We apologize your item could not be found. Not all items are listed on our website. Please contact your account manager for details regarding your searched item.
Material number (eg: xxxxxxxxxxx) no space or hyphen needed.
No Results Found
“Choosing the Right Components for Container Closure Systems,” the second part of our “How to Qualify Container Closure Systems” series, was recently published in the International Journal of Pharmaceutical Compounding. The article addresses ways in which packaging component selection is critical to ensuring that the closure container system will protect and maintain compounded drug quality.1
When selecting a container closure system, outsourcing facilities should first consider how they intend to process containers and closures that have direct drug product contact to ensure sterility. If sterile compounded drug products are desired, all materials must be sterilized and depyrogenated before pharmacy compounding Sterile processing burden may be shifted to packaging suppliers through the use of ready-to-use products with a validated process. Such components will be accompanied by a Certificate of Analysis (COA) for documentation purposes.
Outsourcers must also demonstrate that containers and closures are suitable for use with each drug product. Basic principles for doing so include packaging system protection, compatibility, safety and performance. A variety of test methods and procedures can be used to prove suitability. Once the appropriate test methods are identified, representative drug product packaged in the selected container closure system and manufactured by the standard operating procedures of the Outsourcing Facility can be placed on stability and tested at intervals over the intended shelf life.
Testing results must demonstrate that the drug product maintains stability without interference from the packaging components over the intended shelf life.West can guide outsourcing facilities through FDA and compendia requirements.2 West’s Integrated Solutions program can help Simplify the Journey™ for customers by taking the guesswork out of closure container system selection and testing. For more information about the potential risks to and effects on drug product quality when choosing container closure systems, visit the IJPC website to purchase the full text article here.
For more information, contact an Account Manager or Technical Customer Support (TCS) representative.
Simplify the Journey™ is a trademark of West Pharmaceutical Services, Inc. in the United States and other jurisdictions.
We are pleased to announce our recent publication in the November/December 2019 Issue of the International Journal of Pharmaceutical Compounding. In the article “How to Qualify Container Closure Systems, Part 1,” we address how compounding pharmacies (503Bs) can qualify systems for intended use via container closure integrity (CCI) to meet FDA Guidance requirements.<sup>1</sup>
Vial-based primary packaging systems for sterile drug products must provide protection over shelf life. This requires demonstration of container closure integrity (CCI); this testing should be performed early in the drug product development stage. As we all know, there is not one CCI test method that fits all systems/conditions.
Since the 2012 New England Compounding Center tragedy that linked a deadly fungal meningitis outbreak to a failure to use current good manufacturing practices (cGMP),<sup>1</sup> compounding pharmacies have faced increasing scrutiny and regulation by the U.S. Food and Drug Administration (FDA). While registering with the FDA is still voluntary, only compounding pharmacies that register, and pass inspection, will be granted “503B” status as compounding outsourcing facilities under Section 503B of the Federal Food, Drug, and Cosmetic Act.<sup>2</sup>
With the May 21, 2019 meeting to review the FDA draft guidance governing 503B compounding pharmacies, it has become evident that sterility of drugs produced at such facilities is a major focus of the U.S. Food and Drug Administration (FDA).<sup>1</sup> The meeting discussed the importance of qualifying container closure systems and was aimed at providing more context on what compounding pharmacies need to do.
One of the most important aspects for choosing container closure system for parenteral drug products is to ensure an ideal fit between all components to maintain product sterility.
English
Chinese
