Components Cleaning for Manufacturing Sterilized Medical Device

S

shivaji141

#1
Hi all,

Need your help for a making a single use medical device, class 1. This will be EtO sterilized.

My question is - Do we need to do any cleaning/ ultrasonic bath of the components before assembling the device. Are there any ISO/ASTM standards for this cleaning process and post-cleaning verification.

All my suppliers are ISO9001 certified, but not ISO13485.

We do not want to do the cleaning of complete device before sending out for sterilization and are therefore making it in the clean room.

Looking forward for your comments.

Regards,
CS
 
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J

Jimmy the Brit

#3
Need your help for a making a single use medical device, class 1. This will be EtO sterilized.

My question is - Do we need to do any cleaning/ ultrasonic bath of the components before assembling the device. Are there any ISO/ASTM standards for this cleaning process and post-cleaning verification.

All my suppliers are ISO9001 certified, but not ISO13485.

We do not want to do the cleaning of complete device before sending out for sterilization and are therefore making it in the clean room.
Hi CS,

In addition to the links provided by Ajit you need to ask why you might need to clean these components. Are you trying to make them chemically clean, by removing particles or release agents etc.. , or are you trying to lower their bioburden? If the latter, are you doing it because a high bacterial count may invalidate your sterility assurance level, or because you don't want to contaminate your clean room?

The answer to these questions will determine what level of cleaning, if any, you require. Chemical cleaning may require ultrasonic washing in a suitable solvent, whereas bioburden control could be addressed with surfactant washing or even low dose eBeam ...... I am happy to try to help further, if you can provide more details about the components and your needs.

Jim
 
S

shivaji141

#4
Hi CS,

In addition to the links provided by Ajit you need to ask why you might need to clean these components. Are you trying to make them chemically clean, by removing particles or release agents etc.. , or are you trying to lower their bioburden? If the latter, are you doing it because a high bacterial count may invalidate your sterility assurance level, or because you don't want to contaminate your clean room?

The answer to these questions will determine what level of cleaning, if any, you require. Chemical cleaning may require ultrasonic washing in a suitable solvent, whereas bioburden control could be addressed with surfactant washing or even low dose eBeam ...... I am happy to try to help further, if you can provide more details about the components and your needs.

Jim
We are assemblying the device in class 100K clean room. The reason for cleaning being that I don't want to contaminate the clean room. For my product, I do have plastic parts (all molded in clean room again) and machined parts, wires.. (not from clean room).

I do not know how much will be the bio-burden of components(not got them yet), but I expect parts will be reasonable cleaned and free of dirt when I get them. I "believe" EtO process should be able to sterilize them. So, only requirement for cleaning is that it doesn't contaminate the clean room.

One of my partners is insisting on ultrasonic washing of machined parts- washers, screws etc. If done so, then, it has to be repeated everytime. Additonal process, additional costs. I am worried this implies overdoing things for a class 1 device.

Thanks,

Regards,
CS
 
J

Jimmy the Brit

#5
One of my partners is insisting on ultrasonic washing of machined parts- washers, screws etc. If done so, then, it has to be repeated everytime. Additonal process, additional costs. I am worried this implies overdoing things for a class 1 device.
This is a tough one. If the components are visibly clean when they arrive and have a low bioburden then there is no point in washing, however if they come in covered in process chemicals and with either a high, or very variable bioburden they will need to be cleaned. Is there any chance you could set a cleanliness specification with your supplier - "visibly clean" or something like that. For example I used to use a toothpaste test for hypodermic needles - squirt abrasive white toothpaste through the needle using a syringe and examine the line of paste for dirt/inclusions.

I really believe that controlling the supply is a lot easier than trying to clean in-house.

If nothing else, get some samples and check them out before committing yourself to a lifelong cleaning process that may be unnecessary.

I hope this is useful, but if not let me know and I will think again.

Jim
 

chris1price

Trusted Information Resource
#6
I would agree with Jimmy, push the cleaning back to the supplier. Make certain your specification or agreement says that the product must be free from cutting oils, etc and also says how this is going to be tested.

Depending on the cycles used, EtO can be quite sensitive to bioburden, so don't assume it will always be low. I would start routine bioburden monitoring as early as possible to assess the trends and see how consistant your suppliers are.
 
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