Partner at Jacobs Wyper Architects, 1232 Chancellor St., Philadelphia, PA, 19107, tel: 215.985.0400, www.jacobswyper.com.

Eric Bohn

Warehousing is a crucial yet often-overlooked need of the pharmaceutical industry. Although GMP warehousing can have some specific requirements (e.g., cleanliness, temperature control), some of the same basic questions and criteria drive warehouse design for both GMP and conventional warehouses.

	Considering storage and retrieval methods

	An effective warehouse must be appropriate for the materials being stored. Likewise, a sound understanding of the inventory is necessary to create an efficient and successful operation. Not only do the materials anticipated need to be identified, but the frequency, quantity, and sequence of retrieval must be considered. 

The key attribute of warehousing is the method of storage; in other words, the type of pallet rack that is used. There are many options available; some of the common types are known as “single or selective,” “double deep,” “push back,” “drive-in,” and “flow racks”. Fundamentally, however, the decision for the most appropriate rack focuses on the number of pallets stacked within a horizontal lane of the rack. 

	Placing pallets one deep on a multilevel rack is the traditional and most common approach. This approach provides the greatest flexibility because it gives access to all pallets, at all times. The relative low density of pallets, however, limits the quantity that can be stored. Greater density is achieved by increasing the height of the racks or by placing pallets one behind the other within the same lane. Verticality is a function of the height available; lane depth is driven by the materials stored and the rate of their use. For any given height, stacking pallets more than one deep eliminates aisles and increases both the pallet density per square foot and the amount of storage. 

	When stacking pallets one in front of the other, however, a condition referred to as “first in, last out” is created. The pallet in front must be used before the one behind is available. To justify this method of storage, all the material in that lane must be the same, and the quantity and rate of use needs to be such that the “last” pallet is taken in a timely manner. To store pallets that are never used is an obvious waste of space, inventory, and money. The number of stock-keeping-units (SKUs), the throughput, and inventory turnover all play into this decision. A warehouse, of course, does not need to have only a single type of racking. An analysis of the inventory will also provide the data necessary to determine the diversity and appropriateness of multiple types of rack.

Considering forklifts and aisle spacing. 

In selecting racking, the type of fork truck must also be factored. There are numerous types of trucks, each with different performance characteristics and capital costs. Characteristics include height and depth of reach; sit-down, standing, and “man-up” models as well as the space required for maneuvering. Conventional, sit-down, counterbalance forklifts require a turning radius of up to 13 feet. To allow turning and placement of loads in the racks, this maneuvering dimension must be provided in front of the racks. But there are other options. At the other extreme, a special turret truck is offered that allows narrow aisles of as little as six feet between racks. In large facilities, considerable density can be achieved through these smaller aisles.

	When considering aisles, however, the width needs to work in concert with the column bays. For those fortunate enough to build a new facility, it is possible to optimize these three factors: rack types, forklift, and column spacing. When working in existing facilities, however, the column spacing is a given, and some compromises are often required. 

High-density warehousing with automated storage and retrieval systems (AS/RS)offers a solution for many warehousing challenges. These computer-controlled systems use neither aisles nor forklifts. Each pallet is automatically placed and retrieved from defined storage locations on robotic carriages. AS/RS maximizes storage within a given footprint, reduces labor costs, reduces product damage, and increases the accuracy of inventory management, but capital costs are significant.

	The physical storage of pallets, as basic and simple as it appears, has not been overlooked by the digital revolution. Software to manage and control inventory can greatly reduce costs. It is easy to assume that more storage is better. Large inventories, however, require money tied up in idle materials that are not adding value, and the capital costs to construct and operate larger warehouses must be considered. Contemporary supply chain strategies try to balance the quantity stored to the throughput of the facility. With barcoding and radio-frequency identification, it is possible to know every item in an inventory as well as its real-time status. Production planning and historical data can be used to reduce the time that materials are stored before use. This “just-in-time” approach contrasts with the traditional “just-in-case” philosophy. Efficiency is increased and waste decreased by receiving goods only as needed. Less space is used, smaller inventory investments made, minimal inventory obsolescence occurs, and responsiveness for accommodating product changes is increased.

