Current Edition

What Pharma Producers Need to Know About Changing Regulations on Cleanroom Films and Anti-static Additives

With new USP <661.1> regulations on plastic packaging materials for pharmaceuticals set to take effect in May 2020, and following this, USP <665> (formerly known as USP <661.3>) for plastics used in the drug manufacturing process bringing new requirements, it is decision time for processors and pharmaceutical users of anti-static polyethylene and polypropylene films. In his article, Steve Duckworth from Clariant provides an overview of these changes and how to be sure to protect the value of in-process APIs and finished drug products.