Containment & Isolation White Papers & Case Studies

  1. A High Volume Process For Highly Potent (HP) Active Pharmaceutical Ingredients (APIs) 2/20/2013

    This case study demonstrates how a commercial manufacturing partnership between Alkermes Contract Pharma Services (Alkermes) and a large pharmaceutical company resulted in the establishment of a high volume process for Highly Potent (HP) Active Pharmaceutical Ingredients (APIs).

  2. Alternatives to Traditional Fume Hoods: Ductless Enclosures And Fume Hoods 12/20/2012

    Safety is the primary purpose of any filtered enclosure or ventilated fume hood. In most situations, fume hoods remain the equipment of choice for ventilating hazardous airborne chemicals from the laboratory. By Gary Roepke, Senior Project Engineer, Labconco Corporation

  3. Laboratory Fume Hood Conflict "Energy Savings" vs "Safe Containment" 12/20/2012

    Safety is the primary purpose of any laboratory hood. Facility managers and laboratory planners desire fume hoods that can conserve energy without compromising safety. Exhausting less air through a hood can result in substantial energy savings.

  4. The XPert Nano Enclosure's Ability To Contain Nanoparticles Is NANOSAFE TESTED™ 12/20/2012

    NANOSAFE INC., an independent testing company, evaluated the XPert Nano Enclosure for its ability to contain nanoparticles.

  5. Robotics And Isolator-Barrier Systems: The Perfect Combination For Advanced Aseptic Processing 11/27/2012

    The aim of advanced aseptic processing is the elimination and absolute control of all sources of contaminants – most importantly, humangenerated contamination. By Joshua Russell

  6. Biological Contamination Events In Isolators: What Lessons Can Be Learned? 8/17/2012

    Microbiological deviation and biological contamination events have been observed in pharmaceutical isolators including those used in production, sterility test and pharmacy aseptic services. By James Drinkwater, Bioquell UK Process & Compliance Director

  7. 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

  8. 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).
  9. 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.

  10. 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