ArmorFlex® 110 Film Frequently Asked Questions
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.
WHITE PAPERS & CASE STUDIES
Important Considerations For Implementing A Single-Use Biomanufacturing Strategy
Recent trends in biomanufacturing technology and the biopharmaceutical market are supporting the increased adoption of single-use (SU) manufacturing systems. On the demand-side, the biopharma industry is focusing on niche and rare diseases with smaller patient populations, resulting in the need for smaller, more agile biomanufacturing capacity. By Jodi M. Zobrist and Nicole W. O'Brien, Ph. D., Gallus Biopharmaceuticals, LLC
Inside BioPharma: A Closer Look At Filter Housings
Although traditional stainless steel equipment has lost a great deal of market penetration to single-use alternatives over the past decade, there still is a need for quality filter cartridge systems for sterilizing and polishing filtration processes. By Leon VanWormer, MBA, Sartorius Stedim Biotech
Peristaltic Aseptic Filling Machines With A Single Use Production Philosophy
New drug development is today focused largely on biopharmaceuticals rather than chemicals, which means that the resultant drugs tend to be injectable liquids instead of solids. Furthermore, the new drugs are typically designed for specific populations, hence batch sizes are smaller. Alongside these two trends there are ongoing pressures to increase efficiency, reduce costs, and minimize risks — including cross-contamination between batches. Additionally there is a need for a reduction in the time involved in validation procedures; paperwork and man-hours, for example. Taken together, these factors point towards peristaltic pumps with single-use tubing or tubing sets as representing the future for bio-pharmaceutical fill/finish lines. By Peter Lambert
Meeting BioPharma Needs For Lower Operating Cost And Faster Time To Market
Broad adoption awaits fully scalable GMP systems, improved and less costly disposables, better analytics, greater process automation and low-shear mixing.
Weathering The Storm Of Regulatory Compliance In Aseptic Manufacturing
When the U.S. Food and Drug Administration (FDA) conducts an unscheduled inspection of your aseptic manufacturing process, it can hit with the fury of a New England nor’easter. But just as careful planning and forecasting help us safely ride out the storm, a best-practice control and monitoring system minimizes the danger of FDA noncompliance. By Alex Mello, Microtest
Controlling Bioburden Within Biopharmaceutical Manufacturing Processes
Preventing contaminations within manufacturing process requires consideration to be given to many facets of facility design and operation. The operating philosophy of the facility can change the approach to contamination control.