Daniel Bantz

Tech Manager, Packaging & Performance, Laboratory

April 28, 2017

Future Readiness - Compliance with New USP Chapter <382>

It is imperative for the pharmaceutical industry to be prepared to comply with new compendia chapters as soon as they are enacted.  This comprises knowing of proposed changes as soon as announced, and being well prepared to accommodate them.  Expected to be implemented by late 2018 – the functionality tests section of USP Chapter <381> (Elastomeric Closure for Injections) will be removed, and greatly expanded functionality tests will be incorporated in new USP Chapter <382> (projected title: Elastomeric Closure Functionality in Injectable Pharmaceutical Packaging/Delivery Systems). 

 

 

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Chapter <382> will address fitness-for-intended-use functionality requirements for the following packages and delivery systems: (a) vials, bottles, needle-based injection systems, blow-fill sealed containers, dental cartridges, pen injectors and plastic containers for IVs; (b) corresponding elastomeric components; and (c) corresponding drug products. Functionality tests are also proposed to include syringe plunger break force, guide force and plunger seal integrity as well as syringe tip cap and needle shield tests. Chapter <382> is not self-contained – it will incorporate elements of new USP Chapter <1382> (projected title: Assessment of Elastomeric Closure Functionality in Injectable Pharmaceutical Packaging/Delivery Systems). Chapter <1382> will include discussion of fitness-for-intended-use testing, with guidance for test sample preparation, test population, procedures, data interpretation, and reporting. Chapter <1382> will also contain many relevant ISO and USP references.

 

 The sum of all these changes is to enhance patient safety – through increased focus on testing of packaging and delivery systems at a higher system-level, including elastomeric component interactions with interfacing components and drug products. West continues to have a laser-focus on understanding the latest in the ever-changing regulatory landscape and proud to be first-to-market with advanced testing capabilities and methods to best support customers.

 

For more information about current and upcoming industry guidance, please visit the Industry Trends/ Regulatory section of West’s Knowledge Center here.