HVAC systems perform critical functions in pharmaceutical manufacturing environments, including heating and cooling, humification or dehumidification, filtering air to remove contaminants, ventilating air, and controlling air pressure in specific areas. Depending on the product and manufacturing processes involved, these parameters must be maintained within certain levels to maintain product integrity and operator safety.
Thus, HVAC systems play key roles in producing safe and effective products but are also critical for protecting personnel and promoting their comfort. Additionally, HVAC systems have huge implications for company energy use and overall environmental impact, which should also be considered. To meet these goals, HVAC systems for pharmaceutical manufacturing should be designed in alignment with the standards and methods of Good Manufacturing Practice (GMP) and Good Engineering Practice (GEP).
An international task team produced the guidance document, led by Christopher L. Anderson, PE, CPIP, of Hikma, and Josh L. Williams, PE, of Genesis AEC, with support by ISPE’s HVAC and Sustainable Facilities Community of Practice. The new guide is written to harmonize more seamlessly into other ISPE publications such as the ISPE Baseline Pharmaceutical Engineering Guide Series, and it has also been updated to reflect new regulatory revisions, such as the EMA’s Annex 1 on the manufacture of sterile medical products.
“It's easy to just rely on rules of thumb when considering conventional pharmaceutical design [of HVAC systems],” said Williams. “In the guide, we tried to emphasize ways to approach that with more nuance, to recommend methods to better quantify and fine-tune an approach and not just accept the given wisdom on a topic.”
One central HVAC safety consideration is contamination from external sources or cross contamination between products being made in the same facility, either of which might impact product safety and efficacy. Anderson pointed out that the possibility of such issues can draw the attention of regulatory authorities such as the FDA. This can lead to greater regulatory constraints, and even, at the extreme, impact licensing to operate.
Another key safety issue is in making products whose manufacture involves potentially hazardous elements. Williams noted, “People do need to be protected from failures of the HVAC system which could result in potentially dangerous conditions.”
Such considerations of risk management are a key thread throughout the guidance document. “The [Commissioning and Qualification] process is all predicated upon risk assessment and risk management,” said Anderson. “There are certain things you can do from an HVAC perspective to help mitigate risk.”
The new edition of the guidance document also contains greater emphasis with respect to questions of sustainability and environmental impact, e.g., considerations for energy demand reduction, waste energy recovery, and energy efficient designs. This has become a greater priority in the industry, due to factors like greater overall cultural awareness, regulatory changes, corporate responsibility initiatives, and economic considerations.
Williams pointed out that energy use considerations must come secondary to priorities of product integrity and personnel safety, and stringent HVAC requirements for clean spaces in pharmaceutical manufacturing do require a great deal of energy. “You can’t get around that,” said Williams, “but you can reduce your usage and get there in a more efficient manner.”
Included in the guide are overviews of multiple areas relevant to HVAC implementation, such as practices and system designs for various facility types, HVAC design criteria and project drivers for these, environmental controls and monitoring, commissioning and qualification, and context for documentation, operation, and maintenance. Additionally, the guide provides key considerations with respect to energy use and sustainability, as well as helpful context and background for industry professionals as they consider their HVAC options.
Added Williams, “We hope that this guide is useful to a broad spectrum of people with all levels of experience, that it might be readable by a junior engineer but also have helpful insights for someone who has been in the industry for 30 years.”,
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