Sterilization Validation Procedure Needed?

Hi there! Thanks to everyone who posts in this forum, it is an incredibly valuable resource.

We are a small company (4 people) and we product a device that is Class I in EU and Class II in Canada. We are getting audited for ISO 13485 for the first time this summer. We have self-certified the non-sterile version of our device in EU and are working on "version 2" which will be sterilized. We contract out all manufacturing.

My question is - do we need our own sterilization validation procedure? As well, if we are in the process of validating the sterilization process and packaging will that mean we will be unable to register or if they see we are following our Design and Development procedure (just not complete) will they be satisfied with that?

Cheers!

Jenna

A Quick Bump!

Can someone help?

Thank you very much!!

Hi there,

if you are the legal manufacturer of a product distributed "sterile", and you claim compliance to ISO 13485 - yes, you have to a procedure in place, specifically fulfilling section 7.5.2.2:

7.5.2.2 Particular requirements for sterile medical devices
The organization shall establish documented procedures for the validation of sterilization processes.
Sterilization processes shall be validated prior to initial use.
Records of validation of each sterilization process shall be maintained (see 4.2.4).


You also have to consider your manufacturing controls for your sterile product and its release:

7.5.1.3 Particular requirements for sterile medical devices
The organization shall maintain records of the process parameters for the sterilization process which was
used for each sterilization batch (see 4.2.4). Sterilization records shall be traceable to each production batch
of medical devices (see 7.5.1.1).


7.5.1.2 Control of production and service provision ? Specific requirements
7.5.1.2.1 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 product during manufacture.
If product is cleaned in accordance with a) or b) above, the requirements contained in 6.4 a) and 6.4 b) do not
apply prior to the cleaning process.


Answer to your second question follows from this: you have to have a sterilization validation procedure in place. Since you have already started your sterilization validation, you should have a validation protocol in place. From this, it should not be too hard to word a validation procedure.

I guess you are terminally sterilizing your product? Which sterilization method do you use?

Give me a shout if you need help,

Gerhard

Do you have a procedure for the EO sterilization validation? Thank you.