Earlier in the year, I put together an article highlighting human error as a looming shadow when maintaining noncontaminated cleanroom environments. As well as discussing personnel, I also included cleanroom threats like dysfunctional filtration, contaminated equipment, and temperature and humidity issues.

Since publishing the original article, a few additional pain points to maintaining a cleanroom have been pinpointed, such as stringent protocol compliance, cost of maintenance, and environmental factors.

Stringent protocol compliance:

Cleanrooms require strict adherence to company protocols, procedures, and industry standards to ensure safety and the cleanliness needed to produce medical product. However, maintaining compliance with regulations like International Organization for Standardization (ISO) standards require demanding work, robust documentation, monitoring, and validation processes. This is in addition to an employee’s thorough understanding of how to take necessary precautions to limit contaminants inherent to being a person (skin flakes, oils, sweat, hair).

For more information on precautions employees should take before, while in, and after exiting a cleanroom, see the previous article “Keeping the Cleanroom Clean.”

Cost of cleanroom maintenance:

Cleanrooms are expensive to create and demand significant financial investment to maintain. Construction costs for cleanrooms vary depending on what is needed for production and can vary from $180 sq ft to $2,800 sq ft. or more.

But costs don’t stop there.

Air filtration systems, temperature and humidity monitoring, exhaust systems – VOC, toxic, heat, general, which some facilities preferring to run separate ductwork and abatement for fumes – all have a place in cleanroom environments. In fact, the operating costs of recirculating AHU fans and air-cooled DX units contribute approximately 35% to the total HVAC operating cost. Vibration and noise control is also used, depending on need, including concrete “waffle’ slabs under the cleanroom floor to keep equipment vibration from transferring to other areas of production. If vibration and noise control is not factored into the initial build of the cleanroom, it is expensive to fix later.

Magnetic shielding, which must be used for cleanrooms producing semiconductors, among other products, can be very expensive. Occupational safety and health requirements limit magnetic field strength in areas open to the public to the 5 Gauss limit. Depending on the production, 4 to 5 mm thick shielding on the envelope of the cleanroom with magnetic (Fe-Si) steel (M15 type) may actually lower the strength of magnetic flux from MRI equipment to 1.3 to 2.6 Gauss.

Environmental factors:

Cleanroom environments are sensitive to external influences like temperature, humidity, and air pressure so maintaining consistent and optimal conditions can be demanding, especially for large facilities or regions experiencing extreme weather. Many extreme weather conditions have tested facility cleanroom conditions, including power outages and negative temperatures from the Texas winter storm in 2021, yearly hurricanes hitting America’s southern region, and most current, wildfires decimating regions of Canada and resulting in smoke in the eastern United States. Maintaining these consistent conditions during trying times such as the examples above will circumvent potential equipment malfunctions or production disruption.

Article Source：MDDI