Knowing how to deal with the regulatory issues, understanding the impacts of cleanliness, and recognizing the affect that poor facility layout will have on GMP spaces are only some of the issues an experienced Project Manager must focus on. Completely revised and updated, Sterile Product Facility Design and Project Management, Second Edition provides comprehensive guidance on how to develop and execute biotech and other sterile drug facilities based on current industry best practices. Each chapter highlights a specific issue centered on managing biotech facilities projects in a GMP environment. The author uses real-world examples of common industry practice to lead you through the idiosyncrasies of a biotech project in an effort to answer some of the more common, and often perplexing, questions that can stand in the way of success. You get a mini seminar on each topic covered. Breaking the project life-cycle into four phases, the text takes you through each phase from the Project Manager's viewpoint. Unlike other books that cover design, technology, and validation in general terms, this book addresses the industry specific issues that make biotech facilities so costly and difficult to deliver. It puts the pieces of the puzzle together in a manner that increases your opportunity for success.Example 10.1 Guideline for HVAC Design 1.0 Introduction The HVAC DPE assigned to the project should use the following guidelines to control the quality of the design from a coMP ... B. Cooling load Calculations Cooling load calculations should be done on a room-by-room basis. Careful attention should be given to process equipment loads because these can be significant heat generators.
|Title||:||Sterile Product Facility Design and Project Management, Second Edition|
|Author||:||Jeffrey N. Odum|
|Publisher||:||CRC Press - 2004-03-29|