{"id":15643,"date":"2021-10-05T14:20:52","date_gmt":"2021-10-05T14:20:52","guid":{"rendered":"https:\/\/clinlabint.com\/?p=15643"},"modified":"2021-10-05T14:20:52","modified_gmt":"2021-10-05T14:20:52","slug":"study-shows-glass-pfs-can-be-stored-at-20c-and-40c-without-risk","status":"publish","type":"post","link":"https:\/\/clinlabint.com\/study-shows-glass-pfs-can-be-stored-at-20c-and-40c-without-risk\/","title":{"rendered":"Study shows glass PFS can be stored at -20\u00b0C and -40\u00b0C without risk"},"content":{"rendered":"
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Study shows glass PFS can be stored at -20\u00b0C and -40\u00b0C without risk<\/h1>\/ in E-News<\/a> <\/span><\/span><\/header>\n<\/div><\/section>
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Becton, Dickinson and Company (BD) has completed a preliminary study investigating the impact of deep cold storage (-20\u00b0C and -40\u00b0C) on glass prefillable syringes (PFS).<\/h3>\n

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While traditional vaccine formulations are commonly stored up to about 2\u00b0C-8\u00b0C, new vaccine formulations \u2013 including those for mRNA \u2013 require much colder storage for over a long period of time to ensure drug-product shelf-life and potency. Such low temperatures can induce changes in container dimensions, phase transition \u2013 liquid to solid and vice versa \u2013 and thermal shock. This could compromise the functional performance of the delivery system and Container Closure Integrity (CCI). BD began its investigation on the impact of deep cold storage on glass PFS as soon as information regarding the deep cold storage requirement for mRNA COVID-19 vaccines became available in 2020.<\/p>\n

The researchers conducted a comprehensive analysis of approximately 2,000 PFS after deep cold storage at -20\u00b0C and -40\u00b0C. Tests were conducted on several combinations of glass barrel coatings, formats (from 0.5 to 3 mL), different tip and flange designs, and multiple elastomeric closures with various state-of-theart methods, including Lighthouse Laser Headspace Analysis, at these temperatures.<\/p>\n

The study showed key product functions (PFS system level) were unaltered when stored at -20\u00b0C and -40\u00b0C. In addition, the count of subvisible particles and container closure integrity (CCI) remained unchanged when compared to those stored at room temperature.<\/p>\n

\u201cPFS are a known factor in addressing the complexity and costs of vaccine administration. They have been shown to significantly reduce time and labour associated with drug preparation compared to vial formats, and they support dose sparing,\u201d said Bruno Baney, Vice President of R&D for Pharmaceutical Systems at BD. \u201cThis study confirms the promising opportunity we have to apply our leading scientific capabilities to develop innovative delivery solutions for our customers now and in the future. We\u2019re encouraged by these results and look forward to partnering with pharmaceutical companies to further advance PFS in deep cold conditions.\u201d<\/p>\n

Following its completion of this study, BD anticipates that BD glass barrel PFS systems should be suitable for use when storage temperatures of -20\u00b0C and -40\u00b0C are required.<\/p>\n

BD says detailed study results are available to their customers\/partners upon request.<\/p>\n

The company notes that they are enhancing their manufacturing capacity and technology for PFS and advanced drug delivery systems with previously announced plans to invest $1.2 billion over four years.<\/p>\n<\/div><\/section>
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