	In addition to these fundamental programmatic considerations for storage and retrieval of materials, key building code issues must be considered when designing GMP warehouse facilities.

The first consideration for code compliance in a warehouse is understanding what is being stored. The materials must be identified, and their classification determined. Commodity Class is a classification system that is understood by fire protection engineers and is defined in several standards, most notably the National Fire Protection Agency’s NFPA 13 (1) and the International Fire Code (IFC), Section 3203 (2). When determining the Commodity Class, more than just the material stored needs to be considered. The packaging and pallets must also be included. In pharmaceutical warehouses, raw materials and finished goods usually fall into Commodity Classes III and IV, which include wood, paper, and certain plastics. The following comments, being focused on GMP warehouses, assumes a Commodity Class of III and IV.

The next critical parameter in determining code requirements is the amount and configuration of the storage. As illustrated previously, pallets can be stored on the floor or even stacked. But racking of pallets is the most efficient form of storage and almost the definition of a warehouse. Providing racking configured to include a flue space behind the pallet load is important. Racks with a flue will eliminate the need for in-rack-sprinklers, which are expensive and an inefficient use of capital. 

	Storing materials above 12 feet in height is a significant benchmark. Above this height, racking becomes defined as high-piled combustible storage. The IFC addresses high-piled combustible storage and defines it as “Storage of combustible materials in closely packed piles or combustible materials on pallets, in racks or on shelves where the top of storage is greater than 12 feet” (2). A result of the high-piled combustible storage found in warehouses is the requirement for fire apparatus access roads around the building. Because of the increased fire hazard that high-piled storage represents, ready access by fire trucks is crucial for life safety and property protection. To this end, the IFC requires that an access road configured for fire trucks with a minimum width of 20 feet must be located such that all portions of the exterior walls of the warehouse are within 150 feet of the road. This ensures that the local fire department is able to attack a potential fire from all sides of the warehouse exterior. 

	The next benchmark relates to the size of the warehouse. Once the floor area of the high-piled storage reaches 12,000 ft

, there are additional considerations that need to be met. Automatic sprinklers and fire detection systems are required as well as smoke and heat removal. In addition, access by fire department personnel are mandated. Above the 12,000-ft

threshold, the IFC requires, in Table 3206.2, that smoke and heat removal be provided (2). This can consist of smoke/heat vents or a mechanical smoke evacuation system. However, smoke and heat removal are expensive and often considered undesirable. When an early suppression fast response (ESFR) sprinkler system is provided, an option exists where smoke and heat removal can be avoided. Although an ESFR system also represents an expense, because it is so effective at extinguishing a fire, it is usually considered a sound investment. 

limit also mandates increased access by the fire department. In addition to accessibility for fire trucks, as previously mentioned, the increased hazard requires firefighting personnel have direct access to the building interior. Conventional three-foot-wide, swinging personnel doors provide this building entry. Along the exterior walls that face the fire truck access roads, doors for entry of fire personnel need to be located no more than 125 feet apart. Each of these doors must be clearly identified and a key box installed adjacent. This ensures that firefighters can easily get to and gain access to the interior when needed. It should be noted that loading dock doors are not as easily accessed, and therefore, the code does not allow them to be used as fire personnel access.

	As discussed, rack storage can exceed 40 feet in height. But Chapter 32 of the IFC provides a dimensional limit of 40 foot for high-piled combustible storage. Above this height, the code redefines storage as extra-high-rack combustible storage. Extra-high-rack combustible storage is characterized by a significant increase in the fire-load and requires approval of the local fire code official. In addition, the code suggests the fire official call for additional engineered fire protection. Potential additional protection measures include fire-proofing of exposed steel columns, increase sprinkler density, in-rack sprinklers, or additional fire department hose connections. These kinds of heights are not usually seen with warehouses that are integrated into a manufacturing facility; however, they would not be exceptional for warehouses providing distribution of finished product. 

