Special Topic 1: Deep Cold Storage

Co-Presenter(s)

• AR

  Abriana Rozentsvayg, MA

  Director Packaging Project Engineering, GTS Packaging and Device SVCS
  Pfizer
  Fort Lee, New Jersey, United States

  Presentation Handout

Moderator(s)

• 

  Susan Schniepp

  Distinguished Fellow
  Regulatory Compliance Associates Inc.
  Las Vegas, Nevada, United States

Panelist(s)

• 

  Derek Duncan, PhD

  Director Product Line
  Lighthouse Instruments
  Amsterdam, Noord-Holland, Netherlands
• 

  Michael Edey

  Senior Principal Engineer
  Pfizer Inc.
  Mulgrave, Victoria, Australia

Presenter(s)

• 

  Derek Duncan, PhD

  Director Product Line
  Lighthouse Instruments
  Amsterdam, Noord-Holland, Netherlands

  Presentation Handout
• 

  Michael Edey

  Senior Principal Engineer
  Pfizer Inc.
  Mulgrave, Victoria, Australia

  Presentation Handout

Studies have shown that ultra-cold temperatures (-70° C and colder) can introduce risk to the container closure integrity (CCI) of a sealed sterile product vial. This session will present and describe a robust approach for mitigating this risk using work done for the BNT162 mRNA vaccine as a case study. The work included the application of QbD principles to generate robust analytical data on the primary packaging system in the development phase, and then using this data for risk-based qualification and control of the vial sealing process. The holistic approach described and discussed in this session is useful for upcoming therapies needing an ultra-cold chain for storage and distribution.

Presentations:

• 08:30 – 08:54 EDT

  Effects of Ultra-Cold Chain Storage and Distribution on Vial Container Closure Integrity
  

  Presenter: Derek I. Duncan, PhD – Lighthouse Instruments
• 08:54 – 09:21 EDT

  Mitigating Risk to Container Closure Integrity of a COVID-19 Vaccine Product during Ultra-Cold Chain Storage and Distribution
  

  Presenter: Michael T. Edey – Pfizer Inc.

  Co-Presenter: Abriana Rozentsvayg, MA – Pfizer
• 09:21 – 09:30 EDT

  Live Q&A (ST1)
  

  Moderator: Susan J. Schniepp – Regulatory Compliance Associates Inc.

  Panelist: Derek I. Duncan, PhD – Lighthouse Instruments

  Panelist: Michael T. Edey – Pfizer Inc.