ILC Dover has been developing solutions for the pharmaceutical and biopharmaceutical markets since 1997. We pioneered single use Flexible Containment to address safe powder handling of potent compounds and we’ve recently created a breakthrough solution (the EZ BioPac®) used in the efficient production of media and buffers for biopharmaceutical operations. Through a strategic acquisition we also offer a full line of powder processing equipment. All of our life science products leverage technology solutions from our product base including the space suits for NASA, advanced airships, and innovative respiratory protective equipment.
To create the most effective single use solutions we’ve used our vast material development experience to create the ArmorFlex® line of films. These regulatory compliant films are custom formulated by ILC to deliver superior elongation performance (nearly 500%) which translated into increased ruggedness and high strength. This feature coupled with a unique blend of safe and effective anti-static additives allows all of the DoverPac® products to deliver reliable high-level powder handling performance.
ILC’s manufacturing facilities include an ISO Class 7 Clean Room. This clean room and our customized production equipment allow all of single use products to be produced to the most exacting standards.
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Systems should be analyzed not only for their basic ability to contain the powders of interest, but also for how efficiently they integrate into the production process. For instance, will the system help to eliminate productivity bottlenecks, decrease material waste and the cost of raw materials, and simplify the changeover of the line to new products?
Two methods of containing blenders have been demonstrated. Included here are the use of flexible enclosures and separate, disposable powder transfer systems.
Media and buffer preparation is a key part of the biopharmaceutical manufacturing process, and while it doesn’t have to be carried out in sterile conditions, improving the powder transfer process makes this step cleaner, safer, and more efficient, protects personnel and could cut time and costs as well. By Chris Rombach
ILC Dover has developed a new powder transfer process to solve issues related to contamination and reduce the fill time of each powder bag.
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.
The process for this application consists of the controlled feeding of a mill through a feeder. The powder is introduced into the feeder using a drum transfer system.
One of the simplest, most convenient and most cost-effective ways to ship, receive, and store bulk powder ingredients, including active pharmaceutical ingredients (APIs), intermediates, excipients, and ingredients for buffers and media, is in drums. The contents of these will need to be transferred before use, and this process can be challenging. Integrated drum transfer solutions make the process simpler, cleaner, and faster, improving safety for both workers and patients, as well as protecting any remaining ingredients for storage.
Handling HP/C compounds requires highly specialized facilities and controls. As part of Pharmatek’s overall corporate safety program, they chose to integrate ILC Dover Flexible Containment Solutions into their HP/C facilities.
Alan George is the Product Manager for ILC Dover’s flexible containment and disposable systems and has been actively supporting the development of flexible containment solutions for a wide range of processing equipment for over 13 years. In this Q&A, Alan responds to 7 questions concerning the use of flexibles to support powder charging in biopharmaceutical operations.
ILC Dover, the designer and manufacturer of NASA’s space suits and a wide range of engineered film and fabric products, announced recently it has received certification for its ISO Class 7 Clean Room.
ILC Dover, the designer and manufacturer of NASA's space suits and a wide range of engineered film and fabric products, announced today its innovative, flexible containment systems are being offered for nanotechnology applications.
ILC Dover pioneered flexible containment for the pharmaceutical industry and continues to innovate processes for better performance.