Required Environmental Controls for a Part Provided Sterile?

S

s.parakos

#1
I have a question about environmental controls for a part we provide sterile. The processing is is 4 stages:

  1. We have a part injection moulded for us by a contract manufacturer in a qualified clean room.
  2. A batch of parts is shipped to us and we assemble the final product in-house.
  3. The product is shipped to a contract packager who packages it in a qualified clean room.
  4. The product is gamma sterilized by a validated process.
Stage 2, our in-house handling, is not performed in a qualified clean room. Temperature and humidity are not of issue to the product, neither is dust or other particulate contamination. The only issue we are concerned about is microbial contamination, ie controlling bio-burden levels. The controls we apply are:

  • only trained personnel handle the items.
  • the production area is only used for the assembly task.
  • production staff clean the room, their hands and production equipment before handling.
  • we perform regular bio-burden monitoring of samples after packaging but before sterilization.
My question is, do the above controls satisfy requirements for a device labelled sterile? What other controls could we provide?

thanks for any advice
Simon
 
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Doug Tropf

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#4
I don't have much knowledge on gamma sterilization,
but for ethylene oxide sterilization, the product would
be considered sterile as long as the packaging seal was
not broken (provided it was sterilized in accordance with
a validated cycle and it passed the parametric release or
biological indicator testing criteria).
 
K

kstepke

#6
For the non-cleanroom process, it is largely a risk-based decision. How often do you pull bio-burden samples? I recommend that while it may not be a cleanroom, that you still monitor the and establish control limits. If you stay within your control limits, its reasonable to assume that your bioburden contribution from that process isn't greatly changing and you sterilization validation is still valid.

I've had a similar question to your. While scientifically, this approach make sense, I've never had to defend this to a regulator, and hence always used cleanroom processes. Has anyone else defended a non-cleanroom process for a sterile product?

Thanks.

Kurt
 
J

Jimmy the Brit

#7
While you may not have a clean room you do have a controlled environment, which sounds like it is good enough for your needs. As long as you are monitoring your bioburden and you carry out frequent dose audits then your approach is fine.

Having said that I am with Kurt - a regulator may see it in black and white, especially if their background is not in microbiology. I the past I have gotten round this by making the controlled area "look" right - stainless steel assembly benches, epoxy floors, white wipe clean wall panels if possible - it may not change the efficacy of your process but will make the regulator feel better! Sometimes though, you just have to bite the bullet and put up a clean room, especially if you have significant seasonal variance in your bioburden which may have a weird effect on your VDmax calculations.

Jim
 
K

kstepke

#8
While you may not have a clean room you do have a controlled environment, which sounds like it is good enough for your needs. As long as you are monitoring your bioburden and you carry out frequent dose audits then your approach is fine.

Having said that I am with Kurt - a regulator may see it in black and white, especially if their background is not in microbiology. I the past I have gotten round this by making the controlled area "look" right - stainless steel assembly benches, epoxy floors, white wipe clean wall panels if possible - it may not change the efficacy of your process but will make the regulator feel better! Sometimes though, you just have to bite the bullet and put up a clean room, especially if you have significant seasonal variance in your bioburden which may have a weird effect on your VDmax calculations.

Jim
Jim- Based on your "white room" approach, have you incresed your frequency of area monitoring or bioburden sampling compared to what you would do in a certified cleanroom to compensate for the reduction in air quality control? I'm attempt a cost/benefit evaluation of clean vs white room.
 
J

Jimmy the Brit

#9
Based on your "white room" approach, have you increased your frequency of area monitoring or bioburden sampling compared to what you would do in a certified cleanroom to compensate for the reduction in air quality control? I'm attempt a cost/benefit evaluation of clean vs white room.
I know that we increased bioburden sampling frequency initially, in order to validate that our routine program identified the peaks and troughs associated with the manufacturing environment, including seasonal variations. Once we demonstrated that the routine frequency was adequate (and it was), we reverted to our standard sampling cycle. I think we also ran some anaerobic sampling as well, just to cover all the bases because we were running an EO cycle.

We used the same environmental monitoring program for this area as we did for class 100,000 clean rooms, with the same (dynamic) limits for microbiological limits, but without the particle counting (NVP monitoring of these areas just messes up your particle counter with no benefit). We had occassional excursions on RODAC plates, but nothing that could not be brought back into line with improved cleaning.

Hope this helps,

Jim
 
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