Does your compressed air meet your ISO cleanroom requirements?
The EudraLex Volume 4, EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, Annex 1 Manufacture of Sterile Medicinal Products and the FDA 21 CFR Part 210 Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs define that the quality of the air introduced into a room must be equal to or better than that of the air in the environment:
The ISO 14644 standards for cleanrooms define these levels.
The ISO 8573-1 Compressed air – Part 1: Contaminants and purity classes lists the ammount of solid particulates, water and oil contamination allowed in each cubic meter of compressed air. As of such it is important to correlate the ISO 8573 to the ISO 14644 requirements to define what class of compressed air is required based upon the cleanroom class:
|ISO 14644||ISO 8573-1|
|Class 6||Class 1|
|Class 7||Class 2|
|Class 8||Class 3|
|Class 9||Class 4|
|Vapour pressure dewpoint requirements|
|Class 1:||<-70° C|
|Class 2 :||<-40° C|
|Class 3 :||<-20° C|
|Class 4 :||<+3° C|
|Class 5:||<+7° C|
|Class 6:||<+10° C|
Both the ISO 14644-2 and the ISPE Good Practice Guide – Process Gases specifies the requirement to define a monitoring plan and compressed air should be part of this monitoring plan after the initial risk assessment is carried out.
With the Rotronic Monitoring System, PST offer the perfect platform for monitoring the complete cleanroom.
- Real time monitoring and alarming.
- Access your data from anywhere at any time.
- EU Annex 11/FDA 21 CFR Part 11 compliance.
Integrate any critical control parameter into your monitoring:
- Nonviable particles,
- Viable particles,
- Vapour pressure dewpoint,
Michell SF82 Dew-Point Transmitter for Compressed Air
Simple to install and maintain, the SF82 transmitter series measures dew point and moisture content and is available with a range of industry standard process connections and electrical connectors.Learn More
MICHELL Easidew Dew-Point Transmitter for Compressed Air
Simple to install and maintain, the Easidew sensor is a moisture meter measuring dew point and moisture content and is available with a range of process connections and electrical connectors.Learn More
RMS-MADC-915-A - Wireless Mini Data Logger - Current input (0...20mA)
RMS-MADC-868-A - Wireless Mini Data Logger - Current input (0...20mA)
RMS-MADC-868-V - Wireless Mini Data Logger - Voltage input (0...10V)
The T30 temperature sensors are resistance thermometers (Pt100 = positive measurement resistance), meaning that the resistance increases with increasing temperature. The sensors are compatible with the RMSLOG- T30-L, RMS-LOG-T30-868 and RMS-LOG-T30-915 data loggers.Learn More
RMS-LOG-T30-L - Data Logger
The RMS-LOG-T30 is a data logger with two integrated analog-to-digital converters, to which two PT100 sensors can be connected for high-precision temperature measurement.Learn More