Passbox qualification

Dear forum members,

I have bought a new passbox for my microbiology lab.So before taking it in use,i would like to know if i need to do a qualification for the same?If yes, please provide me the reference guideline.
Thank you in advance.

Regards,
Aparna Jagadale

@aparnajagadale Qualification of every instrument and equipment is not written in guidelines but a common statement is written everywhere that every equipment and instrument should be qualified. therefore your passbox should be qualified after installation performing the test for viable and non-viable particle count.

Dear sir,

Can you please help ,if you have any idea about guideline for passbox qualification.

Regards,
Aparna

Dear Aparna

You must perform 2 test for the qualification of your passbox

Active-passive air microbial count
Surface microbial contamination
Viable and non-viable particle count

You must perform these tests for 3 days, and the maximum limits are depends on your passbox class ( A-B-C-D class)

I’m in a holiday now so i dont have access to all of my files, but i think the referance guide is Gmp or iso

Thank you sir

Regards,
Aparna

Dear Arpana
I will like to add one more think if it’s dynamic pass box u have to calculate area recovery time according to that u have to fix the hold time after door opening and closing .

you can ask to vendor for supplier IQ/OQ protocol, based on you can prepare the in house protocol

Dear all

Thank you for the reply.

Regards,
Aparna