Engineering

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  • Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions

    Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions

    Engineering san Jose (california) December 18, 2020 Check with publisher

    Raw material requirements in a cGMP environment are often overlooked as a Company develops new products. Depending upon the product being developed, e.g., tablets and capsules vs. biotechnology products to include recombinant microorganisms and gene ...

  • EO Sterilization Equipment, Software and Product Validation Per ISO 11135

    EO Sterilization Equipment, Software and Product Validation Per ISO 11135

    Engineering san Jose (california) October 28, 2020 Check with publisher

    ISO 11135:2014: “Sterilization of health-care products – Ethylene oxide – Requirements for the development, validation and routine control of a sterilization process for medical devices”, defines the latest requirements for the validation of Ethylene...