Validation Report - IQ, OQ, PQ and Reports for Injection Moulding and/or Sealers

H

Harmonie - 2009

#1
I just want a few completed validations (IQ, OQ, PQ and reports) to read to give me some ideas on format and cement all the guidence concepts I've read.

ideally, if anyone has links to those with that happened to use injection molding to make something, that's best, but even sealers, etc., would be useful.

Yes, I have some questions, but they are concept- if I have an actual validation then I can ask my question(s) and have something specific to reference (so anyone trying to assist can know what specific issue I'm having trouble with).

Thanks!
 
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G

Gert Sorensen

#3
I just want a few completed validations (IQ, OQ, PQ and reports) to read to give me some ideas on format and cement all the guidence concepts I've read.

ideally, if anyone has links to those with that happened to use injection molding to make something, that's best, but even sealers, etc., would be useful.

Yes, I have some questions, but they are concept- if I have an actual validation then I can ask my question(s) and have something specific to reference (so anyone trying to assist can know what specific issue I'm having trouble with).

Thanks!
I am sorry that I am not able to provide you with a set of completed reports and protocols, but I don't do validation anymore. I can give you some pointers though, maybe that can help a bit. (It's just of the top of my head at 07.30 in the morning).

1. Keep your protocols simple, the more complex they get the harder it is to get a well documented and efficient validation. Some argue that you make only one final report summarizing the results of IQ, OQ and PQ. I cannot recommend that. A protocol generates a report. When you have your IQ, OQ and PQ reports then you make a final report encompassing the results of each. That gives a better overview of the validation (IMO). Remember, bullets and numbers are your friend. A number in a protocol is easy to relate to a number in a report. :)
2. Think of them as the kind of reports that you made during your studies. You define what you want to test, how you will test it, and what your acceptance criteria are. All protocols should be prepared before any validation activities start.
3. "Nobody" can validate alone. Validation should be performed by a group of persons with knowledge of all the processes involved.
4. According to our NB the IQ should be as comprehensive as possible, and cover all aspects of installation, raw materials, surroundings and operation that you can think of. I like that idea, because it leaves the purpose of the OQ to be a thorough Worst Case study.
5. Since you are inquiring relating to plastics, you will want to determine how much variety you can and will accept in your compound. Depending on the finished product you may have a real challenge at this stage. Compounds are tricky things and they can really mess up production if you do not know exactly what the limits of the variety of the compund is.
6. If the validation is to have any value and effect then it shall identify the process monitoring that will give you the certainty that you have full control of your injection moulding (or whatever process). This should not be simply a visual item control or weight control. This should be a combination of controls such as cooling water temperature - before and after the moulding machine (often forgotten), pressure, temperature, preconditioning of compounds, maintenance of the cast etc. You will want to know when production starts to drift, not when it has drifted....

Hope this helps a bit. Any specific questions, let us know. We aim to please.
 
H

Harmonie - 2009

#4
Thank you. Here are some questions (though for the record, if anyone has completed ones please send link!).

During the OQ is when we establish the parameters we want to run at. With a press, where do you start? You mention temp, pressure, water cooling (assume you mean it's temp). Do we start by setting the machine at the parameters we "think" will make a good part (meet the QC tests) and then adjust those up until we have bad parts (and know the high- just below this) and then continue "down" until we establish the lowest points and then have a "low"? In this case, we have just created a "high and a low" and in theory, the product should run somewhere between those. Following this logic-

Do we then do the PQ as 3 or more more runs at what is the middle ground of those established high end and low end (the three runs would be the exact parameters) and if all pass, we are done.

Or, is the whole process (OQ) done by presetting at a determined low and high and adjusting the parameters (temps, etc) during each of these to get a middle ground that will then be run as a PQ? Perhaps better stated, do you start from a known effective set of parameters and just move up till product fails, then go back to this known set and move down until product fails? Or, start at all lows and move up till it's o.k.- then you have a low. Then start real high and back off until you have a high and based on those take the middle and run it three/four times?

My summary to my question would be "getting a little specific by way of example, just how do we develop the hi and low during the OQ and is it correct this would consist of only two "runs" (the hi and low). Then, we see if we are right during the PQ which should be at least three runs all at the same exact parameters (assumed to be the exact middle of the Hi and Low of the OQ).

Vocab: What is the difference between a PQ and a PPQ

Hope this makes my confusion more clear!

Harmony
 
#5
Thank you. Here are some questions (though for the record, if anyone has completed ones please send link!).

During the OQ is when we establish the parameters we want to run at. With a press, where do you start? You mention temp, pressure, water cooling (assume you mean it's temp). Do we start by setting the machine at the parameters we "think" will make a good part (meet the QC tests) and then adjust those up until we have bad parts (and know the high- just below this) and then continue "down" until we establish the lowest points and then have a "low"? In this case, we have just created a "high and a low" and in theory, the product should run somewhere between those. Following this logic-

Do we then do the PQ as 3 or more more runs at what is the middle ground of those established high end and low end (the three runs would be the exact parameters) and if all pass, we are done.

