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The HVAC Process Engineering Forum. [Alexander Delli Paoli, Jr. The HVAC Process Alexander Delli Paoli, Jr. Welcome to “Engineering Forum.” The first series of articles will discuss HVAC pro- This feature discusses applied technical principles cesses for warehouses, offices, laboratories, clean- associated with engineering topics that focus on use- rooms, containment facilities, and other manufac- fulness to practitioners in validation and compliance. turing environments. The series will also touch on We intend this column to be a resource for daily work specialized applications such as containment hoods, applications. biological safety cabinets, and dust collection systems. Engineering technology is a topic of great impor- Subsequent articles will address each of these topics in tance in contemporary pharmaceutical and medical greater detail, driving toward a working familiarity of device manufacturing. Validation and compliance HVAC systems and their typical challenges. professionals must become familiar with facilities, Reader comments, questions, and suggestions for equipment, utilities, and other systems at their sites. discussion topics are needed to help us fulfill the Global regulatory agencies require more than just column objective. Please send your comments and compliance to procedures in the modern manufac- suggestions to column coordinator Alex Delli Paoli turing organizations. They require understanding of at [email protected] or to journal managing processes and topics controlled by site procedures. editor Susan Haigney at [email protected]. Sound procedures, policies, and literally everything involved in regulated manufacturing must be based KEY POINTS on scientific principles whenever possible, must be The following key points are discussed: appropriate for risk, and must be continually moni- • Understand the reason your site needs different types tored and maintained. Outsourcing of manufacturing of HVAC systems and testing functions has further extended these • Recognize all the HVAC components and their responsibilities. purpose Engineering topics are not generally well known • Understand how all the components interact or understood beyond the engineering community. • Be aware of the physics of air: Psychrometrics Personnel resources have been reduced, and indi- • Assure proper safety measures are in place vidual responsibility has increased. Those with lim- • A system is only as good as its maintenance and ited background and experience may find themselves compliance to design criteria. involved in areas with which they have little expertise. Further, the technical information supporting their INTRODUCTION areas may be esoteric and incomprehensible for Heating, ventilation, and air conditioning (HVAC) sys- those not trained in the field. We intend to address tems are critical to pharmaceutical and medical device engineering topics with these considerations in mind. manufacturing. These systems comprise multiple com- These topics will be discussed clearly and in a mean- ponents that are integrated in a reliable process to create ingful way so that our readers will be able to under- a sustainable environment. stand and apply the principles discussed in daily work This discussion provides an overview of the process situations. used to bring air from the randomly variable mixture of For more Author ABOUT THE AUTHOR information, Alex Delli Paoli, Jr., P.E., is managing director of Engineered Strategic Visions, Libertyville, IL, USA. go to Engineered Strategic Visions, Inc. (www.engineervisions.com) is an engineering consulting firm special- gxpandjvt.com/bios izing in project planning and management, manufacturing support, asset and energy management, [and other areas of expertise. He may be reached by e-mail at [email protected]. 20 JOURNAL OF VALIDATION TECHNOLOGY [AUTUMN 2011] ivthome.com Alexander Delli Paoli, Jr. vapors and particles found in the atmosphere to a steady The HVAC process may be compared to a typical manu- state condition acceptable for the environment the system facturing process (see Figures 1 and 2). The manufacturing serves. The following will be discussed: process utilizes individual pieces of equipment to process • HVAC definition—the scope of HVAC and what active drugs and excipients into a final pharmaceutical general areas are encompassed product in commercial packaging. The HVAC process • The process of HVAC—HVAC systems include mul- utilizes multiple equipment components and operations tiple equipment that transforms variable air states to convert incoming air to processed air that meets facility to achieve target attributes needs. Most facilities require a broad scope of air quality. • Why process the environment?—the reasons that For example, a facility might include sterile product manu- air must be processed facturing, non-sterile product manufacturing, warehous- • Components and function of the air handler (e.g., es, docks, offices, and other areas—each of which will the preheat coil and filters, cooling coil, return fan, have differing HVAC requirements. Further, there may be exhaust fan, and associated equipment) different requirements within a given area. For example, • Applications (e.g., warehouses, offices and records a non-sterile manufacturing area may require rooms with storage, laboratories, cleanrooms, containment facili- very low humidity to process moisture sensitive drugs. ties, and general manufacturing areas). The HVAC system and its component subsystems must provide the required environmental conditions. HVAC DEFINITION HVAC is a hybrid engineering discipline based on HVAC Process Comparison to aspects of classical mechanical, electrical, and chemi- Manufacturing Process cal engineering practices. It includes knowledge of fluid The HVAC system process is generally similar to a product mechanics, machine design, and instrument control. It manufacturing process. Both convert input materials further includes a working knowledge of the physical by means of process parameters into a final product properties of several liquids and gases. Material compat- meeting required quality attributes. There are important ibility knowledge is also important for avoiding chemical differences that the HVAC system must overcome to interaction with dissimilar metals, incompatibility with accomplish its objectives. These include input material refrigerants, and other deleterious effects due to cleaning considerations, process capability, and process changes. agents used in the facilities served by the HVAC units. Input materials. The manufacturing process converts Practical considerations such as physical layout and access drugs and inactive materials to pharmaceutical products. for maintenance along with a good sense of aesthetics The incoming materials should be well controlled by are also important to the discipline of HVAC. means of vendor approval and supply chain control. The HVAC started as a formal practice during the Indus- HVAC process converts air from the external environment trial Revolution when it was recognized that mines and to air possessing the quality attributes required for the factories needed to be ventilated (V) (i.e., air contain- respective areas in the site. The input air is uncontrolled, ing noxious fumes and particles needed to be replaced may have unexpected content (e.g., fumes, particulates, with fresh breathable air). Heating (H) was also a need pollen, and insects) and has seasonal variation. Winter beyond the home fireplace to warm shops and factories air will have lower moisture content than summer air. Fur- in northern climates. Air conditioning (AC) became ther, the summer humidity may approach 100% in tropi- practical with the invention of the mechanical refrig- cal areas for extended periods during the rainy season. eration process. It was an obvious extension to H and Process capability. The manufacturing process V. Occasionally, R for refrigeration is included when has defined process limits. These limits are usually not refrigerators and freezers are involved in a project. This exceeded because input materials are well controlled. In is typically shown as HVAC/R. contrast, the HVAC process may be challenged beyond the limit of design capabilities depending on environ- THE PROCESS OF HVAC mental variation. Traditional textbook explanations of HVAC systems Process changes. The manufacturing process is gen- often describe these systems as integrated pieces of erally well established and remains relatively constant equipment (e.g., air handler, fans, ductwork) having throughout the product lifecycle. The process is often individual functions. These descriptions ignore the pro- approved by regulatory agencies and is not able to be cess of HVAC to produce a “product”—air with desired changed without regulatory approval. In contrast, the temperature, humidity, particulate level, and other qual- HVAC process has significant seasonal variation requiring ity attributes. cyclical heating and cooling. These are significant process gxpandjvt.com JOURNAL OF VALIDATION TECHNOLOGY [AUTUMN 2011] 21 Engineering Forum. Figure 1: Manufacturing process. changes. Periodic checks to assure the HVAC systems are operating as intended are key to consistent operation. MANUFACTURING PROCESS API WHY PROCESS THE ENVIRONMENT? Excipient Excipient Any manufacturing, testing, or storage facility and their Excipient related processes strive for a steady state consistent envi- Manufacturing process unit operation ronment to deliver reliable products to customers.
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