Cleaning Validation

In 1988, Cholestyramine Resin USP finished drug product (a cholesterol medication) was recalled due to cross-contamination with low levels of an agricultural pesticide.  The contamination was a result of a lack of validated cleaning procedures and inadequate control of recovered solvent drums. This recall reinforced the need for validated cleaning …

Aseptic Manufacturing

Safety First.  That’s the mantra echoed across almost every industry in the world.  This is especially true in the life sciences industry.  But this safety takes many forms.  The first and foremost is patient safety, the final customer.  For sterile parenteral products, ophthalmic solutions, and medical devices; product sterility is …

Aseptic Fill Lines

Purchasing an aseptic filling line can provide a huge economic advantage to a pharmaceutical company looking to increase its scale and throughput. An aseptic filling line can reliably increase production capacity, standardize quality, and reduce operator labor by combining multiple processes into an integrated system. Unfortunately, many companies don’t accurately …