OQ on a Heat Sealer

bettsaj · Sep 18, 2023

I work for a company that makes surgical procedure packs for the NHS and private sector, all our packs are made using tyvec breather bags which are sealed at one end once they've been filled with the contents required for that particular pack. Earlier in the years we had a new sealer delivered and put into production.

We had an audit in June, and the auditor raised a minor NC against the sealer not having an IQ, OQ or PQ performed. The IQ has been done, but when we bought the sealer it was just delivered and left for us to install etc. This being the case I plan to conduct a retrospective OQ on the machine, but am a bit lost as to where to start, as this would have been carried out by the manufacturer of the machine. The sealer only has one variable which is temperature, the speed of the belt can be varied but that has to be done by opening the machine up and tinkering with the settings inside so not available for operators to change. however the auditor did make a point of stating that we're not monitoring the speed.

I have since timed all our sealers (we have 7 in total) and had them all set to approx. the same speed setting. This now can't be changed and frankly I can't see the point of monitoring it on-going. I can obviously put in the IQ that the sealers were checked, adjusted and the times of all sealers aligned.

Where would I start with an OQ, what have I got to cover??

Any help will be much appreciated

planB · Sep 18, 2023

What is the purpose of your bags? Since you mention Tyvek, do I correctly assume that your procedure packs undergo terminal sterilization?

If yes, you may want to have a look into ISO 11607-2:2019, Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes, and into ISO 11607-1:2019 for additional guidance.

Generally, a "retrospective" validation might be feasible depending on the quality and quantity of in-process data you have compiled through routine operation. A retrospective OQ is hardly possible, though: at least in the scope of ISO 11607-2, an OQ involves challenging critical process parameters to their specified limits, something you typically do not perform during routine operation.

In my understanding, you would have at least two critical parameters: temperature and belt speed; pressure might be another one. Typically, manufacturers of such heat sealers offer qualification/validation assistance on request. Have you already talked back to the equipment manufacturer about such a possibility?

HTH,

chris1price · Sep 19, 2023

Its worth taking a look at the GHTF/SG3/N99-10 Quality Management Systems - Process Validation Guidance. Its an old document but still a good introduction to process validation; and the example they use is a heat sealer.

GHTF Study Group 3 - Quality Systems

GHTF Study Group 3 - Quality Systems documents

www.imdrf.org

v9991 · Apr 16, 2024

bettsaj said:
I work for a company that makes surgical procedure packs for the NHS and private sector, all our packs are made using tyvec breather bags which are sealed at one end once they've been filled with the contents required for that particular pack. Earlier in the years we had a new sealer delivered and put into production.

We had an audit in June, and the auditor raised a minor NC against the sealer not having an IQ, OQ or PQ performed. The IQ has been done, but when we bought the sealer it was just delivered and left for us to install etc. This being the case I plan to conduct a retrospective OQ on the machine, but am a bit lost as to where to start, as this would have been carried out by the manufacturer of the machine. The sealer only has one variable which is temperature, the speed of the belt can be varied but that has to be done by opening the machine up and tinkering with the settings inside so not available for operators to change. however the auditor did make a point of stating that we're not monitoring the speed.

I have since timed all our sealers (we have 7 in total) and had them all set to approx. the same speed setting. This now can't be changed and frankly I can't see the point of monitoring it on-going. I can obviously put in the IQ that the sealers were checked, adjusted and the times of all sealers aligned.

Where would I start with an OQ, what have I got to cover??

Any help will be much appreciated

to add to the context of the requirements / standards cited above:-
note :- logical clarification, the sealing is function of the temperature + speed + material + environment; more or less in some/same order,

* with reference to OQ and PQ, one would expect to demonstrate the performance a) equipment operating ranges b) process operating ranges.
a) equipment operating ranges are obvious, derived either from URS or OEM manual which are intended to be used; these are relevant because, the performance is based on the equipment setup and operating conditions and hence relevant

b) equipment operating conditions ( material, environment and temperature combinations) to ensure that its setup for the target production and performance criteria.

humoor · Apr 27, 2024

Hi, we have perviously validated a sterile barrier for a tyvek pouch as per ISO 11609-2 2006, do we need to redo the validation as per the 2019 version? if not the full revalidation what are the new updates that need to be consider.
Thanks!

OQ on a Heat Sealer

bettsaj

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planB

chris1price

GHTF Study Group 3 - Quality Systems

v9991

humoor

Starting to get Involved

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