Clause 7.5.2 of ISO 13485:2016

[KJ Im]

Hello.

Does this clause 7.5.2 Cleanliness of product of ISO13485:2016 applicable to all the single use device (sterile)?

My company is subsidiary of the manufacturer located in US producing single use devices and we are trying to receive GMP in our country.
In the quality manual of the manufacturer, it is stated that clause 7.5.2 cleanliness of the product is not applicable to our products since there are no agents that need to be removed from components or finished products during the manufacturing process.
However, the auditor reviewing the documents said that clause 7.5.2 is applicable to all the sterile device so the manufacturer should change their quality manual.
Is this correct? or is it possible to not apply clause 7.5.2?

 

[AndreaPBeagle]

Hi KJ,

I think this would be an exclusion as no agents need to be removed. It is applicable so the statement would be exclusion vs not applicable.

change to:
Clause 7.5.2 cleanliness of the product is an exclusion to our products since there are no agents that need to be removed from components or finished products during the manufacturing process.
However, the auditor reviewing the documents said that clause 7.5.2 is applicable to all the sterile device so the manufacturer should change their quality manual.

 

[planB]

Disagreeing with Andrea and agreeing with your auditor:

Cleanliness, i.e. absence of excessive viable and non-viable contamination, is a crucial prerequisite for effective sterilisation. Whether you require a cleaning process prior to sterilisation and/or whether you already manufacture adequately "clean" in environmentally controlled areas ("clean rooms") - section 7.5.2 applies in all cases, as specifically stated in section 7.5.2 c):

7.5.2 Cleanliness of product
The organization shall document requirements for cleanliness of product or contamination control of
product if:[...]
c) product cannot be cleaned prior to sterilization or its use, and its cleanliness is of significance in use;

HTH,

 

[shimonv]

However, the auditor reviewing the documents said that clause 7.5.2 is applicable to all the sterile device

It's a general statement and true for most sterile products, but not all. You will need to provide justification why no cleanliness of any sort is needed.

Shimon

 

[planB]

Out of curiosity: would you know an example of a sterile device that has no (microbial) cleanliness requirements?

 

[shimonv]

Good question
I cannot think of a good example of a single-use sterile device without cleanliness... yes it's odd. Perhaps AndreaPBeagle can explain what is this product.