Validation of newly installed Clean Compressed Air System - Pharmaceutical company

[Pottietoo]

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.

[Juan Dude]

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.

[raghu_1968]

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

[alex.Kennedy]

Juan

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

Regards
Alex

[Juan Dude]

In Reply to Parent Post by alex.Kennedy

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.

[Ajit Basrur]

Also refer an existing thread - Method for Dew Point and Oil content - Qualifying our Compressed Air System (CAS)

[JaxQC]

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).

[paulag]

In Reply to Parent Post by JaxQC

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).

Hello JaxQC,

can you please provide more information about the limits to the three categories you mentioned? Can't find them in ISO 8573-1. What I am trying to do just now is to find out how clean compressed air has to be to use it in a cleanroom class 8 (ISO 14644), both with direct and indirect product contact.

Dear all,

your help would also be highly appreciated!

Thank you very much