By Gail Dutton, Contributing Editor
Continuous improvement doesn't just depend upon Lean principles and/or zero-based budgeting. It depends upon people inspired by a culture that values learning, promotes problem-solving skills, and striving toward big goals by making small improvements every day.
By Dipl.-Ing. Sebastian Kundel, Product Manager Process and Control Valves, Bürkert Fluid Control Systems
In the food and beverage industry, and also in the production of medicines and cosmetics, excellent hygiene in processes and around the plant plays a key role. This is ensured by stringent legislative regulations. Standards such as HACCP (Hazard Analysis and Critical Control Points) for food processing and GMP (Good Manufacturing Practice) for FDA-compliant processes in the pharmaceutical industry define extremely stringent requirements for cleanliness, safety, and product quality.
By Adrian Possumato, Global Director, Healthcare Packaging, Multisorb Technologies
Scientific advances in the pharmaceutical industry have given rise to new stability challenges and consequently, have created an increased need for more advanced desiccants, moisture regulators, oxygen absorbers, and other forms of sorbent technology. In this competitive market, taking a QbD approach by introducing the use of sorbent technology during the early development stages becomes critical to getting your product to market ahead of competitors.
By Andrea Simonetti, TASI Group, Bonfiglioli Engineering and Sepha
This article provides an overview of the process analytical technology (PAT) methodology application to automated equipment developed for 100 percent container closure integrity testing (CCIT) of pharmaceutical items.
By Tara S. Hundley, Anton Paar USA
What drives a pharmaceutical company to scrutinize an instrument manufacturer and every detail of the instrument during instrument qualification? The answer is simple, compliance to regulations. Every company that produces pharmaceutical products must guarantee a consistent quality that meets regulated specifications — for the entire product life cycle, from production to consumption.
By Dr. Laura Ciccolini, Commercial Director, Biopharma Technology Limited
Freeze drying (lyophilization) is a stabilization method that is widely used in the pharmaceutical industry for drugs, vaccines, antibodies, and other biological material. Freeze drying can be a complex process to handle effectively, but despite improvements in analytical and process science a number of misconceptions persist. Below we look at a selection of those we encounter most often.