Selecting a cleanroom for a new business or new product is not as difficult as it may seem. While there are many options and features to consider, focusing on your key requirements will help make the decision making process easier.

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Cleanroom Selection Criteria

Applicable Rules & Regulations

Rules mandated by government regulations, ISO guidelines, or customer requirements are the first key consideration when selecting a cleanroom. For example, government regulation USP797 outlines specific requirements for the manufacture of pharmaceutical products; ISO 14644-5:2004 guidelines specify basic requirements for cleanroom operations. Most often, regulations or customer specifications will dictate the cleanliness level or rating required, which provides a good starting point for choosing the right cleanroom.

Cleanroom Cost

Cost is also an important consideration, especially if you’re starting a new business or developing a new product line. Prices can vary greatly, from custom, fixed-wall construction to modular, free-standing, softwall or hardwall cleanrooms. Fixed wall rooms are typically the most expensive, with modular softwall cleanrooms being the most economical. Additionally, size, shape, configuration, and accessories will all affect the overall cost.

Other Considerations

The location of your cleanroom within your existing building structure, and the number of processes and workers needed in cleanroom, will determine the size and shape of the room. Cleanroom aesthetics are also important: projecting a high-tech image with visual appeal can help attract new customers.

Advantages of Modular Cleanrooms

  • Modular cleanrooms reduce design, engineering, and construction time, and thereby reduce costs. Since they are not an integral part of the larger structure, modular cleanrooms can be disassembled and moved to other locations or facilities, or even sold as an asset. Fixed-wall cleanroom construction does not offer this flexibility.
  • Most modular cleanrooms can easily be expanded by removing one or more walls and adding another module. The pre-fabricated design allows the room to be expanded, relocated, or configured into a different shape, or configured into multiple smaller rooms.
  • All air handling and filtration equipment modules are generally built in to the ceiling of a modular cleanroom. Hookups for electrical and plumbing systems are engineered in as part of the design.
  • It takes less time to install a modular cleanroom than it does to construct a permanent fixed-wall structure. Due to the amount of design, engineering, and the various trades involved, it can take several months to construct a fixed-wall cleanroom. However, a sophisticated modular cleanroom can be constructed in just a few weeks. Onsite assembly of a modular cleanroom is also far less disruptive to surrounding operations than permanent construction.
  • Modular cleanrooms also offer potential tax advantages to businesses. They are not typically considered part of the building, and can often be depreciated faster than a built-in, fixed-wall cleanroom. Tax consultants can provide specific tax advantage information.

Cleanroom Construction Considerations

There are two basic types of modular, hardwall cleanrooms: recirculating and non-recirculating. Your product and process requirements will determine which type of cleanroom is best-suited for your needs.

Recirculating Cleanrooms

Recirculating modular cleanrooms recirculate the air within the cleanroom and prevent it from mixing with outside air, providing better control of temperature and humidity. Air is recirculated back to the high-efficiency particulate absorbing, or HEPA, filters located in the cleanroom’s ceiling. This is accomplished via air return chambers built in to the room’s walls or through existing walls of the building.

Recirculating cleanrooms will experience less contamination load on the HEPA filters because the system is recycling previously-cleaned air. With less contamination loading, the filters will last longer and perform better.

Non-Recirculating Cleanrooms

Non-recirculating, or single-pass, cleanrooms draw in air from above the room through the HEPA filters in the ceiling. The filtered air is then blown into the cleanroom and exits through an approximately two-inch gap located below the walls or through adjustable wall grills. Due to the lack of return air ductwork, non-recirculating cleanrooms are less costly to construct than recirculating cleanrooms.

Cleanroom Performance

Testing a Cleanroom: As-Built, At-Rest, Operational

Most businesses are aware of their cleanroom performance requirements because of customer, industry, or government specifications. These performance requirements identify the cleanroom class level required at a given state or condition. There are three levels of condition (states) for testing and characterizing the performance of cleanrooms: as-built, at-rest, and operational. Specific test methods for these three classifications are outlined in ISO 14644-3:2005.

Most cleanrooms are rated and sold in the as-built category: an empty room with the filter system running, but without workers or production equipment. However, adding workers and equipment will introduce contamination and affect the room rating. A cleanroom may be rated ISO 6 at rest, but ISO 7 during operation (see Table 1).

Cleanroom classification chart

To comply with performance requirements, the as-built empty room should be tested and benchmarked, followed by testing and documentation of the at-rest and operational states. If contamination in the at-rest or operational states are not in compliance, corrective steps need to be taken. These steps can range from examining the production process and number of workers in the cleanroom to testing the room’s air flow performance.

Cleanroom Air Flow & Air Changes Per Hour

To ensure optimal cleanroom performance, air flow design and frequency of air changes should be evaluated. Cleanrooms are classified according to the number and size of particles permitted per volume of air in a specific amount of time. There is a relationship between cleanroom class ratings and the room’s air changes per hour. For a cleaner room rating, more air exchanges become necessary. For example, a typical ISO Class 7 cleanroom will have 60 to 150 changes of air per hour, while an ISO Class 6 room will have 150 to 240 changes per hour (see Table 2).

cleanroom classification requirements

All areas within a cleanroom should have similar air changes during each hour to ensure required performance. For example, a cleanroom with only one air return or exit, located at the opposite end of the room from the fan and filter, will likely produce stagnant air spots. This type of design causes air to flow almost horizontally across the room to the venting location, in a line-of-sight fashion. Areas of inadequate air movement retain higher levels of contamination. Adding or moving air returns will enable a more vertical and even air flow, improving overall air quality. The right balance of filter and air returns must be maintained to create positive air pressure inside the cleanroom. Positive air pressure produces outward air movement, preventing the inflow of contaminants and assisting in the expulsion of particles generated by