USP on Plastic Packaging

[membership level=”0,4″][The content continues for paid members only.] Login or Subscribe [/membership][membership level=”1,5,6,7,8,9,10,11,12″][membership] USP’s June/July Pharmacopeial Forum includes revisions to its “Plastic Materials of Construction (<661.1>) and “Plastic Packaging Systems for Pharmaceutical Use” (<661.2>). Four new polymers with test methods and specifications are included, along with new guidance on spectral transmission requirements for light-resistant containers. Furthermore, the “Biological Reactivity Tests, In Vitro” (<87>) requirement for packaging systems used for oral and topical dosage forms is being removed, while the effort to revise <87> and “Biological Reactivity Tests, In Vivo” (<88>) proceeds. The guidance now states a product’s packaging system is considered safe if “deemed appropriate for pharmaceutical use by the appropriate regulatory authority,” and with respect to oral and topical dosage forms, compliant with food regulations. Register to the USP Pharmacopeial Forum website to read the complete drafts. The chapter is open for comment until September 30, 2016.
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