Clean Room Class ISO 8

[spacey]

Hello

Apologies for this not being a Medical device question but wondering if anyone can help me please with a question on Clean Room Class ISO 8

We are a household product manufacturer and have recently been asked to investigate the costs of creating a clean room environment for future manufacture of household products for a new cosmetic based customer, which explains the clean room requirement.

We are being advised we would need to achieve ISO 8 clean room standard

Is it possible anyone could help please with the following questions

1. Would we need to purchase both ISO 14644-1:2015 and ISO 14644-8:2022 standards.

2. With the above standards would we need to get certification, accreditation or is this not required.

Thank you

 

[Philip B]

Why do you need Class 8? What is the rationale for this? I'd investigate this further before committing to the (expensive) process of building and validating a cleanroom.

You can't be certified against the 14644 series of standards. Typically, you use a specialist external contractor to test your cleanroom against the relevant parts of these standards. They then supply a test report and you can then claim compliance with the cleanroom classification supported by the testing.

 

[spacey]

Thanks above reply, this is one of the reason posting this.

I was not sure if we could be certified against 14644 series so it is good to know this.

Thank you

 

[Wearerofmanyhats]

@Dave Woodcox may have something to say here.