Clause 7.5.2 Cleanliness of product: particular situation

[kkamp]

In clause 7.5.2. Cleanliness of product describes situations in which an organization must document its product cleanliness requirements (as I understand it).
The clause mentions the following:

The organization shall document requirements for cleanliness of product or contamination control of product if:
a) product is cleaned by the organization prior to sterilization or its use;
b) product is supplied non-sterile and is to be subjected to a cleaning process prior to sterilization or its use;
c) product cannot be cleaned prior to sterilization or its use, and its cleanliness is of significance in use;
d) product is supplied to be used non-sterile, and its cleanliness is of significance in use;
e) process agents are to be removed from product during manufacture.

If product is cleaned in accordance with a) or b) above, the requirements contained in 6.4.1 do not apply prior to the cleaning process.

I have a medical device that needs to be sterilized prior to use. However, the sterilization of this product is performed by an external company (my company only manufactures the device). Which case clause may apply?

Could you give me examples of how the other cases are applied in other contexts?

Thanks.

 

[planB]

A medical device needs to be clean prior to sterilization. Clause 7.5.2. provides you with several options how to achieve that. Based on the information you provided above, any option could apply. Could you be more specific about your device, in terms of
- are you the legal manufacturer?
- do you distribute your device (terminally) sterilized or is the device processed at the point of use?

 

[kkamp]

A medical device needs to be clean prior to sterilization. Clause 7.5.2. provides you with several options how to achieve that. Based on the information you provided above, any option could apply. Could you be more specific about your device, in terms of
- are you the legal manufacturer?
- do you distribute your device (terminally) sterilized or is the device processed at the point of use?

- The company is the legal manufacturer.
- The sterilized device must be distributed. However, sterilization isn't performed by our company; it's performed by an external company.

 

[planB]

This sounds to me as if "the company" uses terminal contract sterilization. In this case clause 7.5.2 (a) or (c) may apply to "the company". Clause 7.5.2 (e) might also apply, but is typically not related to sterilization.

 

[kkamp]

This sounds to me as if "the company" uses terminal contract sterilization. In this case clause 7.5.2 (a) or (c) may apply to "the company". Clause 7.5.2 (e) might also apply, but is typically not related to sterilization.

What is the difference between clause 7.5.2 a) and c)?

 

[Becsbecster]

Is clause 7.5.2 (e) applicable? This is critical for biocompatibility assessments.

 

[EmiliaBedelia]

a) would apply if the product is being cleaned. In this case you would need to specify the cleaning process requirements (eg, equipment, parameters, cleaning agents, etc) and show that it meets your requirements for product cleanliness.

c) would apply if there is some reason that the product cannot be cleaned - for example, if the material it's made of or the manufacturing process prevent it from being cleaned for some reason. In that case you would need to control the production environment and manufacturing process since you are not cleaning off any contamination or manufacturing agents.

These are pretty straightforward questions - does it matter whether the device is clean or not? If yes, you have to define how clean it needs to be and how you control the cleanliness. The clauses here just provide examples of different situations where the required evidence might be different depending on the device.

Even if you have a supplier to do the cleaning on your behalf, you still need to identify the cleanliness requirements and ensure that the process is controlled to meet those requirements. You, as the manufacturer, are responsible for ensuring that your suppliers are performing correctly and meeting your requirements.