a href="https://microbe-investigations.com/jis-l-1922/"> <span class="elementor-icon-list-text">JIS L 1922</span> </a> </li> </ul> </div> </div> </div> </div> <div class="elementor-column elementor-col-33 elementor-inner-column elementor-element elementor-element-7bab9ba" data-id="7bab9ba" data-element_type="column"> <div class="elementor-widget-wrap elementor-element-populated"> <div class="elementor-element elementor-element-a6673e8 elementor-widget elementor-widget-heading" data-id="a6673e8" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <p class="elementor-heading-title elementor-size-default">Plastics/Coatings</p> </div> </div> <div class="elementor-element elementor-element-89e878a elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list" data-id="89e878a" data-element_type="widget" data-widget_type="icon-list.default"> <div class="elementor-widget-container"> <ul class="elementor-icon-list-items"> <li class="elementor-icon-list-item"> <a href="https://microbe-investigations.com/iso21702/"> <span class="elementor-icon-list-text"> ISO21702</span> </a> </li> </ul> </div> </div> </div> </div> <div class="elementor-column elementor-col-33 elementor-inner-column elementor-element elementor-element-7cb318a" data-id="7cb318a" data-element_type="column"> <div class="elementor-widget-wrap elementor-element-populated"> <div class="elementor-element elementor-element-a3e0eca elementor-widget elementor-widget-heading" data-id="a3e0eca" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <p class="elementor-heading-title elementor-size-default">disinfectants</p> </div> </div> <div class="elementor-element elementor-element-2c7b5be elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list" data-id="2c7b5be" data-element_type="widget" data-widget_type="icon-list.default"> <div class="elementor-widget-container"> <ul class="elementor-icon-list-items"> <li class="elementor-icon-list-item"> <a href="https://microbe-investigations.com/en-14476/"> <span class="elementor-icon-list-text">EN 14476 </span> </a> </li> <li class="elementor-icon-list-item"> <a href="https://microbe-investigations.com/en-14675/"> <span class="elementor-icon-list-text">EN 14675</span> </a> </li> <li class="elementor-icon-list-item"> <a href="https://microbe-investigations.com/astm-e1053/"> <span class="elementor-icon-list-text">ASTM E1053 </span> </a> </li> <li class="elementor-icon-list-item"> <a href="https://microbe-investigations.com/en-16777/"> <span class="elementor-icon-list-text">EN 16777</span> </a> </li> </ul> </div> </div> </div> </div> </div> </section> </div> </div> <div class="elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-e081e6a" data-id="e081e6a" data-element_type="column"> <div class="elementor-widget-wrap elementor-element-populated"> <div class="elementor-element elementor-element-962e6b7 elementor-hidden-desktop elementor-hidden-tablet elementor-widget elementor-widget-heading" data-id="962e6b7" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <p class="elementor-heading-title elementor-size-default"><a href="https://microbe-investigations.com/entomology-chemistry/">Entomology & Chemistry</a></p> </div> </div> <div class="elementor-element elementor-element-561a5b3 elementor-hidden-desktop elementor-hidden-tablet elementor-widget-divider--view-line elementor-widget elementor-widget-divider" data-id="561a5b3" data-element_type="widget" data-widget_type="divider.default"> <div class="elementor-widget-container"> <div class="elementor-divider"> <span class="elementor-divider-separator"> </span> </div> </div> </div> <section class="elementor-section elementor-inner-section elementor-element elementor-element-1746d01 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="1746d01" data-element_type="section"> <div class="elementor-container elementor-column-gap-default"> <div class="elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-6250993" data-id="6250993" data-element_type="column"> <div class="elementor-widget-wrap elementor-element-populated"> <div class="elementor-element elementor-element-7528694 elementor-widget elementor-widget-heading" data-id="7528694" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <p class="elementor-heading-title elementor-size-default">Mosquito Repellent Testing</p> </div> </div> <div class="elementor-element elementor-element-d443338 elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list" data-id="d443338" data-element_type="widget" data-widget_type="icon-list.default"> <div class="elementor-widget-container"> <ul class="elementor-icon-list-items"> <li class="elementor-icon-list-item"> <a href="https://microbe-investigations.com/arm-in-cage-test/"> <span class="elementor-icon-list-text">Arm In Cage</span> </a> </li> <li class="elementor-icon-list-item"> <a href="https://microbe-investigations.com/room-test/"> <span class="elementor-icon-list-text">Room Test</span> </a> </li> <li class="elementor-icon-list-item"> <a href="https://microbe-investigations.com/tunnel-test/"> <span class="elementor-icon-list-text">Tunnel Test</span> </a> </li> <li class="elementor-icon-list-item"> <a href="https://microbe-investigations.com/olfactometer-test/"> <span class="elementor-icon-list-text">Olfactometer Test</span> </a> </li> </ul> </div> </div> </div> </div> <div class="elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-867f464" data-id="867f464" data-element_type="column"> <div class="elementor-widget-wrap elementor-element-populated"> <div class="elementor-element elementor-element-9ed14d9 elementor-widget elementor-widget-heading" data-id="9ed14d9" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <p class="elementor-heading-title elementor-size-default"><a href="https://microbe-investigations.com/tick-repellent-testing/">Tick Repellent Testing</a></p> </div> </div> </div> </div> </div> </section> </div> </div> </div> </section> <section class="elementor-section elementor-inner-section elementor-element elementor-element-e216a41 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="e216a41" data-element_type="section"> <div class="elementor-container elementor-column-gap-default"> <div class="elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-7feb674" data-id="7feb674" data-element_type="column"> <div class="elementor-widget-wrap elementor-element-populated"> <div class="elementor-element elementor-element-352fb15 elementor-widget elementor-widget-heading" data-id="352fb15" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <p class="elementor-heading-title elementor-size-default"><a href="https://microbe-investigations.com/fungicidal-yeasticidal-testing/">Fungicidal & Yeasticidal</a></p> </div> </div> <div class="elementor-element elementor-element-0b5f568 elementor-widget-divider--view-line elementor-widget elementor-widget-divider" data-id="0b5f568" data-element_type="widget" data-widget_type="divider.default"> <div class="elementor-widget-container"> <div class="elementor-divider"> <span class="elementor-divider-separator"> </span> </div> </div> </div> </div> </div> <div class="elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-aa69b12 elementor-hidden-mobile" data-id="aa69b12" data-element_type="column"> <div class="elementor-widget-wrap elementor-element-populated"> <div class="elementor-element elementor-element-7bd26bb elementor-widget elementor-widget-heading" data-id="7bd26bb" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <p class="elementor-heading-title elementor-size-default">Odor Testing</p> </div> </div> <div class="elementor-element elementor-element-28dc7df elementor-widget-divider--view-line elementor-widget elementor-widget-divider" data-id="28dc7df" data-element_type="widget" data-widget_type="divider.default"> <div class="elementor-widget-container"> <div class="elementor-divider"> <span class="elementor-divider-separator"> </span> </div> </div> </div> </div> </div> </div> </section> <section class="elementor-section elementor-inner-section elementor-element elementor-element-3024338 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="3024338" data-element_type="section"> <div class="elementor-container elementor-column-gap-default"> <div class="elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-b38470e" data-id="b38470e" data-element_type="column"> <div class="elementor-widget-wrap elementor-element-populated"> <section class="elementor-section elementor-inner-section elementor-element elementor-element-59f5f9b elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="59f5f9b" data-element_type="section"> <div class="elementor-container elementor-column-gap-default"> <div class="elementor-column elementor-col-33 elementor-inner-column elementor-element elementor-element-91db9ef" data-id="91db9ef" data-element_type="column"> <div class="elementor-widget-wrap elementor-element-populated"> <div class="elementor-element elementor-element-5a65352 elementor-widget elementor-widget-heading" data-id="5a65352" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <p class="elementor-heading-title elementor-size-default">Textiles</p> </div> </div> <div class="elementor-element elementor-element-bfb6fae elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list" data-id="bfb6fae" data-element_type="widget" data-widget_type="icon-list.default"> <div class="elementor-widget-container"> <ul class="elementor-icon-list-items"> <li class="elementor-icon-list-item"> <a href="https://microbe-investigations.com/aatcc-30/"> <span class="elementor-icon-list-text">AATCC 30</span> </a> </li> </ul> </div> </div> </div> </div> <div class="elementor-column elementor-col-33 elementor-inner-column elementor-element elementor-element-cbb6a25" data-id="cbb6a25" data-element_type="column"> <div class="elementor-widget-wrap elementor-element-populated"> <div class="elementor-element elementor-element-0031fce elementor-widget elementor-widget-heading" data-id="0031fce" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <p class="elementor-heading-title elementor-size-default">Plastics/Coatings</p> </div> </div> <div class="elementor-element elementor-element-c588d81 elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list" data-id="c588d81" data-element_type="widget" 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33.4625C1.61841 38.894 4.28515 43.8831 8.20102 47.799C12.1169 51.7148 17.106 54.3816 22.5375 55.462C27.9689 56.5424 33.5988 55.9879 38.7151 53.8686C43.8315 51.7494 48.2045 48.1605 51.2812 43.556C54.3578 38.9514 56 33.5379 56 28C55.9917 20.5765 53.039 13.4594 47.7898 8.21021C42.5406 2.961 35.4235 0.00833366 28 0ZM28 53.9759C22.8625 53.9759 17.8403 52.4524 13.5686 49.5982C9.29686 46.7439 5.96746 42.687 4.00141 37.9405C2.03535 33.1941 1.52094 27.9712 2.52323 22.9323C3.52551 17.8935 5.99948 13.2651 9.63227 9.63226C13.2651 5.99947 17.8935 3.5255 22.9324 2.52322C27.9712 1.52093 33.1941 2.03534 37.9406 4.00139C42.687 5.96745 46.7439 9.29684 49.5982 13.5686C52.4524 17.8403 53.9759 22.8624 53.9759 28C53.9676 34.8867 51.2282 41.4889 46.3585 46.3585C41.4889 51.2281 34.8867 53.9676 28 53.9759Z" fill="black"></path><path d="M27.8874 6.18292H27.8872C23.5945 6.18292 19.3981 7.45588 15.8288 9.84082C12.2595 12.2258 9.47754 15.6156 7.83477 19.5816C6.19199 23.5476 5.76217 27.9116 6.59965 32.1219C7.43713 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32.4869 23.9202 31.8076 19.7865L31.7487 19.426C31.184 16.0057 28.8269 15.4154 26.5473 14.8449C25.5977 14.6322 24.6669 14.3429 23.7641 13.9797C19.6819 12.2341 19.1126 11.2659 19.4612 9.98739C19.6324 9.35839 19.9019 9.2283 21.1986 8.84252C22.9697 8.389 24.6176 7.54691 26.0228 6.37736C29.0268 3.88435 29.4442 3.12658 29.1777 2.37009C33.1968 3.12018 36.9447 4.92414 40.0381 7.59753C43.1315 10.2709 45.4594 13.7178 46.784 17.5859ZM24.9996 1.983C25.7764 1.98308 26.5528 2.0222 27.3257 2.10021C27.2148 2.26081 27.1551 2.45126 27.1546 2.64645C26.415 3.44396 25.6131 4.18127 24.7564 4.85137C23.5556 5.84774 22.1466 6.56216 20.6332 6.94203C19.3512 7.32313 18.0243 7.71741 17.5479 9.46569C16.5673 13.0587 20.4294 14.7102 22.9849 15.8031C23.9837 16.2082 25.014 16.531 26.0655 16.7683C28.4048 17.3543 29.4536 17.6998 29.7921 19.749L29.851 20.108C30.4056 23.4807 30.8177 25.9946 33.5605 25.9946C33.8271 25.9933 34.0933 25.9726 34.3568 25.9326C35.7465 25.7301 37.0796 24.6402 38.3685 23.5864C39.6644 22.5267 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15.5038 26.6465 15.6207 27.0167C15.4468 27.0659 15.2656 27.0837 15.0855 27.0694C14.5208 27.038 13.0025 26.7088 11.1009 24.3323C9.58733 22.4392 8.68026 21.5403 7.56563 21.6146C6.4626 21.6797 5.87699 22.6197 4.99162 24.0426L4.75304 24.4249C4.54467 24.7572 4.22012 25.1576 3.85837 25.1786C3.38664 25.2088 2.72667 24.6232 2.49585 24.3358C2.36926 24.1836 2.1989 24.0741 2.0079 24.0221C2.26624 18.0952 4.80058 12.4963 9.0833 8.39101C13.366 4.28574 19.0671 1.99045 24.9996 1.983Z" fill="black"></path></svg> </span> </div> <div class="elementor-icon-box-content"> <span class="elementor-icon-box-title"> <span > Global Footprint </span> </span> </div> </div> </div> </div> </div> </div> <div class="elementor-column elementor-col-25 elementor-top-column elementor-element elementor-element-1b8a44d" data-id="1b8a44d" data-element_type="column"> <div class="elementor-widget-wrap elementor-element-populated"> <div class="elementor-element elementor-element-2a482c6 elementor-position-left elementor-vertical-align-middle elementor-mobile-position-left elementor-widget__width-auto elementor-widget-mobile__width-auto elementor-view-default elementor-widget elementor-widget-icon-box" data-id="2a482c6" data-element_type="widget" data-widget_type="icon-box.default"> <div class="elementor-widget-container"> <div class="elementor-icon-box-wrapper"> <div class="elementor-icon-box-icon"> <span class="elementor-icon elementor-animation-"> <svg xmlns="http://www.w3.org/2000/svg" width="52" height="57" viewBox="0 0 52 57" fill="none"><path d="M17.9445 37.1048L11.5668 44.9806L9.99163 43.7051L16.3693 35.8292L17.9445 37.1048ZM50.3678 0.261771L50.7825 1.51597C53.7671 10.5415 51.1809 21.827 43.939 30.7699C41.9057 33.2809 39.6097 35.4817 37.1379 37.3223L36.4107 37.8499L37.8882 41.101L28.7906 56.3201L24.6615 52.9764L24.4941 40.9751L24.423 40.859C23.4379 39.323 22.2231 37.9615 20.7952 36.8052C19.3109 35.6032 17.6558 34.6712 15.868 34.0197L4.12911 36.3496L0 33.0059L12.9951 20.9429L16.5372 21.7246L16.9574 20.7852C18.2346 18.0357 19.8876 15.381 21.8867 12.9123C28.9387 4.20382 39.0884 -0.658912 48.4034 0.0721538L50.3678 0.261771ZM35.6036 40.9725L34.6999 38.9857L34.7219 38.972C32.3147 40.473 29.7782 41.6452 27.1834 42.4476L26.5424 42.6456L26.6748 51.9987L28.25 53.2742L35.6036 40.9725ZM15.7807 23.6341L13.5957 23.1509L3.09172 32.9015L4.66689 34.177L13.8941 32.3511L13.952 31.7287C14.1723 29.2841 14.6986 26.8229 15.5121 24.4028L15.7807 23.6341ZM22.67 40.9314L18.8434 45.6569L17.2682 44.3814L21.0948 39.6559L22.67 40.9314ZM49.2658 15.5205L35.6947 4.53172C31.2444 6.57704 26.9836 9.8389 23.4619 14.1878C19.0127 19.6821 16.506 25.9695 15.9707 31.9106C18.158 32.6297 20.2194 33.7308 22.0708 35.23C23.9227 36.7297 25.4287 38.5178 26.5845 40.5113C32.2852 38.7483 37.9144 34.989 42.3639 29.4943C45.8857 25.1452 48.1905 20.2991 49.2658 15.5205ZM39.9284 13.1777C42.5382 15.2911 42.9406 19.12 40.8272 21.7298C38.7138 24.3396 34.8849 24.7421 32.2751 22.6287C29.6653 20.5153 29.2629 16.6864 31.3762 14.0765C33.4896 11.4667 37.3186 11.0643 39.9284 13.1777ZM38.6528 14.7528C36.9129 13.3439 34.3603 13.6122 32.9514 15.3521C31.5425 17.092 31.8108 19.6446 33.5507 21.0535C35.2905 22.4624 37.8431 22.1941 39.2521 20.4543C40.661 18.7144 40.3927 16.1618 38.6528 14.7528ZM48.8582 2.15233L48.2086 2.08964C44.857 1.82671 41.3111 2.36692 37.8265 3.65003L49.6849 13.2518C50.2497 9.33935 49.9764 5.53387 48.8582 2.15233Z" fill="black"></path></svg> </span> </div> <div class="elementor-icon-box-content"> <span class="elementor-icon-box-title"> <span > Speed </span> </span> </div> </div> </div> </div> </div> </div> <div class="elementor-column elementor-col-25 elementor-top-column elementor-element elementor-element-097abe7" data-id="097abe7" data-element_type="column"> <div class="elementor-widget-wrap elementor-element-populated"> <div class="elementor-element elementor-element-ed60bb9 elementor-position-left elementor-vertical-align-middle elementor-mobile-position-left elementor-widget__width-auto elementor-widget-mobile__width-auto elementor-view-default elementor-widget elementor-widget-icon-box" data-id="ed60bb9" data-element_type="widget" data-widget_type="icon-box.default"> <div class="elementor-widget-container"> <div class="elementor-icon-box-wrapper"> <div class="elementor-icon-box-icon"> <span class="elementor-icon elementor-animation-"> <svg xmlns="http://www.w3.org/2000/svg" width="23" height="25" viewBox="0 0 23 25" fill="none"><path d="M20.5 0H2.5C2.1717 0 1.84661 0.0646644 1.54329 0.190301C1.23998 0.315938 0.964379 0.500087 0.732233 0.732233C0.263392 1.20107 0 1.83696 0 2.5V16.5C0 17.163 0.263392 17.7989 0.732233 18.2678C0.964379 18.4999 1.23998 18.6841 1.54329 18.8097C1.84661 18.9353 2.1717 19 2.5 19H8V23H7C6.86739 23 6.74021 23.0527 6.64645 23.1464C6.55268 23.2402 6.5 23.3674 6.5 23.5C6.5 23.6326 6.55268 24.7598 6.64645 24.8536C6.74021 24.9473 6.86739 25 7 25H16C16.1326 25 16.2598 24.9473 16.3536 24.8536C16.4473 24.7598 16.5 23.6326 16.5 23.5C16.5 23.3674 16.4473 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</span> </div> <div class="elementor-icon-box-content"> <span class="elementor-icon-box-title"> <span > LIMS system </span> </span> </div> </div> </div> </div> </div> </div> </div> </section> <section class="elementor-section elementor-top-section elementor-element elementor-element-af35227 elementor-section-full_width elementor-section-height-min-height elementor-section-stretched elementor-section-height-default elementor-section-items-middle" data-id="af35227" data-element_type="section" data-settings="{"stretch_section":"section-stretched","background_background":"classic"}"> <div class="elementor-container elementor-column-gap-default"> <div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-6fa1958" data-id="6fa1958" data-element_type="column"> <div class="elementor-widget-wrap elementor-element-populated"> <section class="elementor-section elementor-inner-section elementor-element elementor-element-d165ee2 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="d165ee2" data-element_type="section"> <div class="elementor-container elementor-column-gap-default"> <div class="elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-10078f5" data-id="10078f5" data-element_type="column"> <div class="elementor-widget-wrap elementor-element-populated"> <div class="elementor-element elementor-element-ac6dd0d elementor-widget elementor-widget-heading" data-id="ac6dd0d" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <h1 class="elementor-heading-title elementor-size-default">USP 61</h1> </div> </div> <div class="elementor-element elementor-element-14e4675 elementor-widget elementor-widget-text-editor" data-id="14e4675" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p>Microbial Enumeration Test</p> </div> </div> <div class="elementor-element elementor-element-9dffa24 elementor-widget elementor-widget-button" data-id="9dffa24" data-element_type="widget" data-widget_type="button.default"> <div class="elementor-widget-container"> <div class="elementor-button-wrapper"> <a class="elementor-button elementor-button-link elementor-size-sm" href="https://microbe-investigations.com/request-a-quote/"> <span class="elementor-button-content-wrapper"> <span class="elementor-button-text">GET A QUOTE</span> </span> </a> </div> </div> </div> </div> </div> <div class="elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-f8a176e" data-id="f8a176e" data-element_type="column"> <div class="elementor-widget-wrap"> </div> </div> </div> </section> </div> </div> </div> </section> <section class="elementor-section elementor-top-section elementor-element elementor-element-0dc4dfa elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="0dc4dfa" data-element_type="section"> <div class="elementor-container elementor-column-gap-default"> <div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-8dcaf10" data-id="8dcaf10" data-element_type="column"> <div class="elementor-widget-wrap