ISO 13485 Class 7 Cleanroom Requirements

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cranky

Hi there

Besides the particle count for ISO class 7 are there any other special requirements for this class? I mean temperature, humidity, airflow changes, bioburden requirements. The cleanroom I'm responsible for is class 8 and due new customer requirements we need to improve the environment conditions so we can achieve a class 7 cleanroom.

Thanks for your help! :bigwave:
 

Ronen E

Problem Solver
Moderator
Re: ISO class 7 requirements

Hi there

Besides the particle count for ISO class 7 are there any other special requirements for this class? I mean temperature, humidity, airflow changes, bioburden requirements. The cleanroom I'm responsible for is class 8 and due new customer requirements we need to improve the environment conditions so we can achieve a class 7 cleanroom.

Thanks for your help! :bigwave:

Hello and welcome to the cove :bigwave:

Upgrading your entire cleanroom to class 7 can be challenging and maybe unnecessary. Have you considered creating a limited-space class 7 environment inside your existing class 8 environment (e.g. laminar flow cabinet etc.)?

Have you already consulted ISO 14644 in detail?

Apart from that, humidity and temperature should be dictated by the product/process needs, and maybe addressed as significant process parameters through your new process validation. Begin with a risk assessment to determine the extent and nature of validation required for the new environment.

Bioburden is a factor in the sterilisation process and should be addressed through sterilisation validation / revalidation / monitoring. If the product and process don't change (except the cleanroom class) then I'd say your current bioburden requirements would be a good baseline to start from.

Cheers,
Ronen.
 

somashekar

Leader
Admin
Hi there

Besides the particle count for ISO class 7 are there any other special requirements for this class? I mean temperature, humidity, airflow changes, bioburden requirements. The cleanroom I'm responsible for is class 8 and due new customer requirements we need to improve the environment conditions so we can achieve a class 7 cleanroom.

Thanks for your help! :bigwave:
ISO class refers to particulate size and count. Rest are work environment related that are directly controlled by the air using a condenser (for temperature) humidifier (for humidity). The CFM of the blower and the volume of your clean room determines the airflow change (number of airchange per hour). Bioburden is more contributed to the cleanroom air by the personnel and practice of working within the enclosed space.
 
C

cranky

Ronen, Somashekar

Thanks for your advice, this new customer already knows that we are classified as Class 8, however prior to begin to work with them they have requested to upgrade our clean room environment to class 7. They have not defined yet any other related requirements such as bioburden conditions, air flow changes, temperature and humidity, however in order to gain some time I'm doing some research for any other Class 7 requirements. By the way, devices to be assembled in the Class 7 room will be IV sets.

Forgot to ask, is there any special requirements for the dressing/gowning room for a class 7 room? Will it need to be upgraded also?

Regards.
 

Ninja

Looking for Reality
Trusted Information Resource
Howdy cranky,

The requirement is based on partcle count...not how you achieve it.
Some things to note:

- There are various requirements for different particle sizes. Many customers only care about 0.5um and up...but some care about the whole spread. Check out the requirements for 0.1um, 0.2um also...
- Gowning and dress is simply a tool, as are airflow, bioburden (love that term...I'm a Bioburden!...I always thought I was just plain human), # of inlets, location of returns, inlet & return balancing, local process particulate capture, etc.
Use the tools to achieve the particle count requirement...

Make sure to measure the particle count with people actively working in the room, otherwise you just have a meaningless number.

Note also that dress is a multifaceted tool...it can affect employee attitude and expected behavior as well. A minor point to be sure, but get the mileage where you can.

Note lastly that appearance affects not only your employees, but your customer's impression as well. Show me a dingy looking cleanroom with an acceptable particle count, I'll consider having it measured myself or shopping elsewhere.
While you are upgrading the cleanroom, keep your eyes open for the additional low hanging fruit :).
 
C

cranky

Thanks for your comments Ninja :agree1:

Our current gowning/dressing room is environmentally controlled, while I do not perform any particle count nor bioburden (he he he) analysis we keep good practices while personnel stays there, good cleaning practices and a rational dressing procedures so the gowning/dressing room does not become a contamination source for the cleanroom.

I read somewhere else that the tighter the cleanroom class, the tighter the cleaning conditions for the gowning room, well from my point of view it could be logical. I just needed some basis and confirmation from your side regarding this. :yes:
 
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Dirt Doctor

In general, I find that asking for increased cleanroom cleanliness class is what I would refer to as a "pseudo-requirement". That is, the focus should properly be on what cleanliness level that part or assembly has to meet and how, and NOT on the airborne particulate classification, which at best is an INDIRECT measure and therefore only partially relevant at best. However, almost everyone seems to fall into this trap....
 
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M

Mel Kimsey

Re: ISO class 7 requirements

With cleanrooms in mind, do I need to run the hepa filter continuously, even when we're not using it? We have a 10x10 small cleanroom used for medical devices, but it can be 2-3 weeks between production runs when it's not used at all, and no one is in it. Does the filter need to run during that time, or once a week for a day or so? When it's not in use I turn it down low, but we clean it before we use it anyway, so why keep the filter running when no one is in it at all for an extended period?
 
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