Choose Wisely: Considerations in Selecting Your Vial/Stopper/Seal Components

Primary packaging components play a critical role in maintaining the safety and efficacy of parenteral drug products. A number of factors must be considered when selecting a combination of components such as drug/container interactions, inter-component compatibility for maintaining container closure integrity (CCI), and component compatibility with manufacturing processes. This 6 hour workshop will provide an overview of these factors within the context of glass vials, elastomeric stoppers, and aluminum seals. Topics to be covered will include the processes used to manufacture these components, extractables and leachables, chemically-induced particulate formation, assessing the inter-compatibility of components, the impact of storage conditions on CCI, and recommended handling practices in fill-finish operations.

Program Agenda:

First Session: Basic review of primary packaging components (9:00 am - 12:00 pm; includes Q&A)

• Glass vials​
  • Manufacturing​
  • Vial nomenclature​
  • Glass compositions​
  • Regulatory resources​
  • Quality levels​

• Elastomer stopper​
  • Manufacturing​
  • Stopper nomenclature​
  • Common formulation families​
  • Regulatory resources​
  • Quality levels​

• Aluminum crimp seals​
  • Manufacturing​
  • Seal nomenclature​
  • Quality levels

LUNCH: 12:00-1:00pm

Second Session: Considerations for packaging selection (1:00 - 4:00 pm; includes Q&A)​

• Drug-container interactions​
  • Extractables and leachables​
  • Delamination and other chemically derived particulate​

• Container closure integrity​
  • Dimensional interference fit, stack-up, modelling approaches, and testing​
  • Storage conditions (particularly cold storage below Tg of elastomer stopper)​

• Component performance on fill-finish lines​
  • Significance of breakage and cracks in glass​
  • Mechanically derived particulate​
  • Recommended handling practices​

Up to 6.0 PDH Hours will be offered for this event; we will NOT be offering each session as a standalone segment.

Walk-in registrations will be allowed (for $20 surcharge per ticket type).

Cancellation Policy: Full refund or credit voucher for a future program will be given up until 7-days before program; After September 18th, no refunds or credit vouchers will be provided.

Speakers:

Dr. Matthew Hall, Corning Pharmaceutical Technologies

Dr. Matthew Hall is the Technical Affairs Director for Corning Pharmaceutical Technologies (CPT), a manufacturer of pharmaceutical glass tubing and containers for parenteral drug products. A member of the commercial team, Dr. Hall serves as a technical expert in support of sales and marketing functions and as a liaison to the larger pharmaceutical industry ecosystem, including professional organizations and equipment manufacturers. Prior to joining CPT in 2019, he was a faculty member in the glass science and biomaterials at the Kazuo Inamori School of Engineering at Alfred University for 14 years. Dr. Hall holds a BS degree in Ceramic Engineering from the Missouri University of Science & Technology, MS and PhD degrees in Glass Science from Alfred University, and a MBA degree from the University of Rochester.

Dr. Bettine Boltres - West Pharmaceutical Services

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.

Thank you to our sponsors for this event: