CS Analytical Laboratory, the world’s only FDA regulated contract laboratory exclusively dedicated to providing regulatory solutions and qualification testing services specifically for drug product and medical device container systems, is pleased to announce that it has expanded its service offering to directly address all aspects of the new USP 382 General Chapter Elastomeric Closure Functionality in Injectable Pharmaceutical Packaging/Delivery Systems. While requirements of these new testing requirements will not become official until December 1, 2025, the USP has granted a provision and encourages early adoption of the new standard.

“As expected, the changes being implemented as part of the new USP 382 chapter require a broader spectrum of qualification test requirements, often referencing other USP general and guidance chapters,” commented Brandon Zurawlow, CS Analytical Chief Scientific Officer. “With our unique focus on container and package system testing, expanding our service offering to directly address all aspects of USP 382 is a natural progression for CS Analytical’s service line. We are aligned with the USP in encouraging early adoption, and look forward to working with clients to meet these new regulatory requirements.”

The USP 382 chapter provides a more extensive and comprehensive approach to the functional testing currently part of USP 381 chapter, and takes into account the different package configurations an elastomeric component may be used in. Key points of the USP 382 chapter include:

  • Testing is required for all elastomer materials that will be used for packaging of parenteral dosage forms.
  • Test are designed to meet specific use situations for the elastomer. If the elastomer will serve as a plunger, required tests are different from the elastomer that will serve as a multi-dose stopper used as the closure for a vial.
  • Functional test requirements are to be applied to the elastomer component in the same manner and format as it is intended to be used. If the elastomer is to be sterilized, the elastomer should be sterilized prior to the performance of functional suitability testing.
  • The chapter includes a direct reference to USP 1207 that addresses the concepts of “maximum allowable leakage limit” and “inherent integrity”, which are critical elements of any comprehensive container qualification program for high-risk products and consider both the package system and the dose it is intended to contain.

The CS Analytical Team, leveraging years of experience and state-of-the-art laboratories explicitly designed and created for these types of analyses in a cGMP environment, is equipped to ensure the test program outlined for a particular elastomeric component adequately evaluates the suitability for its intended use.