We are a service provider for Medical Device Companies, we will assemble and package their devices as well as sterilize them. There is one part of 13485:2003 that is giving me a headache it seems like I am missing something:



*Processing Agents- includes any materials or substances used in, or used to aid the manufacSection 7.5.1.2 of ISO 13485:2003 states:

"Cleanliness of Product and contamination control

The organization shall establish documented requirements for cleanliness of product if:

a) product is cleaned by the organization prior to sterilization and/or its use, or

b) product is supplied non-sterile to be subjected to a cleaning process prior to sterilization and/or its use, or

c) product is supplied to be used non sterile and its cleanliness is of significance in use, or

d) process agents are to be removed from the product during manufacture."


[COLOR=DarkGreen]I would say that if product that we are assembling needs to be cleaned prior to sterilization that as long as it is addressed in the Assembly Instructions they are using we should be ok. That would include cleaning or removing excess processing agents* used in the assembly of the device.

*Processing Agents- includes any materials or substances used in, or used to aid the manufacturing process, this would include:
cleaning agents
lubricating oils
mould release agents
or any substances which is not intended to be included in the finished device. In addition, processing agents should be identified and labeled to avid confusion or processing errors.COLOR]

Johnny:

I believe you are OK, since assembly instructions are considered procedures, but how clean does it have to be? Do you have standards or specs to meet? Is this within the assembly instructions? How did you address this requirement in your QM?

Johnny:

I believe you are OK, since assembly instructions are considered procedures, but how clean does it have to be? Do you have standards or specs to meet? Is this within the assembly instructions? How did you address this requirement in your QM?

Al-

All good questions. Any product we clean the requirements come from the customer and it is documented within the assembly instructions. As far as covering it in the QM it is stated just that way, that any product/materials that require cleaning prior to sterilization will be documented in the assembly instructions etc...

I knew we were covering the requirement, but for some reason I just didn't feel comfortable and wanted some re-assurance. Thanks!!