For regulated spaces creating electronic records of environmental monitoring and other sensitive data, accuracy and security are of paramount concern. How data is handled in regulated environments like cleanrooms is crucial to both regulatory compliance and data security. Besides the damage a data breach can do to a company’s reputation, a company has a legal obligation to protect user and customer data.
September 02, 2021
An ISO 14644-1 classified cleanroom is a room or contained environment where it is crucial to keep particle counts low. Typically, these particles are dust, airborne microbes, aerosol particles, and chemical vapors. Beyond particle counts, cleanrooms often have controls for a number of other parameters like pressure, temperature, and humidity. Additionally, to be considered a cleanroom, the space needs High-Efficiency Particulate Air (HEPA) filters to remove particles from the air.
July 13, 2021
Setra's latest product innovation of wireless transmitters builds on our over fifty years of experience delivering industry leading sensing technology. Our new wireless sensing product line can easily measure and monitor a variety of environmental parameters. Wireless transmitters are used throughout a number of applications, including but not limited to:
April 06, 2021
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.