Biologics, sterile manufacturing, medical devices

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life-critical pharmaceutical products. Strict requirements and regulations define cleanliness levels. And it’s no wonder – after all, airborne contamination directly impacts the quality of pharmaceutical products and medical devices.</p> <p> </p> <h2>Hi-tech and biotech need the cleanest air possible</h2> <p> Manufacturing biological drugs (biologics) is a unique and complex process. Biologics are made from proteins from living organisms that have been engineered to produce therapeutic proteins in large quantities. They are extremely sensitive and can be negatively affected by even the slightest process change. </p> <p>Similarly high requirements exist for medical devices that are used in critical situations. They are subject to strict regulations, so their manufacture requires cleanrooms to ensure that they meet these regulations.  </p> <p>Filling pharmaceuticals is a highly critical process that requires a completely clean and controlled environment. Filtration systems help to maintain cleanliness levels throughout the different process zones, from grade A to grade C or D. In all these situations, the direction of the airflow needs to be controlled to prevent any cross contamination from infiltrating the final product. </p> <h2> Different aseptic processing areas have different requirements </h2> <p style="margin-bottom: 0.0001pt;">Aseptic processing facilities require different air filtration solutions for each of these areas:</p> <p style="margin-bottom: 0.0001pt;"> </p> <table border="1" cellspacing="0" cellpadding="0" style="margin-left: 5.4pt; border: none;"> <tbody> <tr> <td valign="top" style="width: 205.55pt; padding: 0cm 5.4pt; border-style: solid; border-width: 1pt; text-align: left;"> <p style="margin-bottom: 0.0001pt;"><strong><span style="color: black;">Area</span></strong></p> </td> <td valign="top" style="width: 253.35pt; padding: 0cm 5.4pt; border-left: none; border-top-style: solid; border-right-style: solid; border-bottom-style: solid; text-align: left;"> <p style="margin-bottom: 0.0001pt;"><strong><span style="color: black;">Solution</span></strong></p> </td> </tr> <tr> <td style="width: 205.55pt; padding: 0cm 5.4pt; border-top: none; border-right-style: solid; border-bottom-style: solid; border-left-style: solid; text-align: left;"> <p style="margin-bottom: 0.0001pt;"><span style="color: black;">MAU and AHU</span></p> <p style="margin-bottom: 0.0001pt;"><span style="color: black;">Wash and prep</span></p> <p style="margin-bottom: 0.0001pt;"><span style="color: black;">Depyrogenation tunnels and sterile preparation rooms </span></p> </td> <td style="width: 253.35pt; padding: 0cm 5.4pt; border-top: none; border-left: none; border-right-style: solid; border-bottom-style: solid; text-align: left;"> <p style="margin-bottom: 0.0001pt;"><span style="color: black;">High-end pre-filtration for minimising total cost of ownership and protecting critical areas</span></p> <p style="margin-bottom: 0.0001pt;"> </p> <p style="margin-bottom: 0.0001pt;"><span style="color: black;">Efficient HEPA filter systems for smooth cleanroom operations – Camfil <a href="/en-sg/products/housings-frames--louvers/terminal-housing/cleanseal"><strong>CleanSeal™</strong></a> and <a href="/en-sg/products/epa-hepa--ulpa-filters/cleanroom-panels/megalam"><strong>Megalam™</strong></a> </span></p> <p style="margin-bottom: 0.0001pt;"> </p> <p style="margin-bottom: 0.0001pt;"><span style="color: black;">Increase depyrogenation tunnel throughput with <a href="/en-sg/products/high-temperature-filters/box-type-up-to-350-c/absolute-d-pyro"><strong>Absolute