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.
March 02, 2021
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.
February 02, 2021
Why continuously monitor a cleanroom?
Cleanroom monitoring is performed for two reasons:
May 28, 2020
Cleanrooms are highly regulated environments that require the continuous monitoring of particle counts. In manufacturing cleanrooms, the safety and quality of products can be affected if too many particles enter the space. Setra’s CEMS provides a solution for environmental data, including particle counting, monitoring and recording needs required by various industries such as:
April 28, 2020
Cleanrooms are among the most strictly regulated critical environments, often continuously monitoring temperature, differential pressure, and relative humidity, in addition to the size and quantity of every particle. Continuous environmental monitoring helps ensure the quality of products manufactured in those clean spaces.
April 07, 2020
Setra's Continuous Environmental Monitoring Solution (CEMS) is an adaptive system of hardware and web-based software providing access to environmental data in real-time. Setra's proprietary CEMS software accepts flexible data inputs and integrates analog and digital hardware, providing a 24/7 centralized monitoring solution with user-friendly data visualizations. With CEMS, users not only monitor environmental data but also visualize trends and issue alarms, demonstrating patterns in data to influence strategic actions.