Cleanrooms for medical device and pharmaceutical manufacturing are highly regulated spaces and there are numerous standards that need to be considered. When it comes to how data is handled in regulated cleanroom environments, the United States FDA issued 21 CFR Part 11 guidance that should be followed closely.

Through the ever-evolving pandemic, there have been many regulations and guidelines given for how to make spaces safe when handling COVID-19. In general, the guidance for health care focuses on developing plans for both temporary AIIRs and individual spaces that are negatively pressurized. When creating these spaces, it is important to have a design where the air is exhausted directly outside where it can be diluted or that it passes through a HEPA filter that removes at least 99.97% of harmful particles before it is recirculated.

Throughout the COVID-19 pandemic, there has been an emergence of new technologies advertised for helping remove the pathogen from the air. However, these methods have major flaws that present significant implementation challenges or make them ineffective at preventing the spread of COVID-19.

In cases where a long-term care facility may not be able to set up negative pressure isolation, but they are still looking to improve the air quality and safety of that isolation space and surrounding areas, the Setra AIIR Watch can used to purify and recirculate the air. Regardless of the application, the air that passes through the Setra AIIR Watch is being sterilized to 99.99% effectiveness with the UV-C light and HEPA filtration inside. The key to this effective sterilization is the particles that are trapped by the HEPA filter inside the unit have UV-C bulbs entrained on them to neutralize viruses and bacteria on first pass through the Setra AIIR Watch. Instead of getting exhausted out to create negative pressure, the sterilized air can be recirculated to increase air changes per hour and purify the air in the space

Environmental monitoring, especially particle counting, in cleanrooms is used to show that said cleanroom operates within its set parameters before and during manufacturing processes. The safety and quality of products can be affected if too many particles enter the manufacturing space or process. However, this monitoring is commonly still a manual process in many cleanrooms instead of routine or continuous particle counting. Cleanrooms are highly regulated environments that require the utmost attention to air quality and cleanliness.

Throughout the COVID-19 pandemic, the residents of long-term care facilities, senior living communities, and nursing homes have been one of the most impacted populations. With many at risk people living in single buildings or communities, as soon as one person becomes infected with COVID-19 the likelihood of the disease spreading among the community increases. Because COVID-19 is an airborne infection, understanding how to properly isolate an infected person from others can help increase the safety and reduce the risk of spreading the disease.

Why continuously monitor a cleanroom?

Cleanroom monitoring is performed for two reasons:

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Due to the coronavirus pandemic, most in-person tradeshows for 2021 have been cancelled or rescheduled. Instead, this year Setra will be hosting a free, online Virtual Showcase.

Amidst the COVID-19 pandemic, hospitals are expanding their isolation room capacity. Currently, Brownfield Regional Medical Center is using the AIIR Watch to create extra isolation rooms for any infectious disease patients in their facility.