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  • Clean Rooms - Non-Aseptic Pharma Manufacturing/Health Care: o o o o o o

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    The document discusses requirements for clean rooms used in non-aseptic pharmaceutical manufacturing and healthcare facilities. It outlines necessary personnel procedures, premises, production systems, cleaning procedures, product protection levels, and air pressure controls. Clean rooms must also include auxiliary equipment like changing rooms, air showers, and sterilization apparatuses. For non-aseptic manufacturing, humidity and filter efficiency are more important than in aseptic production. Isolation rooms in healthcare need to restrict air movement between departments and maintain positive pressure to prevent cross-contamination.

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    Clean Room-54

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    The document discusses requirements for clean rooms used in non-aseptic pharmaceutical manufacturing and healthcare facilities. It outlines necessary personnel procedures, premises, production systems, cleaning procedures, product protection levels, and air pressure controls. Clean rooms must also include auxiliary equipment like changing rooms, air showers, and sterilization apparatuses. For non-aseptic manufacturing, humidity and filter efficiency are more important than in aseptic production. Isolation rooms in healthcare need to restrict air movement between departments and maintain positive pressure to prevent cross-contamination.

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    54 views1 page

    Clean Rooms - Non-Aseptic Pharma Manufacturing/Health Care: o o o o o o

    Uploaded by

    CIVIL
    The document discusses requirements for clean rooms used in non-aseptic pharmaceutical manufacturing and healthcare facilities. It outlines necessary personnel procedures, premises, production systems, cleaning procedures, product protection levels, and air pressure controls. Clean rooms must also include auxiliary equipment like changing rooms, air showers, and sterilization apparatuses. For non-aseptic manufacturing, humidity and filter efficiency are more important than in aseptic production. Isolation rooms in healthcare need to restrict air movement between departments and maintain positive pressure to prevent cross-contamination.

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    of 1

    www.PDHcenter.com PDH Course M143 www.PDHonline.

    org

    o Personnel procedures

    o Adequate premises

    o Use of closed production systems

    o Adequate and validated cleaning procedures

    o Appropriate levels of protection of product

    o Correct air pressure cascade

    The air handling system must take into account the contamination and cross

    contamination issues; establish product sensitivity to environment and to the therapeutic

    risk.

    • Auxiliary equipment and facilities: The bio-clean rooms must include the auxiliary

    equipments such as changing rooms, air showers, hand-washing equipment, emergency

    eyewash & showers, jet towels, alcohol spray disinfections apparatus, Autoclave, EO gas

    sterilization apparatus, Germicide, pass box etc. etc…. The additional measures include;

    appropriate gowning, change rooms, validated sanitation, compressed air blows etc.

    2
    Clean Rooms –Non-aseptic Pharma Manufacturing/Health Care
    The clean spaces for non-aseptic product manufacturing follows the same general approach as

    aseptic pharmaceutical manufacturing, but with fewer critical parameters and components to be

    qualified. In making powdered materials, humidity level and control may be more rigorous; in

    these cases the HEPA filters perform more of a dust catching role than bacterial control. Here

    filter efficiency is more important than pinhole testing.

    Isolation Rooms in Health Care


    The basic air conditioning requirements for health care facilities are

    (1) The need to restrict air movement in and between the various departments;

    Page 54 of 61

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