elementor-element-populated"> <div class="elementor-element elementor-element-9d58bc3 elementor-widget elementor-widget-text-editor" data-id="9d58bc3" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p><a href="https://microbe-investigations.com/">Home</a> >> USP 61</p> </div> </div> </div> </div> </div> </section> <section class="elementor-section elementor-top-section elementor-element elementor-element-c1d49af elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="c1d49af" data-element_type="section"> <div class="elementor-container elementor-column-gap-default"> <div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-4747e94" data-id="4747e94" data-element_type="column"> <div class="elementor-widget-wrap elementor-element-populated"> <div class="elementor-element elementor-element-6fe7cdd elementor-widget elementor-widget-text-editor" data-id="6fe7cdd" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <h2 style="text-align: center;"><b>Introduction to USP 61 Microbial Enumeration Test</b></h2> </div> </div> </div> </div> </div> </section> <section class="elementor-section elementor-top-section elementor-element elementor-element-02974e5 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="02974e5" data-element_type="section"> <div class="elementor-container elementor-column-gap-default"> <div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-06e310d" data-id="06e310d" data-element_type="column"> <div class="elementor-widget-wrap elementor-element-populated"> <div class="elementor-element elementor-element-6b61c62 elementor-widget elementor-widget-text-editor" data-id="6b61c62" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p><span style="font-weight: 400;">The United States Pharmacopeia (USP) 61 Microbial Enumeration Test is a quality test to check the presence and quantity of micro-organisms in non-sterile products including pharmaceuticals, cosmetics and in raw materials. USP 61 is also referred to as the ‘Microbial bioburden test’, ‘Microbial Limits Test’ or ‘Microbial enumeration test.’ The test is a standard method used to assess microbial load with potential risks to ensure conformity with regulations.</span></p><p><span style="font-weight: 400;">The microbial enumeration test determines total aerobic microbial count (TAMC) and total yeast mold count (TYMC) in the test sample.</span></p><h2><b>Importance of USP 61 Microbial Enumeration Test</b></h2> </div> </div> </div> </div> </div> </section> <section class="elementor-section elementor-top-section elementor-element elementor-element-7ca1232 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="7ca1232" data-element_type="section"> <div class="elementor-container elementor-column-gap-default"> <div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-cae633b" data-id="cae633b" data-element_type="column"> <div class="elementor-widget-wrap elementor-element-populated"> <div class="elementor-element elementor-element-1f4d915 elementor-widget elementor-widget-text-editor" data-id="1f4d915" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <ul><li><p><span style="font-weight: 400;">Microbial enumeration tests are highly essential for pharmaceuticals and cosmetics products that come into contact with the human body. Excessive number of microbes in these products can lead to infections or spoilage and pose various health risks. Therefore, periodic testing of these products keeps microbial contamination under control, significantly reducing the risk of infections from using contaminated products. Testing also ensures that the products comply with the necessary regulatory requirements, hence, reducing possible legal penalties from the sale of contaminated products.</span></p></li></ul> </div> </div> </div> </div> </div> </section> <section class="elementor-section elementor-top-section elementor-element elementor-element-b84c9c6 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="b84c9c6" data-element_type="section" data-settings="{"background_background":"classic"}"> <div class="elementor-container elementor-column-gap-default"> <div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-e9104d8" data-id="e9104d8" data-element_type="column" data-settings="{"background_background":"classic"}"> <div class="elementor-widget-wrap elementor-element-populated"> <div class="elementor-element elementor-element-8d9de1b elementor-widget elementor-widget-text-editor" data-id="8d9de1b" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <div class="uncode_text_column"><p>Organisms typically used in this method: <strong><a href="https://www.microbe-investigations.com/antibacterial-strains/#st"><em><span class="underline-on-hover">Staphylococcus aureus</span></em> (ATCC 6538P)</a>, </strong><strong><a href="https://www.microbe-investigations.com/antibacterial-strains/#kl"><em><span class="underline-on-hover">Klebsiella pneumoniae</span></em> (ATCC 4352), </a></strong><strong><a href="https://www.microbe-investigations.com/antibacterial-strains/#ec"><em><span class="underline-on-hover">Escherichia coli</span></em> (ATCC 8739), </a><a href="https://microbe-investigations.com/antibacterial-strains/"><i>Pseudomonas aeruginosa (<strong>ATCC 15442</strong>), Enterococcus hirae <strong>(ATCC 10541)</strong>, MRSA (ATCC 33591), Salmonella entercia <strong>(ATCC 10708)</strong>, Candida Albicans <strong>(MTCC 3017)</strong></i></a></strong></p></div> </div> </div> </div> </div> </div> </section> <section class="elementor-section elementor-top-section elementor-element elementor-element-4a60329 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="4a60329" data-element_type="section"> <div class="elementor-container elementor-column-gap-default"> <div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-0dae97a" data-id="0dae97a" data-element_type="column"> <div class="elementor-widget-wrap elementor-element-populated"> <div class="elementor-element elementor-element-2a4dba2 elementor-widget elementor-widget-image" data-id="2a4dba2" data-element_type="widget" data-widget_type="image.default"> <div class="elementor-widget-container"> <img fetchpriority="high" decoding="async" width="2116" height="1344" src="https://microbe-investigations.com/wp-content/uploads/2023/06/USP-61.png" class="attachment-full size-full wp-image-10613" alt="USP 61 - Microbial Enumeration Test" srcset="https://microbe-investigations.com/wp-content/uploads/2023/06/USP-61.png 2116w, https://microbe-investigations.com/wp-content/uploads/2023/06/USP-61-300x191.png 300w, https://microbe-investigations.com/wp-content/uploads/2023/06/USP-61-1024x650.png 1024w, https://microbe-investigations.com/wp-content/uploads/2023/06/USP-61-768x488.png 768w, https://microbe-investigations.com/wp-content/uploads/2023/06/USP-61-1536x976.png 1536w, https://microbe-investigations.com/wp-content/uploads/2023/06/USP-61-2048x1301.png 2048w" sizes="(max-width: 2116px) 100vw, 2116px" /> </div> </div> </div> </div> </div> </section> <section class="elementor-section elementor-top-section elementor-element elementor-element-7161734 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="7161734" data-element_type="section"> <div class="elementor-container elementor-column-gap-default"> <div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-379e873" data-id="379e873" data-element_type="column"> <div class="elementor-widget-wrap elementor-element-populated"> <div class="elementor-element elementor-element-c45209e elementor-widget elementor-widget-text-editor" data-id="c45209e" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <h2><b>Test Requirements for USP 61 Testing </b></h2><p><span style="font-weight: 400;">The test requirements for microbial enumeration test are:</span></p><ol><li style="font-weight: 400;" aria-level="1"><span style="font-weight: 400;">A 1:10 dilution of the sample must be prepared using suitable buffers.</span></li><li style="font-weight: 400;" aria-level="1"><span style="font-weight: 400;">No more than 100 CFU of microbial strain must be added to the sample, ensuring inoculation volume is less than 1%.</span></li><li style="font-weight: 400;" aria-level="1"><span style="font-weight: 400;">Media should be verified to support microbial growth using growth promotion tests.</span></li><li style="font-weight: 400;" aria-level="1"><span style="font-weight: 400;">If the sample shows antimicrobial activity, antimicrobial agents must be neutralized with neutralizing agents to avoid interference with microbial counts.</span></li><li style="font-weight: 400;" aria-level="1"><span style="font-weight: 400;">Appropriate test methods must be used (membrane filtration or plate count method) to test the sample. The choice of the test method depends on the nature of the product and the required microbial limit.</span></li><li style="font-weight: 400;" aria-level="1"><span style="font-weight: 400;">Appropriate test methods must be used to test the sample (membrane filtration or plate count method). The choice of method depends on the nature of the product and the required microbial limit.</span></li><li style="font-weight: 400;" aria-level="1"><span style="font-weight: 400;">Bacterial samples should be incubated at 30–35°C whereas fungal samples should be incubated at 20–25°C.</span></li><li style="font-weight: 400;" aria-level="1"><span style="font-weight: 400;">Negative controls should be carried out to ensure that there is no external contamination.</span></li></ol> </div> </div> </div> </div> </div> </section> <section class="elementor-section elementor-top-section elementor-element elementor-element-4d79efb elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="4d79efb" data-element_type="section"> <div class="elementor-container elementor-column-gap-default"> <div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-0104dbf" data-id="0104dbf" data-element_type="column"> <div class="elementor-widget-wrap elementor-element-populated"> <div class="elementor-element elementor-element-e0fc0a4 elementor-widget elementor-widget-text-editor" data-id="e0fc0a4" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <h2><b>Products tested at MIS using USP 61 Testing </b></h2><p><span style="font-weight: 400;">The standard applies to nonsterile pharmaceutical products, cosmetics, nutraceuticals, and certain medical devices. The most commonly tested products include oral drugs, topical creams, lotions, and raw materials, among others.