Containment & Isolation White Papers & Case Studies
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Weathering The Storm Of Regulatory Compliance In Aseptic Manufacturing
7/30/2012
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
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Containing Potent Pharmaceutical Powders - A Strategy Guide
4/23/2012
With the rise in popularity of High Potency Active Pharmaceutical Ingredients (HPAPIs) there has come increased interest in the containment and safe manufacture of such compounds. As drugs become more potent, they become increasingly dangerous to the health of plant personnel and manufacturers face significant challenges in ensuring the protection of their workers. By Mina Ibrahim, P.Eng., MBA
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The Logistics Of Filling And Freeze Drying Using Multiple Isolators
1/18/2012
The use of isolator technology to fill and lyophilize pharmaceuticals presents many logistical challenges. Aventis Pasteur has developed procedures to fill, partially stopper, freeze-dry and cap its products in the Pilot Plant using three isolators (Transfer, Filling, and Lyophilizer).
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White Paper: Glove Integrity Testing — Pressure Decay Method: Performance Qualification
10/28/2011
In recent years, Glove Integrity Testing has been profoundly discussed and numerous articles have been written on this topic. However, many doubts still remain within the industry due to the lack of norms and clear guidance available. In 2008 Annex 1 to EU Guidelines to Good Manufacturing Practice reiterated the importance of having glove integrity testing.
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Development Of The Labconco Protector® XStream® High Performance Laboratory Fume Hood
8/3/2011
Safety is the primary purpose of any laboratory hood. Facility managers and laboratory planners desire fume hoods that can conserve energy without compromising safety.
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Case Study: NANOSAFE TESTED™ Summary
8/3/2011
NanoSafe, Inc. developed a testing program to independently evaluate the generation and containment of a controlled nanoaerosol inside a Labconco XPert® Nano™ System.
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Sterile Drug Products Produced By Aseptic Processing — Current Good Manufacturing Practice
7/28/2011
This guidance is intended to help manufacturers meet the requirements in the Agency's current good manufacturing practice (CGMP) regulations (2l CFR parts 210 and 211) when manufacturing sterile drug and biological products using aseptic processing. By PharmaSystems, Inc.
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White Paper: Design/Build Cleanroom Specifications And Proposals
6/2/2011
When using the design/build method of delivery for a cleanroom project, proper creation of the project specification is critical. The contractor must then present a proposal in a manner by which the owner can accurately assess the value they are receiving. By AdvanceTEC
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Design/Build Cleanroom Specifications And Proposals
6/2/2011
When using the design/build method of delivery for a cleanroom project, proper creation of the project specification is critical. The contractor must then present a proposal in a manner by which the owner can accurately assess the value they are receiving. By AdvanceTEC
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Designing Biopharma And Pharmaceutical Cleanrooms
5/23/2011
Richard Paley of Bovis Lend Lease takes a look at the key issues in the design, specification and selection of cleanrooms, considering the impact on the final build solution and comparing different classes and finishes to show the advantages or disadvantages of each. By Bovis Lend Lease