Selecting Container Closure Components with Confidence: A Data-Driven Approach to Container Closure Integrity

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Summary
Speakers

Selecting a container closure system for a sterile injectable can be a daunting task in early drug development. FDA rightly points out that “a packaging system found acceptable for one drug product is not automatically assumed to be appropriate for another.”¹Drug developers must ultimately prove that the container closure system and its components are suitable for intended use. The basic principles for determining that the proposed container closure system is suitable are:

-It adequately protects the drug product
-It is compatible with the drug product
-It is composed of materials that are considered safe for use with the drug and the route of administration
-Its integrity performance ensures that the drug product is safe to be administered.

When first evaluating and selecting packaging components for drug containment in a vial an initial theoretical assessment of dimensional fit can be executed to predict if each component, the stopper, vial and seal, are dimensionally compatible. Utilizing modeling techniques such as those found in West’s DeltaCube™ Modeling Platform can further enhance predictability through the use of large data sets to examine the underlying statistical dimensions of each component along with variable compression forces required to seal the vial. These methods can provide confidence before Container Closure Integrity Testing is performed to experimentally verify that the components and capping processes for sealing the vial will provide acceptable container closure integrity and ultimately protect the drug product over its shelf life.

The data presented in this webinar will highlight West’s newest offering in our Ready Pack™ containment portfolio, Corning® Valor® Glass vials, in combination with West’s highest quality NovaPure® stoppers, and Flip-Off® CCS (Clean, Certified, Sterilized) seals.

1 - Guidance for Industry Container Closure Systems for Packaging Human Drugs and Biologics, May 1999

Dr. Bettine Boltres

Director Scientific Affairs & Technical Solutions, Glass Systems

As Director Scientific Affairs & Technical Solutions, Glass Systems, Dr. Bettine Boltres is supporting the scientific exchange between West and the pharmaceutical industry. This is complementing her work as Product Manager for Schott Pharmaceutical Tubing, where she provided scientific consulting for glass primary packaging. Bettine is an active member of the USP Packaging and Distribution Expert Committee, the European Pharmacopoeia Commission Group of Experts 16 (elastomers and plastics) and the GLS Working Party (glass). She is Convenor of the ISO Working Group 4 (Elastomers) and member of the Working Group 2 (glass). Additionally, Bettine is on the PDA Board of Directors and in 2015 she published the book “When Glass Meets Pharma”, which builds the bridge between glass for pharmaceutical primary packaging and drug substances. Dr. Boltres is a (bio)chemist by training, receiving a diploma in chemistry from the university of Frankfurt, Germany and a PhD in biochemistry from the university of Cologne, Germany