ABSTRACT

This revised publication serves as a handy and current reference for professionals engaged in planning, designing, building, validating and maintaining modern cGMP pharmaceutical manufacturing facilities in the U.S. and internationally. The new edition expands on facility planning, with a focus on the ever-growing need to modify existing legacy facilities, and on current trends in pharmaceutical manufacturing which include strategies for sustainability and LEED building ratings. All chapters have been re-examined with a fresh outlook on current good design practices.

chapter |18 pages

Legacy Facility Master Planning

chapter |36 pages

Architectural Design Issues

chapter |34 pages

High-Purity Water

chapter |20 pages

Process Engineering

chapter |32 pages

Sterile Manufacturing Facilities

chapter |44 pages

Biotechnology Facilities

chapter |14 pages

Codes and Standards

chapter |14 pages

Containment Technology

chapter |36 pages

Occupational Health and Safety

chapter |18 pages

Sustainability

chapter |28 pages

Packaging and Warehousing