At ILC Dover, we are always "creating what’s next" by listening carefully to our customers. In response to customer input and emerging regulations, we've developed a robust new film to support our DoverPac® Containment Solutions line. This revolutionary product, ArmorFlex® 110, delivers permanent static dissipative properties while meeting FDA and 2002/72/EC requirements for food contact.
Maik W. Jornitz, President, G-CON Manufacturing LLC
Past experiences have shown that too often product quality is based on sole reliance of vendor certifications, statements and promises. To diminish such reliance new technologies started to be implemented, like process analytical technologies (PAT), process controls, automation etc. often once again overexerted as the solution to all problems. Activities that supposedly result in higher product quality due to better process controls. Maik W. Jornitz, Chief Operating Officer, G-CON Manufacturing LLC
When sampling and dosing active pharmaceutical ingredients (APIs) or high-potency APIs (HPAPIs), containment can be critical. Good laboratory practices (GLP) and the proper equipment designed and calibrated to facilitate GLP when transferring, mixing or blending APIs can reduce product waste, product contamination and minimize lost profit as well as create a healthier, contaminant free environment for lab operators. By Jason Frye
With the use of catalytic aeration, M + P is able to reduce the duration of the aeration phase in isolators by about 50 %. The aeration phase is the most time consuming cycle during H2O2 decontamination. By Felix Henning, Optima Packaging Group GmbH
Barrier technology has become overwhelmingly accepted as the basis for new aseptic processing facilities in 2013. The traditional clean room facilities of the 20th century are being rapidly replaced with advanced barrier based technology filling facilities. This technological evolution is dramatically reducing the risk of product contamination and risk of infection to patients. By Sterling Kline, RA IPS
You have been tasked by senior management to look into purchasing a cleanroom environment for a possible new product line. The mandate is that the cleanroom system provider must guarantee temperature, humidity, pressurization, and classification. As with any purchase, it is always best to be an educated buyer and have researched the options available to you. Knowing what questions to ask and what the cumulative effect is to those answers will make for a sound decision process and an overall successful project. By Rick Dobson, AES Clean Technology
This case study demonstrates how a commercial manufacturing partnership between Alkermes Contract Pharma Services (Alkermes) and a large pharmaceutical company resulted in the establishment of a high volume process for Highly Potent (HP) Active Pharmaceutical Ingredients (APIs).