Or, is the whole process (OQ) done by presetting at a determined low and high and adjusting the parameters (temps, etc) during each of these to get a middle ground that will then be run as a PQ? Perhaps better stated, do you start from a known effective set of parameters and just move up till product fails, then go back to this known set and move down until product fails? Or, start at all lows and move up till it's o.k.- then you have a low. Then start real high and back off until you have a high and based on those take the middle and run it three/four times?

My summary to my question would be "getting a little specific by way of example, just how do we develop the hi and low during the OQ and is it correct this would consist of only two "runs" (the hi and low). Then, we see if we are right during the PQ which should be at least three runs all at the same exact parameters (assumed to be the exact middle of the Hi and Low of the OQ).

Vocab: What is the difference between a PQ and a PPQ

Hope this makes my confusion more clear!

Harmony
Hi Harmonie,

You have raised very valid questions.

There are various routes in validating the product. The methodology which I adopt is as follows -

I would like to start with Installation Qualification (IQ), where in I run the molding press for minimum of 4 hours at the parameters based on our past experience or manufacturer recommendation or from the tool maker's experience. This results generated from this study can be analysed using PpK / CpK studies. After the successful PpK / CpK studies, establish your preliminary high and low parameters to be studied during the OQ studies.

In Operational Qualification (OQ), run OQ at high parameters and OQ at low parameters for a minimum of 6 hours and drawing samples at 15 min intervals. These OQ parameters are the same which were earlier determined at IQ phase. Check for the acceptance of the OQ high and OQ Low with CpK values. if the CpK values are acceptable, then you have validated the High and Low parameters.

In Performance Qualification (PQ), run the process at an optimum range (between the High and Low values validated in OQ) for minimum of 24 hours and drawing samples for CpK values.

This PQ run could be either once / 3 times, based on your internal requirements.

Btw, I havenot heard about PPQ - do you have the expanded form ?

Hope this clarifies.
 
B

Bwana.Jo

#6
I just want a few completed validations (IQ, OQ, PQ and reports) to read to give me some ideas on format and cement all the guidence concepts I've read.

ideally, if anyone has links to those with that happened to use injection molding to make something, that's best, but even sealers, etc., would be useful.

Yes, I have some questions, but they are concept- if I have an actual validation then I can ask my question(s) and have something specific to reference (so anyone trying to assist can know what specific issue I'm having trouble with).

Thanks!
Hello Harminie

I'd like to provide to perfect guideline including validation sample for heat sealing equipment.(see from 25 page)

This validation guideline source is GHTF (www.ghtf.org) FDA is also respect this guideline. :notme:

One the another source is WHO. Personally, this guideline has more detail and satisfying me. Please check also.:agree1:
 

Attachments

B

Bwana.Jo

#7
Ask the other expertise

IMO, heat sealer is affordable to apply validation but (plastic) application to injection mold, I don't agree.

Decision making should made prior to proceed validation (accroding to ISO 14969 _ Guideline of ISO 13485) and when you make decision there is considerable valid definition existing (according to the GHTF guidance a process has to be either validated or verified)

Actually, I have very confused at least 2~3 years, 5 years ago about which process should be validated or what process does not need.

This answer is provided at ISO 14969. As a 'should be validated' and 'may be satisfactorily covered by verification' (see 55 page).

You must distinguish also verification and validation. I can tell you this discretion is not easy and difficult. [this is very similarity with comparing and distinguish 'Risk vs Hazard' and it also not easy]

Personally, I used concept "destroy" when process validation decison. If you complete your process, what method or way to examine or evaluate your process results ? Is that way going work perfect ? Then, can you sell after evaluation ? - (that's why I explained distinguish or discertion of V & V, what is differential character) (it is easy to determine, but if somebody request explain more, it is little difficult for me cause my Eng is second language)

Heat sealer ? Can you enumerate result's features?
I think most important feature is "Sealingness" can you examine this character perfectly ? watertight test? sealing destroy test ?
And finally, can you sell them which used above test method ?

From the last december, I would applied 'Risk Consideration' on the PQ protocol & report. There must be 'foreseeable' vs 'reality'.

You can check previous a few my post. ('Bwana.Jo' and/or 'Alex.Jo'):bigwave:
 
T

tiredofculling

#8
I have a similar question, someone is asking to see our IQ/OQ/PQ but these are tasks, no? I'm under the impression they want to see certified tasks, which doesn't make much sense from my side and I asked them specifically what they're asking for. They said they're looking for our IQ/OQ/PQ. This is all pre-project, so how do you show someone validations for something that hasn't even occurred yet?
 

kuyakut

Involved In Discussions
#9
You can draft a validation plan , wherein you will write down your action plan how you will validate the tools/equipment/ product, acceptance criteria and so on. This validation plan will be then transferred into your IQ /OQ and PQ protocol. What your customer is looking on how you will validate the product.
 
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