</span></p> </div> </div> </div> </div> </div> </section> <section class="elementor-section elementor-top-section elementor-element elementor-element-7880734 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="7880734" data-element_type="section"> <div class="elementor-container elementor-column-gap-default"> <div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-b05b62a" data-id="b05b62a" data-element_type="column"> <div class="elementor-widget-wrap elementor-element-populated"> <div class="elementor-element elementor-element-c64c0a1 elementor-widget elementor-widget-text-editor" data-id="c64c0a1" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <h2><b>USP 61 Microbial Enumeration Test Method Explained</b></h2><ul><li style="font-weight: 400;" aria-level="1"><span style="font-weight: 400;">Test samples are inoculated on Soybean-Casein Digest Agar for the Total Aerobic Microbial Count (TAMC) and on Sabouraud Dextrose Agar for the Total Yeast and Mold Count (TYMC).</span></li><li style="font-weight: 400;" aria-level="1"><span style="font-weight: 400;">Test samples suspected to contain antimicrobial agents which might interact with the test outcome must be subjected to neutralization and dilution techniques to ensure that the product’s antimicrobial agents will not suppress the growth of suspected microorganisms in samples.</span></li><li style="font-weight: 400;" aria-level="1"><span style="font-weight: 400;">Test organisms used in neutralization and dilution tests are </span><i><span style="font-weight: 400;">Pseudomonas aeruginosa</span></i><span style="font-weight: 400;"> (ATCC 15442), </span><i><span style="font-weight: 400;">Escherichia coli</span></i><span style="font-weight: 400;"> (ATCC 8739), </span><i><span style="font-weight: 400;">Staphylococcus aureus </span></i><span style="font-weight: 400;">(ATCC 6538P), </span><i><span style="font-weight: 400;">Enterococcus hirae </span></i><span style="font-weight: 400;">(ATCC 10541), </span><i><span style="font-weight: 400;">Klebsiella pneumoniae</span></i><span style="font-weight: 400;"> (ATCC 4352), MRSA (ATCC 33591), </span><i><span style="font-weight: 400;">Salmonella enterica</span></i><span style="font-weight: 400;"> (ATCC 10708), </span><i><span style="font-weight: 400;">Candida albicans</span></i><span style="font-weight: 400;"> (MTCC 3017).</span></li><li style="font-weight: 400;" aria-level="1"><span style="font-weight: 400;">After a specified incubation period, microbial enumeration can be done using either plate count or membrane filtration test method.</span></li></ul> </div> </div> </div> </div> </div> </section> <section class="elementor-section elementor-top-section elementor-element elementor-element-02e4bf8 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="02e4bf8" data-element_type="section"> <div class="elementor-container elementor-column-gap-default"> <div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-335c4fe" data-id="335c4fe" data-element_type="column"> <div class="elementor-widget-wrap elementor-element-populated"> <div class="elementor-element elementor-element-ff561d1 elementor-widget elementor-widget-text-editor" data-id="ff561d1" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <h2><b>Suitable Method for USP 61 Microbial Enumeration Test</b></h2><h2><b> </b></h2><p><span style="font-weight: 400;">Suitability testing checks if the chosen microbial enumeration method will recover microorganisms in the presence of the test product. This is done by testing if the product being examined has any inhibitory activity against the microorganisms being recovered. Should the product possess antimicrobial activity, inactivators or neutralizers are added to eliminate or neutralize such effects. </span></p> </div> </div> </div> </div> </div> </section> <section class="elementor-section elementor-top-section elementor-element elementor-element-b2ff921 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="b2ff921" data-element_type="section"> <div class="elementor-container elementor-column-gap-default"> <div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-1cbddea" data-id="1cbddea" data-element_type="column"> <div class="elementor-widget-wrap elementor-element-populated"> <div class="elementor-element elementor-element-cd8cf24 elementor-widget elementor-widget-text-editor" data-id="cd8cf24" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <h2><b>Interpretation of USP 61 Microbial Enumeration Test Results</b></h2><p> </p><ol><li style="font-weight: 400;" aria-level="1"><b>Total Aerobic Microbial Count (TAMC) </b><span style="font-weight: 400;">is expressed as CFU which is equivalent to the number of colonies on Soybean-Casein Digest Agar. In addition, the presence of fungal colonies on the Soybean-Casein Digest Agar shall also be counted in the TAMC.</span></li><li style="font-weight: 400;" aria-level="1"><b>Total Yeast and Mold Count (TYMC) </b><span style="font-weight: 400;">is equivalent to the number of colonies (CFU) found on the Sabouraud Dextrose Agar. Any colonies of bacteria count toward TYMC.</span></li></ol> </div> </div> </div> </div> </div> </section> <section class="elementor-section elementor-top-section elementor-element elementor-element-fce9eb8 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="fce9eb8" data-element_type="section"> <div class="elementor-container elementor-column-gap-default"> <div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-500cf2c" data-id="500cf2c" data-element_type="column"> <div class="elementor-widget-wrap elementor-element-populated"> <div class="elementor-element elementor-element-4fdafbb elementor-widget elementor-widget-text-editor" data-id="4fdafbb" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <h2><b>Acceptable guidelines for USP 61 Microbial Enumeration Test</b></h2><p> </p><p><span style="font-weight: 400;">Non-sterile products are not required to be absolutely microorganism-free. However, it is important to ensure that these products do not harbor any harmful pathogens. This is particularly important for products applied to sensitive parts such as the eyes or the mucus membrane. The acceptable limits of microbial count as per USP standards are: </span></p><ul><li style="font-weight: 400;" aria-level="1"><span style="font-weight: 400;">For products designed for infants, used under the eye area or mucous membranes: <200 CFU/ml or 10</span><span style="font-weight: 400;">2 </span><span style="font-weight: 400;">CFU/ml</span></li><li style="font-weight: 400;" aria-level="1"><span style="font-weight: 400;">For other products: <2000 CFU/ml or 10</span><span style="font-weight: 400;">3 </span><span style="font-weight: 400;">CFU/ml</span></li></ul> </div> </div> </div> </div> </div> </section> <section class="elementor-section elementor-top-section elementor-element elementor-element-7e3ed7e elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="7e3ed7e" data-element_type="section"> <div class="elementor-container elementor-column-gap-default"> <div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-5aa2e8d" data-id="5aa2e8d" data-element_type="column"> <div class="elementor-widget-wrap elementor-element-populated"> <div class="elementor-element elementor-element-964ad3c elementor-widget elementor-widget-text-editor" data-id="964ad3c" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <h2><b>Frequency of Conducting USP 61 Microbial Enumeration Testing</b><span style="font-weight: 400;"> </span></h2><p> </p><p><span style="font-weight: 400;">Testing frequency will vary with the product and stage of production. In the case of finished products, the test can be done on a batch basis before releasing it to the market so that the product meets the quality requirement. In the case of raw materials, testing may be required for every new lot or at regular intervals, depending on the criticality of the materials.</span></p> </div> </div> </div> </div> </div> </section> <section class="elementor-section elementor-top-section elementor-element elementor-element-f04e6e9 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="f04e6e9" data-element_type="section"> <div class="elementor-container elementor-column-gap-default"> <div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-c56bb94" data-id="c56bb94" data-element_type="column"> <div class="elementor-widget-wrap elementor-element-populated"> <div class="elementor-element elementor-element-2d2f2ad elementor-widget elementor-widget-text-editor" data-id="2d2f2ad" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <h2><b>Benefits of USP 61 Microbial Enumeration Test</b></h2><p><br /><b></b></p><ul><li aria-level="1"><b>Regulatory compliance</b></li></ul><p style="padding-left: 40px;"><span style="font-weight: 400;">This test enables manufacturers to meet the highest health standards provided by regulatory bodies like the FDA and EMA. </span></p><ul><li aria-level="1"><b>Market access</b></li></ul><p style="padding-left: 40px;"><span style="font-weight: 400;">Adherence to this standard is mandatory to get approval for the sale of pharmaceuticals, cosmetics, and other non-sterile products.</span></p><ul><li aria-level="1"><b>Quality control</b></li></ul><p style="padding-left: 40px;"><span style="font-weight: 400;">The test is used as an indicator of quality assurance to help manufacturers ensure that the microbial quality of their products is checked and regulated at every stage of its processing. </span></p><ul><li aria-level="1"><b>Prevention of spoilage</b></li></ul><p style="padding-left: 40px;"><span style="font-weight: 400;">Testing assists in identifying the microbial contaminants that may lead to spoilage, thus allowing manufacturers to take appropriate preventive measures.