Is there any recommendation for IQ & OQ of Liquid Particle counter ?
IQ is an assessment to determine if the equipment was properly installed. Without knowing what the equipment is, how it operates, what utilities it uses, etc., it’s difficult to really say much about what should be done. Factors to consider include electrical hook-up; ambient room conditions (heating/cooling, lighting, ventilation, cleanliness); other utilities such as water (including type); etc.
OQ is an assessment to determine if YOUR requirements for the equipment are met. Without knowing your requirements, it’s not possible to say what should be done. You’ll want to try to assess the functionality in terms of anticipated range of uses. Both success (particle counts in a range) and failure (particle counts out of range) should be demonstrated (presuming that’s what the equipment does). You’ll also want to demonstrate any safety features. You’ll need to document your requirements to form the basis for the OQ.
Not sure how much that helps. If you’re at a complete stand-still, I would suggest contracting out for some expert help. That is a very cost-effective way to jump-start the process and get you where you need to be in a timely manner.
dear all
how we do PQ for particle counter?
is there any particle standar?
Certified Particle Size Standards traceable to the Standard Meter through the National Institute of Standards and Technology (NIST).
Demonstrate the traceability of their analytical methods as required by ISO 9000, ISO 10012, ANSI/NCSL Z540, GMP/GLP and other standards and regulations.
You can contact Thermo Fischer Scientific.
operate the equipment for long time
Now I realize that Particle Counter is not need Performance qualification but just do calibration periodically.
Because Particle Counter just measure single parameter (amount particle) not like a HPLC ( system).
If you do IQ OQ it just ok, but in my opinion it is optional.