Light obscuration testing is the preferred method of sub-visible particle quantification but is not suitable for every preparation.
A well-defined contamination control program is essential to maintain quality through aseptic manufacture of parenteral drug products.
A well-defined contamination control program is essential to maintain quality through aseptic manufacture of parenteral drug products.
FDA’s new guidance on in-vitro permeation test studies published in October 2022 gives technical and statistical requirements for conducting these tests to compare topical generic drugs with their reference products.
Single-use processing requires instruments providing the accuracy of traditional technologies but configured in form factors designed specifically for this service
Modular cleanroom construction can offer a number of important advantages over conventional (stick-built) approaches. Learn more about the benefits of modular here.
The global pharma industry drug pipeline is bursting with more than 3,800 injectable drugs of which more than 70% are biologics in clinical phases