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When to perform accelerated aging studies and transport test(OQ or PQ)

enorht

Starting to get Involved
#1
Hi guys,

I want to validate a new sterile packaging. For the validation of the sterile packaging, i am going to perform:
- an IQ on the equipment of the installation (verification of safety, alarms, utilities, manufacturer recommendations, ...)
- an OQ with dye penetration testing, burst test, traction test, sterility test ... at the operating limits (temperature, pressure, ...)
- an PQ with three lots with the same mechanical test and sterility test.

I want to know when (during OQ or PQ) do I need to perform on my worst-case before the mechanical test and sterility test:
- the accelerated aging (ASTM F1980)
- the sterilization
- the transport (ASTM F4169)

I planned to perform on my worst-case the three stress tests on the OQ (at minimum critical limits) and on the three lots of PQ. However, it is maybe too much. I do not know if I can just perform the three stress tests during the OQmin on the worst-case parts before the functional tests. And during the PQ, i will just test mechanical test and sterility test on some product packaged which were stored three months (routine average), transported normally (by a truck for example), and sterilized at routine dose.

Thanks for your help
 
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chris1price

Trusted Information Resource
#2
Personally, I would do them as part of the OQ, its too late to find there are issues when you do the PQ. My experience is that if you call it PQ, management will want to sell the product as quickly as possible, they wont be happy if you say there is 3 months of testing after the PQ has finished.

Think of it as one long product qualification, split into individual elements
-Packaging qualification (burst test, dye penetrant, peel test, etc)
-Transport
-Sterility
-Product functionality

Before starting these you need to get through IQ/OP/PQ for the processes (manufacturing, packaging machine, sterilization process)

However, at the end of the day, the name you give them (OQ or PQ) doesn't really matter as long as you get the work done and document it properly.
 

enorht

Starting to get Involved
#3
So for your, we should not do for OQ:
1) Packaging at minimum critical process parameters (low temperature of sealing, etc.)
2) sterilization
3) transport

And then, test burst test, dye penetration, peel test for packaging OQ + transport in OQ + sterility in OQ + product functionality? But test separately:
1) Packaging at minimum critical process parameters (low temperature of sealing, etc.)
2) sterilization (search for VDmax25 and doing min max radiation)
3) transport (no need to have a packaging which were done at minimum critical process parameters)?

Thanks,
 
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