Blogs

Extractables and Leachables

2018-05-10T07:13:27+00:00

Extractable and leachable studies have become a hot topic within the Pharmaceutical industry. Some individuals consider Extractables and Leachables as one entity, but they are really considered two different studies.

Extractables and Leachables 2018-05-10T07:13:27+00:00

How clean is clean? – Cleaning, sanitizing, decontaminating… are you at par with FDA guidelines?

2018-05-10T07:13:27+00:00

Modern cleaning validation procedures must be implemented to prove that the equipment is reasonably free of any residue. It must be documented to be safe, causes no product quality concerns, and the process is contaminant-free in accordance with FDA, cGMPs, and USP guidelines.

How clean is clean? – Cleaning, sanitizing, decontaminating… are you at par with FDA guidelines? 2018-05-10T07:13:27+00:00