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Patrick Curran1, Vinod Vilivalam1, Suzanne Kuiper2 and Derek Duncan2 An increasing number of pharmaceuticals including vaccines, stem cells and proteins require cold storage to maintain efficacy prior to use. However, the ability to maintain container closure integrity (CCI) during cold storage is not completely understood.
1West Pharmaceutical Services, Inc. and 2Lighthouse Instruments B.V.
Concerns about CCI failure have been raised for the storage and shipment of pharmaceutical products in rubber-stoppered vials under cold conditions (e.g. -80°C or dry ice). Commonly used butyl stoppers are believed to lose their elastic properties below their glass transition temperature (Tg) posing a risk to sealability [1], [2]. The temporary loss of CCI under cold conditions can allow cold, dense gas from the surrounding low-temperature storage environment to leak into the stored vial. The ingress of the gas can contribute to loss of efficacy of the stored drug product due to interaction with the gas as well as overpressurization of the vial. Overpressurization occurs when cold, dense gas becomes trapped within the vial as the rubber stopper warms to a temperature above its Tg after it is removed from the cold storage conditions. After the rubber stopper has regained its elastic properties and reseals the vial, the headspace pressure of the vial increases as the cold, dense gas warms to room temperature.
Conclusions
The rubber stoppers tested in this study are suitable for use with glass and Daikyo Crystal Zenith® polymer vials for cold temperature storage (-80°C or dry ice) and for transport in dry ice. Rubber-stoppered glass vials and Crystal Zenith polymer vials demonstrated CCI at temperatures as low as -80°C, well below the Tg’s of the rubber stoppers (between -60°C and -65°C).
Read the full scientific poster here
Daikyo Crystal Zenith® is a registered trademark of Daikyo Seiko, Ltd.
Daikyo Crystal Zenith® technology is licensed from Daikyo Seiko, Ltd.
Why is meeting customer needs no longer enough? In an expanding global economy with international competition, meeting customer needs is simply not enough. Meeting customer needs leads to customer satisfaction but does not lead to customer loyalty, which is what keeps companies in business.
The answer is – it depends. Your Technical Customer Service (TCS) representative can help you decide. Butyl rubber, derived synthetically from petrochemicals, is a copolymer of isobutylene, and to a smaller extent, isoprene. Subsequent halogenation results in a halobutyl rubber – typically bromobutyl or chlorobutyl.
How does West respond to increased demand to produce supplies needed for use with treatments to combat the coronavirus? The answer is – with years of experience, careful planning, and a robust manufacturing program. We are committed to doing our part to speed the successful development and large-scale manufacture of high-quality components required to serve customer needs for the delivery of a safe, effective COVID-19 vaccine, which includes expanding labor and equipment resources.
Vaccines have helped reduce the instance of infectious diseases around the globe, nearly eradicating past plagues, such as smallpox and polio. A very effective method of delivery is intradermal (ID) injection – now made easier with two novel products on the market.
Beyond the challenges of ensuring that data privacy laws are observed across the globe, West IT is faced with the need to safeguard intellectual property, trade secrets, and confidential company and employee data while ensuring that we can serve our global customers. This is becoming increasingly more complex with the rapid advances in mobility and cloud computing. At West, IT is evaluating the best way to enable our employees to take advantage of these rapid advances in technology while still ensuring protection for confidential company information.
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