Dear All;
Could you give me general ideas how i can deal with the IQ and OQ validation of the aerofill machine? Which conditions/factors i have to consider? (Note, the machine has been installed for 10 years-I don't know much about its background)
Wish your day is a blessed one.
Lekerz
10 years and working fine I guess. You are better off.
Do you have the user manual of this machine. Try to get it and look into it and find out what and how things need to be done to install it. Against this checklist verify at the machine that the said conditions are met and are well intact. If there are any process monitoring and controlling instruments in that machine, ensure that they are duly calibrated. A record of the checklist satisfactorly done is your IQ record.
Goes to say that the machine is fit and validated for its use.
What are the parameters that you have to set on the machine to get your desired quantity aerofilled ? Have you made a check on the filled aeropacks if these are meeting your desired results, the pressure at which the contents are packed and the quantity ? ... any more ?
Tweek those parameters a little.
Do you correct the desired results more better against your specifications and tolerances ?
Yes, then you have fine tuned the settings and found out new and better setting limits to meet your requirements more pricisely.
No, then you have your optimum settings already and get back to it.
Record these and your OQ records and Operational validation are done.
Operate within the settings and move on, and be sensitive to changes that may come up to the aerofill machine inputs which may require you to revalidate the OQ.