In this free webinar, learn how to develop container closure integrity testing (CCIT) methods for deep cold storage product. Attendees will learn how to design packaging development studies for primary packaging component selection. The featured speakers will discuss how to design process development to characterize vial sealing quality characterization and optimize capping & crimping lines as part of a container closure integrity assurance (CCIA) strategy. Attendees will learn how to design and execute qualification studies including production line qualification studies with respect to CCI during cold storage and package system transportation validation. The speakers will discuss how to design and execute product CCI testing including clinical batch CCI testing and package system CCI stability testing.
TORONTO, June 7, 2023 /PRNewswire-PRWeb/ -- 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.
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