However, the need for a second edition was evident, as options available to HVAC designers and engineers have evolved due to technological advancements and shifting project pressures. The updates in the second edition reflect these changes, providing readers with a more current perspective on the challenges and resources involved.
“Since the original guide was published, both the technology and guidance on how to implement an HVAC system for the pharmaceutical industry has changed. There is also a need for more efficiency and a push toward decarbonization,” said guide co-lead author Josh Williams, Senior Mechanical Engineer, Genesis AEC. “There are new products that are being produced now that didn’t exist then, or even five years ago, and new technology sectors that are coming about due to recent advances in cell and gene processing techniques.”
“The new guide also reflects new and updated regulations such as Annex 1,” said guide co-lead author Christopher Anderson, CPIP, HVAC Engineer, Hikma. “It is a valuable resource if you are looking for answers of where to start when designing an HVAC system or what to do if a problem arises.”
Designing HVAC systems for the pharmaceutical industry involves unique considerations. Facilities where medicine and other health-related treatments are manufactured must be exceptionally clean and safe environments to protect both personnel and products.
As a result, HVAC systems in pharmaceutical settings require higher levels of reliability, robustness, design scrutiny, and operational assurance compared to less stringent applications. Given that HVAC systems can consume a significant portion of the energy used by a facility, their design necessitates a blend of good engineering practice (GEP) and good manufacturing practice (GMP).
“If an HVAC system is not designed properly, there is a significant risk of potential danger to individuals within the facility from product contamination and cross contamination among ingredients which could lead to loss of life-saving products, and discomfort or suboptimal operating conditions for facility workers,” Williams said.
“Auditors always want to see well-designed systems,” Anderson added. “If you look at FDA 403s there are plenty of examples of companies being cited for HVAC systems that are either not properly qualified or not properly operated. Issues with the HVAC systems can lead to noncompliance with regulations which can affect overall business operations, while a good well-designed system will help your company get through an audit quicker.”
This updated guide aims to clarify GMP HVAC issues that are critical to the safety, identity, strength, purity, and quality of pharmaceuticals, biopharmaceuticals, advanced therapy medicinal products, and medical devices, from raw materials to finished products. It covers HVAC control and monitoring requirements and addresses GEP issues related to sustainability, economics, and environmental health and safety. The guide provides best practices for implementing international regulatory and industry guidance, with appendices containing industry examples and templates for the reader’s reference.
Written by industry experts with input from members of the ISPE HVAC Community of Practice, additional topics covered in the guide include:
- Energy use and sustainability considerations
- System configurations by facility type
- HVAC and environmental controls and monitoring
- Commissioning, qualification, and quality risk management
- Life cycle documentation, operations, and maintenance
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