Cleanroom Housekeeping and Personnel Hygiene Audit Checklist

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

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.

Debbie Low said:

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

Click to expand...

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..

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.

Debbie Low said:

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

Click to expand...

Welcome to the Cove

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

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

Cleanroom audit

Cleanroom checklist

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

I have a few question which require advise from you folks:-

1. Is there any guidance on the limiting of number of personnel going in and out of the cleanroom?

2. Is it appropriate to store jumpsuit and booties in pigeon hole? Jumpsuit in the top cubicle and booties in the bottom (for each personnel). I suppose the jumpsuit and booties should not be placed too near to each other, am I right? Even if they are seperated by the top and bottom pigeon hole. My worries here is the contamination issue. If we will to hang the jumpsuit in one corner and booties at the opposite side, will that help? Currently, the pigeon hole are not cleaned, and we will have difficult to contain the jumpsuit if we need to clean the pigeon hole due to space constraint. Can anyone shield some light on this issue?

Appeciate your help!

Debbie Low said:

I have a few question which require advise from you folks:-

1. Is there any guidance on the limiting of number of personnel going in and out of the cleanroom?

2. Is it appropriate to store jumpsuit and booties in pigeon hole? Jumpsuit in the top cubicle and booties in the bottom (for each personnel). I suppose the jumpsuit and booties should not be placed too near to each other, am I right? Even if they are seperated by the top and bottom pigeon hole. My worries here is the contamination issue. If we will to hang the jumpsuit in one corner and booties at the opposite side, will that help? Currently, the pigeon hole are not cleaned, and we will have difficult to contain the jumpsuit if we need to clean the pigeon hole due to space constraint. Can anyone shield some light on this issue?

Appeciate your help!

Click to expand...

Hi Debbie,
not sure if ISO 14644 gives some direction for the first question.
However you can demonstrate by means of Desing of Experiment that a certain number of personnel in square meter can jeopardize material.
Usually we proceed in that sense. At the end you can demonstrate the contamination satures after a certain number of people in two or three tiles on the shop floor.
As to the second part, it is possible the contamination.
You can think about to review layout of the smock room or foresees a bootie change for each clean room entrance in a day shift. Also in this case, you can make an experiment and analyze data