	Warehouses have many common features and yet each one is unique. Understanding inventory and the demand for those materials is crucial to an optimized facility. In addition, to promote life safety and property protection, the code identifies unique measures needed to mitigate the inherent dangers found in these facilities. Warehouses are different from manufacturing and offices and require the appropriate knowledge. When designing or renovating a warehouse, it is important to consult the code and integrate the requirements from the start. 

NFPA 13, Standard for the Installation of Sprinkler Systems 

(2019).
	2. International Code Council, 

2018 International Fire Code: Chapter 32: High-Piled Combustible Storage (2018), 

https://codes.iccsafe.org/content/IFC2018/CHAPTER-32-HIGH-PILED-COMBUSTIBLE-STORAGE, accessed 8 Jan. 2019.


	Vol. 43, No. 2
	February 2019
	Pages: 43–45

	When referring to this article, please cite it as E. Bohn and "Fundamentals of GMP Warehouse Design," 

	Eric Bohn, AIA and Magdalena Krapf, AIA, LEED AP, are both partners at JacobsWyper Architects, 1232 Chancellor St., Philadelphia, PA19107, tel: 215.985.0400.

Articles

Storage and retrieval methods and the unique requirements found in building codes are crucial considerations. 

Fundamentals of GMP Warehouse Design

	“Process Architecture” or “Process Architect” are phrases commonly applied to the specialized fields of technology, software, and business management. This definition places architecture in the purview of software and business professionals. When applied to the construction of buildings, however, architecture is a profession that, like law and medicine, requires licensure to protect the public’s health, safety, and welfare. Further, those involved in the design of buildings dedicated to pharmaceutical manufacturing are aware that Process Architecture describes architects with the skills needed to design facilities compliant with current good manufacturing practices (cGMPs). In this context, the term is not uncommon, but neither is it formally defined. This article will discuss the special attributes that a process architect brings to the design of such facilities and perhaps begin to bring definition and clarity to the term.

	Architects are trained and interested in the spatial considerations of a building or structure. In less specialized building types, such as commercial offices or houses, the focus is on how spaces help people perform their intended activity. Process Architecture, however, adds complexity to the equation by going beyond the needs of people and considers the processes and equipment needed for the manufacture of products. 

	When thinking about the configuration of a manufacturing facility, the equipment and processes becomes the focus. The layout of the equipment (referred to as a general arrangement plan) needs to establish relationships that optimize its operation. Consideration of operator stations and ergonomics as well as the loading and unloading of materials are key, as well as access for maintenance and sampling for in-process testing.

	The movement of material to, from, and between the equipment needs to integrate the various components into a unified process, often across multiple rooms and even entire buildings. The types of material, their containers, and status within the process must be addressed by the size and configuration of the spaces and the location of circulation. The entire material flow-from raw material receiving to shipping of the finished product and all movements between-must be considered. Provisions for entering and exiting production spaces, especially when they are classified cleanrooms, must be adequate and well planned. The means of segregation and containment of product necessary to eliminate cross contamination is crucial, as is the development of efficient circulation (i.e., flows) and appropriately placed staging; both are effective means to reduce or eliminate the risk of mix-ups. 

	With this focus on processes, however, people cannot be forgotten. Instead, they are considered in the context of the activity at hand; the manufacture of safe and efficacious drugs. The movement of personnel in a way that ensures sanitary conditions and the elimination of contamination is a clear design objective outlined in the GMPs. It requires careful planning of both personnel and material circulation, which provides a framework for a well-structured hygiene zoning plan. An important component for this integration is the gowning strategy. The approach needed informs the deliberate placement of lockers, gown rooms, and airlocks that are necessary for entry and exit of clean spaces. Creating a strongly ordered layout with attention paid to the hierarchy of cleanliness levels also provides for efficient distribution of heating, ventilation, and air-conditioning and utility systems.

