Contamination control is the primary design goal of any cleanroom. Any potential source of contamination into the cleanroom must be thoroughly evaluated and minimized. Lighting fixtures should be subjected to contamination evaluation. Unfortunately, there are no established standards to prequalify fixtures for a particular cleanroom class. The National Sanitary Foundation (NSF) does provide listing and testing of materials used in food, pharmaceutical, medical or other FDA applications. Fixtures used in these applications should be required to carry the NSF listing mark. Manufacturers often advertise fixtures as being suitable for cleanroom use with no data or standard qualifications to substantiate their claims.
For those of us in lab design, we know that cleanrooms can be one of the most complex spaces to design. Cleanrooms provide a space where the particulate count in the air is regulated. A wide variety of clients require clean spaces to conduct their business, whether it’s based on their own SOPs (standard operating procedures) or required by regulatory agencies. Cleanrooms offer an indoor environment unique to any other indoor environment—and with it, pose some unique design challenges.
While the cost of materials used in cleanroom construction is always a concern, the durability of those materials is far more of an issue because of the high cost of repairs once the cleanroom is in operation. For example, if the flooring cracks or loses its ability to contain spilled chemicals, it may be necessary to tear up the finish, repair the cracks, and install another floor.
Concrete is an excellent construction material. Pourable and formable, concrete develops into a hard structural material capable of supporting heavy loads and is durable enough to last for many years. But concrete is porous and subject to wear and to attack from corrosive chemicals. Also, it tends to abrade and give off large amounts of dust, while spilled materials tend to seep into and through it. Even with additives to increase hardness and seal the surface, concrete cannot be exposed in cleanrooms. Still, it forms the base for almost all flooring materials that do provide the required characteristics. These materials must be compatible with the concrete substance and must adhere well for long-term durability.
While there are discrete steps in the design and construction of a cleanroom, those projects deemed successful incorporate certain practices that promote flow of the construction process toward completion on time and within budget. Proper front end planning is not completed until it results in appropriate values for design parameters; "buy-in" at all levels of management, and clear direction for the design phase. Engineering the cleanroom in accordance with recognized industry practice would produce construction documents that facilitate clear procurement and construction planning as well as a focused, efficient, construction effort. A full return on the energy expended through the construction phase cannot be realized without a well-executed start-up and certification process that provides baseline data for effective operation and maintenance. This paper describes the steps in the cleanroom design/construction undertaking and offers practical suggestions on how to avoid pitfalls along the way.
Modular clean room construction can offer a number of important advantages over conventional (stick-build) approaches. For example, modular walls are an inherently dry construction material with little or no modification required for installation, thus minimizing dust generation. Modular systems can also be manufactured from materials that are non-shedding and non-particulating.
Any construction project, whether cleanroom-related or not, is subject to building codes. Regardless of construction technique, the overall objective of a building project is the same. The components of the clean room facility must satisfy local and national building regulations for fire protection and structural design. Materials are required to meet minimal flame and smoke development requirements (Class A non-combustible) or have fire separation walls (1- or 2-hour fire-rated for hazardous areas).
The question of modular versus conventional clean room construction is increasingly common in high-tech industries, and one that may have a different answer depending on each individual project. Speed to market, however, is critical for almost all manufacturing companies, and it’s particularly important for the pharmaceutical and biopharmaceutical industries, which need to maximize the patent protection period after what is usually a long and expensive product development cycle. It’s also crucial for the microelectronics industry where technology changes on a near-daily basis.
As the demand for complex cleanrooms in the life sciences grows, construction challenges mount. Making the right decisions during the building and commissioning phases of cleanrooms will help to ensure that they are successful, better integrated, more operable and sustainable. Generally speaking, teamwork among designers, operators, maintenance people and builders that focuses on project timelines will achieve the best results. The suggestions below will help drug and device manufacturers step back and better envision the whole facility during the build process.
The Initial Plan for Factory Construction
• Type of product, product capacity, and design specification
• Calculation of the cleanroom area
• Consideration on airflow, cleanliness, and cleanroom category
• The arrangement for process equipment
• Classification data collection for process equipment's facility requirement(Include water, electricity, gas)
• Moving lines of the process, relocation, shipping, personnel access arrangements
• The location arrangement, safety and convenience consideration for factory system
• Factories funding and milestone planning
• The investigation on the environment special requirement of the product
• Reserved for future development and expansion
• Environmental Protection Impact Assessment Plan
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