Setra Blog

Let’s face facts; manual monitoring of cleanroom particulate counts is costly, monotonous and highly error prone. Cleanroom managers are very aware that by far the greatest contamination threats come from individuals entering controlled spaces. Understandably, to reduce the number people accessing these critical environments, many companies are tasking the cleanroom operations staff already working within these spaces with the additional responsibility for manual environmental monitoring (EM).While this approach has obvious benefits, such as lower labor costs and reduced contamination risks, it also introduces significant new data integrity issues.

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 ofparticle countersand 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:

医疗设备和制药制造的洁净室是高度规范的空间，有许多标准需要考虑。当涉及到如何在规范的洁净室环境中处理数据时，美国FDA发布了21 CFR Part 11指南，应该密切遵循。

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.