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Sealing Temp

I want to know about at the time of packing validtion we set the sealing temp. If sealing temp. exceed the set limit what impact on the tablets.

The tablet is not heat sensetive.

Without knowing more detail, it is difficult to be precise, but the impact of exceeding the set sealing temperature may be more on the packaging than on the product. For example, it may become very difficult to open the packet due to the seal being too strong - and perhaps as the user needs more force to open the pack, they may tear the pack apart (spilling the contents?) or tear open more than they need (exposing the contents to atmosphere?) or other effects.

The main risk my company would run in exceeding maximum set sealing temperatures is that packs become difficult to open, and the use of increased tugging or ripping would cause the contents to spill out - making them ususable.

I hope that helps!

Dear Rudra,

I agree in that the impact of an higher sealing temperature is mainly on the packaging, but some impact on the tablet cannot be excluded and is dependant from a variety of factors (temperature, time, thermal contact of the tablet with the blister, etc. ). I would test for degradants of the API, check the appearance of the tablets (yellowing, cracks in coating, etc) and put a retention sample on stability and test periodically.

Regards

Alfred

For the packing of blisters into ‘containers’, another would be to pack loggers in the ‘containers’ (with PI etc) and send it through simulating the out of spec condition. You will be suprised at how the container stops the heat from reaching the packed tablets. But if this is on a piece of equipment such as a blister sealer, then I would say that you need to simulate the various out of spec limits and continue as Alfred has mentioned.

Hope this is of some help.

[quote=Cat]Without knowing more detail, it is difficult to be precise, but the impact of exceeding the set sealing temperature may be more on the packaging than on the product. For example, it may become very difficult to open the packet due to the seal being too strong - and perhaps as the user needs more force to open the pack, they may tear the pack apart (spilling the contents?) or tear open more than they need (exposing the contents to atmosphere?) or other effects.

The main risk my company would run in exceeding maximum set sealing temperatures is that packs become difficult to open, and the use of increased tugging or ripping would cause the contents to spill out - making them ususable.

I hope that helps![/quote]

Sir,
Thank you your suggestion. I am try to explain what i want to know by one example.
I am having one tab. i am going to pack this by alu-alu strip and when i start packing the sealing temp. is well in limit but after some time it is increased, by this what are the impact on the tablet due to this higher temp.
I am asking about what are the impact on tablet not on packaging material. Thanks

Rudra,
I believe Cat gave you right guidelines. Set out of specification parameters for lidding temperatute, pressure and dwelling time and observe increase in degradation products, visual examination and accelerated stability. How high is your worst case temperature?

Waynem: where is it possible to get small scale temperature loggers?

Thank you all of you for your guidance.

Rudra, on what type of equipment do you perform validation. Is it rotary or platen blister line? If you are interested we can share experience… What type of dosage form (pharmacological class) is your worst case product?
You can send private message…

[quote=Aral]Rudra,
I believe Cat gave you right guidelines. Set out of specification parameters for lidding temperatute, pressure and dwelling time and observe increase in degradation products, visual examination and accelerated stability. How high is your worst case temperature?

Waynem: where is it possible to get small scale temperature loggers?[/quote]

Aral,

at least in our experience the dataloggers are not too useful. We have used Maxim/Dallas button data loggers, and they can only be used replacing tablets of more than 17 mm in diameter due to the size of the button. On top, the data they show are not real, because the heat transfer through the packaging is quite low, and the mass and the thermal conductivity of the button relatively high, compared to the tablets. The result is that the button does not nearly reach the temperature the tablet reaches during sealing or shrinkwrapping. The most reproducible results (at least for the peak temperature) we have achieved were with thermosensitive labels attached to the tablets. The downside is that the information about the dwell time is lost, because the label shows only the peak temperature reached, but does not give any information about for how long.

Regards

Alfred

Alfred,
I appreciate your answer. I think that method with thermosensitive labels would be very useful for me to validate blister sealing process with out of spec parameters. I think that max temperature data would suffice. I only have doubts about senitivity of this method.
What is your opinion about influence of blister perforation on seal water vapour ingress? We have conducted a small scale study on moisture sensitive product but we didn’t find significant difference…