STP1051

    The Biological Production Facility—Design for Protection of the Worker and the Community

    Published: Jan 1990


      Format Pages Price  
    PDF (96K) 6 $25   ADD TO CART
    Complete Source PDF (2.3M) 6 $55   ADD TO CART


    Abstract

    Facilities for the manufacture of biologicals require careful assessment of the building construction and location, the heating, ventilating, and air conditioning, the movement of personnel and materials, personnel vaccination, security, major equipment selection and validation, protective equipment, decontamination procedures, environmental monitoring and control, and overall process validation.

    This paper expands on these major design considerations and discusses the safety organization necessary to ensure the safety of the biological worker and those in the surrounding neighborhood, as well as the safety of the product being manufactured.

    Keywords:

    bioprocessing, biological facilities, biomanufacturing, sterile facilities, sterile processing


    Author Information:

    Damm, PG
    Consulting engineer, Ambler, PA


    Paper ID: STP26068S

    Committee/Subcommittee: E48.01

    DOI: 10.1520/STP26068S


    CrossRef ASTM International is a member of CrossRef.