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.

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

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:

As COVID-19 is an ever-increasing problem, making facilities ready to handle potential spikes of the virus is paramount. The safest way to handle the virus is to create isolation rooms where it can be quarantined if it appears. Setra's AIIR Watch can be brought into various spaces to quickly create isolation rooms.

Last week, Setra hosted a webinar focused on COVID preparedness and our latest product, the AIIR Watch. For more information on how best to prepare for potential spikes in COVID-19 and learn more about how the AIIR Watch can help create isolation spaces, watch this recording of the webinar.

Join Setra for an upcoming webinar on October 29 at 11am EST discussing how to prepare in the event of COVID-19 spikes. Featured products will include Setra Lite and the new Setra AIIR Watch.

In the wake of the coronavirus, it is imperative for hospitals to be prepared for future outbreaks of infectious diseases. For these situations, the safest method for treating patients is isolation rooms. The safety and effectiveness of such rooms is contingent upon proper control of the room's differential pressure.

During a disease outbreak, there are several risks dentists encounter. One serious risk is contracting an illness from aerosol particles created during a procedure. Aerosols are splatters, mists, or droplets in the air, and can include saliva, blood, and plaque. Three main sources of airborne contamination in dental offices are dental instrumentation, saliva and respiratory sources, and the operation site. Aerosol particles can be generated with: