Hi all
I'm mega impressed with all of the knowledge in this forum and I'm hoping someone can help me out with this question.

I am trying to work out what the minimum cleanroom requirements are for a Class IIb (EU) wound dressing which is terminally sterilised. I'm aware of ISO14644 but I'm not sure where I should look for a list or guidance for specific groups of product type or product class.

Many thanks for your help.
DOC

...I'm mega impressed with all of the knowledge in this forum...
I can't help you with your question, but I'm mega happy to welcome you among the posters!:bigwave:

Hi all
I'm mega impressed with all of the knowledge in this forum and I'm hoping someone can help me out with this question.

I am trying to work out what the minimum cleanroom requirements are for a Class IIb (EU) wound dressing which is terminally sterilised. I'm aware of ISO14644 but I'm not sure where I should look for a list or guidance for specific groups of product type or product class.

Many thanks for your help.
DOCYou might find an appropriate standard, like EN 556, on the list of harmonized standards for medical devices (http://ec.europa.eu/enterprise/newapproach/standardization/harmstds/reflist/meddevic.html).

Hi,

I'm not sure that it is specified as to the classification required for your cleanroom. It would depend on the type of product, its intended use and method of sterilisation. The purpose of the cleanroom is to control the environment particularly the bioburden. Like all things though it is a trade off. Obviously the higher the class of cleanroom the high the cost to you. Do you have a microbiologist to advise you, or can youtalk to your notified body?

From experience I would have thought that a class 7 or 8 would have been adequate, however without knowing your product etc it is hard to be specific.

Regards

Microbe:)

Thanks Microbe - The main product will be a Class IIb wound dressing which will be terminally sterilized by irradiation. At this stage there is a new production facility being planned. Thanks for your suggestion & I will propose that a microbiologist is consulted but I was just wondering if there is any list/standard/other which we could provide to the project team planning the new facility to confirm the cleanroom requirements. As you mention the higher the class the greater the expense but the consequences of getting it wrong at this stage would probably be even more expensive!

I'm not a microbiologist but it sounds as if a key point will be to have a cleanroom which can ensure a bioburden not more than that in the sterilisation validation.

To the best of my knowledge, you are not going to find a list of clean room ratings versus products. The purpose of a clean room is to minimize the level of bioburden, and airborne particulates that can support bioburden (or in the case of electronics; the particulates themselves) so that devices that are going to be sterilized will have the best chance of achieving their Sterility Assurance Level (SAL). This is usually expressed as 1 x 10 to the minus 6.
This means that it is up to you to determine the level of cleanliness that is required prior to sterilization. The interesting thing here is that most medical devices can be manufactured in a reasonable clean area and will meet the SAL after sterilization assuming the the sterilization protocol is effective. An expensive clean room is not necessary. However, if you don't have one then you have to explain your reasoning to the third party inspector.

To the best of my knowledge, you are not going to find a list of clean room ratings versus products. The purpose of a clean room is to minimize the level of bioburden, and airborne particulates that can support bioburden (or in the case of electronics; the particulates themselves) so that devices that are going to be sterilized will have the best chance of achieving their Sterility Assurance Level (SAL). This is usually expressed as 1 x 10 to the minus 6.
This means that it is up to you to determine the level of cleanliness that is required prior to sterilization. The interesting thing here is that most medical devices can be manufactured in a reasonable clean area and will meet the SAL after sterilization assuming the the sterilization protocol is effective. An expensive clean room is not necessary. However, if you don't have one then you have to explain your reasoning to the third party inspector.How about validation of the process as an explanation.

Process Validation should be an excellent answer. it would work for me.

I can tell you from experience that I have worked both manufacturing and packaging wound dressings for a couple of different companies, and we never had a "certified" clean room. I think it's a measure of ensuring and demonstrating that you can control potential contamination and bioburden. As long as you are monitoring your bioburden and performing sterilization validations and doing dose audits, you should be able to demonstrate that your product has reached your prescribed sterility assurance level without having a "certified" clean room.