Setra Blog

Setra’s wide array of non-viable particle counters are used throughout critical environments to measure particle concentrations of various sizes; these counters use a long-life laser diode, light scattering, and photo detector to calculate particle size and quantities as the sampled air passes through. Particle counters are required for cleanroom certification but are also often used for continuous, sequential, or periodic monitoring of the space between certifications and to ensure that particle levels are maintained below critical thresholds during manufacturing. This post will look at Setra’s different particle counters and their differences to help you decide upon the correct unit(s) for your application.

Setra’s comprehensive range of世界杯2022赛程时间表最新 and air quality monitors are the most advanced, high-performance instruments available. This industry-leading position has developed from an enduring, intense focus on innovation and original intellectual property creation.

Cleanrooms are specially constructed, highly regulated environments for controlling atmospheric conditions and eliminating dust particles. As such, these spaces require continuous monitoring of many environmental parameters. Without this continuous monitoring, the quality of manufactured product and safety of cleanroom personnel could be at risk.

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.

AnISO 14644-1classified 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.

Setra's latest product innovation of wireless transmitters builds on our over fifty years of experience delivering industry leading sensing technology. Ournew wireless sensing product linecan easily measure and monitor a variety of environmental parameters. Wireless transmitters are used throughout a number of applications, including but not limited to:

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.

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.

Why continuously monitor a cleanroom?

Cleanroom monitoring is performed for two reasons: