Cleaning, Sterilization & Bio Decontamination White Papers & Case Studies
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The Benefits Of Isolator And Aseptic Processing
Isolators have been around the Pharmaceutical Industry since the early 1980s and in the Nuclear Industry (glovebox technology) since the 1950s. The intent of isolators is to create an airtight barrier or enclosure around a piece of equipment or process which provides absolute separation between the operator and product. By Gary Partington
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Applications And Integration Of Hydrogen Peroxide Vapor For Biotech/Bioprocess
The increase in size and scale of bio-processing is presenting a new challenge. Traditional methods of sterilisation, to maintain clean facilities, are becoming difficult to deploy in a controlled and regulatory compliant way. By Richard Lucas, Ph.D., Bioquell UK Ltd.
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Green Washing: A Sustainability Checklist
Planning a lab that meets today’s requirements for sustainability is a top demand for lab planners and architects. The U.S. Green Building Council certified its first LEED Building in 2002 and since then the movement to create sustainable buildings has put pressure on architects to become experts in environmental efficiency.
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Integration Of Tray Dryers & Nutsche Filter In Containment Isolator System
Walker Barrier Systems was tasked with providing a system to contain potent and toxic active pharmaceutical compounds to 0.5μg/m³ exposure level (TWA over operation duration), for an existing Lab space. The unit was designed for product filtration, drying in vacuum heat oven, hand sieving and discharging and final dispensing for further processing, using a Hicoflex system, for an existing Laboratory. By Gary Partington
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Material Compatibility With Vaporized Hydrogen Peroxide (VHP) Sterilization
Various sterilization methods (including gamma irradiation an ethylene oxide) have been widely used for terminal medical device sterilization. No single method offers the perfect sterilization solution for every application. By G. McDonnell
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Multivariate Data Analysis For Biotech and Bioprocessing
The modern biopharmaceutical/biotechnology manufacturing facility contains many sophisticated control, data logging, and data archiving systems. Massive amounts of data are collected from sources such as raw materials analysis, process outputs, and final quality assessments, which are stored in data warehouses.
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Flexibility In Sterility Testing And Managing Risks Of False Positives
This paper reviews the background to false positives and false negatives associated with the sterility test process. It explores the potential causes of such results and suggests methods of mitigation. By James Drinkwater, Bioquell UK Process & Compliance Director
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Unither Pharmaceuticals Deploys Fully Automated Production Line
Unither is a world leader in the manufacture of formulations for the pharmaceutical industry. Its plant at Gannat, in the Department of Allier, is a specialised production site for manufacture of pharmaceuticals.
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Top 10 Considerations When Selecting An Isolator Supplier
While price is certainly an important reason for buying any piece of capital equipment, it is not always the top reason. There are important considerations to examine when selecting an isolator supplier.
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Improving Corrective And Preventive Measures In The Pharma Supply Chain
The pharmaceutical quality of medicinal products is of utmost importance to patient health and outcome: poor quality can lead to adverse effects - which can sometimes be severe enough to lead to morbidity and death, as well as treatment failure and hence, prolonged illness, lack of trust in the healthcare system, distributor and manufacturer, and a waste of financial resources.