D-Pyro</strong></a>, the most efficient high-temperature filter on the market </span></p> <p style="margin-bottom: 0.0001pt;"> </p> </td> </tr> <tr> <td style="width: 205.55pt; padding: 0cm 5.4pt; border-top: none; border-right-style: solid; border-bottom-style: solid; border-left-style: solid; text-align: left;"> <p style="margin-bottom: 0.0001pt;"><span style="color: black;">Aseptic filling</span></p> <p style="margin-bottom: 0.0001pt;"><span style="color: black;">Mini-environments like restricted access barrier systems (RABS) and isolators</span></p> </td> <td style="width: 253.35pt; padding: 0cm 5.4pt; border-top: none; border-left: none; border-right-style: solid; border-bottom-style: solid; text-align: left;"> <p style="margin-bottom: 0.0001pt;"><span style="color: black;"><a href="/en-sg/products/epa-hepa--ulpa-filters/cleanroom-panels/megalam"><strong>Megalam</strong></a> and push-push filters for work environment protection </span></p> <p style="margin-bottom: 0.0001pt;"> </p> <p style="margin-bottom: 0.0001pt;"><span style="color: black;"><a href="/en-sg/products/housings-frames--louvers/safety-housing/camsafe"><strong>CamSafe™</strong></a> range to protect workers and the environment</span></p> </td> </tr> <tr> <td style="width: 205.55pt; padding: 0cm 5.4pt; border-top: none; border-right-style: solid; border-bottom-style: solid; border-left-style: solid; text-align: left;"> <p style="margin-bottom: 0.0001pt;"><span style="color: black;">Packing areas</span></p> </td> <td style="width: 253.35pt; padding: 0cm 5.4pt; border-top: none; border-left: none; border-right-style: solid; border-bottom-style: solid; text-align: left;"> <p style="margin-bottom: 0.0001pt;"><span style="color: black;"><strong><a href="/en-sg/products/air-cleaners--air-purifiers/industrial-range">CamCleaner™</a> </strong>for maintaining a clean, safe warehouse</span></p> </td> </tr> </tbody> </table> <h2> </h2> <h2>Gain peace of mind for all your sensitive processes </h2> <p>Camfil is a leader in air filtration solutions for the life science industry and works in close cooperation with several of the largest global pharma manufacturers. We offer filters, housings and air cleaners designed to comply with strict demands on safety, traceability and control.</p> <h3>Our complete range of ProSafe™ filters for medical and sterile manufacturing offers these benefits:</h3> <ul> <li>Specially developed for process safety in medical and sterile manufacturing environments</li> <li>Inert to microbial growth and contamination in accordance with ISO 846 </li> <li>Most energy-efficient filters – their high quality does not compromise operational efficiency</li> <li>Tested resistance to chemicals used for cleaning and decontamination in cleanrooms </li> <li>Free of harmful chemical components such as formaldehyde, phthalates and bisphenol-A</li> <li>Sturdy and resistant to moisture and corrosion for a hygienic HVAC system in accordance with VDI 6022</li> </ul> <p>Camfil’s <a href="/en-sg/products/housings-frames--louvers/terminal-housing/cleanseal"><strong>CleanSeal™</strong></a><a href="/en-sg/products/housings-frames--louvers/safety-housing/camsafe"> </a>filter housing is also specially designed for life sciences. It is a robust, fully welded, leak-proof solution that is easy to install, handle and maintain.