Expert Advice Community

Guest

Sterilization procedure template

  Quote
Guest
Guest user Created:   Sep 30, 2020 Last commented:   Sep 30, 2020

Sterilization procedure template

1. We have a procedure “Sterilization” covering below topics:
Elements of the validation process - Bioburden Method validation - Bioburden enumeration -Sterilization process validation –
Sterility testing - Validation by The Bacteriostasis/Fungistasis Test - Sterility testing - EO residue - Bacterial endotoxins (LAL) test –
Product Package Testing - Functional test - Validation records and approval - Impact on manufacturing and packing in routine –Process review – requalification – Concession.

However we have a separate procedure on Sterility monitoring, covering below topics:
Microbial environmental monitoring - Product bioburden monitoring - Sterility testing (confirmation) -Bacterial endotoxins (LAL) test
Product Package integrity testing

In the sample we see from your documentation we only find “Sterilization”. Are the monitoring topics included in the Sterilization procedure template?

2. https://i.imgur.com/8mbxWX1.png

The documents show a very adequate relationship to the ISO13485 paragraph that is the basis for the requirement.
Although most of these requirements are (then again) based on Article, annexes of the EU MDR (2017/745)
For example: For 7.3.9 (ISO) is based (now in MDR) on Annex IX, 2.2 c and Article 10.
Are there any referrals in the document point to these specific MDR article/requirements (possible?)

Assign topic to the user

Assign

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

Expert
Kristina Zvonar Brkić Sep 30, 2020
1. We have a procedure “Sterilization” covering below topics: Elements of the validation process - Bioburden Method validation - Bioburden enumeration -Sterilization process validation – Sterility testing - Validation by The Bacteriostasis/Fungistasis Test - Sterility testing - EO residue - Bacterial endotoxins (LAL) test – Product Package Testing - Functional test - Validation records and approval - Impact on manufacturing and packing in routine –Process review – requalification – Concession. However, we have a separate procedure on Sterility monitoring, covering below topics: Microbial environmental monitoring - Product bioburden monitoring - Sterility testing (confirmation) -Bacterial endotoxins (LAL) test Product Package integrity testing In the sample we see from your documentation we only find “Sterilization”. Are the monitoring topics included in the Sterilization procedure template?

Yes, monitoring and validation topics are included in the Sterilization procedure. We wanted to simplified documentation so we prepare just one procedure for that. 

On this link you can find out how to manage the medical device sterilization process according to ISO 13485:2016

The documents show a very adequate relationship to the ISO13485 paragraph that is the basis for the requirement. Although most of these requirements are (then again) based on Article, annexes of the EU MDR (2017/745) For example: For 7.3.9 (ISO) is based (now in MDR) on Annex IX, 2.2 c and Article 10. Are there any referrals in the document point to these specific MDR article/requirements (possible?)

No, in our procedures we refer only to the MDR in general. However, this is a very good suggestion, we will think about it to implement in our documentation. Thank you for pointing it out to us.

Quote
0 0

Comment as guest or Sign in

HTML tags are not allowed

Sep 30, 2020

Sep 30, 2020