Biopharmaceutical Manufacturing Facilities

BTEC Instructor: Michael Flickinger, Ph.D.
ISPE Instructor: Jeff Odum

12-14 May 2008
Intermediate/Advanced Course - ISPE CEUs 1.8

Get an overview of concepts used in the development of sound designs for facilities that manufacture biopharmaceutical products in today’s regulatory environment. The course includes a review of the actual BTEC facility design and provides case study examples of regulatory issues important in the USA and Europe that involve industry trends and changing regulatory policy, using the Biopharmaceutical Manufacturing Facilities Baseline® Guide as the primary reference tool. Participants will discuss current case studies on a wide array of facility topics, and complete class activities that involve developing facility scope of work and deliverables and seeing the “real life” results of the decision making process. Bring a digital camera and laptop computer for the hands-on design problem sessions of this course. A complimentary copy of the Biopharmaceutical Manufacturing Facilities Baseline® Guide will be provided.

This course contains knowledge related to the CPIP™ technical knowledge competency element Facilities and Equipment. Visit www.ISPE-PCC.org for details.

Course topics include: recent trends in facilities design related to regulatory considerations; critical aspects for good personnel and product flow; design for minimizing product contamination; satisfying both biocontainment and cGMP considerations; facilities design issues related to dealing with disposables; appropriate design and capacity of classified spaces; and case studies on vaccine manufacture.

Hands-on sessions in the BTEC facilities provide experience in GMP suite design: upstream, downstream, and support facilities; and bulk product sterile fill and finish facilities design criteria.

Take Back to Your Job

  • How to evaluate your current facility design for optimal operation
  • Approaches for evaluating designs from A & E firms 
  • Economic impact of facility design – What is really necessary to meet regulations?
  • Critical considerations for designing modifications to existing facilities

Attendance Suggested For

  • Architects and engineers involved in facility designs for biopharmaceutical manufacturing facilities
  • Architects new to the field for the design GLP laboratory and GMP manufacturing facilities 
  • Process and facilities engineers involved in design, construction or start-up of GMP facilities

Schedule

Monday

  • 8.30 - 10.00 Introduction to Facility Design: Odum
  • 10.30 - 12.00 Regulatory Implications: Odum
  • 13.30 - 15.00 Operations and Process Definition: Odum
  • 15.30 - 17.00 Intro to BTEC Facility Design Problems (hands-on): Flickinger

Tuesday

  • 8.30 - 10.00 Equipment Design Impacts on Facility Design: Odum
  • 10.30 - 12.00 Facility, Utility Attributes: BTEC Attributes: Odum, Flickinger
  • 13.30 - 15.00 BTEC Case Study (hands-on): Odum, Flickinger
  • 15.30 - 17.00 Facility Design Problem Investigation (hands-on): Flickinger

Wednesday

  • 8.30 - 10.00 Area Classifications: Odum
  • 10.30 - 12.00 System Definition, Qualification: Odum
  • 13.30 - 15.00 Presentation of BTEC Facility Design Proposals (Jury): Odum
  • 15.30 - 17.00 Presentation of BTEC facility Design Proposals (Jury): Flickinger