Cleaning and Sterilization - ISO 13485 sections 6.4 and 7.5.1.2.1

C

chasf

#1
Section 7.5.1.2.1 states: If product is cleaned in accordance with a) or b) above, the requirements contained in 6. 4 a) and 6. 4 b) do not apply prior to the cleaning process.

How does this apply to our production setting?
Do 6.4 a and 6.4 b apply?
What would be the extent of documented controls needed?

Our company supplies components to the Medical Device manufacturer they are cleaned by us in an ultrasonic cleaner and in some cases passivated by our certified supplier then sent to the the customer. All sterilization takes place after shippment. We use controls for handling after cleaning takes place by use of protective gloves to keep device components in a clean condition.
 
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J

Jimmy the Brit

#2
Section 7.5.1.2.1 states: If product is cleaned in accordance with a) or b) above, the requirements contained in 6. 4 a) and 6. 4 b) do not apply prior to the cleaning process.

How does this apply to our production setting?
Do 6.4 a and 6.4 b apply?
What would be the extent of documented controls needed?

Our company supplies components to the Medical Device manufacturer they are cleaned by us in an ultrasonic cleaner and in some cases passivated by our certified supplier then sent to the the customer. All sterilization takes place after shippment. We use controls for handling after cleaning takes place by use of protective gloves to keep device components in a clean condition.
Hi Chasf,

What I believe this clause is saying is that if you are cleaning your product using a validated cleaning process prior to sterilization or use, then you do not need to worry about control of the manufacturing environment or personnel hygiene prior to the washing stage.

In reality the burden of proof is on you - you must demonstrate that the U/S washing or passivation stages (I am assuming acid passivation??) are adequate to remove all contaminants from your product. I would recommend a worst case validation to test the limits of your process - I once coated injection moulded components in oil and releasing agents, just to see if the dry cleaning fluid in our U/S bath was robust enough to remove it all - it was, thankfully.

The important part is recovering the clean components and handling them in such a way to avoid recontamination prior to sterilization, because the ISO 13485 sections 6.4 a) and b) definitely apply post-washing. You use gloves and this may well be adequate for your process, but I suggest that you validate it, probably using a bioburden recovery as this is the easiest way to prove product protection. In my experience the critical thing is to ensure that the product is dry before packing as wet product will rapidly become contaminated (in 4 to 6 hours).

If there is a sterilization stage later in the process there should be pre-sterilization bioburden records available - this could give you the data you need to retrospectively validate the efficacy of your washing and recovery process (or it could show that bioburden is not well controlled, in which case your process has a hole in it).

I hope this helps, and I haven't just made your life a whole lot more complicated, ;)

Jim
 
C

chasf

#3
Thanks for your concern but things here were already complicated as we make the transition from ISO 9001:2000 to ISO 13485:2003.

Our manufacturing process involves contact with synthetic water soluble coolants and or synthetic oils also stainless steel shot peen media as well as handling buy 4-6 different people.

In this type of setting what steps would we take to control contamination in relation to personal hygiene?

Would this control need to be validated?

Another question that comes to mind is if we did satisfy the requirements of 6.4 would we still need to validate our cleaning processes?
 
J

Jimmy the Brit

#4
Our manufacturing process involves contact with synthetic water soluble coolants and or synthetic oils also stainless steel shot peen media as well as handling buy 4-6 different people.

In this type of setting what steps would we take to control contamination in relation to personal hygiene?

Would this control need to be validated?
The easiest way to address the handling/personal hygiene issue is to separate the product from the personnel, post-washing, but of course that is expensive and technically demanding. If you recover washed components in a clean room, or laminar flow hood and immediately store into impermeable packaging then you only need to demonstrate control up until the point of sealing the primary pack - but you then have to valiidate and control the clean room etc...

You indicated in your earlier mail that you were using gloves to recover washed components, presumably to seal them into a polythene bag or similar. If your gloves are sterile, or at least non-linting and disinfected, regularly, and your bags are clean single use, then this may be adequate, as long as the bioburden downstream is within the specification required by your sterilization process.

Another question that comes to mind is if we did satisfy the requirements of 6.4 would we still need to validate our cleaning processes?
As a personal comment, if I was auditing a facility and saw a cleaning process I would always ask for a justification and validation data for the process. You must be washing for a reason, and therefore I would want to see evidence that your process acheived its intended purpose.

It doesn't have to be too demanding to validate the cleaning process - as I said before, check the pre-sterilization bioburden, this may provide excellent data to support your current practices.

Jim
 
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