How to Qualify Container Closure Systems for Compounding Pharmacy (503Bs)
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.1
The FDA Guidance requires container closure systems be tested for integrity under appropriate storage conditions and beyond the desired beyond-use date (BUD).2 The article breaks down the USP <1207> concept of maximum allowable leak limit (MALL) (i.e., the smallest gap, or leak rate, that places drug product quality at risk) and methods for measuring CCI.3 CCI data can show loss of sterility, permeation of gas, or loss of vacuum due to defects in container closure systems. Assessing CCI data against MALL and drug product critical sensitivities can establish whether container closure systems can provide required performance over drug BUD at required storage conditions, i.e. intended use. Our article shows representative CCI data on vial systems, along with the benefits and other type of information gleaned from different CCI methods.
West can guide 503Bs through the agency and compendia requirements. West’s Integrated Solutions strategy can help Simplify the Journey™ for customers by taking the guesswork out of designing and executing CCI studies. For a breakdown of how CCI can demonstrate container closure systems are fit-for-purpose, 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.
- Kim A., Gehrmann M.R., McCaw, J., McAndrew T.P. How to Qualify Container Closure Systems for Intended Use, Part 1. International Journal of Pharmaceutical Compounding. 2019; 23(6): 454-461.
- Food and Drug Administration. Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act Guidance for Industry), December 2018; Available at: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM403496.pdf. Accessed 22 November 2019.
- United States Pharmacopeia Chapter <1207> Package Integrity Evaluation – Sterile Products (2016).