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Validation of Forced Aeration Process

akyt

Registered
#1
Hello people,

My company has a forced aeration process after the sterilization cycle, which considerably reduces the time to remove EO residue from products. The process is carried out in a dedicated sterilization chamber, in which vacuum pulses and inert gas injection are responsible for aerating the product.

We are needing to validate this process and some doubts have arisen. The ISO 11135: 2014 standard talks about evaluating the product and packaging performance in the worst process conditions, and I understand that this aeration is stressful for the product. So, how can I proceed with the validation?

I need to ensure that forced aeration is effective in removing waste, and at the same time does not affect the product performance and the packaging integrity. Any ideas on what tests, conditions and sampling should I use?

Thank you very much in advance.
 
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chris1price

Trusted Information Resource
#2
Hi, without additional knowledge of your products, identifying the tests, etc is difficult. However, what you are describing is standard practice.

Sterilisation and aeration can both cause damage to products. Significant vacuum is applied and the resultant outgassing can inflate and damage, even burst, packaging. Remember the product may not be at room temperature, possible 60C or higher. PVC balloons are easily damaged at these conditions. You should consider performing all design verification tests after sterilisation (and aeration), and after your shelf-life testing. You should clearly document the rationale for not performing any tests after exposure.
 

akyt

Registered
#3
Thank you very much for your contribution.

Our sterilization and forced aeration process is carried out at 55°C. I have some specific tests to evaluate the product's performance and I can apply them. Likewise, I will also apply tests to the packaging. Do you think that only the sterile barrier system seal integrity test (ASTM F1929) is sufficient?
Should I do these same tests after exposure to aging?

Another doubt, in an environmental aeration the ISO 10993-7 standard requires 3 cycles. In this case, how many forced aeration cycles should I consider for evaluation? Is one cycle sufficient?
 

chris1price

Trusted Information Resource
#4
Its up to you to decide the best test method depending on the packaging configuration. I would recommend using a quantitative test (peel test, or burst test) as well as the dye penetration test. Whichever, you need to validate the method and establish failure criteria before you start the testing. Take a look at ISO11607 for a list of test methods.

Yes, you should repeat the seal tests and product tests after aging. Doing it immediately after sterilisation will give you the confidence to progress to ageing, after which it should be repeated in full.

Per ISO10993-7, you are doing the three cycles for testing of residuals. It doesn't matter whether the aeration is forced or ambient, you still need to establish the aeration time.
 
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