ResourceGeneral Lab
Performance Testing of Pharmaceutical Isolators Based on USP 797 Requirements
Performance Testing of Pharmaceutical Isolators Based on USP 797 Requirements
27 Jul 2015This application note demonstrates the testing of two models of pharmaceutical isolators against the United States Pharmacopeia requirements laid out in an in-process revision to chapter 797 of their regulations. The SterilSHIELD and the ChemoSHIELD were tested according to CETA CAG 002-2006 and subjected to a simulated process-generated cross-contamination.
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Safety EquipmentLaboratory safety equipment is essential to the effective operation of all laboratories and is required to minimize the risk of harm during experiments. Safety equipment includes radiation safety, radioactive / hazardous waste disposal, alarms and personal safety.Fumehoods and Biological Safety CabinetsFume hoods and biological safety cabinets are used to provide personnel, sample and environmental protection by limiting exposure to hazardous materials either by venting or enclosing hazardous sample space. Fume hoods include filtered and ductless fume hoods, general ducted fume hoods, laminar flow cabinets and cabinets for powder weighing. There are three classes of biological safety cabinet, dependent on the level of protection provided. Class I provide personnel and environmental protection, class II provide product, personnel and environmental protection. Class III provide the highest level of protection and are designed for use with high-risk biological agents. Other ventilated workspaces for the laboratory include glove boxes, glove bags, anaerobic and hypoxic workstations. Find the best fume hoods and biological safety cabinets in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Contamination PreventionContamination prevention aims to control and minimize the risk of contamination during experiments. Biological safety cabinets and sterilization equipment are examples of technologies used to prevent contamination.PharmaceuticalsPharmaceuticals are medicinal drugs used in healthcare to diagnose, prevent, cure and treat illnesses. Pharmaceuticals that are excreted after use appear in wastewater and can have detrimental effects on the environment.Laboratory SafetyLaboratory safety is essential to the effective operation of all laboratories and is required to minimize the risk of harm during experiments. Guidelines, regulations, and equipment should be available in all laboratories to ensure that the working environment is safe and secure.USP Method