With the new regulations taking effect from July, it would be prudent to evaluate your environmental monitoring equipment and SOP's, to ensure you meet these new requirements.
The TGA document :
PE-009-08 requires that a cleanroom is classified and then monitored.
Classification:Proving that a cleanroom meets the required ISO class (ISO 14644-1)
Monitoring: Continued, ongoing verification that a cleanroom has not shifted from "normal" conditions.
Certifying that a cleanroom (or clean area) meets a defined class of the ISO 14644-1 standard.
- Performed every 6 to 12 months (as required in ISO 14644-2)
- To a specific procedure
- Number of sample points (v of floor area, in m2)
- Location of sample points (equidistant and work height)
Verifies that a cleanroom can be used for a certain function.
- Cleanrooms and clean air devices should be classified according to ISO 14644-1
- Classification should be clearly differentiated from process monitoring
- In Grade A, a minimum sample volume of 1m3 should be taken per location
- Portable particle counters with short length of tubing should be used
- Isokinetic sampling heads should be used in unidirectional flow zones
- Cleanrooms and clean air devices should be routinely monitored in operation
- Grade A: Continuous monitoring required during setup and operation
- Grade B: Recommend same as Grade A; frequency can be reduced
- Grade C,D: In accordance with principles of quality risk management
At Kenelec Scientific we offer consultancy services to help you with all your cleanroom monitoring applications. We don't just sell you the instruments and walk away we are there to guide you through all the stages of installation validation and operation of your monitoring equipment.
You can be assured that you have the correct instructions and equipment to carry out your monitoring requirements. Backed up with excellent technical support we are there for you. We offer excellent after sales services to keep your equipment in top condition and we also train your staff on the correct sampling methods and equipment handling procedures.