Cleanroom Housekeeping and Personnel Hygiene Audit Checklist

[Debbie Low]

I am currently soucing for information to come out with procedures and checklist for good practices in cleanroom for ISO class 7 and 8 (medical device).

Basically, I am looking at how to create an audit checklist in terms of personnel discipline and hygiene in a cleanroom; the do and don'ts in a cleanroom.

As for the procedure, I will need information on the good practices (for personnel) in cleanroom.

Hope that someone out there is able to share this information.

Many Thanks!

Debbie

[BradM]

Hello Debbie! Welcome to the Cove!

I can't remember if Class 7/8 are Class 100 (EU Grade A; or whatever).
I wished they would decide on one classification and stay with it.

Most of what I have seen has been fairly straightforward:

1. No makeup
2. No jewelry
3. No one with a particular illness/disease (they should check with their supervisor.
4. Assure all proper gowning materials are there. Include a provision of what to do/who to call if it is not there.
5. If this is Class 100 (Grade B and such), then everything should be covered, nothing touching the floor, etc.

Gloves, crossing on clean side of bench, etc.

Now, you mention audit checklist. Are you going to be auditing a particular area, or are you putting it in a procedure?

If you are writing the procedure, I would start with standing in front of the gowning room, and write the steps up until you enter the clean area.

Now, if you have personnel already trained in the clean room areas, I would ask them to do the same thing (independent of what you're doing). A lot of times little things/little steps get missed. You end up having to revise the procedure several times in a short time frame.

Not sure it helps.But welcome.

[qusys]

In Reply to Parent Post by Debbie Low

I am currently soucing for information to come out with procedures and checklist for good prcactices in cleanroom for ISO class 7 and 8 (medical device).

Basically, I am looking at how to create an audit checklist in terms of personnel discipline and hygiene in a cleanroom; the do and don'ts in a cleanroom.

As for the procedure, I will need information on the good practices (for personnel) in cleanroom.

Hope that someone out there is able to share this information.

Many Thanks!

Debbie

In addition to what BradM said,
I would add the tools that you cannot use inside clean room, I mean penl with ink ( I work in semicon environment , there you can use specif pens and pencils), paper ( usage of lint free paper).
Besides there are also some protocol for personne; move slowly, do not run, etc.. etc..
I would suggest also procedure for housekeeping, how to clean, when etc..

[Ronen E]

ISO class 8 = 100,000
ISO class 7 = 10,000
No point imposing class 100 requirements on a class 100,000 operation; it's not a good allocation of resources.
Further, though there are a lot of similarities, there are also significant differences between semi-conductors and medical cleanroom practices and highlights. Semi-conductors is focused on 0 free floating particles (regardless of viable matter presence), while medical is mainly concerned with viable substance, be it in the form of free particles or not.
You could look for formal GMP guidance (available free online); there are plenty of examples in there.

Cheers,
Ronen.

[Ajit Basrur]

In Reply to Parent Post by Debbie Low

I am currently soucing for information to come out with procedures and checklist for good practices in cleanroom for ISO class 7 and 8 (medical device).

Basically, I am looking at how to create an audit checklist in terms of personnel discipline and hygiene in a cleanroom; the do and don'ts in a cleanroom.

As for the procedure, I will need information on the good practices (for personnel) in cleanroom.

Hope that someone out there is able to share this information.

Many Thanks!

Debbie

Welcome to the Cove

A good start would be ISO 14644-5, Cleanrooms and associate controlled environments - Part 5: Operations

[Debbie Low]

Thanks folks for the valuable information provided.

Just to clarify that ISO 7 / 8 is referring to Class 10,000 and 100,000 respectively.

Basically, we have 2 types of cleanroom in our premises and I am suppose to come out with the procedure (for good practice in cleanroom) and audit checklist for the 2 class of cleanroom.

I will be conducting weekly audit for the cleanroom ( not a particular area) which include the following:

1. Personnel discipline and hygiene
2. housekeeping
3. GMP compliance

Yes, the personnel are already trained in the clean room areas but there are little things that are missed out.

Appreciate if someone can provide examples of procedure and checklist.

Advance Thanks

[harry]

Cleanroom audit

Cleanroom checklist

[Debbie Low]

Hi Harry,

Thanks for the link provided.

The audit checklist is more on process audit instead of personnel audit. Is there any example of checklist related to auditing of presonnel

Thanks for the help