Hi all~

I got a question about non-sterile device, e.g rapid test kits. Does it need to follow the standard ISO 14644 to have a clean room? Or I it only need to have certain guideline to control the environment?

Thanks!

Non-sterile devices are usually produced in unsterile but controlled environments. There is no requirement to fulfill 14644, as far as I know :cool: however, you may benefit by using it as a guideline to establish the control that you should have anyway.

This issue seams to be a bit tricky.
If the product is non-sterile doesn't that mean it can be manufactured any where?
what provisions would require the manufacturer to use the controled enviroment?


even for class I sterile products I would argue that you do not have to use clear room and just controlled zone so that your sterilization is sucessfull.

Am I right?

:notme:

This issue seams to be a bit tricky.
If the product is non-sterile doesn't that mean it can be manufactured any where?
what provisions would require the manufacturer to use the controled enviroment?


even for class I sterile products I would argue that you do not have to use clear room and just controlled zone so that your sterilization is sucessfull.

Am I right?

:notme:

In short: I would say that you are right. But, just because a product is supplied non-sterile it does not mean that you wouldn't want to control the production facilities. Let's say that you supply this non-sterile product to hospitals. Don't you want to make sure that you can control the bio-burden somewhat? Wouldn't you like to know if your products were contaminated due to, for instance, faulty cleaning or bad personal hygiene? That is not to say that a Class I product is to be produced in a clean room, but you should still control the surroundings and the personal hygiene IMO.

This issue seams to be a bit tricky.
If the product is non-sterile doesn't that mean it can be manufactured any where?
what provisions would require the manufacturer to use the controled enviroment?


even for class I sterile products I would argue that you do not have to use clear room and just controlled zone so that your sterilization is sucessfull.

Am I right?

:notme:

Hi Gereard,

When the manufacturing environments are to be designed for a product with a particular process, various criteria are considered viz.

1. Product Protection
2. Personnel Protection, and
3. Environmental Protection.

Thus the concept that the product is a Class I and non sterile will not require a cleanroom is not correct. Consideration should be given to the 3 factors that I have listed above.

Personnel Protection is to provide comfort conditions wrt temperature and humidity, so as not to contaminate the product.

Product Protection to prevent from contamination and cross contamination and also from manufacturing environment.

Environmental protection is to take care of environmental discharges.

Hope it clarifies.

Hi all~

Thank you for all reply. Is that mean an non-sterile device could be produce in contorlled environment other than cleanroom? Is it depend on different product?

The environment control would be accepted, if I can produce a device that within the specification and it work effectively. Is it right?

Hi all~

Thank you for all reply. Is that mean an non-sterile device could be produce in contorlled environment other than cleanroom? Is it depend on different product?

The environment control would be accepted, if I can produce a device that within the specification and it work effectively. Is it right?

True :bigwave:

Thanks~

One more question about ISO 13485 and GMP. For FDA requirement, both system should be applied to producer. However, most of rules from 13485 and GMP are quite similar. Should we have 2 sets of system to control or we have combine two system in one ? Base on ISO 13485, could I add on some GMP requirements to fulfil GMP?

Thanks~

One more question about ISO 13485 and GMP. For FDA requirement, both system should be applied to producer. However, most of rules from 13485 and GMP are quite similar. Should we have 2 sets of system to control or we have combine two system in one ? Base on ISO 13485, could I add on some GMP requirements to fulfil GMP?

One system will suffice. Keep it simple - for everybodys sake. :)

Thanks~

One more question about ISO 13485 and GMP. For FDA requirement, both system should be applied to producer. However, most of rules from 13485 and GMP are quite similar. Should we have 2 sets of system to control or we have combine two system in one ? Base on ISO 13485, could I add on some GMP requirements to fulfil GMP?One system can meet all the requirements.

Qualityalways and Gert,

Thank you for your comments.


This makes seanse.
What bittes me know is how do you define the controlled enviroment...
I trust this is less than CR conditions.
is there any standard to give a hint?
or everyone needs to work out his own sollutions...

:)

Qualityalways and Gert,

Thank you for your comments.


This makes seanse.
What bittes me know is how do you define the controlled enviroment...
I trust this is less than CR conditions.
is there any standard to give a hint?
or everyone needs to work out his own sollutions...

:)

In short, you define the solutions :(
Normally, you would consider things like:
Classification: I once worked at a factory with a controlled room Class 300,000. But it is up to you.
Dress: Can personell use their own garments or do you supply? If you supply, is it a coat, or a full body suit?
Control of personal hygiene
Shoes
Hairnet
Makeup
Nail polish
Jewellery
Edibles
Drinks
Gum
Paper and cardboard
Pallets
Windows/air condition
And so on, and so on.

Base your rules on what you can control, and what the risk is to the end user. 14644 can be used for inspiration, but I am not aware that there are any guidances on controlled rooms.

Remember to document your requirements, and the tests that you perform....

:bigwave:

One system can meet all the requirements.

Thanks. However, if I applicate for FDA , it needs the CGMP requirement. Then, how to do this in ISO 13485? Also, are there any guidance for vitro Diagnostic Devices? As I know, this kind of device would not be a Class I device. Is it difficult to registration in FDA and CE?

Many Thanks!