ETO Sterilizer Validation (ISO 11135:2007)

[Aqeel Abbas]

Thanks a lot for the detailed list. I appreciate if you can expand the following in some more details:

URS, VP/VMP,Validation Status Summary.

Can you also mention which tests are covered in IQ, OQ and PQ?

 

[medwise]

URS: User Requirement Specification. This is a document in which you request your supplier or vendor about what you require for your sterilization process. For example that you require them to calibrate their temperature probes caliberated annually, that their PLC is validated etc.

VMP: This document is a document which contains the validation plan i.e what you validate, when you validate (validation schedule) and who validates it (personnel responsibilities).

We have done full cycle EtO validation in 2007 and since then we do half cycle validation every year to make sure our cycle is validated. You will only do full validation when there is a major change such as device material change, packaging change or introduction of a new device which can be worst than your worst case device or the weight/volume of the load has changed.

If your supplier is ISO 13485:2003 certified thast does not mean you won't validate them. According to clause 7.4 you are require to perform supplier qualification, avaluation and monitoring and also at the end of the day you are the manufacturer and releasing the product for sale so it is your responsibility to validate the process.

Hope this helps!

 

[The Specialist]

Thanks a lot for the detailed list. I appreciate if you can expand the following in some more details:

URS, VP/VMP,Validation Status Summary.

Can you also mention which tests are covered in IQ, OQ and PQ?

URS: Identifies requirements for equipment based on process requirements;

Capacity
Operating Parameters/Requirements (specifications)
Regulatory Requirements
Documentation Requirements
Testing Requirements
Environmental Requirements
Power/Utility Requirements and/or Limits
Automation requirements
Monitoring/Alarm Requirements
SOP Requirements
Maintenance Requirements/Service & Support Requirements

(Not exhaustive – dependant on equipment and installation)

VP (Validation Plan): Laying down the requirements of validation and testing methods/documentation turn-over package, in accordance with risk and impact assessment (either included in VP or as separate document);

cGMP risk/Impact assessment
Identification of validation requirement
‘Matrix’ to show where critical elements shall be tested (e.g. IQ/OQ/PQ)

IQ (installation Qualification): Detail of equipment (in this instance) to determine suitability of equipment against pre-determined specifications (derived from URS) with regard its installation;

Equipment detail, description, model no and serial no.
Unique identifier (if given one)
Drawings Record and critical (controlled drawings check – against physical installation)
Connected services and utilities (incl. conformation of suitability and validity)
Device and instrument list and identification of ‘critical’ (to determine calibration requirements)
Instrument calibration and certification records
Hardware/Software Installation and version numbers, version control/service agreement/power fail restart recovery procedure, software back-up storage and procedure, 21 CFR pt 11 compliance assessment.

Supplier manual listing/reference planned maintenance listing and spare parts list.
Operational SOPs (pre-requisite to operation of equipment)

OQ (Operational Qualification): Operational testing of all equipment functions/operating parameters, alarms and interlocks (etc) identified as ‘critical’ in VP (e.g. – ranges of operation – temperature, fans, airflow etc…). Operational testing of both manual and automated functionality and software (critical) – set-points, ramp-up time etc…


PQ (performance qualification): Testing the ‘output’ against pre-determined requirements/specifications using pre-determined operational set-points/controls etc.
Determination of reproducibility of process (system/equipment) – these tests are carried out for each differing ‘process’ and are usually carried out min. 3 times against defined batch documentation/job cards/work instructions.


VR (validation report) reports on validated status of the equipment and/or process as defined in your Validation Plan and URS.
(See previous post for detail) and summarises all validation activity and documentation aoutput.

Validation reports that are written as part of a revalidation plan/ validation review process:
Concentrate only on validation activities/change controls/deviations/CAPAs etc… since the original validation. This report will assess and close out any identified ‘gaps’ since last qualification and report on current validated status.

Hope this is extensive enough for starters.

 

[romanfa]

Hello !

I am validation engineer in medical device factory.

A new ETO sterilizer is planned and installation completed.
Now it is my part to perform IQ and OQ for the ETO sterilizer.

I read the relevant ISO (11135-1-2007) And (11135-2-2008), but I still have essential misunderstand.

According to ISO I have to perform temperature and RH mapping in empty chamber without ETO.
In PQ 3 batch of product will be tested after incubation.

The question : Where I supposed to test the complete operation of ETO sterilizer with ETO gas inside- Alarms and etc.

Thank all