Equipment Cleaning Validation Requirements - Medical Device Class II or Class III

For a medical device class II or class III, is it required an equipment cleaning validation? Is there any reference for medical devices?
Is the equipment cleaning validation equal to clean-in-place (CIP)?

Re: Equipment Cleaning Validation

Similar to why a validation is carried out for various other special processes, this also typically comes to validation requirement because "How clean is clean" cannot be measured.

Re: Equipment Cleaning Validation

somashekar said:

Similar to why a validation is carried out for various other special processes, this also typically comes to validation requirement because "How clean is clean" cannot be measured.

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Yes and no: Here is my $.02
Validation is the right tool for various processes. However, cleanliness can be supported with the implementation of proper Cleanroom controls (see Standards for different classification) and Microbiological testing (such as ISO 11737-1 for Bioburden, aerobic & anaerobic bacteria, spores & fungi).

This standard help us "determine the total number of viable microorganisms in or on a medical device, container or component after completion of all in-process steps before sterilization" and acts as an early warning system for possible problems with production or environment.

We can claim "cleanliness" if there is no bacteria, spores or fungi present.

RMV09 said:

For a medical device class II or class III, is it required an equipment cleaning validation? Is there any reference for medical devices?
Is the equipment cleaning validation equal to clean-in-place (CIP)?

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Hi,

"Class II or Class III" is not a clear-enough definition to answer this question upon. It depends what sort of devices and processes are involved, e.g. whether or not a clean room is utilized.

Although environmental monitoring and bio-burden testing are possible, I would say that this is not the best option cost-wise. A cleaning validation is required just once, and normally no more testing is required if nothing goes wrong or the circumstances change (except for maybe periodic re-validations). E monitoring and BB testing, on the other hand, would be required routinely, and this may sum up to significant costs (especially if you don't have the equipment, expertise and right certifications in-house).

Cheers,
Ronen.

Ronen E said:

Hi,

"Class II or Class III" is not a clear-enough definition to answer this question upon. It depends what sort of devices and processes are involved, e.g. whether or not a clean room is utilized.

Although environmental monitoring and bio-burden testing are possible, I would say that this is not the best option cost-wise. A cleaning validation is required just once, and normally no more testing is required if nothing goes wrong or the circumstances change (except for maybe periodic re-validations). E monitoring and BB testing, on the other hand, would be required routinely, and this may sum up to significant costs (especially if you don't have the equipment, expertise and right certifications in-house).

Cheers,
Ronen.

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Ronen,

What is your prove that the validation conditions are still in play if you do not monitor the environment, people, gowning, air and bioburden?

As an auditor, I would ask for information that show than your process is in contol state... A cleaning validation is only tell me that only at the time of validation process was under control. Without a data, how do we know without monitoring that 3 months later it is still good?

Regards,
Mike

Hi,

I thought you were referring to product BB testing and extended E monitoring as a substitute to cleaning validation. Of course I stand for the basic E and BB monitoring of the clean-room. I only meant to point out that with the lack of a proper cleaning validation much more frequent / extensive E & BB testing would be required for maintaining a similar confidence level.

Another, more general, comment: A "validation" is usually meant to provide confidence that given certain inputs, a process would consistently provide certain outputs, regardless of noise. As such, I would include in any cleaning validation extreme values of controlled parameters, and also test the sensitivity to noises (uncontrolled parameters), as much as practicable. If done properly, such validation could provide confidence of the cleanliness level even at the extremes that can be expected in the validated environment. Demonstrating effectiveness at nominal or optimal conditions is not a validation. It's a verification.

Cheers,
Ronen.