	When done well, Process Architecture not only supports GMP-compliant processes but results in operational efficiencies and a corresponding reduction in operating costs. It can reduce or eliminate spatial bottlenecks, as well as wasteful material handling, and in so doing create a leaner process with increased throughput. 

	Returning for a moment to the software industry, consider the Institute of Electrical and Electronics Engineers (IEEE) definition of architecture: “the fundamental organization of a system, embodied in its components, their relationships to each other and the environment, and the principles governing its design and evolution” (1). When placed in the context of designing for pharmaceutical facilities, this definition holds up well. Process Architecture then, is about the fundamental organization of the pharmaceutical manufacturing facility as embodied in its components, their relationships to each other, and the environment. Process Architects specialize in the integration of processes and equipment into facilities that are GMP compliant and optimized for their purpose. 

	Any competent architect can take a program of spaces and create an organized layout. The unique requirements and circumstances of facilities needing to meet cGMPs, however, is a higher order of complexity. The knowledge required is specific to our industry and results in a facility supportive of the processes, material, and personnel flows of an efficient operation. And at its best, Process Architecture provides an attractive, well-ordered environment and, maybe, even some beauty for the people working there.

Standard 1471-2000: IEEE Recommended Practice for Architectural Description of Software-Intensive Systems 

	Eric Bohn is partner at JacobsWyper Architects, 1232 Chancellor St., Philadelphia, PA 19107,  tel: 215.985.0400.

Process architects for pharmaceutical manufacturing facilities must understand cGMPs and how to optimize a design for equipment, processes, and people.

Considering Process Architecture for Pharma Facilities

	Warehousing is a critical yet often-overlooked need of the pharmaceutical industry. Although GMP warehousing can have some specific requirements (e.g., cleanliness, temperature control), in this article, the author discusses some of the basic questions and criteria that drive warehouse design for both GMP and conventional warehouses.

	The key attribute of warehousing is the method of storage; in other words, the type of pallet rack that is used. There are many options available; some of the common types are known as “single or selective,” “double deep,” “push back,” “drive-in,” and “flow racks”. Fundamentally, however, the decision for the most appropriate rack focuses on the number of pallets stacked within a horizontal lane of the rack. 

	When stacking pallets one in front of the other, however, a condition referred to as “first in, last out” is created. The pallet in front must be used before the one behind is available. To justify this method of storage, all the material in that lane must be the same, and the quantity and rate of use needs to be such that the “last” pallet is taken in a timely manner. To store pallets that are never used is an obvious waste of space, inventory, and money. The number of SKUs (stock-keeping-units), the throughput, and inventory turnover all play into this decision. A warehouse, of course, does not need to have only a single type of racking. An analysis of the inventory will also provide the data necessary to determine the diversity and appropriateness of multiple types of rack.

	In selecting racking, the type of fork truck must also be factored. There are numerous types of trucks, each with different performance characteristics and capital costs. Characteristics include height and depth of reach; sit-down, standing, and “man-up” models as well as the space required for maneuvering. Conventional, sit-down, counterbalance forklifts require a turning radius of up to 13 feet. To allow turning and placement of loads in the racks, this maneuvering dimension must be provided in front of the racks. But there are other options. At the other extreme, a special turret truck is offered that allows very narrow aisles of as little as six feet between racks. In large facilities, considerable density can be achieved through these smaller aisles.

	High-density warehousing with an automated storage and retrieval systems (AS/RS)offers a solution for many warehousing challenges. These computer-controlled systems use neither aisles nor forklifts. Each pallet is automatically placed and retrieved from defined storage locations on robotic carriages. AS/RS maximizes storage within a given footprint, reduces labor costs, reduces product damage, and increases the accuracy of inventory management, but capital costs are significant.

