Biopharmaceutical Facilities


This module will provide the learner with an in-depth knowledge of the regulatory, technical and managerial challenges associated with the design, construction and fitting out of a modern biopharmaceutical manufacturing facility. Site planning, design, commissioning, start-up and validation will be explored and discussed in this module. Following on from facility design and construction, matters such as materials and personnel flow, equipment and the utilities necessary for successful production of biopharmaceuticals will also be covered. Cleanroom classification/design, day-to-day operation, monitoring, maintenance, cleaning, and housekeeping of cleanroom and general facilities will be examined to ensure adherence to regulatory and GMP guidelines.

Learning Outcomes

  1. Effectively plan the layout and functional areas in a biopharmaceutical manufacturing facility whilst adhering to the regulatory framework around how facilities are designed and operated.

  2. Indicate a thorough understanding of how personnel, equipment, materials, product, and waste flow within a facility and indicate a knowledge of the access and controls required within such facilities such as security.

  3. Elucidate and justify the various cleanroom classifications employed in sterile manufacturing and explain the equipment, instrumentation, and control systems employed to control and monitor such facilities.

  4. Clearly state the function and purpose of utility and support systems within a biopharmaceutical manufacturing facility.

  5. Illustrate an understating of the preventive maintenance, cleaning, and housekeeping practices that pertain to sustaining biopharmaceutical manufacturing facilities.

  6. Identify and interpret the relevant EU and U.S. standards and guidelines employed in a biopharmaceutical manufacturing facility.

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