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    Airlock Between C&amp D

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    The document summarizes standards for clean rooms in Europe for manufacturing sterile medical products. It states that manufacturing must be done in clean areas with airlocks for personnel and equipment. Clean areas must maintain an appropriate cleanliness standard with filtered air. Operations like component preparation and filling must be separated. Manufacturing is divided into products that are terminally sterilized and those done aseptically. Clean areas are classified by their required environmental cleanliness levels to minimize contamination risks. Areas must reach specified air-cleanliness levels when unoccupied ("at rest") to meet conditions when occupied ("in operation").

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    Airlock Between C&amp D

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    premin
    12 views1 page
    The document summarizes standards for clean rooms in Europe for manufacturing sterile medical products. It states that manufacturing must be done in clean areas with airlocks for personnel and equipment. Clean areas must maintain an appropriate cleanliness standard with filtered air. Operations like component preparation and filling must be separated. Manufacturing is divided into products that are terminally sterilized and those done aseptically. Clean areas are classified by their required environmental cleanliness levels to minimize contamination risks. Areas must reach specified air-cleanliness levels when unoccupied ("at rest") to meet conditions when occupied ("in operation").

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    Airlock Between C&D

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    The document summarizes standards for clean rooms in Europe for manufacturing sterile medical products. It states that manufacturing must be done in clean areas with airlocks for personnel and equipment. Clean areas must maintain an appropriate cleanliness standard with filtered air. Operations like component preparation and filling must be separated. Manufacturing is divided into products that are terminally sterilized and those done aseptically. Clean areas are classified by their required environmental cleanliness levels to minimize contamination risks. Areas must reach specified air-cleanliness levels when unoccupied ("at rest") to meet conditions when occupied ("in operation").

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as DOC, PDF, TXT or read online from Scribd
    Download as doc, pdf, or txt
    12 views1 page

    Airlock Between C&amp D

    Uploaded by

    premin
    The document summarizes standards for clean rooms in Europe for manufacturing sterile medical products. It states that manufacturing must be done in clean areas with airlocks for personnel and equipment. Clean areas must maintain an appropriate cleanliness standard with filtered air. Operations like component preparation and filling must be separated. Manufacturing is divided into products that are terminally sterilized and those done aseptically. Clean areas are classified by their required environmental cleanliness levels to minimize contamination risks. Areas must reach specified air-cleanliness levels when unoccupied ("at rest") to meet conditions when occupied ("in operation").

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    Download as DOC, PDF, TXT or read online from Scribd
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    The most recent set of standards for Europe has come into operation on the 1 January 1997.

    This is contained in a 'Revision of the Annexe to the EU Guide to Good Manufacturing Practice-Manufacture of Sterile Medicinal Products'. The following is an extract of the information in the standard that is relevant to the design of clean rooms: 'General The manufacture of sterile products should be carried out in clean areas, entry to which should be through airlocks for personnel and/or for equipment and materials. Clean areas should be maintained to an appropriate cleanliness standard and supplied with air which has passed through filters of an appropriate efficiency. The various operations of component preparation, product preparation and filling should be carried out in separate areas within the clean area. Manufacturing operations are divided into two categories; firstly those where the product is terminally sterilised, and secondly those which are conducted aseptically at some or all stages. Clean areas for the manufacture of sterile products are classified according to the required characteristics of the environment. Each manufacturing operation required an appropriate environmental cleanliness level in the operational state in order to minimise the risks of particulate or microbial contamination of the product or materials being handled. In order to meet "in operation" conditions these areas should be designed to reach certain specified air-cleanliness levels in the "at rest" occupancy state. The "at-rest" state is the condition where the installation is complete with production equipment installed and operating but with no operating personnel present. The "in operation" state is the condition where the installation is functioning in the defined operating mode with the specified number of personnel working.

    Meaning: Any personnel/ material being passing through into a cleaner area has to achieve " at rest condition" for the higher classification area before moving into the higher classification area .

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