	The physical storage of pallets, as basic and simple as it appears, has not been overlooked by the digital revolution. Software to manage and control inventory can greatly reduce costs. It is easy to assume that more storage is better. Large inventories, however, require money tied up in idle materials that are not adding value, and the capital costs to construct and operate larger warehouses must be considered. Contemporary supply chain strategies try to balance the quantity stored to the throughput of the facility. With barcoding and radio-frequency identification, it is possible to know every item in an inventory as well as its real-time status. Production planning and historical data can be used to reduce the time that materials are stored before use. This “just-In-time” approach contrasts with the traditional “just-In-case” philosophy. Efficiency is increased and waste decreased by receiving goods only as needed. Less space is used, smaller inventory investments made, minimal inventory obsolescence occurs, and responsiveness for accommodating product changes is increased.

	The design and operation of modern warehouse facilities has many tools at its disposal. All are focused on creating effective and efficient operations. Understanding inventory and the demand for those materials is crucial to an optimized facility. With less money tied up in inventory, a well-organized and well-run facility frees up resources for use elsewhere, increasing the value that the warehouse operation delivers.

Understanding inventory and the optimal type of retrieval is crucial for designing a pharmaceutical warehouse facility.

Fundamentals of GMP Warehouse Design: Considering Storage and Retrieval Methods

	Single-use technology is a proven alternative to traditional stainless-steel vessel and pipe bioprocessing. Available for all stages of processing, from media prep and upstream operations to buffers and downstream processing, single-use systems (also known as disposables) are found in licensed biopharmaceutical manufacturing facilities around the world. The most common applications today are hybrid systems combining both disposable and traditional stainless-steel unit operations. Most importantly, single-use connectors, sampling, and transfer systems provide for truly closed processes.  

	Being a closed process by itself represents savings over traditional fixed systems. The most obvious is the downgrading that can be achieved in cleanroom classification of the process spaces. An open process that would typically require Grade B space can now be Grade C or perhaps even lower. With each higher grade of classification, a greater number of air changes is required with a corresponding greater operational cost per square foot. As a result, reducing the classification of a space provides operational savings that continues year after year. In addition, downgrading space classifications can reduce or even eliminate the gowning rooms and airlocks that are needed to transition to those higher classifications. Every time gowning and airlocks are removed, savings accrue from a broad range of reductions, including gowning supplies, gowning time and labor, material transfer time and labor, cleaning supplies and labor, and environmental testing. From an operational perspective, these accumulate over time and provide opportunity for greater productivity.

	If thoughtfully designed, stainless-steel process trains can also be closed operations. However, non-disposable equipment requires maintenance, especially cleaning between batches. With stainless steel, this is achieved through robust clean-in-place, sanitization-in-place (CIP/SIP) systems. In contrast, single-use technology is simply disposed of. It eliminates the need for CIP/SIP and all that goes with it. The equipment, piping, and space that houses CIP/SIP tanks and pumps are no longer needed. There is a reduced burden on the utilities supporting the system, and the need for purified water, water-for-injection (WFI), or clean steam is eliminated, at least as far as CIP/SIP is concerned. CIP requires a tremendous amount of water. The elimination of its use is environmentally friendly, and there is no need for cleaning chemicals. The elimination of CIP/SIP and its supporting utilities simplifies facility design in many ways, reduces energy use, and has a corresponding reduction in capital and operational costs.

	Although single-use technologies can reduce the amount of cleanroom production space and associated technical support requirements, single-use technologies also increase the amount of consumables that are handled. Single-use bag and tube sets need to be stored before use, and these same items need to be deactivated and staged for disposal after use. Even with sophisticated just-in-time receiving and shipping technologies, the space implications must be addressed. Increased warehousing and space dedicated to deactivating and staging of the used disposables must be accommodated. Although these unique space needs are added requirements, their capital and operational costs are significantly lower than the higher-grade GMP process spaces demanded by stainless steel.

