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<section class="hero-banner" style="background-image:url(https://www.thermofisher.com/blog/behindthebench/wp-content/uploads/sites/9/2024/06/iStock-1483296090_pillpackages.jpg)"> </section> <div class="site-inner"><div class="content-sidebar-wrap"><main class="content"><article class="post-18394 post type-post status-publish format-standard has-post-thumbnail category-pharmamfg tag-drug-manufacturing tag-pharma tag-pharma-manufacturing tag-pharma-quality tag-pharmaceutical-manufacturing entry" aria-label="The Essential Role of Checkweighers in Pharmaceutical Production"><header class="entry-header"><h1 class="entry-title">The Essential Role of Checkweighers in Pharmaceutical Production</h1> <span class="post-info-author"> By <a href="https://www.thermofisher.com/blog/behindthebench/tf-author/kimberly-durkot/" title="Posts by Kimberly Durkot" rel="author">Kimberly Durkot, Product Marketing Manager</a> </span> <span class="post-info-date"> 06.18.2024 </span> </header><div class="entry-content"><p>The pharmaceutical industry is a complex and ever-evolving sector that requires the highest levels of accuracy and precision. One of the critical components of this industry is the <a href="https://www.thermofisher.com/us/en/home/industrial/manufacturing-processing/improving-pharmaceutical-biotech-manufacturing-processes-production-methods.html?icid=CAD_blog_LSM_2024June">pharmaceutical production line</a>, where countless drugs are packaged and prepared for distribution. A key player in ensuring the efficiency and accuracy of this process is the checkweigher.</p> <p>A <a href="https://www.thermofisher.com/us/en/home/industrial/manufacturing-processing/improving-pharmaceutical-biotech-manufacturing-processes-production-methods/solutions.html?icid=CAD_blog_LSM_2024June#product-inspection">checkweigher</a> is an automated scale designed to provide a very high level of weighing accuracy and repeatability. They are typically found on packaging lines after bottle, blister, or carton filling equipment, and at the end of the line to confirm case weights. With an increasing focus on track and trace, serialization, and ePedigree compliance in the industry, the role of checkweighers has become even more pivotal.</p> <h2>Ensuring Drug Integrity Through the Supply Chain</h2> <p>In addition to counterfeiting issues, drug cargo theft is also on the rise, ranging from truck hijackings to elaborate pharmaceutical warehouse break-ins. Stolen pharmaceuticals frequently end up in developing countries or distributed via illegal online channels. As a result, quality, transport conditions, efficacy and other aspects are frequently compromised.</p> <p>A drug pedigree is a statement of origin that identifies each prior sale, purchase or trade of a drug, including the date of those transactions and the names and addresses of all parties involved. FDA’s Counterfeit Drug Task Force noted several years ago that widespread use of electronic track-and-trace technology could help secure the integrity of the drug supply chain by providing an accurate drug pedigree, which is a record of the chain of custody of the product as it moves through the supply chain from manufacturer to pharmacy.</p> <p>The Drug Quality and Security Act (DQSA) of 2013 was signed into law on November 27, 2013. Title II of the DQSA is the Drug Supply Chain Security Act (DSCSA) which outlines steps to develop an electronic system to identify and trace pharmaceutical products throughout the supply chain in the USA. The first major “Deadline” facing drug manufacturers due to this new regulation is November 27, 2017, at which time a unique serial number must be applied to all drug packages and cases shipped into the U.S. market. The DSCSA requires the pharmaceutical industry to exchange information at the individual package level as products travel through the supply chain by November 27, 2023.</p> <p><a href="https://www.thermofisher.com/us/en/home/industrial/manufacturing-processing/improving-pharmaceutical-biotech-manufacturing-processes-production-methods/technologies.html?icid=CAD_blog_LSM_2024June#checkweighing">Checkweighing</a> plays a significant role in meeting these track and trace requirements for package components.</p> <h2>Integrating Checkweighing into an ePedigree Solution</h2> <p>Integrating marking and verification equipment — the key elements of a track and trace / serialization / ePedigree solution — with a checkweigher, helps in automatically tracking products from the point of code verification to a reject mechanism. This provides the opportunity to have reject verification and fail-safe reject operation included in the system, both of which are of critical importance for most pharma applications.</p> <p>A <a href="https://www.thermofisher.com/us/en/home/industrial/manufacturing-processing/improving-pharmaceutical-biotech-manufacturing-processes-production-methods/solutions.html?icid=CAD_blog_LSM_2024June#product-inspection">checkweigher</a> designed specifically for pharmaceutical applications, and which complies with the industry’s GMPs, has the ability to provide the highest level of weighing accuracy. This will serve as a good foundation for an integrated track and trace system.</p> <h2>Checkweighing Checklist</h2> <p>A key consideration for the pharmaceutical industry is the checkweigher’s operating speed. A system that can meet today’s requirements and has the capability to meet higher future speed requirements is ideal. Furthermore, the checkweigher’s motor type and mounting location should minimize vibration, which improves checkweigher accuracy.</p> <p>Look for checkweigher designs which provide superior product handling from the infeed conveyor onto the weigh table at high speeds. (A “knife-edge” design provides smooth transition, which also improves accuracy.) Additionally, side belts with horizontal and vertical adjustment ensure the correct position of the bottle or carton during marking and verification. (See more detailed suggestions in White Paper: <em><a href="https://www.thermofisher.com/TFS-Assets/CAD/Technical-Notes/FINAL_White_Paper_Checkweigher_CodingandTracking.pdf?icid=CAD_blog_LSM_2024June">What pharmaceutical companies should know: Combining checkweighing with coding and verification for track and trace / serialization / ePedigree compliance</a>)</em></p> <h2>Summary</h2> <p>As the pharmaceutical industry continues to evolve, the importance of <a href="https://www.thermofisher.com/us/en/home/industrial/manufacturing-processing/improving-pharmaceutical-biotech-manufacturing-processes-production-methods/technologies.html#checkweighing">checkweighing</a> in ensuring the accuracy and efficiency of the production line cannot be overstated. With the increasing necessity for serialization and traceability, these devices are poised to play an even more significant role in the industry.</p> <p>As regulations continue to evolve and the industry moves toward greater transparency and traceability, the role of the checkweigher will undoubtedly continue to grow in importance.</p> <h2>Additional Resources</h2> <ul> <li>White Paper: <em><a href="https://www.thermofisher.com/TFS-Assets/CAD/Technical-Notes/FINAL_White_Paper_Checkweigher_CodingandTracking.pdf?icid=CAD_blog_LSM_2024June">What pharmaceutical companies should know: Combining checkweighing with coding and verification for track and trace / serialization / ePedigree compliance</a></em></li> <li>Online Resources: <a href="https://www.thermofisher.com/us/en/home/industrial/manufacturing-processing/improving-pharmaceutical-biotech-manufacturing-processes-production-methods.html?icid=CAD_blog_LSM_2024June">Improving Pharmaceutical and Biotech Manufacturing Processes</a></li> 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