Authors: Eugene T. Polini, West Pharma Services, Derek Duncan, Lighthouse, Lloyd Waxman West Pharma Services and Vinod Vilivalam, West Pharma Services
(authors of presented poster – not of blog)
West Pharma Services presented a poster at the 2016 PDA Annual Show in San Antonio, TX, on container closure integrity (cci) in extremely low temperatures (-165 deg. C). The study evaluated cci issues with low temperature storage two types of rubber stoppers and two types of vials (one plastic and one glass) giving a matrix of 170 samples. The goal of the study was to determine if cci would be affected if materials were put at extremely low, cryogenic, temperatures. The types of vials used – glass and plastic were all ready to fill versions but none of the vials had liquid or a lyo cake in them.
The results were shocking – with all but one glass vial failing cci while all the plastic vials maintained cci after 8 days at cryogenic temperatures. They reasoned that the plastic forms a seal at these temperature with the rubber stopper, enhancing the cci. The glass vials did not exhibit this bond. They found that once the vials were brought to room temperature they would re-seal and therefore pass traditional cci testing, such as microbial ingress, dye ingress. However, by using the Lighthouse method (laser headspace analysis) it was found to have failed.
A full version of this presentation can be found by contacting epolini@westpharma.com. The information in this study should be interesting to companies that require cryogenic temperatures to store their products – it suggests that perhaps CZ plastic vials or other vials made of plastic might be the best container to maintain closure integrity.