	The disposal of single-use technologies raises obvious concerns regarding its environmental impact. The materials are plastic, which the public typically associates with being non-sustainable. This concern, along with the continual waste generated, presents the obvious question regarding sustainability. But sustainability can be a complex question and requires a lifecycle assessment to provide a comprehensive answer. Single-use technology presents pluses and minuses on both sides. The production, distribution, and disposal of components generates potentially significant amounts of waste; however, it also reduces the generation of large quantities of WFI, process water, and steam. In fact, numerous studies have shown some environmentally beneficial aspects of single-use (1–3). In a comprehensive lifecycle assessment study reported in 

, it was found that “single-use process technology can have less impact on the environment than traditional process technology in a broad range of environmental impact categories … in this study, single-use process technology exhibited lower environmental impact compared to traditional process technology in all midpoint and endpoint damage categories that were considered” (4). The conclusion drawn is that compared to stainless steel, single-use systems are sustainable.

	The implementation of single-use technology in a facility has important differences from traditional, fixed stainless-steel installations. These changes, however, are not extreme; overall, they are more about the shifting of space and cost from one area to another. There are shifts in the configuration of spaces as well as shifts in capital and operational costs. Expensive classified cleanroom spaces can be reduced, but inexpensive storage space is increased; there is an increased cost for consumables but reduced turnaround time between batches; and there is an overall increase in production time compared to the labor expended. Despite these realignments, a consistent picture emerges that the savings are many, especially with the elimination of CIP/SIP. The consensus has developed that single-use systems save both capital and operational costs over fixed stainless steel. Although a facility with single-use technology in all its unit operations returns the most savings, savings are possible even with hybrid facilities. As companies experience these unit savings it seems natural that pressure will build for more, and more complete implementation of single-use systems.

		A. Brown, et al. “An Environmental Life Cycle Assessment Comparing Single-Use and Conventional Process Technology” 

www.biopharminternational.com/environmental-life-cycle-assessment-comparing-single-use-and-conventional-process-technology

		H.L. Levine, et al. “Efficient, Flexible Facilities for the 21st Century” 

 (Dec. 1, 2012), www.bioprocessintl.com/manufacturing/facility-design-engineering/efficient-flexible-facilities-for-the-21st-century-337813/, accessed April 25, 2017.	

		C. Scott and W. Whitford. “Single-Use and Sustainability” 

. (April 1, 2014), www.bioprocessintl.com/2014/single-use-and-sustainability-351059, accessed April 25, 2017.	

		M. Pietrzykowski, et al. “An Environmental Lifecycle Assessment of Single-Use and Conventional Process Technology: Comprehensive Environmental Impacts” 

www.biopharminternational.com/environmental-lifecycle-assessment-single-use-and-conventional-process-technology-comprehensive-envi

:
	When referring to this article, please cite it as E. Bohn, "Facility Design Issues for Single-Use Processes," 


	Eric Bohn is partner at JacobsWyper Architects, 1232 Chancellor St., Philadelphia, PA 19107,  tel: 215.985.0400, 

Single-use systems demonstrate advantages over stainless-steel systems for biopharmaceutical manufacturing facilities. 

Facility Design Issues for Single-Use Processes

	The use of airlocks is a principle that is well-established in the design of cGMP facilities. Despite the apparent simplicity of inserting small rooms into the plan of a pharmaceutical manufacturing facility, there is confusion regarding their proper use and definition. Airlock seems like a simple enough term, but airlocks have several distinct functions that, although closely related, are freely mixed and often cause confusion. This article looks at these functions and definitions.

	Airlocks are an architectural device that helps implement heating, ventilation, and air conditioning (HVAC) control of air classification or quality. Their purpose is to allow a shift between cleanliness levels, for example, from ISO 8 to ISO 7 or Grade C to B. This shift is achieved by maintaining room pressurization (by the direction of air flow through doors) and isolating the levels from each other. This common understanding of airlocks is defined in industry literature (1).

