Equipment and Processing Report-11-16-2011

We have changed the brand of our stoppers for a product that we freeze-dry in vials. Since the change, we have observed a significant increase in rejects for collapsed cakes. Why are the cakes collapsing? What can we do to prevent this problem?

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the November 2011 edition from Sartorius Stedim Biotech and Thermo Fisher Scientific.

Implementing a zero-waste strategy is not merely an option, it can be seen as a crucial business imperative.

Until now, the industry has adhered to the tradition of producing three batches of product to validate its manufacturing processes. But FDA?s new process-validation guidance does not prescribe any number of batches that is necessary for compliance.