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Sterilization Validation Plan

#1
Recently, on my company, we have started to develop a new medical device class IIb which presents a sensors that needs reprocessing, including sterilization performed by the healthcare professional (hydrogen peroxide)

We have already contacted a laboratory that will perform the validation, but they have requested a sterilization validation plan, and this is something we have no experience at all.

Does someone have any example or template on this kind of validation? I assume this is not a design validation, it would look more like a process validation? What about the concept validation master plan? Is it the same?
 
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#2
beltrans,

I am assuming that you are talking about the same device as in this biocompatibility thread. As pointed out there, you will need support by knowledgeable and experienced team members also for this validation activity.

There is no ready-to-use template, even not (yet) a published dedicated ISO standard (as for EO, irradiation or steam) for validating a hydrogen peroxide sterilisation process. Whether you define these activities in a "master" plan or in any other type of protocol, is up to you, as long as you coverall required IQ (if applicable), OQ and PQ activities related to involved equipment and the actual sterilisation process.

HTH,
 
#3
Hi Beltrans,
Sterilization validations can be quite tricky especially with respect to reprocessing. There are several ways to attack this problem. Yes, it would look like a process validation but needs to follow the regulations for sterile reprocessing. You'll be hard pressed to find an example or template out there.
 
#4
ve started to develop a new medical device class I
Recently, on my company, we have started to develop a new medical device class IIb which presents a sensors that needs reprocessing, including sterilization performed by the healthcare professional (hydrogen peroxide)

We have already contacted a laboratory that will perform the validation, but they have requested a sterilization validation plan, and this is something we have no experience at all.

Does someone have any example or template on this kind of validation? I assume this is not a design validation, it would look more like a process validation? What about the concept validation master plan? Is it the same?
Hi Beltrans, my company needs to do hydrogen peroxide sterilization as well. How does your test go? Your experience will be extremely valuable to us!
 
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