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.
Cleanrooms vary in both size and complexity and are used by a number of specialized industries. Any manufacturing with strictly controlled processes, as well as some healthcare spaces, will have a cleanroom.
Compounding pharmacies require cleanrooms for their production of specially mixed medications. With the type of materials used, it is a necessity to have a room highly environmentally controlled. The cleanrooms in compounding pharmacies are typically ISO 7 or 8.
Medical Device Manufacturing
Quality in medical device manufacturing is dependent on the efficiency of the cleanroom. Airborne particles and microorganisms must be monitored and controlled to ensure the safety of products manufactured.
Manufacturing electronics requires strict environmental conditions, as any particulates in the air can impact the sensitive nature of the products. Cleanrooms for semiconductor manufacturing typically are sealed to be airtight and have a focus on eliminating electrostatic charges.
Pharmaceutical manufacturing necessitates cleanrooms for production in a variety of spaces, including biopharma, vaccine manufacturing, and aseptic processing.
Clean Room Sensors
Cleanroom Particle Counter
Continuous particulate monitoring in cleanrooms helps prove a cleanroom is consistently operating within set parameters according to its ISO classification. Product quality is at risk of contamination if the particulate level in the manufacturing space is too high. However, this monitoring is commonly still a manual process since continuous non-viable particle counting is not yet common practice in the majority of cleanrooms. Non-viable particles often act as vehicles for airborne bacteria, viruses, and other contaminants, and measuring them can indicate levels of viable particles. Continuous particle monitoring, with properly set alarms, can indicate potential issues within an otherwise sterile processing environment. A measurable spike in particle counts can indicate potential issues within an otherwise sterile processing environment. Additionally, particle monitoring data can help exonerate a compliant clean room in the case of an incident investigation.
Setra’s SPC5000 or SPC7000 series airborne particle counters provide real-time monitoring of particulate counts in a cleanroom. Ideal for monitoring potential contamination in cleanrooms and ensuring adherences to ISO standards, Setra’s particle counters seamlessly integrate to environmental monitoring systems for data retention and reporting.
Differential Pressure Transmitters and Room Pressure Monitors
Of the numerous applications for differential pressure transducers, one of the most critical is measuring pressure in a cleanroom. These sensors perform measurements of HEPA filter cleanliness, airflow, and proper pressure between the cleanroom and adjacent space. Differential pressure monitoring is a key component to maintaining proper control of a cleanroom.
Setra’s Model 264 low differential pressure transducer has long been considered the standard for HVAC pressure measurements. Used in HVAC building automation, high accuracy pharmaceutical, and healthcare facilities, reliability and quality make the 264 a trusted choice for any low differential pressure application.
Setra’s Model 267 is a highly configurable multirange low differential pressure transducer. An optional LCD display and an accuracy of ±0.5 % make the Model 267 ideal for high accuracy pharmaceutical applications.
The Setra LITE Room Pressure Monitor monitors and displays differential pressure in rooms. With a light ring indicator and optional audible alarm, Setra LITE clearly displays room conditions, making monitoring easier for both in-room staff and facility managers. The dual alert option for LITE means pressure status can be seen both inside and outside the monitored space. With Setra LITE dual alert, rooms can have simple, permanent monitoring of pressure where status is desired in both spaces.
Temperature and Relative Humidity Sensors
Relative humidity is the percentage of the partial pressure of water vapor compared to the equilibrium vapor pressure of water at a specific temperature. In simpler terms, it describes how much water vapor is in the air compared to how much there could be at a given temperature. By monitoring relative humidity, the occupants of an environment can make any necessary adjustments to maintain the proper %RH. Accuracy also plays an important role; the less accurate a sensor, the higher the risk a humidity excursion could negatively impact an environment.
Temperature is another crucial factor for cleanrooms. Not only can too high or too low of a temperature negatively impact product, but it can also encourage the growth of viruses, bacteria, and other common particles. Monitoring temperature, in conjunction with relative humidity, is critical for proper cleanroom operation.
Setra’s temperature and humidity products are designed to continuously monitor critical environments. Compatible with both BACnet and Modbus, the Setra SRH200 Humidity and Temperature Transmitter can be adapted to many applications with both duct and wall mount options. Setra also now offers wireless temperature sensors, with options for ambient environments to ultra-low temperature sensors.
Cleanroom Environmental Monitoring
An environmental monitoring system is designed to gather, analyze on detailed cleanroom sensor data. With this information, it is easier to recognize when issues arise and take action before its too late. A data-driven approach for management of cleanrooms means that without compromising safety or quality, there is less product separation issues, less product waste, and fewer interruptions during manufacturing.
Setra’s Continuous Environmental Monitoring System (CEMS) is an environmental monitoring software that gathers all the data from in-room cleanroom sensors as an alternative to using a chart reader. Designed to adapt, CEMS can easily accommodate the specific needs of each cleanroom. Real-time alarm notifications can be seen both in software and sent to users via text message or email. Instant, up-to-date reports and graphs provide easy data visualization in the room monitoring software. Regardless if the site has existing 3rd party hardware or is looking to install new Setra sensors, CEMS can receive and analyze data.
CEMS accepts data inputs from a variety of measurement sensors, including:
- Door status and door counts
A continuous monitoring system means accessing sensor data, alarm events, and audit logs for compliance reporting is simple. Meet the necessary requirements for a variety of regulations with CEMS:
- ISO 14644
- USP <797> and USP <800>
- EU Annex 11
- Joint Commission
- FDA 21 CFR Part 11
Cleanrooms require a combination of sensors and software to maintain safety. Setra provides both the hardware and our CEMS software as an environmental monitoring system as a full sensing solution. Depend on Setra’s trusted sensors and software for monitoring cleanrooms.