Medizintechnik

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  • Process engineering - Turnaround management - Fundamentals

    Technical rule [CURRENT] 2021-11

    VDI 2775 Blatt 1:2021-11

    Process engineering - Turnaround management - Fundamentals

    The standard provides assistance for the successful implementation of a turnaround in the pharmaceutical, chemical, and petrochemical industry according to a project approach. It describes ...

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  • Process engineering - Turnaround management - Integration of project measures into a turnraround

    Draft technical rule [PRE-ORDER] 2026-01

    VDI 2775 Blatt 2:2026-01 - Draft

    Process engineering - Turnaround management - Integration of project measures into a turnraround

    The standard provides assistance for the successful integration of an investment project into an operational turnaround in the pharmaceutical, chemical and petrochemical industries (construction ...

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  • Traditional Chinese medicine - Simplified accelerated stress simulation methods

    Standard [CURRENT] 2024-12

    ISO 8284:2024-12

    Traditional Chinese medicine - Simplified accelerated stress simulation methods

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  • BS ISO 20658. Medical laboratories. Requirements for collection and transport of samples

    Draft standard 2022-08-03

    22/30447779 DC:2022-08-03 - Draft

    BS ISO 20658. Medical laboratories. Requirements for collection and transport of samples

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  • Standard Terminology Relating to Manufacturing of Pharmaceutical and Biopharmaceutical Products in the Pharmaceutical and Biopharmaceutical Industry

    Standard [CURRENT] 2023

    ASTM E 2363:2023

    Standard Terminology Relating to Manufacturing of Pharmaceutical and Biopharmaceutical Products in the Pharmaceutical and Biopharmaceutical Industry

    1.1 This standard covers terminology used by the E55 Committee relating to pharmaceutical and biopharmaceutical industry for manufacture of pharmaceutical and biopharmaceutical products. Terms ...

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  • Standard Guide for Process Understanding Related to Pharmaceutical Manufacture and Control

    Standard [CURRENT] 2023

    ASTM E 2475:2023

    Standard Guide for Process Understanding Related to Pharmaceutical Manufacture and Control

    1.1 The purpose of this guide is to establish a framework and context for process understanding for pharmaceutical manufacturing using the principles of quality by design (QbD) (Juran, 1992; 2 ...

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  • Standard Guide for Application of Continuous Manufacturing (CM) in the Pharmaceutical Industry

    Standard [CURRENT] 2023

    ASTM E 2968:2023

    Standard Guide for Application of Continuous Manufacturing (CM) in the Pharmaceutical Industry

    1.1 This guide introduces key concepts and principles to assist in the appropriate selection, development and operation of CM technologies for the manufacture of pharmaceutical products. Athough ...

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  • Standard Practice for Qualification of Visual Inspection of Pharmaceutical Manufacturing Equipment and Medical Devices for Residues

    Standard [CURRENT] 2022

    ASTM E 3263:2022

    Standard Practice for Qualification of Visual Inspection of Pharmaceutical Manufacturing Equipment and Medical Devices for Residues

    1.1 This practice provides statistically valid procedures for determining the visual detection limit of residues and the qualification of inspectors to perform the visual inspection of ...

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  • Standard Guide for Application of Continuous Manufacturing (BioCM) in the Biopharmaceutical Industry

    Standard [CURRENT] 2022

    ASTM E 3326:2022

    Standard Guide for Application of Continuous Manufacturing (BioCM) in the Biopharmaceutical Industry

    1.1 This guide is intended as a complement to Guide E2968 . It provides key concepts and principles to assist in the appropriate selection, development, and operation of continuous processing ...

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  • Standard Guide for Development and Validation Considerations of Advanced Process Control (APC) in Commercial Pharmaceutical Manufacturing

    Standard [CURRENT] 2025

    ASTM E 3424:2025

    Standard Guide for Development and Validation Considerations of Advanced Process Control (APC) in Commercial Pharmaceutical Manufacturing

    1.1 This guide provides guidance on the development, validation, and implementation of advanced process control (APC) methodologies in a good manufacturing practice (GMP) pharmaceutical environment.

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    from 71.96 EUR VAT excluded

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