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ISPE Good Practice Guide Heating Ventilation And Air Conditioning, ISBN-13: 978-1931879576

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ISPE Good Practice Guide Heating Ventilation And Air Conditioning

[PDF eBook eTextbook]

 

  • 288 pages
  • Publisher: ISPE (2009)
  • Author(s): Goldschmidt, Norman A.; Moore Jr., Donald R.; Blazewicz, Bernard; Gantz, William A.; Gardner, Peter B.; Haycocks, Nicholas; Koller, Norman C.; Roberts, Ronald; Schnipper, Ted N.
  • Language: English
  • ISBN-10: 1931879575
  • ISBN-13: 978-1931879576

 

HVAC systems can be critical systems that affect the ability of a pharmaceutical facility to meet its objective of providing safe and effective product to the patient. The ISPE Good Practice Guide on HVAC provides designers and the project team with suggestions to help determine the user requirements and the functional design that define the facility’s objectives. It also provides options to be considered in creating a design that has low lifecycle cost and that is sustainable.

Heating, Ventilation, and Air Conditioning (HVAC) systems can critically affect the ability of a pharmaceutical facility to meet its objective of providing safe and effective product to the patient. The design of these systems requires a blend of Good Manufacturing Practice (GMP) and Good Engineering Practice (GEP) to help provide a safe and healthy work place, protect the environment, and manage energy responsibly. HVAC can consume a major portion of the energy used by a facility and must be considered in any company’s sustainability and carbon management policies.

This Guide aims to clarify GMP HVAC issues, those critical to the Safety, Identity, Strength, Purity, and Quality of pharmaceuticals, biopharmaceuticals, and medical devices from raw materials to finished goods, including the requirements for HVAC control and monitoring. This Guide also addresses issues of GEP related to sustainability, economics, and environmental health and safety.

To achieve these goals, the Guide Team aims to provide the Life Science Community with common language and understanding of critical HVAC issues, guidance on accepted industry practices to address these issues, and a common resource for HVAC information currently included in appendices of the various ISPE Baseline® Guides.

The intended audience for this Guide is global with particular focus on US (FDA) and European (EMEA) regulated facilities.

The information provided in this Guide reflects the cumulative knowledge and experiences of the authors, editors, and reviewers with input from members of the ISPE HVAC Community of Practice (COP). There is no single approach to satisfy every HVAC situation; therefore, this Guide cannot address every HVAC situation. A recurring theme throughout the Guide is the importance of understanding the role of HVAC performance in protecting product, personnel, and the environment.

This Guide includes appendices which provide industry examples and templates that may be of use to the reader.

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