</p> <h2>Benefits of Camfil air filtration solutions</h2> <p>Control your sensitive production environment with dedicated air filtration solutions for aseptic environments. You will gain these overall benefits:</p> <ul> <li>Protect your products from contamination and cross contamination, ensuring product quality</li> <li>Minimise product rejects and liability</li> <li>Prevent employees from coming into contact with biological matter </li> <li>Protect the environment by ensuring the relevant biosafety levels</li> <li>Comply with strict environmental and workplace regulations</li> <li>Minimise operational costs with energy-efficient filter performance</li> <li>Perform easy, safe filter changes with minimal disruption to operations and no risk of contamination</li> </ul> </div> <button type="button" class="u-limitHeightBtn d-none mt-1 btn btn-sm btn-outline-primary" data-height="120" data-less="Show less" data-more="Show more"> Show more </button> </div> <div class="col-12 col-sm-4"> </div> <div class="col-12 ApplicationListing mb-0"> <ul class="row d-flex flex-wrap list-unstyled"> <li class="col-12 col-sm-6 col-lg-4 mb-4"> <a href="/en-sg/support-and-services/support/product-finder#application=45029%7C44992%7CMRKT22" class="ApplicationListing-link"> <div class="ApplicationListing-imageWrapper mb-3"> <div class="ApplicationListing-imageOverlay"> <span class="btn btn-outline-light ApplicationListing-imageOverlayBtn"> Show products </span> </div> <img src="https://www.camfil.com/dam/images/30788/90070/A_Containment1.png?width=400&height=300&bgcolor=white&placeholder=pixelated" data-src="https://www.camfil.com/dam/images/30788/90070/A_Containment1.png?width=400&height=300&bgcolor=white" class="d-block img-fluid u-lazyAnimated" alt="A Containment1" /> </div> <h2 class="ApplicationListing-title u-heading">Containment</h2> <p>It's imperative to protect people and the environment from highly dangerous biological, chemical or radioactive risks during research or production operation, especially within defense, the military and university labs.</p> </a> </li> <li class="col-12 col-sm-6 col-lg-4 mb-4"> <a href="/en-sg/support-and-services/support/product-finder#application=45358%7C44992%7CMRKT22" class="ApplicationListing-link"> <div class="ApplicationListing-imageWrapper mb-3"> <div class="ApplicationListing-imageOverlay"> <span class="btn btn-outline-light ApplicationListing-imageOverlayBtn"> Show products </span> </div> <img src="https://www.camfil.com/dam/images/30693/90058/A_Cleanroom_.png?width=400&height=300&bgcolor=white&placeholder=pixelated" data-src="https://www.camfil.com/dam/images/30693/90058/A_Cleanroom_.png?width=400&height=300&bgcolor=white" class="d-block img-fluid u-lazyAnimated" alt="A Cleanroom_" /> </div> <h2 class="ApplicationListing-title u-heading">Cleanroom</h2> <p>Controlled environments must protect critical processes and personnel. A high level of air cleanliness is essential to protect products and to contain hazardous compounds. High-quality filtration systems help ensure regulatory compliance and maintain efficient operations.</p> </a> </li> <li class="col-12 col-sm-6 col-lg-4 mb-4"> <a href="/en-sg/support-and-services/support/product-finder#application=45940%7C44992%7CMRKT22" class="ApplicationListing-link"> <div class="ApplicationListing-imageWrapper mb-3"> <div class="ApplicationListing-imageOverlay"> <span class="btn btn-outline-light ApplicationListing-imageOverlayBtn"> Show products </span> </div> <img src="https://www.camfil.com/dam/images/31074/90468/Air-handling-unit.png?width=400&height=300&bgcolor=white&placeholder=pixelated" data-src="https://www.camfil.com/dam/images/31074/90468/Air-handling-unit.png?width=400&height=300&bgcolor=white" class="d-block img-fluid u-lazyAnimated" alt="MARKER IMAGE Make Up Air Unit" /> </div> <h2 class="ApplicationListing-title u-heading">Air handling unit (AHU)</h2> <p>Protect people, processes, products and equipment while keeping maintenance and energy costs low by keeping air handling units unclogged.