EFHSS Questions and Answers - Question Q00490

Hello to all,

I am in the process of obtaining an autoclave unit that will be used for research purposes (steam cycle development and product/packaging functionality tests). I would like to obtain a template for performing the required installation and commissioning (IQ/OQ).

Would someone please provide me with a contact, site, or resource for obtaining an applicable qualification template? thank you

Danny Hutson
Process Microbiology Manager

Dear Danny,

EN 285 Sterilization - Steam sterilizers - Large sterilizers, and EN 554 Sterilization of medical devices - Validation and routine control of sterilization by moist heat (see our CEN Standards page for information on how to obtain them) provide the information you're looking for.

Best regards,
Wim Renders

Dear Danny,

Your question seems to be difficult to answer as most of the questions are answered in a few days. I think the problem is that there is not a single answer which would answer your question. As you most probably know in the pharmaceutical industry the qualification of equipment is standard.
This procedure starts already before ordering a machine and ends with the complete validation report.
The following steps are more or less standard:

1. URS-User Requirement Specification - what does the user want to have?
2. Functional Specifications - what has the machine to do and how is it achieved?
3. Design specification - to be made and discussed with possible supplier(s) That is hardware including software.
4. When a supplier is selected the project will be realised and if we are talking about a machine which can be tested in the production facility a FAT - Factory acceptance test, will be preformed.

This is the check if the supplier has made according to your expectations. In this FAT the start with the IQ/OQ can be made. Depending of the design and machine type many items are installed and can be verified.
If we are talking about a steriliser you can roughly say that the IQ/OQ looks like:

IQ

1. Documentation control
2. Verification components, hardware and software to contract specification
3. Control of instruments and calibration
4. Control piping and valves compared to P&ID

OQ

1. Verification connected media
2. Verification calibration instrumentation
3. Testing of the control system, alarms and indicators
4. Leakage test
5. Temperature distribution in empty chamber (normally also part of the PQ)

After the FAT showed that you will get what you were expecting the machine can be installed.
After installation and commissioning the machine has to pass the SAT - Site acceptance test, including the finalisation of the IQ/OQ.
When all this is finalised the PQ - performance qualification takes place. When the results of the PQ are according to the demands as written down in the URS the machine can be handed over to the user.

This whole procedure is generally applicable for all kind of projects but there is (as far as I know) not a standard document which could answer all your questions. You can bring in whatever you like in the documents as long as you can find a supplier who confirms that his machine can fulfil the requirements.
I do not know if my answer is according to your expectations but please do not hesitate to contact me directly,

Kind Regards,
Henk Ras
Export manager


Sanamij B.V.
Rotterdam - The Netherlands
www.sanamij.com