Dear all ,
first of all thanks…
What will be the frequency of Autoclave/Dry heat sterilizer/Depyrogenation Tunnel Re validation or re qualification?
if any one knows please reply with reference…
Thanks…
Hi there
qualification concerns your equipment
validation concerns the processes you run on the equipment.
Out of my experience once your equipment is qualified you start your process validation mappings with loads.
After successful conclusion, you then do an annual mapping with the worst case load.
I do not have a clue why they need to be repeated, but I think it is to check the performance of your machine. Cause mechanical components know wear and this can adversely affect your process. Hence revalidation is more important with sterilizing systems.
Greetings
Johan
Good inputs from Johan.
The question about why they need to be repeated is really a question of how to keep the system in a validated state. As Johan noted, once you qualify the equipment and validate the process (and confirm you have a repeatable and stable process), your system is in a validated state. As time goes on, things happen: preventive maintenance, maintenance, other changes, etc. These potentially move the system out of a validated state and so you need to determine what needs to be done to bring the system back into a validated state. This is often a repeat of some or all of the qualification / validation conducted initially.
So the frequency is defined by you. If you can show that the system is stable over time, your re-validation requirements would be limited and less frequent. Otherwise, it may need to be more frequent.
[quote=yodon]Good inputs from Johan.
The question about why they need to be repeated is really a question of how to keep the system in a validated state. As Johan noted, once you qualify the equipment and validate the process (and confirm you have a repeatable and stable process), your system is in a validated state. As time goes on, things happen: preventive maintenance, maintenance, other changes, etc. These potentially move the system out of a validated state and so you need to determine what needs to be done to bring the system back into a validated state. This is often a repeat of some or all of the qualification / validation conducted initially.
So the frequency is defined by you. If you can show that the system is stable over time, your re-validation requirements would be limited and less frequent. Otherwise, it may need to be more frequent.[/quote]
Thanks a lot,
Any guidelines for this/
I have 5 Saturated steam sterilizer.Which have recipe-1…6 valid cycle which performed during initial execution. then preventive maintenance,maintenance done periodically…
every 6 month interval we re-qualify any of the 6 recipe with one empty chamber heat distribution & One Heat penetration cycle …
My Q is
is it valid for this. or you have to complete your cycle such as 3 consecutive Empty HD, 3 loaded Hd then 3 loded HP for every 6 months for one recipe?
or when u requalified then U have to valid each & every cycle?
As Johan pointed out, a confirmation of performance using your worst-case loading and cycle should be all that is necessary. If you can be confident with your worse-case loading/cycle then you will be assured that your normal loading/cycle is performing per specification. The frequency is yours to determine based on usage, maintenance history, etc. if you find that annual requalification is sufficient and you can support that, then it’s fine. If you find that your system is degrading performance faster then maybe 6mo. would be best. Either way using a risk based approach factoring in your usage, maintenance history, loading, etc., you should be able to determine how often to requalify your autoclave.