</p> </a> </li> </ul> </div>  <div class="InsightsListComponent col-12 mb-7"> <div class="row"> <div class="col-12"> <h2 class="mb-4 ">Latest articles</h2> </div> <div class="col-md-6 mb-5"> <div class="InsightsListComponent-card"> <a href="/en-sg/insights/commercial-and-public-buildings/camcarb-xg" class="d-block"> <img src="/-/media/images/qbank/__images/products/both-cylinders-8000pxpng.png?h=405&iar=0&w=720&rev=c6a6f415be2c4c609dc4c5eae8506e70&mode=crop&placeholder=pixelated&hash=26C770BD144DFF8D7D01AECA0DDAF8A7" class="img-fluid u-lazyAnimated" alt="" width="720" height="405" data-src="/-/media/images/qbank/__images/products/both-cylinders-8000pxpng.png?mode=crop&rev=c6a6f415be2c4c609dc4c5eae8506e70&iar=0&h=405&w=720&hash=29A3DF62505F336233B79B4305542530" /> </a> <div class="pt-3"> <h2 class="h3"><a href="/en-sg/insights/commercial-and-public-buildings/camcarb-xg">CamCarb XG</a></h2> <span class="InsightsListComponent-dateText u-textSize14 mb-2">Created Monday, 4 September 2023</span> <p class="mb-2">CamCarb XG Engineered for energy and maintenance cost savings in molecular contamination control applications</p> <span class="u-textSize14"> <a href="/en-sg/insights/food-and-beverage" class="InsightsListComponent-tagBtn mr-2 mb-1">Food and beverage</a> <a href="/en-sg/insights/electronics-and-optics" class="InsightsListComponent-tagBtn mr-2 mb-1">Electronics and optics</a> <a href="/en-sg/insights/commercial-and-public-buildings" class="InsightsListComponent-tagBtn mr-2 mb-1">Commercial and public buildings</a> </span> </div> </div> </div> <div class="col-md-6 mb-5"> <div class="InsightsListComponent-card"> <a href="/en-sg/insights/life-science-and-healthcare/the-mighty-hepa-filter" class="d-block"> <img src="/dfsmedia/baeefe6b74df44be8a2bccfb2c57af8e/33974-source/resize/720x405/options/keepaspectratio/cleanroom-adobestock-240748797" alt="Camfil trailer parked in front of nuclear power plant and cooling towers." class="img-fluid u-lazyAnimated" placeholder="pixelated" /> </a> <div class="pt-3"> <h2 class="h3"><a href="/en-sg/insights/life-science-and-healthcare/the-mighty-hepa-filter">The mighty HEPA filter</a></h2> <span class="InsightsListComponent-dateText u-textSize14 mb-2">Created Sunday, 7 April 2024</span> <p class="mb-2">In the realm of controlled environments, where precision, purity, and protection are paramount, High-Efficiency Particulate Air (HEPA) filters emerge as unsung heroes</p> <span class="u-textSize14"> <a href="/en-sg/insights/food-and-beverage" class="InsightsListComponent-tagBtn mr-2 mb-1">Food and beverage</a> <a href="/en-sg/insights/life-science-and-healthcare" class="InsightsListComponent-tagBtn mr-2 mb-1">Life science and healthcare</a> <a href="/en-sg/insights/sustainability" class="InsightsListComponent-tagBtn mr-2 mb-1">Sustainability</a> <a href="/en-sg/insights/education-and-experience" id="startTagHidden" class="InsightsListComponent-tagBtn mr-2 mb-1 d-none">Education and experience</a> <button id="plusMinusBtn" class="InsightsListComponent-tagBtn mr-2 mb-1">+</button> </span> </div> </div> </div> <div class="col-md-6 mb-5">  <div class="InsightsListComponent-card"> <div class=""> <div class="pr-3"> <a href="/en-sg/insights/case-studies/tco-optimised-dust-extraction-solution-in-a-medical-laboratory" class="d-block"> <img src="/dfsmedia/baeefe6b74df44be8a2bccfb2c57af8e/111923-source/resize/720x405/options/keepaspectratio/carding-textile-adobestock-74777623" class="img-fluid u-lazyAnimated" placeholder="pixelated" /> </a> </div> <div class="pt-3"> <h2 class="h3"><a href="/en-sg/insights/case-studies/tco-optimised-dust-extraction-solution-in-a-medical-laboratory">TCO optimised dust extraction solution in a medical laboratory</a></h2> <span class="InsightsListComponent-dateText u-textSize14 mb-2">Created Saturday, 26 October 2024</span> <p class="InsightsListComponent-desc mb-2">Camfil´s Gold Series dust collector allows French life science company significant savings on energy costs and to safely handle ST1 explosive dust from carding process of alginate fibers.