By Mark von Stwolinski

The first edition of the ISPE Biopharmaceutical Manufacturing Facilities Baseline Guide was issued in June 2004. Its concepts have been phased-in over the past several years.

Since 2004, the Industry, processing technology and views to manufacturing have significantly matured. The second edition Guide defines the current Industry facility design benchmarks and discusses industry trends, including Future Facility and Flexible Facility.

The Guide addresses many factors that drive current facility designs, including smaller batch sizes with higher titers, single use systems, process closure technologies and the need for production flexibility. The factor with the greatest impact on facility design is probably the application of closed processing technology on a majority of the process operations.

Closed processing fully segregates the product from the room environment so aspects of the room environment are no longer Critical Process Parameters (CCPs) to the Croduct Quality Attributes (CQAs). Environmental particulates and viables don’t impact the product, potentially eliminating the need for classified environments for fully closed systems. Decoupling the product from the facility allows for new and innovative facility design solutions, including multi-product production in the same processing room and production in controlled non-classified (CNC) environments.

Guide Highlights

  • Regulatory support of production ballrooms from the January 2013 PIC/S CGMPs
  • Process Closure definitions, closure discussions and sample Risk Assessment tools
  • An overview of how traditionally designed production facilities with open processing, classified room environments and flows designed to reduce the ‘challenge’ to that environment can adapt to the introduction of process closure.
  • Discussion and examples of how these concepts readily apply to new construction and facility retrofits facilitating flexibility, increased production capacity and facility re-purposing.

This Guide defines the interconnectivity between product exposure and facility design and presents the CGMP facility design continuum from exposed product production facilities to Flexible and Future Facilities.

Have you read the Guide? Do you have questions or opinions about its content? Share them in the comments section below.