</span></p><ul><li aria-level="1"><b>Broad applicability</b></li></ul><p style="padding-left: 40px;"><span style="font-weight: 400;">The test is applicable to nonsterile products, making it a flexible method that can be used for assessing a wide range of products. </span></p><ul><li aria-level="1"><b>Consumer confidence</b></li></ul><p style="padding-left: 40px;"><span style="font-weight: 400;">Products that comply with this standard can enhance the brand’s reputation and consumer trustworthiness.</span></p> </div> </div> </div> </div> </div> </section> <section class="elementor-section elementor-top-section elementor-element elementor-element-4c1ff9a elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="4c1ff9a" data-element_type="section"> <div class="elementor-container elementor-column-gap-default"> <div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-f40f981" data-id="f40f981" data-element_type="column"> <div class="elementor-widget-wrap elementor-element-populated"> <div class="elementor-element elementor-element-09e33b9 elementor-widget elementor-widget-text-editor" data-id="09e33b9" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <h2><b>Applications of USP 61 Microbial Enumeration Test</b></h2><p> </p><h3><b>Pharmaceuticals</b></h3><p> </p><ul><li style="font-weight: 400;" aria-level="1"><span style="font-weight: 400;">Ensuring the microbiological quality of non-sterile pharmaceutical products, including tablets, capsules, syrups, and topical medications.</span></li><li style="font-weight: 400;" aria-level="1"><span style="font-weight: 400;">Testing raw materials and excipients used in drug formulation to ensure they meet microbiological standards.</span></li></ul><h3><b>Cosmetics</b></h3><p> </p><ul><li style="font-weight: 400;" aria-level="1"><span style="font-weight: 400;">Evaluating the microbial load in cosmetic products including creams, lotions, shampoos, and makeup.</span></li><li style="font-weight: 400;" aria-level="1"><span style="font-weight: 400;">Testing for microbial contamination in raw materials used in cosmetic formulations.</span></li></ul><h3><b>Personal care products</b></h3><p> </p><ul><li style="font-weight: 400;" aria-level="1"><span style="font-weight: 400;">Assessing the microbiological quality of personal care products such as soaps, deodorants, and toothpaste.</span></li><li style="font-weight: 400;" aria-level="1"><span style="font-weight: 400;">Ensuring that products intended for personal hygiene do not contain harmful levels of microorganisms.</span></li></ul><h3><b>Food and beverages</b></h3><p> </p><ul><li style="font-weight: 400;" aria-level="1"><span style="font-weight: 400;">Testing non-sterile food products and beverages for microbial contamination to ensure they are safe for consumption.</span></li><li style="font-weight: 400;" aria-level="1"><span style="font-weight: 400;">Monitoring the microbiological quality of ingredients and packaging materials used in the food industry.</span></li></ul><h3><b>Nutritional supplements</b></h3><p> </p><ul><li style="font-weight: 400;" aria-level="1"><span style="font-weight: 400;">Ensuring the microbiological safety of dietary supplements including vitamins, minerals, and herbal products.</span></li><li style="font-weight: 400;" aria-level="1"><span style="font-weight: 400;">Testing raw materials and finished products for microbial contamination.</span></li></ul><h3><b>Medical devices</b></h3><p> </p><ul><li style="font-weight: 400;" aria-level="1"><span style="font-weight: 400;">Evaluating the bioburden on non-sterile medical devices and components prior to sterilization.</span></li><li style="font-weight: 400;" aria-level="1"><span style="font-weight: 400;">Ensuring that medical devices meet microbiological quality standards to prevent infections in patients.</span></li></ul><h3><b>Biopharmaceuticals</b></h3><p> </p><ul><li style="font-weight: 400;" aria-level="1"><span style="font-weight: 400;">Testing biologically derived products such as vaccines, cell cultures, and tissue engineering products for microbial contamination.</span></li><li style="font-weight: 400;" aria-level="1"><span style="font-weight: 400;">Ensuring the microbiological quality of biopharmaceutical raw materials and intermediates.</span></li></ul><h3><b>Veterinary products</b></h3><p> </p><ul><li style="font-weight: 400;" aria-level="1"><span style="font-weight: 400;">Assessing the microbiological quality of nonsterile veterinary products including medications, supplements, and care products for animals.</span></li><li style="font-weight: 400;" aria-level="1"><span style="font-weight: 400;">Ensuring that veterinary products are free from harmful microbial contamination.</span></li></ul><h3><b>Water testing</b></h3><p> </p><ul><li style="font-weight: 400;" aria-level="1"><span style="font-weight: 400;">Monitoring the microbiological quality of water used in pharmaceutical and cosmetic manufacturing processes.</span></li><li style="font-weight: 400;" aria-level="1"><span style="font-weight: 400;">Ensuring that water used in product formulations meets microbiological safety standards.</span></li></ul><h3><b>Household products</b></h3><p> </p><ul><li style="font-weight: 400;" aria-level="1"><span style="font-weight: 400;">Testing household cleaning products, detergents, and disinfectants for microbial contamination.</span></li><li style="font-weight: 400;" aria-level="1"><span style="font-weight: 400;">Ensuring that these products are safe for use in homes and do not harbor harmful microorganisms.</span></li></ul><h3><b>Packaging materials</b></h3><p> </p><ul><li style="font-weight: 400;" aria-level="1"><span style="font-weight: 400;">Assessing the microbiological quality of packaging materials used for pharmaceuticals, cosmetics, and food products.</span></li><li style="font-weight: 400;" aria-level="1"><span style="font-weight: 400;">Ensuring that packaging materials do not introduce microbial contamination to the products they contain.</span></li></ul><h3><b>Research and development</b></h3><p> </p><ul><li style="font-weight: 400;" aria-level="1"><span style="font-weight: 400;">Conducting microbiological testing during the development of new pharmaceutical and cosmetic products.</span></li><li style="font-weight: 400;" aria-level="1"><span style="font-weight: 400;">Evaluating the effectiveness of preservatives and antimicrobial agents in product formulations.</span></li></ul><p><span style="font-weight: 400;">Microbe Investigations Switzerland has incorporated fully equipped bio-suites and analytical facilities for microbial enumeration tests. We also perform </span><a href="https://microbe-investigations.com/usp-60-test-for-burkholderia-cepacia-complex/"><span style="font-weight: 400;">USP 60</span></a><span style="font-weight: 400;"> and </span><a href="https://microbe-investigations.com/usp-62-test/"><span style="font-weight: 400;">USP 62 </span></a><span style="font-weight: 400;">tests to assess the growth of specific microorganisms in non-sterile products. Our experts understand the client’s needs and expectations first and take complete responsibility to provide reliable and accurate results. </span></p><p><a href="https://microbe-investigations.com/consult-an-expert/"><span style="font-weight: 400;">Contact our experts</span></a><span style="font-weight: 400;"> now to discuss your Microbial enumeration test requirements and other related antimicrobial tests. </span></p> </div> </div> </div> </div> </div> </section> <section class="elementor-section elementor-top-section elementor-element elementor-element-f0bad04 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="f0bad04" data-element_type="section"> <div class="elementor-container elementor-column-gap-default"> <div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-958593f" data-id="958593f" data-element_type="column"> <div class="elementor-widget-wrap elementor-element-populated"> <div class="elementor-element elementor-element-8e3ae96 elementor-widget-divider--view-line elementor-widget elementor-widget-divider" data-id="8e3ae96" data-element_type="widget" data-widget_type="divider.default"> <div class="elementor-widget-container"> <div class="elementor-divider"> <span class="elementor-divider-separator"> </span> </div> </div> </div> </div> </div> </div> </section> <section class="elementor-section elementor-top-section elementor-element elementor-element-60cbf5a elementor-section-content-middle elementor-hidden-tablet elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="60cbf5a" data-element_type="section"> <div class="elementor-container elementor-column-gap-default"> <div class="elementor-column elementor-col-33 elementor-top-column elementor-element elementor-element-ffc3f27" data-id="ffc3f27" data-element_type="column"> <div class="elementor-widget-wrap elementor-element-populated"> <div class="elementor-element 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elementor-element-d66e44c elementor-widget elementor-widget-image" data-id="d66e44c" data-element_type="widget" data-widget_type="image.default"> <div class="elementor-widget-container"> <img loading="lazy" decoding="async" width="389" height="389" src="https://microbe-investigations.com/wp-content/uploads/2023/02/2-1.png" class="attachment-full size-full wp-image-8986" alt="" srcset="https://microbe-investigations.com/wp-content/uploads/2023/02/2-1.png 389w, https://microbe-investigations.com/wp-content/uploads/2023/02/2-1-300x300.png 300w, https://microbe-investigations.com/wp-content/uploads/2023/02/2-1-150x150.png 150w" sizes="(max-width: 389px) 100vw, 389px" /> </div> </div> </div> </div> </div> </section> <section class="elementor-section elementor-top-section elementor-element elementor-element-72254d7 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="72254d7" data-element_type="section"> <div class="elementor-container elementor-column-gap-default"> <div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-16f2582" data-id="16f2582" data-element_type="column"> <div class="elementor-widget-wrap elementor-element-populated"> <div class="elementor-element elementor-element-210e088 elementor-widget-divider--view-line elementor-widget