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    Non-sterile manufacturing

    Non-sterile manufacturing refers to drug production methods which do not completely eliminate potential contaminants. Depending on the item being manufactured, procedures are designed to control the burden of contamination to a safe level, without enduring the added time and expense to eliminate the burden of contamination. Factors specific to the drug's activity, target patient population, and route of administration are considered when determining standards for non-sterile manufacturing procedures.

    What's Popular in Non-sterile manufacturing

    Trending News

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      JUL 28, 2022
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    SEP 29, 2022
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    JUL 28, 2022
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    The benefits of lyophilization in assay kit development: Maximizing the integrity and shelf life of reagents
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    Freeze drying, lyophilization, and cryodesiccation are all terms used to describe the process of removing water from a s ...
    Sponsored By: Cytiva
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    JUL 01, 2022
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    Avoiding Eco-Fatigue
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    Non-sterile manufacturing
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    Webinars

    • MAR 30, 2021 | 8:00 AM
      Utilizing the Gibcoâ„¢ CTSâ„¢ Roteaâ„¢ System, a versatile closed manufacturing system, for cell and gene therapy development
      Utilizing the Gibcoâ„¢ CTSâ„¢ Roteaâ„¢ System, a versatile closed manufacturing...
      DATE: March 30, 2021 TIME: 08:00am PST In this talk, we will discuss the value of moving towards modular and automated, closed-system technologies designed to enable scalable and cost-effect...
      Speaker: Mary Ann Santos , Emily Benz , Eric Dubofsky
      Sponsored By: Thermo Fisher Scientific/Gibco
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      SEP 29, 2020 | 8:00 AM
      Microbial Quality Control in Manufacturing of Medicinal Products
      Microbial Quality Control in Manufacturing of Medicinal Products
      DATE: September 29, 2020 TIME: 8:00 am PDT There is a steady increase in FDA 483s related to microbiology. Though most are for sterile products, non-sterile and terminally sterilized product...
      Speaker: Ziva Abraham
      Sponsored By: Sartorius
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      SEP 03, 2015 | 12:00 PM
      CSPA Microbiology Preservative Subcommittee (MPS): Supporting & Enhancing  the Microbiological Quality of Consumer, Household & Industrial Products
      CSPA Microbiology Preservative Subcommittee (MPS): Supporting...
      Consumer, Household, and Industrial (CH&I) formulations have increasingly driven towards more environmentally acceptable ingredients within water-based formulations, microbial control str...
      Speaker: Tony Rook
      Presented at: Microbiology Virtual Event Series 2015
      2
    MAR 30, 2021 | 8:00 AM
    Utilizing the Gibcoâ„¢ CTSâ„¢ Roteaâ„¢ System, a versatile closed manufacturing system, for cell and gene therapy development
    Utilizing the Gibcoâ„¢ CTSâ„¢ Roteaâ„¢ System, a versatile closed manufacturing...
    DATE: March 30, 2021 TIME: 08:00am PST In this talk, we will discuss the value of moving towards modular and automated, closed-system technologies designed to enable scalable and cost-effect...
    Speaker: Mary Ann Santos , Emily Benz , Eric Dubofsky
    Sponsored By: Thermo Fisher Scientific/Gibco
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    SEP 29, 2020 | 8:00 AM
    Microbial Quality Control in Manufacturing of Medicinal Products
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    DATE: September 29, 2020 TIME: 8:00 am PDT There is a steady increase in FDA 483s related to microbiology. Though most are for sterile products, non-sterile and terminally sterilized product...
    Speaker: Ziva Abraham
    Sponsored By: Sartorius
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    SEP 03, 2015 | 12:00 PM
    CSPA Microbiology Preservative Subcommittee (MPS): Supporting & Enhancing  the Microbiological Quality of Consumer, Household & Industrial Products
    CSPA Microbiology Preservative Subcommittee (MPS): Supporting...
    Consumer, Household, and Industrial (CH&I) formulations have increasingly driven towards more environmentally acceptable ingredients within water-based formulations, microbial control str...
    Speaker: Tony Rook
    Presented at: Microbiology Virtual Event Series 2015
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