Why continuously monitor a cleanroom?
Cleanroom monitoring is performed for two reasons:
- 认证环境符合FDA (ISO分类)，USP, BOH和任何其他监管机构的规范要求。洁净室必须满足这些标准和要求，以保证产品安全。洁净室是一个活跃的环境，有流动的人员、过程和产品。污染可能随时发生，并对空间内生产的产品的产量和质量产生负面影响。如果没有一个持续的环境监测系统，这些事件可能会在几天甚至几周内都没有被发现，导致价值数百万美元的产品流过被污染的洁净室，并可能导致非常昂贵的产品丢弃或召回情况。大多数连续环境监测系统的用户在最初几次污染事件通知后就能看到充分的投资回报。
- To record historical data which supports audits and internal standard operating procedures (SOPs). Historical data can be useful in many ways. Such information can be useful to determine maintenance and cleaning schedules, as well as be the records required by many regulatory agencies, customers, and internal data retention mandates.
Why not have people manually check each area?
That is what has been done historically, but taking one reading is not sufficient to fully understand how many particles are in the space at a given point or over time. And more importantly, manual recordings are very labor intensive and prone to human error.
为了确保生产的产品质量，应该在多个地方进行颗粒计数，特别是在产品暴露或过程产生脱落的地方。一个持续的环境监测系统将在粒子数量激增引起问题之前检测到它们，有助于避免潜在的灾难性和昂贵的污染问题。
How to best monitor a cleanroom?
The first step to monitoring a cleanroom is to understand both the design of and risks for your cleanroom:
- Where are the most crucial, active, and dirty production areas that would be most impacted by contamination?
- Assess data from particle counters when cleanroom is in operation to better understand which locations are most at risk (or dirty)
- A continuous environmental monitoring system can track, record, and alarm in real-time when limits are reached
What size particles need to be monitored?
This depends on what is being produced and the ISO Class the cleanroom is looking to achieve. First, consider what size particles can impact production and classification level. Next, take into account budget and how best to position particle counters in the cleanroom. Keep in mind that particles can be a variety of sizes, so a particle counter that can monitor multiple particle sizes could be the most effective tool, like theSetra Particle Counter 5000 or 7000 series.
Where is the best place to sample particulate counts?
同样，这取决于在洁净室内生产的是什么，以及相应的工艺流程。为了确保生产的产品质量，应该在多个地方进行颗粒计数，特别是在产品暴露或过程产生脱落的地方。请注意，在过滤/清洁空气扩散器(HEPA/ULPA)附近采集颗粒计数样本可能导致读数不反映产品级别或工作表面的实际颗粒读数。
Why not use a building automation system to monitor a cleanroom?
Technically, you can monitor a cleanroom with a building management or automation system (BMS/BAS). However, the main responsibility of these control systems is to help the facilities team keep the building running between a given set of control points. It is often challenging or not possible to get real-time environmental data from these systems for reporting purposes. While control of the building is critical to maintaining a safe environment, a continuous environmental monitoring system allows quality, engineering, or contamination control teams to meet regulatory requirements for data and reporting. It also supports real-time notifications of deviations in the environment to avoid costly contamination issues.
It is possible to integrate our continuous environmental monitoring system with a BMS/BAS. We support uni-directional integration of data from the continuous environmental monitoring system to the control system.
What's the difference between a building automation system and an environmental monitoring system?
建筑自动化系统被设计用来控制设施中的各种参数，并立即根据洁净室的规格进行调整。环境监测系统旨在收集、通知和分析更详细的洁净室环境数据。虽然这两种系统可能有重叠之处，但它们明显不同，都是最先进的洁净室所必需的。
Looking to learn more about cleanroom environmental monitoring? Take a look atthis video!