elementor-widget-divider" data-id="210e088" data-element_type="widget" data-widget_type="divider.default"> <div class="elementor-widget-container"> <div class="elementor-divider"> <span class="elementor-divider-separator"> </span> </div> </div> </div> </div> </div> </div> </section> <section class="elementor-section elementor-top-section elementor-element elementor-element-722b721 elementor-reverse-mobile elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="722b721" data-element_type="section"> <div class="elementor-container elementor-column-gap-default"> <div class="elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-1077692" data-id="1077692" data-element_type="column"> <div class="elementor-widget-wrap elementor-element-populated"> <div class="elementor-element elementor-element-197a3cf elementor-widget elementor-widget-heading" data-id="197a3cf" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <h4 class="elementor-heading-title elementor-size-default">FAQs</h4> </div> </div> <div class="elementor-element elementor-element-ae2b454 elementor-widget elementor-widget-accordion" data-id="ae2b454" data-element_type="widget" data-widget_type="accordion.default"> <div class="elementor-widget-container"> <div class="elementor-accordion"> <div class="elementor-accordion-item"> <div id="elementor-tab-title-1821" class="elementor-tab-title" data-tab="1" role="button" aria-controls="elementor-tab-content-1821" aria-expanded="false"> <span class="elementor-accordion-icon elementor-accordion-icon-right" aria-hidden="true"> <span class="elementor-accordion-icon-closed"><i class="fas fa-plus"></i></span> <span class="elementor-accordion-icon-opened"><i class="fas fa-minus"></i></span> </span> <a class="elementor-accordion-title" tabindex="0">What is the USP 61 test?</a> </div> <div id="elementor-tab-content-1821" class="elementor-tab-content elementor-clearfix" data-tab="1" role="region" aria-labelledby="elementor-tab-title-1821"><p>This test, also known as the Microbial Enumeration Test, determines the Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) in non–sterile product samples.</p></div> </div> <div class="elementor-accordion-item"> <div id="elementor-tab-title-1822" class="elementor-tab-title" data-tab="2" role="button" aria-controls="elementor-tab-content-1822" aria-expanded="false"> <span class="elementor-accordion-icon elementor-accordion-icon-right" aria-hidden="true"> <span class="elementor-accordion-icon-closed"><i class="fas fa-plus"></i></span> <span class="elementor-accordion-icon-opened"><i class="fas fa-minus"></i></span> </span> <a class="elementor-accordion-title" tabindex="0">What are the products that can be tested using this test?</a> </div> <div id="elementor-tab-content-1822" class="elementor-tab-content elementor-clearfix" data-tab="2" role="region" aria-labelledby="elementor-tab-title-1822"><p>The test is applicable to Cosmetics and Personal care products.</p></div> </div> <div class="elementor-accordion-item"> <div id="elementor-tab-title-1823" class="elementor-tab-title" data-tab="3" role="button" aria-controls="elementor-tab-content-1823" aria-expanded="false"> <span class="elementor-accordion-icon elementor-accordion-icon-right" aria-hidden="true"> <span class="elementor-accordion-icon-closed"><i class="fas fa-plus"></i></span> <span class="elementor-accordion-icon-opened"><i class="fas fa-minus"></i></span> </span> <a class="elementor-accordion-title" tabindex="0">What is the turnaround time for the USP 61 test?</a> </div> <div id="elementor-tab-content-1823" class="elementor-tab-content elementor-clearfix" data-tab="3" role="region" aria-labelledby="elementor-tab-title-1823"><p>The test takes 5 to 6 days to complete.</p></div> </div> <div class="elementor-accordion-item"> <div id="elementor-tab-title-1824" class="elementor-tab-title" data-tab="4" role="button" aria-controls="elementor-tab-content-1824" aria-expanded="false"> <span class="elementor-accordion-icon elementor-accordion-icon-right" aria-hidden="true"> <span class="elementor-accordion-icon-closed"><i class="fas fa-plus"></i></span> <span class="elementor-accordion-icon-opened"><i class="fas fa-minus"></i></span> </span> <a class="elementor-accordion-title" tabindex="0">How many microbial strains can be tested using USP 61 test methods?</a> </div> <div id="elementor-tab-content-1824" class="elementor-tab-content elementor-clearfix" data-tab="4" role="region" aria-labelledby="elementor-tab-title-1824"><p><span style="font-weight: 400;">We perform the test using the following microbial strains: </span><i><span style="font-weight: 400;">Pseudomonas aeruginosa </span></i><span style="font-weight: 400;">(ATCC 15442),</span><i><span style="font-weight: 400;"> Escherichia coli </span></i><span style="font-weight: 400;">(ATCC 8739), </span><i><span style="font-weight: 400;">Staphylococcus aureus</span></i><span style="font-weight: 400;"> (ATCC 6538P), </span><i><span style="font-weight: 400;">Enterococcus hirae </span></i><span style="font-weight: 400;">(ATCC 10541),</span><i><span style="font-weight: 400;"> Klebsiella pneumoniae </span></i><span style="font-weight: 400;">(ATCC 4352), MRSA (ATCC 33591), </span><i><span style="font-weight: 400;">Salmonella enterica </span></i><span style="font-weight: 400;">( ATCC 10708), </span><i><span style="font-weight: 400;">Candida Albicans </span></i><span style="font-weight: 400;">(MTCC 3017). Additional strains can be added on request.</span></p></div> </div> <div class="elementor-accordion-item"> <div id="elementor-tab-title-1825" class="elementor-tab-title" data-tab="5" role="button" aria-controls="elementor-tab-content-1825" aria-expanded="false"> <span class="elementor-accordion-icon elementor-accordion-icon-right" aria-hidden="true"> <span class="elementor-accordion-icon-closed"><i class="fas fa-plus"></i></span> <span class="elementor-accordion-icon-opened"><i class="fas fa-minus"></i></span> </span> <a class="elementor-accordion-title" tabindex="0">What are the acceptance criteria for microbial counts in USP 61 testing?</a> </div> <div id="elementor-tab-content-1825" class="elementor-tab-content elementor-clearfix" data-tab="5" role="region" aria-labelledby="elementor-tab-title-1825"><p>The acceptance criteria is TAMC of 100-1000 cfu/ml and TYMC of 10-100 cfu/ml.</p></div> </div> <div class="elementor-accordion-item"> <div id="elementor-tab-title-1826" class="elementor-tab-title" data-tab="6" role="button" aria-controls="elementor-tab-content-1826" aria-expanded="false"> <span class="elementor-accordion-icon elementor-accordion-icon-right" aria-hidden="true"> <span class="elementor-accordion-icon-closed"><i class="fas fa-plus"></i></span> <span class="elementor-accordion-icon-opened"><i class="fas fa-minus"></i></span> </span> <a class="elementor-accordion-title" tabindex="0">What methods are used for microbial enumeration in USP 61 testing?</a> </div> <div id="elementor-tab-content-1826" class="elementor-tab-content elementor-clearfix" data-tab="6" role="region" aria-labelledby="elementor-tab-title-1826"><p>The primary methods include Membrane Filtration, Plate-Count Methods (Pour-Plate and Surface-Spread Methods), and the Most-Probable-Number (MPN) Method.</p></div> </div> <div class="elementor-accordion-item"> <div id="elementor-tab-title-1827" class="elementor-tab-title" data-tab="7" role="button" aria-controls="elementor-tab-content-1827" aria-expanded="false"> <span class="elementor-accordion-icon elementor-accordion-icon-right" aria-hidden="true"> <span class="elementor-accordion-icon-closed"><i class="fas fa-plus"></i></span> <span class="elementor-accordion-icon-opened"><i class="fas fa-minus"></i></span> </span> <a class="elementor-accordion-title" tabindex="0">Why is microbiological examination of nonsterile products important?</a> </div> <div id="elementor-tab-content-1827" class="elementor-tab-content elementor-clearfix" data-tab="7" role="region" aria-labelledby="elementor-tab-title-1827"><p>It ensures that the products meet established specifications for microbiological quality, safeguarding consumer health by preventing contamination.</p></div> </div> <div class="elementor-accordion-item"> <div id="elementor-tab-title-1828" class="elementor-tab-title" data-tab="8" role="button" aria-controls="elementor-tab-content-1828" aria-expanded="false"> <span class="elementor-accordion-icon elementor-accordion-icon-right" aria-hidden="true"> <span class="elementor-accordion-icon-closed"><i class="fas fa-plus"></i></span> <span class="elementor-accordion-icon-opened"><i class="fas fa-minus"></i></span> </span> <a class="elementor-accordion-title" tabindex="0">What is the enumeration test?</a> </div> <div id="elementor-tab-content-1828" class="elementor-tab-content elementor-clearfix" data-tab="8" role="region" aria-labelledby="elementor-tab-title-1828"><p>The enumeration test is a quantitative method used to determine the number of viable microorganisms present in a sample. This test is crucial for ensuring the microbiological quality of non-sterile products, including pharmaceuticals, cosmetics, personal care products, and medical devices.</p></div> </div> <div class="elementor-accordion-item"> <div id="elementor-tab-title-1829" class="elementor-tab-title" data-tab="9" role="button" aria-controls="elementor-tab-content-1829" aria-expanded="false"> <span class="elementor-accordion-icon elementor-accordion-icon-right" aria-hidden="true"> <span class="elementor-accordion-icon-closed"><i class="fas fa-plus"></i></span> <span class="elementor-accordion-icon-opened"><i class="fas fa-minus"></i></span> </span> <a class="elementor-accordion-title" tabindex="0">What is the total aerobic microbial count?</a> </div> <div id="elementor-tab-content-1829" class="elementor-tab-content elementor-clearfix" data-tab="9" role="region" aria-labelledby="elementor-tab-title-1829"><p>The Total Aerobic Microbial Count (TAMC) is a microbiological test used to quantify the number of viable aerobic bacteria present in a sample. This test is an essential part of quality control for non-sterile pharmaceutical products, cosmetics, personal care products, and other items that must adhere to specific microbiological safety standards.