Charity

Whether the goal is high yields or regulatory compliance, controlled environments are integral to pharmaceutical manufacturing processes. Air showers are vital to maintaining the clean environment; they help protect operations from the constant threat of air particulate contamination. Medical device, bio-tech, and pharmaceutical industries require contaminant-free environments and use air showers as part of their operations.

A facility transformation begins long before the A&E and other service providers are invited to the table. Typically, a business model is used to map out and project demand for specific products, estimate product production rates, and time lines for expected product introduction and product ramp-up to match the expected demand. Several factors are considered to determine where the facility should be located: proximity to the customer pool, availability of qualified on-site resources and availability of existing infrastructure, market conditions, and regulatory climate.

The building housing this expansion was comprised of offices, labs, manufacturing and support spaces, with a total of over 220,000 square feet of space. Distinctive air-handling zones existed for the offices, the labs and the manufacturing areas. Offices were served by several packaged single-zone systems. The labs and the manufacturing areas used air handlers utilizing chilled water and hot water coils.

In terms of cleanliness, the manufacturing space was design to meet ISO 7 classification in at rest condition. Entry and exit points were specified at air changes per hour that met ISO 7 requirements for this non-sterile drug product. The air change rate in the gowning rooms was set higher to promote particle capture at entry and exit points. The corridors were clean but not classified or CNC. A transition zone occurred inside the gowning room to take into account the movement between the CNC space and the ISO 7 area, as depicted in the image below. This transitional zone was physically demarked by a step-over bench that separated the clean side from the dirty side. Gowning at the entry point was downed at a level that was prescribed by the user as part of the administrative protocols to minimize both introduction of particles and cross contamination of the API from external sources. For this facility, people entering the manufacturing area from the CNC corridor downed a second layer of gowning (the first layer was downed at the entrance to the CNC space). People moving from one production suite to the next needed to follow gowning protocols at each entry and exit point.

A strategy was developed for the movement of materials and people throughout the cleanroom. Eventually, a layout of the facility was agreed upon. It is important to understand that the development of the layout was a critical factor in that the design work cannot proceed fully without a “frozen” layout. More often than not, there is a level of hesitation from the parties involved — typically on the owner side — with endorsing a final layout. It is safe to assume that even with the best intentions, changes will occur after the layout is frozen and endorsed, and design professionals can only hope for a properly managed change process. Layout development is a process that does not follow a straight line. It is seldom, if ever, a black and white type of solution. Instead, this is the part of the design that takes a great deal of effort to achieve consensus. The process is interactive, and that involves multiple steps. Teams gathered to discuss what was required (the action), and a space program is preliminary developed in response (the reaction). Unless all the stakeholders are present, which is rarely the case, this can be a time-consuming process.