Guys, I have to do IQ, OQ PQ validation protocols on a newly installed clean air compressed air installation for a pharmaceutical company. Can someone assist with advice or references to possible templates and/or case studies.

Hi, your question went ignored all this time because you posted your question on another unrelated thread so I created a new thread with your post to better help you.

I don't think there is such a thing as a thing as templates and/or case studies but we can help with any question you may have doing one.

If it is the newly installed compressed air system, you can refer the supplier manual for the technical information for the preparation of IQ & OQ protocols.

With respect to PQ you shall get information from the following ISO standards.

a. ISO 8573-1 : Test method for Contaminants and purity classes.
b. ISO 8573-2 : Test method for aerosol.
c. ISO 8573-3 : Test method for humidity.
d. ISO 8573-4 : Test method for particles.
e. ISO 8573-7 : Test method for viable microbial counts.
f. ISO 8573-8 : Test method for mass conc. particles.

Regards / Raghu

Juan

There are plenty of templates for iq/oq/pq on the internet.
Just search and you will find.

Regards
Alex

Juan

There are plenty of templates for iq/oq/pq on the internet.
Just search and you will find.

Regards
Alex

I made that comment because I haven't found any but by all means please feel free to help the TS out and post some here.

Also refer an existing thread - Method for Dew Point and Oil content - Qualifying our Compressed Air System (CAS) (http://elsmar.com/Forums/showthread.php?t=33779)

It'll make a difference which category you need for 1) Direct product contact, 2) Indirect product contact & 3) breathing air as to what targets you are going for. Also note that for solid particles it is both quantity of particles and size of the particles (ie <5, 10-25, 25-50, 50-100,>100).