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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.
bioprocessing, biological facilities, biomanufacturing, sterile facilities, sterile processing
Consulting engineer, Ambler, PA