I am curious that what items I should execute for initial PQ.
Our Customers want us to have IQ,OQ,PQ for Sealing machine.
When we bought it, we did not have a Qualification. I can do IQ,OQ.
However, in PQ, what items should I do?
I think there are 2 ways.
Leak test using methylene blue solution and
Adhesive strength test. ( I have no idea to check adhesive strength test. How can I do? Could you explan it)
Could you advise me any proper test items for PQ and
Are above tests right?
have a good day.:)[/quote]
Chief, you have new equipment for sealing. You need to eastablish process (typically OQ) prior to PQ. During PQ, process parametr(s) are set at NOMINAL typically with three seperate lots. In short, Sealing is special process that requires OQ and PQ. The IQ is just checklist to verify information can be performed prior to PQ. Please let me knwo if you need further assistance.
I think, you are on right track for testing by leak test and peel strength test. I am wondering what are your Key Process Input Varieables for sealing process for OQ?
Regards,
Both are referenced within the ISO standard for sterile barrier packaging ISO11607, though you may not be looking at sterile product. In addition the GHTF guidance document on validation uses a heat sealer as its validation example and can be found on the IMDRF site here
.
Normally for the OQ for heat sealing you would look at pressure, temperature and time but the picture looks like an impulse sealer and I haven’t ever used one to know what controls are available but I think it might just be time control. In which case you would look at time within the OQ but you might want to review the overall process for other potential sources of variation that you want to include in the validation.
In my case I use a thermoforming machine with line speed, sealing pressure, temperature and dwell time as the input parameters. You can have other parameters but you have to perform a screening experiment to figure out the key parameter. Then you can do an experiment to optimize your key parameter.
You can use GHTF guidance for validation process as our friend Funky mosquito said.
I hope I can help with this.
Regards,
Henry
[quote=godisfree]
Dear all
I am curious that what items I should execute for initial PQ.
Our Customers want us to have IQ,OQ,PQ for Sealing machine.
When we bought it, we did not have a Qualification. I can do IQ,OQ.
However, in PQ, what items should I do?
I think there are 2 ways.
Leak test using methylene blue solution and
Adhesive strength test. ( I have no idea to check adhesive strength test. How can I do? Could you explan it)
Could you advise me any proper test items for PQ and
Are above tests right?
Yes, you need to perform samr above tests during PQ. The diffrence between OQ and PQ is during OQ you challenges limits of Key Input variables and during PQ you need to test consistency of process by performing 3 lots or 3 batches by opening 3 work orders or Joborders with NOMINAL Input Variable setting. Inshort, PQ reuires 3 work orders and perform at Nominal Input parametr and perform Cpk study for Seal Strength and Zero failures for Leak test. You also need to justify the sample size during the PQ for each run. Plese let me know if you need halp for sample size.
