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Cleanroom Construction

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Cleanroom Construction Protocols and Requirements

Every construction project can sometimes use dangerous and unreliable materials that can harm humans. That is why a thorough analysis and study prior to construction is made to ensure that these possibilities are taken care of. This is even more significant for cleanroom construction since a lot of considerations have to be considered to guarantee quality and efficiency of the cleanroom.

In planning for cleanroom construction, you start with the type of design you want to implement on your cleanroom. There are lots of different types of cleanrooms such as hard-wall, soft-wall, portable, or self-contained cleanrooms. They can either be rigid and permanent or small and portable. These modular enclosures are usually assembled in the manufacturing of plants and use materials that do not attract air contaminants or shed particles. They also make use of materials that guard the room from temperature variance, ultraviolet lights, and excessive noise.

Airflow is also another factor that has to be thoroughly studied in cleanroom construction. There are two air flow principles that can be applied to cleanrooms. First is the laminar air flow, which makes use of a system that constantly blows HEPA or ULPA filtered air stream downward through ceiling mounted terminal filter units. Certainly laminar flow is preferred in many cleanroom settings. Turbulent air flow on the other hand is a system that makes use of velocity HEPA or ULPA filters and air flow hoods that jet stream the filtered air on different directions, because there is not 100% filter coverage or devices to create a laminar flow in the cleanroom.

Entry rooms or gowning rooms require special attention in cleanroom construction. Gowning rooms need to be positive pressure with the areas outside the cleanroom area, but typically need to negative pressure to the actual cleanroom area. This keeps particles from the gowning process and particles outside the cleanroom from making it in the clean zones. The gowning rooms are where shoes and clothing are kept to ensure that no dirt and dust get into the room and anyone that has to enter a cleanroom needs to go through an airlock chamber and sometimes an air shower to avoid bringing in particles on the staff’s gowns.

The planning and constructing a cleanroom can be a tedious job. Rigid protocols need to be followed in order minimize contamination inside the cleanroom area. The lower the particle count inside the facility the more rigid the construction protocol becomes. The chart below shows the cleanroom classifications according to the various standards.

Cleanroom Classifications

Federal Standard 209E

ISO Standard 14644-1

European Standard

Biosafety Levels

Class 1

ISO 3

Grade A

Biosafety Level BSL-1

Class 10

ISO 4

Grade B

Biosafety Level BSL-2

Class 100

ISO 5

Grade C

Biosafety Level BSL-3

Class 1,000

ISO 6

Grade D

Biosafety Level BSL-4

Class 10,000

ISO 7

   

Class 100,000

ISO 8

   

See More Information on Cleanroom Construction Levels

For a pharmaceutical facility with active ingredients, regulatory bodies have to validate your plan before design and construction can start. You have to get their approval in order to proceed with your cleanroom construction in addition to the local municipalities’ approval for construction. There are pre-set standards that these regulatory bodies will look into. Some of them are the sizing of equipment, flow diagrams that includes placement of the equipment and people and utilities to service. These factors will be checked according to the type of work intended to be done on the cleanroom. Most cleanroom construction is intended mostly for pharmaceutical, microelectronics, nanotechnology and biotechnology industries. These industries require a controlled environment because dust and pollutant particles can unfavorably affect product during the manufacturing process.

Overall, cleanroom construction requires a lot of planning and designing analysis. There are lots of construction firms specializing on cleanroom constructions that you can work with. The World Wide Web is one great avenue that can provide you a list of options that you can entrust construction of your cleanroom to. You may use the above discussed items as a starter on what needs to be taken into account.

Digital Air Control’s staff is extremely familiar with cleanroom design and construction. Our staff has collectively nearly 80 years of design, installation, and overseeing cleanroom construction. In need of a cleanroom facility, please prepare your questions and give us a call.

 

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