</p> <p class="InsightsListComponent-tags m-0 u-textSize14"> <a href="/en-sg/insights/life-science-and-healthcare" class="InsightsListComponent-tagBtn mr-2 mb-1">Life science and healthcare</a> <a href="/en-sg/insights/case-studies" class="InsightsListComponent-tagBtn mr-2 mb-1">Case studies</a> </p> </div> </div> </div>  </div> <div class="col-md-6 mb-5">  <div class="InsightsListComponent-card"> <div class=""> <div class="pr-3"> <a href="/en-sg/insights/life-science-and-healthcare/cleanseal-exhaust-integrity" class="d-block"> <img src="/-/media/images/qbank/__web/products/housings_frames_louvers/terminal-housings/product-image-cleanseal-exhaust-mip-cutboxnewmain.png?h=405&iar=0&w=720&rev=9515f4ad9a274ef3a6ec7b076aa89099&mode=crop&placeholder=pixelated&hash=75130479DE3B56FDD4DC52A16C294099" class="img-fluid u-lazyAnimated" alt="" width="720" height="405" data-src="/-/media/images/qbank/__web/products/housings_frames_louvers/terminal-housings/product-image-cleanseal-exhaust-mip-cutboxnewmain.png?mode=crop&rev=9515f4ad9a274ef3a6ec7b076aa89099&iar=0&h=405&w=720&hash=6DA9BBC5975CE6BAF76FD14D1FAB182F" /> </a> </div> <div class="pt-3"> <h2 class="h3"><a href="/en-sg/insights/life-science-and-healthcare/cleanseal-exhaust-integrity">Next generation HEPA exhaust housing</a></h2> <span class="InsightsListComponent-dateText u-textSize14 mb-2">Created Friday, 4 November 2022</span> <p class="InsightsListComponent-desc mb-2">CleanSeal Exhaust Integrity is the next generation of exhaust HEPA housings for sensitive processes. This premium range is designed to ensure a safe operation with critical or hazardous substances. Compliant for ISO14644 testing and allows you to easily inject aerosol together with in situ filter validation scan.</p> <p class="InsightsListComponent-tags m-0 u-textSize14"> <a href="/en-sg/insights/life-science-and-healthcare" class="InsightsListComponent-tagBtn mr-2 mb-1">Life science and healthcare</a> </p> </div> </div> </div>  </div> <div class="col-md-6 mb-5">  <div class="InsightsListComponent-card"> <div class=""> <div class="pr-3"> <a href="/en-sg/insights/air-quality/camfil-city---a-virtual-world-for-clean-air-solutions" class="d-block"> <img src="/-/media/images/qbank/__web/camfil-city/images/camfil-city-promobox.png?h=405&iar=0&w=720&rev=01b17ce526f0408b8b413c434b0a78b8&mode=crop&placeholder=pixelated&hash=5A7D5254AFF2880BCECFB7B244E5BA28" class="img-fluid u-lazyAnimated" alt="" width="720" height="405" data-src="/-/media/images/qbank/__web/camfil-city/images/camfil-city-promobox.png?mode=crop&rev=01b17ce526f0408b8b413c434b0a78b8&iar=0&h=405&w=720&hash=E5C2C2E8C7797198277930316BB502D6" /> </a> </div> <div class="pt-3"> <h2 class="h3"><a href="/en-sg/insights/air-quality/camfil-city---a-virtual-world-for-clean-air-solutions">Camfil City - a virtual world for clean air solutions. protecting people, processes and our environment</a></h2> <span class="InsightsListComponent-dateText u-textSize14 mb-2">Created Tuesday, 5 July 2022</span> <p class="InsightsListComponent-desc mb-2">Not all people who purchase our products are experts in air filtration and they shouldn’t have to be either. 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