Cleanroom Basics

A modular cleanroom is a cleanroom that is made from prefabricated parts that are then assembled on-site. They use negative pressure plenum design, HEPA fan filter units, and commercial off the shelf AC to reduce cost and are easily reconfigurable for future needs. They can be designed, manufactured and installed in half the time of standard construction. They can be designed for ISO-4 thru ISO-8 cleanrooms classes and meet CGMP requirements. They can provide chemically resistant or static dissipative walls and flooring. The following videos show how modular cleanrooms are assembled.

Modular cleanrooms offer faster installation, are available for ISO-5 thru ISO-8 cleanroom classifications, and can be used for all industries: medical device, pharmaceutical, electronics, aerospace, industrial and government. Modular cleanrooms are comparable in cost to standard constructions and can be permitted. Modular cleanrooms can be relocated if your company moves. Modular cleanrooms are easy to modify or expand. Modular cleanrooms are often treated as equipment enclosures and can be section 179 depreciated in one year rather than 39 years for standard construction. See blog below.

ISO-14644-1 and FEDSTD 209e set the particle counts and HEPA air changes per hour required for ISO-4 thru ISO-8 or class 10 thru class 100,000 cleanrooms. Other cleanroom classification requirements include cleanroom wall type, cleanroom ceiling type, cleanroom flooring type, cleanroom differential air pressure. Other cleanroom standards include Europe GMP Annex A, B, C, and D and USP797/800. Cleanrooms in pharmaceutical and medical device industry in United States are subject to Current Good Manufacturing Practive (CGMP) criteria.

ISO 14644-1 cleanroom classifications measure particle counts per cubic meter. ISO cleanroom standard is used most commonly in pharmaceutical and medical devices industry. The electronics industry uses both ISO 14644-1 and FED Std 209E which measures particles per cubic feet. ISO-4/class 10 is the most demanding requirement only allowing 10 particles per cubic foot. ISO-8/class 100,000 is the least demanding allowing 100,000 particles per cubic foot. By comparison a typical office space will have between 500,000 and 1,000,000 particles per cubic foot. See following blog for more information.

Cleanrooms rely on HEPA (high efficiency particulate air) filters to keep the air clean. The recirculating design means the HEPA fan filter units keep recleaning the clean air resulting the lowest possible particle counts. Dedicated air conditioning and humidifiers/dehumidifiers are used to hold the extremely tight temperature and humidity tolerances required for semiconductor, battery, and pharmaceutical industries. Airlocks are used to prevent particles from entering the cleanroom. Cleanroom personnel wear cleanroom garments to keep from contaminating the cleanroom. The following 5 blogs give detailed information on how to design your cleanroom.

Modular cleanrooms offer material and equipment options for ESD control. Modular cleanrooms can be installed much faster than standard construction. Modular cleanrooms are easily modified. Electrostatic discharge is major concern in semiconductor and electronics cleanrooms. Modular cleanroom can incorporate static dissipative walls, static dissipative flooring and humidity control to reduce static.

Cleanrooms use HEPA fan filter units to remove contamination from the cleanroom. By increasing the number of air changes per hour we remove more of the particles. The higher number of air changes per hour the higher the cleanroom classification (and lower number of particles). Humans are the largest source of contamination in a cleanroom so personnel must wear cleanroom garments to encapsulate human particles and prevent them from entering the cleanroom. Regular cleaning is another way to control contamination in the cleanroom. Read the following 4 blogs to learn more.

Cleanroom air quality standards are limits on size and quantity of non viable particles per ISO-14644-1 cleanroom classifications. Viable particles standards are limits per pharmaceutical and medical device FDA validation documents. Viable particles are mold, bacteria, virus, or fungus. Non viable particles are measured with laser particle counters. Viable particles are measured using settling plates which are incubated then counted. Read the following blog to learn more.

People typically monitor differential pressure, temperature, and humidity in a cleanroom environment. Differential pressure confirms that HEPA filtration is working correctly to keep cleanroom clean. Positive pressure prevents contamination from entering cleanroom. Temperature confirms that AC is working to keep cleanroom cool. A cool cleanroom is important for personnel comfort since they are wearing bunny suits. Temperature control is important for many manufacturing processes done in cleanrooms. Humidity to confirm that humidifier and/or dehumidifier is working to keep room at humidity specification. Humidity control is important to control static in semiconductor or electronic cleanrooms. Humidity control is critical when doing semiconductor photolithography. The following 3 blogs have more information.

Cleanroom validation is part of FDA required drug validation process for CGMP (Current Good Manufacturing Practice). The cleanroom validation process includes design qualification, installation qualification, operational qualification and performance qualification. The cleanroom design must meet manufacturing needs. The cleanroom installation must done to ensure that design is fully implemented. The operational qualification ensures that the cleanroom when completed meets the design specification.

As built particle testing is used to do cleanroom certification that the cleanroom meets ISO class. The cleanroom is tested via ISO 14644-1 by taking the prescribed number of particle measurements in each room. The air changes per hour can be computed by comparing the volume of each room vs. the number of HEPA fan filter units or by physically measuring air flow thru each. Finally differential room pressure is measured via Magnehelic gauges. Cleanroom validation requires Design Qualification, Installation Qualification, Operational Qualification, and Perfomance Qualification. The following three blogs discuss how cleanroom certification is done, what are common mistakes during the process and how certification is part of FDA validation.

Cleanroom cost depends on size, classification and type of cleanroom. Higher rated ISO-5 cleanrooms cost more than ISO-8 cleanrooms due to large number of HEPA fan filter units and higher AC requirements. For cleanrooms with high heat loads or large exhaust cfm the AC can make up to 40% of the cost of the cleanroom project. Special requirement such as chemical resist cleanroom walls or static dissipative cleanroom flooring add cost. Tight temperature and humidity control such as in semiconductor cleanrooms also significantly raise cost. Following blog has more information.

Modular cleanroom ROI is the Return On Investment by choosing a modular cleanroom over a stick built (standard construction) cleanroom. Modular cleanrooms provide significant cost savings thru faster installation, lower cost, and superior tax treatment and longer life. Other benefits that save money are easy modification and the cleanroom can be disassembled and moved to new location. Read blog to learn more.

Pharmaceutical and medical device cleanroom requirements come from customer product and cleanroom validation document. That document is required by the FDA CGMP (Current Good Manufacturing Practice) to get approval for the medical device or pharmaceutical product. Industrial cleanrooms are not regulated but conform with ISO 14644-1 and FED Std 209E cleanroom classifications. Read following 2 blogs to learn more about CGMP cleanrooms and cleanroom validation.