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.
Advantages using RMS
- 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,
- Hydrocarbon,
- Vapour pressure dewpoint,
- Oil,
- Oxygen,
- Airflow…
