Containment & Isolation White Papers & Case Studies

  1. 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.

  2. 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
  3. 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
  4. 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
  5. 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
  6. Flexible Containment Solutions Guide Mill Containment System — Underdrive Design

    White Paper: Flexible Containment Solutions Guide Mill Containment System — Underdrive Design

  7. 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.

  8. 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.

  9. 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

  10. 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.