	An airlock is a space that provides segregation of cleanliness zones. While always designed for the higher level of cleanliness, when in use, the room will switch back and forth between levels as the doors open and close. When one door is opened, the opposite door maintains the boundary. And when opened to the lower classification level, the airlock effectively downgrades (see

). Once all the doors are closed, the room re-establishes itself at the higher level. Similarly, when a door is opened, air flows into or out of the room, and the pressurization at the open door goes neutral; the door opposite becomes the new boundary. 

	Whenever there is a change in air classification, a gowning activity also occurs. Personnel are the dirtiest entity entering a cleanroom. Contaminants generated by personnel must be properly encapsulated to restrict particulate counts to the levels appropriate for the cleanliness level in question. Depending on the nature of the process (i.e., oral solid dose, aseptic, biologic), restricting particulates may mean adding more coverage or possibly a change of garments. Upon leaving a cleanliness zone, the potential to carry contaminates out of the higher air classification must also be considered. In any case, a garment adjustment is necessary when moving to a new zone.

	Because airlocks and gowning rooms are both required between air classifications, they are often considered the same. There are instances, however, when gowning occurs and a change of air classification does not. A case in point could be a multiproduct facility where containment is crucial. In this example, gowns exposed to product in a processing area need to be considered contaminated and should not be introduced back to a common corridor serving adjacent processing rooms. Given that gowning rooms are not necessarily airlocks, it is important to be clear on the need and purpose of the gowning room and to deploy them accordingly; not just whenever airlocks occur.

	Transition spaces are the odd duck. They are essentially airlocks, but they do not meet the classic definition. While airlocks are indispensable to the proper segregation of air classifications, the term “transition space” is used to distinguish those instances when there is no change in cleanliness level. In these situations, the air classifications on both sides of the transition space are the same, but maintaining pressurization and direction of air flow is still crucial. Such conditions are primarily found where containment is required. A good example is in a biological facility where a transition space is necessary to maintain a biosafety boundary. Both sides may be Grade C, but to properly segregate the adjacent processing rooms or rooms served by a common corridor, it is necessary to confine contaminants to within each room. In an oral solid-dosage facility, containment could be needed where there are adjacent processes using dusty operations. In both cases, the transition space allows for containment within the process room through the control of pressurization and the direction of air flow.

	The term “airlock” is often used loosely, which can result in a lack of understanding of process segregation. The primary role of an airlock is the isolation of cleanliness zones. Like airlocks, gown rooms are always needed when moving between different cleanliness zones, but gowning rooms are needed in other instances as well. For any facility, a gowning strategy needs to be thought through independent of the cleanliness zones and, if appropriate, additional gown rooms provided. On the other hand, transition spaces are functionally airlocks, at least in terms of pressurization. Sometimes, process spaces need to have the segregation that airlocks provide even though there is not a change in air classifications. Again, process segregation is a topic that needs to be thought of independent of the extent of cleanliness zones. Given that these functions are so closely related and even overlap, it is easy to understanding the blending of these terms together as airlocks. When looking at a pharmaceutical manufacturing facility design, however, it is important to recognize that these different cGMP aspects need to be considered based on their own criteria. When these factors are considered carefully and employed deliberately, a more effective facility can be achieved that is both cGMP compliant and operationally efficient. 

ISPE Baseline Guide, Vol. 3: Sterile Product Manufacturing Facilities

, Second Edition (Bethesda, MD, Sept. 2011.)


	When referring to this article, please cite it as E. Bohn, "Airlocks for cGMP Facilities," 

Airlocks, gowning rooms, and transition spaces have different uses and should be considered separately in cGMP pharmaceutical facility design.

Understanding Airlocks for cGMP Facilities


	When referring to this article, please cite it as E. Bohn, " Airlocks for cGMP Facilities," 