Container Closure Integrity Testing: Mitigating Ultracold Storage and Transport Risk, Upcoming Webinar Hosted by Xtalks

TORONTO (PRWEB) June 07, 2023

Certain sterile pharmaceutical products require deep cold storage, either near -80˚C or even at cryogenic temperatures (down to -180˚C). Messenger RNA and live viral vaccines, gene therapies or products that contain active cells often need deep cold storage to maintain stability and/or activity.

Studies have shown that deep cold storage temperatures can introduce risk to pharmaceutical primary packaging systems. In particular, the cold temperatures pose risks to the container closure integrity (CCI) of vial-rubber stopper combinations traditionally used to fill sterile pharmaceutical products [1-3]. It is therefore critical that robust development and qualification work is done to demonstrate the CCI performance of any primary packaging components used for a product needing deep cold storage and transport temperatures.

In this webinar, the featured speakers will elaborate on a specific program for generating appropriate packaging data for deep cold storage products. This program ensures good CCI during ultracold storage and transport and enables meeting recent regulatory requirements. The program is based on a holistic science-based approach that has been developed and recently described [4] and enables coordinated robust packaging data generation in a number of stages following a product life cycle approach.

Register today to learn how to maintain container closure integrity of primary packaging components during ultracold storage and transport.

Join Derek Duncan, PhD, Director Product Lines, Lighthouse Instruments; and Brandon Zurawlow, Chief Scientific Officer, CS Analytical, for the live webinar on Thursday, June 22, 2023, at 10am EDT (4pm CEST/EU-Central).

For more information, or to register for this event, visit Container Closure Integrity Testing: Mitigating Ultracold Storage and Transport Risk.

REFERENCES:

[1] Zuleger, B.; Werner, U.; Kort, A.; Glowienka, R.; Wehnes, E.; Duncan, D. Container/Closure Integrity Testing and the Identification of a Suitable Vial/Stopper Combination for Low-Temperature Storage at –80 °C. PDA J. Pharm. Sci. Technol. 2012, 66 (1), 453–465.

[2] Presentation ‘Ensuring container closure integrity of a gene therapy cancer vaccine needing deep cold storage’, Josine Wilmer, 2019 PDA Parenteral Packaging Conference, Venice, Italy.

[3] Presentation ‘Correlating Vial Seal Tightness to Container Closure Integrity at Various Storage Temperatures’, Derek Duncan and Roger Asselta, 2015 PDA Parenteral Packaging Conference, Frankfurt, Germany.

[4] Presentation ‘Mitigating Risk to Container Closure Integrity of a COVID 19 Vaccine Product During Ultra Cold Chain Storage and Distribution’, Derek Duncan, Michael Edey, Anna Rozentsvayg, 2021 PDA/FDA Joint Regulatory Conference.

ABOUT XTALKS

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global life science, food and medical device community. Every year, thousands of industry practitioners (from life science, food and medical device companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

To learn more about Xtalks visit http://xtalks.comFor information about hosting a webinar visit http://xtalks.com/why-host-a-webinar/

Contact:Vera KovacevicTel: +1 (416) 977-6555 x371Email: [email protected]

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