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  1. 2504475

    PDA ▹

    Points to Consider for the Aseptic Processing of Sterile Pharmaceutical Products in Isolators

    Report / Survey by Parenteral Drug Association, 01/01/2020.

    Languages: English

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  2. 2504472

    PDA PTC PUPSIT 1▹

    Points to Consider for Risks Associated with Sterilizing Grade Filters and Sterilizing Filtration

    Report / Survey by Parenteral Drug Association, 02/01/2020.

    Languages: English

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  3. 2504474

    PDA PTC PUPSIT 2▹

    Points to Consider for Implementation of Pre-Use Post-Sterilization Integrity Testing (PUPSIT)

    Report / Survey by Parenteral Drug Association, 03/01/2020.

    Languages: English

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  4. 2034296

    PDA TR 1▹

    Technical Report No. 1, (TR 1) Validation of Moist Heat Sterilization Processes: Cycle Design, Development

    Report / Survey by Parenteral Drug Association, 2007.

    Languages: English

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  5. 2254359

    PDA TR 13▹

    Technical Report 13 Revised 2022, (TR 13) Fundamentals of an Environmental Monitoring Program

    Report / Survey by Parenteral Drug Association, 04/22/2022.

    Languages: English

    Historical Editions: PDA TR 13

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  6. HISTORICAL

    2030452

    PDA TR 13▹

    This document has been replaced. View the most recent version.

    Technical Report 13 Revised, (TR 13) Fundamentals of an Environmental Monitoring Program

    Report / Survey by Parenteral Drug Association, 06/01/2014.

    Languages: English

    Historical Editions: PDA TR 13

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  7. 2250081

    PDA TR 13-2▹

    Technical Report No. 13-2 Fundamentals of an Environmental Monitoring Program Annex 1: Environmental Monitoring of Facilities Manufacturing Low Bioburden Products

    Report / Survey by Parenteral Drug Association, 11/01/2020.

    Languages: English

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  8. 2898883

    PDA TR 15▹

    Technical Report No. 15, Revised 2009 (TR 15) Validation of Tangential Flow Filtration in Biopharmaceutical Applications

    Report / Survey by Parenteral Drug Association, 06/01/2009.

    Languages: English

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  9. 2030657

    PDA TR 22▹

    Technical Report No. 22, (TR 22) Revised 2011 Process Simulation for Aseptically Filled Products

    Report / Survey by Parenteral Drug Association, 12/01/2011.

    Languages: English

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  10. 2077871

    PDA TR 26▹

    Technical Report No. 26, (TR 26) Sterilizing Filtration of Liquids

    Report / Survey by Parenteral Drug Association, 2008.

    Languages: English

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