By Eric Langer, President and Managing Partner, BioPlan Associates, Inc.
Biopharmaceutical manufacturing is one of the most demanding industries on its suppliers: demanding that its vendors be prequalified as primary or secondary, requiring confirmations of product provenance, certificates of analysis, and other sometimes onerous documentation. All of this is done for drug product quality and consistency.
By Adrian Possumato, Multisorb Technologies
Pharmaceuticals are subject to a variety of degradation pathways that compromise drug safety and shelf life. By far the greatest degradation is caused by hydrolysis and oxidation. However, other mechanisms include racemization, photodegradation, elimination, and complexation.
By Jack Chopper, Chief Electrical Engineer, Filamatic, LLC
For those who are part of an organization that views the plant floor and enterprise data as necessarily disparate, the unification challenges are both technical and organizational. The technical ones are easy, but the organizational ones — not so much. Most people resist change because it forces them out of their comfort zones. In reality, that’s precisely what we need to do! If we expect to drive change, we need to anticipate operating outside of our own comfort zones, and we’ll need to ask others to do the same. We must lead by example. I’d like to offer some tips and hints designed to encourage participation by the folks who are capable of connecting the enterprise information and plant floor information systems.
By Sharon Nowak, Coperion K-Tron
The combination of twin-screw extruders, loss-in-weight feeding, and pneumatic refill systems is quickly becoming the manufacturing process of choice when developing pharmaceutical solid dosage forms.