</p></div> </div> <div class="elementor-accordion-item"> <div id="elementor-tab-title-18210" class="elementor-tab-title" data-tab="10" role="button" aria-controls="elementor-tab-content-18210" aria-expanded="false"> <span class="elementor-accordion-icon elementor-accordion-icon-right" aria-hidden="true"> <span class="elementor-accordion-icon-closed"><i class="fas fa-plus"></i></span> <span class="elementor-accordion-icon-opened"><i class="fas fa-minus"></i></span> </span> <a class="elementor-accordion-title" tabindex="0">What is the microbial limit test?</a> </div> <div id="elementor-tab-content-18210" class="elementor-tab-content elementor-clearfix" data-tab="10" role="region" aria-labelledby="elementor-tab-title-18210"><p>The Microbial Limit Test (MLT) is a set of procedures used to assess the microbiological quality of non-sterile pharmaceutical products, cosmetics, and personal care items. It determines whether a product meets predefined microbiological criteria to ensure safety and quality for consumers.</p></div> </div> <div class="elementor-accordion-item"> <div id="elementor-tab-title-18211" class="elementor-tab-title" data-tab="11" role="button" aria-controls="elementor-tab-content-18211" aria-expanded="false"> <span class="elementor-accordion-icon elementor-accordion-icon-right" aria-hidden="true"> <span class="elementor-accordion-icon-closed"><i class="fas fa-plus"></i></span> <span class="elementor-accordion-icon-opened"><i class="fas fa-minus"></i></span> </span> <a class="elementor-accordion-title" tabindex="0">What is the microbial count?</a> </div> <div id="elementor-tab-content-18211" class="elementor-tab-content elementor-clearfix" data-tab="11" role="region" aria-labelledby="elementor-tab-title-18211"><p>Microbial count, also known as microbial enumeration, is a method used to determine the number of microorganisms (such as bacteria, yeasts, and molds) present in a sample. This measurement is crucial in various industries, including pharmaceuticals, food and beverages, cosmetics, and water quality, to ensure product safety, quality, and compliance with regulatory standards.</p></div> </div> <div class="elementor-accordion-item"> <div id="elementor-tab-title-18212" class="elementor-tab-title" data-tab="12" role="button" aria-controls="elementor-tab-content-18212" aria-expanded="false"> <span class="elementor-accordion-icon elementor-accordion-icon-right" aria-hidden="true"> <span class="elementor-accordion-icon-closed"><i class="fas fa-plus"></i></span> <span class="elementor-accordion-icon-opened"><i class="fas fa-minus"></i></span> </span> <a class="elementor-accordion-title" tabindex="0">What is the bioburden test?</a> </div> <div id="elementor-tab-content-18212" class="elementor-tab-content elementor-clearfix" data-tab="12" role="region" aria-labelledby="elementor-tab-title-18212"><p>A bioburden test is a procedure used to determine the number and types of viable microorganisms present on a product or surface before it undergoes sterilization. This test is essential in various industries, including pharmaceuticals, medical devices, and food production, to ensure that products are safe and meet regulatory standards for microbial contamination.</p></div> </div> <div class="elementor-accordion-item"> <div id="elementor-tab-title-18213" class="elementor-tab-title" data-tab="13" role="button" aria-controls="elementor-tab-content-18213" aria-expanded="false"> <span class="elementor-accordion-icon elementor-accordion-icon-right" aria-hidden="true"> <span class="elementor-accordion-icon-closed"><i class="fas fa-plus"></i></span> <span class="elementor-accordion-icon-opened"><i class="fas fa-minus"></i></span> </span> <a class="elementor-accordion-title" tabindex="0">How long does bioburden testing take?</a> </div> <div id="elementor-tab-content-18213" class="elementor-tab-content elementor-clearfix" data-tab="13" role="region" aria-labelledby="elementor-tab-title-18213"><p>The duration of bioburden testing depends on the incubation periods required for different microorganisms. Typically, the incubation period for bacterial bioburden testing is 3 to 5 days at 30 to 35°C. For fungal bioburden testing, the incubation period is 10 to 14 days at 20 to 25°C. These periods allow sufficient time for the microorganisms to grow and be counted accurately.</p></div> </div> <div class="elementor-accordion-item"> <div id="elementor-tab-title-18214" class="elementor-tab-title" data-tab="14" role="button" aria-controls="elementor-tab-content-18214" aria-expanded="false"> <span class="elementor-accordion-icon elementor-accordion-icon-right" aria-hidden="true"> <span class="elementor-accordion-icon-closed"><i class="fas fa-plus"></i></span> <span class="elementor-accordion-icon-opened"><i class="fas fa-minus"></i></span> </span> <a class="elementor-accordion-title" tabindex="0">How are samples prepared for the microbial limits test?</a> </div> <div id="elementor-tab-content-18214" class="elementor-tab-content elementor-clearfix" data-tab="14" role="region" aria-labelledby="elementor-tab-title-18214"><p><span style="font-weight: 400;">Samples are prepared by aseptic dilution in a sterile diluent to provide low-concentration levels for the plating. This is necessary to avoid errors in counting microbial colonies.</span></p></div> </div> <div class="elementor-accordion-item"> <div id="elementor-tab-title-18215" class="elementor-tab-title" data-tab="15" role="button" aria-controls="elementor-tab-content-18215" aria-expanded="false"> <span class="elementor-accordion-icon elementor-accordion-icon-right" aria-hidden="true"> <span class="elementor-accordion-icon-closed"><i class="fas fa-plus"></i></span> <span class="elementor-accordion-icon-opened"><i class="fas fa-minus"></i></span> </span> <a class="elementor-accordion-title" tabindex="0">What happens if a product fails the microbial limits test?</a> </div> <div id="elementor-tab-content-18215" class="elementor-tab-content elementor-clearfix" data-tab="15" role="region" aria-labelledby="elementor-tab-title-18215"><p><span style="font-weight: 400;">In case a product fails the test, an investigation is done to identify the source of contamination. The product can either be reformulated or rejected depending on the results obtained.</span></p></div> </div> <div class="elementor-accordion-item"> <div id="elementor-tab-title-18216" class="elementor-tab-title" data-tab="16" role="button" aria-controls="elementor-tab-content-18216" aria-expanded="false"> <span class="elementor-accordion-icon elementor-accordion-icon-right" aria-hidden="true"> <span class="elementor-accordion-icon-closed"><i class="fas fa-plus"></i></span> <span class="elementor-accordion-icon-opened"><i class="fas fa-minus"></i></span> </span> <a class="elementor-accordion-title" tabindex="0">How does the microbial enumeration test ensure product safety for consumers?</a> </div> <div id="elementor-tab-content-18216" class="elementor-tab-content elementor-clearfix" data-tab="16" role="region" aria-labelledby="elementor-tab-title-18216"><p><span style="font-weight: 400;">The test ensures that the microbial levels are within the acceptable limits in non-sterile products thus reducing the possible adverse health effects like infections and allergic reactions.</span></p></div> </div> <div class="elementor-accordion-item"> <div id="elementor-tab-title-18217" class="elementor-tab-title" data-tab="17" role="button" aria-controls="elementor-tab-content-18217" aria-expanded="false"> <span class="elementor-accordion-icon elementor-accordion-icon-right" aria-hidden="true"> <span class="elementor-accordion-icon-closed"><i class="fas fa-plus"></i></span> <span class="elementor-accordion-icon-opened"><i class="fas fa-minus"></i></span> </span> <a class="elementor-accordion-title" tabindex="0">How can you minimize contamination during the microbial enumeration test process?</a> </div> <div id="elementor-tab-content-18217" class="elementor-tab-content elementor-clearfix" data-tab="17" role="region" aria-labelledby="elementor-tab-title-18217"><p><span style="font-weight: 400;">A controlled environment, working with sterile equipment, exercising good laboratory practices, and maintaining strict aseptic conditions can help reduce the possibility of contamination.</span></p></div> </div> <div class="elementor-accordion-item"> <div id="elementor-tab-title-18218" class="elementor-tab-title" data-tab="18" role="button" aria-controls="elementor-tab-content-18218" aria-expanded="false"> <span class="elementor-accordion-icon elementor-accordion-icon-right" aria-hidden="true"> <span class="elementor-accordion-icon-closed"><i class="fas fa-plus"></i></span> <span class="elementor-accordion-icon-opened"><i class="fas fa-minus"></i></span> </span> <a class="elementor-accordion-title" tabindex="0">What are the potential interferences that can affect the test results?</a> </div> <div id="elementor-tab-content-18218" class="elementor-tab-content elementor-clearfix" data-tab="18" role="region" aria-labelledby="elementor-tab-title-18218"><p><span style="font-weight: 400;">Sample ingredients that inhibit microbial growth, such as preservatives or poor sample preparation techniques, can give false positives for a microorganism’s presence.</span></p></div> </div> <div class="elementor-accordion-item"> <div id="elementor-tab-title-18219" class="elementor-tab-title" data-tab="19" role="button" aria-controls="elementor-tab-content-18219" aria-expanded="false"> <span class="elementor-accordion-icon elementor-accordion-icon-right" aria-hidden="true"> <span class="elementor-accordion-icon-closed"><i class="fas fa-plus"></i></span> <span class="elementor-accordion-icon-opened"><i class="fas fa-minus"></i></span> </span> <a class="elementor-accordion-title" tabindex="0">What is the difference between USP 61 and USP 62?</a> </div> <div id="elementor-tab-content-18219" class="elementor-tab-content elementor-clearfix" data-tab="19" role="region" aria-labelledby="elementor-tab-title-18219"><p><span style="font-weight: 400;">USP 61 is for the determination of the presence of total viable aerobic bacteria and fungi. USP 62 deals with the detection of specific microbiological agents that may be pathogenic.