Containment & Isolation White Papers & Case Studies
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White Paper: 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
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Flexible Containment Solutions Guide: Document Transfer Enclosure
The Flexible Document Transfer Enclosure is designed to allow paperwork used in pharmaceutical processing to be handled in a contained way so that powders are not transferred onto the documents and to areas or individuals that are not protected.
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Flexible Containment Solutions Guide Mill Containment System — Underdrive Design
White Paper: Flexible Containment Solutions Guide Mill Containment System — Underdrive Design
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FS209E And ISO Cleanroom Standards
Before global cleanroom classifications and standards were adopted by the International Standards Organization (ISO), the U.S. General Service Administration’s standards (known as FS209E) were applied virtually worldwide. However, as the need for international standards grew, the ISO established a technical committee and several working groups to delineate its own set of standards.
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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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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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Dissolved Ozone Measurements: Installation And Calibration According To ASTM D7677-11
In the last three decades Ozone has become a very important and efficient tool to achieve high quality pharmaceutical grade water. This paper will address two main topics that are critical for the effective use of ozone within the water processes of the life science industry. By Georges Schmidt, Hach Lange Sàrl, Geneva, Switzerland
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Fumigation Within A Pharmaceutical Aseptic Filling Line
Bioquell's Room Bio-Decontamination Service was required for a major multi-national pharmaceutical company needed a solution that woul removed Staphylococcus edpdermidis from specific zones in an aseptic filling line with areas ranging from European GMP Grade A to Grade D. The solution neeeded to meet FDS regulatory requirements and have proven efficacy documentation againt S. epidermidis.
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Variability In Sterility Test Processes And The Benefits Of Modular Workstations
This paper reviews some of the current operational practices that incorporate sterility testing and provides an insight into the role of hydrogen peroxide vapor bio-decontamination and continuous particle monitoring. By James Drinkwater, Bioquell UK Process & Compliance Director