</span></p></div> </div> <div class="elementor-accordion-item"> <div id="elementor-tab-title-18220" class="elementor-tab-title" data-tab="20" role="button" aria-controls="elementor-tab-content-18220" aria-expanded="false"> <span class="elementor-accordion-icon elementor-accordion-icon-right" aria-hidden="true"> <span class="elementor-accordion-icon-closed"><i class="fas fa-plus"></i></span> <span class="elementor-accordion-icon-opened"><i class="fas fa-minus"></i></span> </span> <a class="elementor-accordion-title" tabindex="0">What is the USP 61 update?</a> </div> <div id="elementor-tab-content-18220" class="elementor-tab-content elementor-clearfix" data-tab="20" role="region" aria-labelledby="elementor-tab-title-18220"><p><span style="font-weight: 400;">A recent update of the standard was recently approved by the Pharmacopeial Discussion Group (PDG). The update included changes in the procedure used to verify the suitability of the membrane filtration method.</span></p></div> </div> <script type="application/ld+json">{"@context":"https:\/\/schema.org","@type":"FAQPage","mainEntity":[{"@type":"Question","name":"What is the USP 61 test?","acceptedAnswer":{"@type":"Answer","text":"<p>This test, also known as the Microbial Enumeration Test, determines the Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) in non\u2013sterile product samples.<\/p>"}},{"@type":"Question","name":"What are the products that can be tested using this test?","acceptedAnswer":{"@type":"Answer","text":"<p>The test is applicable to Cosmetics and Personal care products.<\/p>"}},{"@type":"Question","name":"What is the turnaround time for the USP 61 test?","acceptedAnswer":{"@type":"Answer","text":"<p>The test takes 5 to 6 days to complete.<\/p>"}},{"@type":"Question","name":"How many microbial strains can be tested using USP 61 test methods?","acceptedAnswer":{"@type":"Answer","text":"<p><span style=\"font-weight: 400;\">We perform the test using the following microbial strains: <\/span><i><span style=\"font-weight: 400;\">Pseudomonas aeruginosa <\/span><\/i><span style=\"font-weight: 400;\">(ATCC 15442),<\/span><i><span style=\"font-weight: 400;\"> Escherichia coli <\/span><\/i><span style=\"font-weight: 400;\">(ATCC 8739), <\/span><i><span style=\"font-weight: 400;\">Staphylococcus aureus<\/span><\/i><span style=\"font-weight: 400;\"> (ATCC 6538P), <\/span><i><span style=\"font-weight: 400;\">Enterococcus hirae <\/span><\/i><span style=\"font-weight: 400;\">(ATCC 10541),<\/span><i><span style=\"font-weight: 400;\"> Klebsiella pneumoniae <\/span><\/i><span style=\"font-weight: 400;\">(ATCC 4352), MRSA (ATCC 33591), <\/span><i><span style=\"font-weight: 400;\">Salmonella enterica <\/span><\/i><span style=\"font-weight: 400;\">( ATCC 10708), <\/span><i><span style=\"font-weight: 400;\">Candida Albicans <\/span><\/i><span style=\"font-weight: 400;\">(MTCC 3017). Additional strains can be added on request.<\/span><\/p>"}},{"@type":"Question","name":"What are the acceptance criteria for microbial counts in USP 61 testing?","acceptedAnswer":{"@type":"Answer","text":"<p>The acceptance criteria is TAMC of 100-1000 cfu\/ml and TYMC of 10-100 cfu\/ml.<\/p>"}},{"@type":"Question","name":"What methods are used for microbial enumeration in USP 61 testing?","acceptedAnswer":{"@type":"Answer","text":"<p>The primary methods include Membrane Filtration, Plate-Count Methods (Pour-Plate and Surface-Spread Methods), and the Most-Probable-Number (MPN) Method.<\/p>"}},{"@type":"Question","name":"Why is microbiological examination of nonsterile products important?","acceptedAnswer":{"@type":"Answer","text":"<p>It ensures that the products meet established specifications for microbiological quality, safeguarding consumer health by preventing contamination.<\/p>"}},{"@type":"Question","name":"What is the enumeration test?","acceptedAnswer":{"@type":"Answer","text":"<p>The enumeration test is a quantitative method used to determine the number of viable microorganisms present in a sample. This test is crucial for ensuring the microbiological quality of non-sterile products, including pharmaceuticals, cosmetics, personal care products, and medical devices.<\/p>"}},{"@type":"Question","name":"What is the total aerobic microbial count?","acceptedAnswer":{"@type":"Answer","text":"<p>The Total Aerobic Microbial Count (TAMC) is a microbiological test used to quantify the number of viable aerobic bacteria present in a sample. This test is an essential part of quality control for non-sterile pharmaceutical products, cosmetics, personal care products, and other items that must adhere to specific microbiological safety standards.<\/p>"}},{"@type":"Question","name":"What is the microbial limit test?","acceptedAnswer":{"@type":"Answer","text":"<p>The Microbial Limit Test (MLT) is a set of procedures used to assess the microbiological quality of non-sterile pharmaceutical products, cosmetics, and personal care items. It determines whether a product meets predefined microbiological criteria to ensure safety and quality for consumers.<\/p>"}},{"@type":"Question","name":"What is the microbial count?","acceptedAnswer":{"@type":"Answer","text":"<p>Microbial count, also known as microbial enumeration, is a method used to determine the number of microorganisms (such as bacteria, yeasts, and molds) present in a sample. This measurement is crucial in various industries, including pharmaceuticals, food and beverages, cosmetics, and water quality, to ensure product safety, quality, and compliance with regulatory standards.<\/p>"}},{"@type":"Question","name":"What is the bioburden test?","acceptedAnswer":{"@type":"Answer","text":"<p>A bioburden test is a procedure used to determine the number and types of viable microorganisms present on a product or surface before it undergoes sterilization. This test is essential in various industries, including pharmaceuticals, medical devices, and food production, to ensure that products are safe and meet regulatory standards for microbial contamination.<\/p>"}},{"@type":"Question","name":"How long does bioburden testing take?","acceptedAnswer":{"@type":"Answer","text":"<p>The duration of bioburden testing depends on the incubation periods required for different microorganisms. Typically, the incubation period for bacterial bioburden testing is 3 to 5 days at 30 to 35\u00b0C. For fungal bioburden testing, the incubation period is 10 to 14 days at 20 to 25\u00b0C. These periods allow sufficient time for the microorganisms to grow and be counted accurately.<\/p>"}},{"@type":"Question","name":"How are samples prepared for the microbial limits test?","acceptedAnswer":{"@type":"Answer","text":"<p><span style=\"font-weight: 400;\">Samples are prepared by aseptic dilution in a sterile diluent to provide low-concentration levels for the plating. This is necessary to avoid errors in counting microbial colonies.<\/span><\/p>"}},{"@type":"Question","name":"What happens if a product fails the microbial limits test?","acceptedAnswer":{"@type":"Answer","text":"<p><span style=\"font-weight: 400;\">In case a product fails the test, an investigation is done to identify the source of contamination. The product can either be reformulated or rejected depending on the results obtained.<\/span><\/p>"}},{"@type":"Question","name":"How does the microbial enumeration test ensure product safety for consumers?","acceptedAnswer":{"@type":"Answer","text":"<p><span style=\"font-weight: 400;\">The test ensures that the microbial levels are within the acceptable limits in non-sterile products thus reducing the possible adverse health effects like infections and allergic reactions.<\/span><\/p>"}},{"@type":"Question","name":"How can you minimize contamination during the microbial enumeration test process?","acceptedAnswer":{"@type":"Answer","text":"<p><span style=\"font-weight: 400;\">A controlled environment, working with sterile equipment, exercising good laboratory practices, and maintaining strict aseptic conditions can help reduce the possibility of contamination.<\/span><\/p>"}},{"@type":"Question","name":"What are the potential interferences that can affect the test results?","acceptedAnswer":{"@type":"Answer","text":"<p><span style=\"font-weight: 400;\">Sample ingredients that inhibit microbial growth, such as preservatives or poor sample preparation techniques, can give false positives for a microorganism’s presence.<\/span><\/p>"}},{"@type":"Question","name":"What is the difference between USP 61 and USP 62?","acceptedAnswer":{"@type":"Answer","text":"<p><span style=\"font-weight: 400;\">USP\u00a0 61 is for the determination of the presence of total viable aerobic bacteria and fungi. USP 62 deals with the detection of specific microbiological agents that may be pathogenic.<\/span><\/p>"}},{"@type":"Question","name":"What is the USP 61 update?","acceptedAnswer":{"@type":"Answer","text":"<p><span style=\"font-weight: 400;\">A recent update of the standard was recently approved by the Pharmacopeial Discussion Group (PDG). The update included changes in the procedure used to verify the suitability of the membrane filtration method.<\/span><\/p>"}}]}</script> </div> </div> </div> </div> </div> <div class="elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-e5e1c6a" data-id="e5e1c6a" data-element_type="column" data-settings="{"background_background":"classic"}"> <div class="elementor-widget-wrap elementor-element-populated"> <div class="elementor-element elementor-element-9d3ce3a elementor-widget elementor-widget-heading" data-id="9d3ce3a" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <h4 class="elementor-heading-title elementor-size-default">Contact us for more information</h4> </div> </div> <div class="elementor-element elementor-element-4937f46 eael-contact-form-7-button-full-width elementor-widget elementor-widget-eael-contact-form-7" data-id="4937f46" data-element_type="widget" 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