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Expiry dates of sterilized materials

Dear Sir,
i want to know on which basis expiry of sterilized materials are to be decided.
& if we want to increase the expiry of such sterilized materials what will be the procedure to do so?

thanks & regards,
yogesh

[quote=ster.yogesh]Dear Sir,
i want to know on which basis expiry of sterilized materials are to be decided.
& if we want to increase the expiry of such sterilized materials what will be the procedure to do so?

thanks & regards,
yogesh[/quote]
Dear Yogesh,

Yes, you can established by bio-burden studies.

[quote=ster.yogesh]Dear Sir,
i want to know on which basis expiry of sterilized materials are to be decided.
& if we want to increase the expiry of such sterilized materials what will be the procedure to do so?

thanks & regards,
yogesh[/quote]

If you are just thinking to enhance or improve the expiry from sterilization point of view then you should also consider the product own stability and degradation profile. All it is based on stability staudies to set a shelf life, which covers both product degradation profile and sterilization intigrity of product in the primary container.

To know the sterilized material expiry or hold time you have to carried out the hold time study of sterilized material on that basis u can used the sterilized material for the specified period which is calculated by hold time study.

Dear Shahid,
Consideration of product stability or degradation product in sterilization hold time study is out of question because if the material is sterilzed then it should be free from any foriegn material (including product or their degradation products) so just perform bio burden study and establish max holding time of sterilized material.

thanks

How can we determine hold time by knowing the bioburden??
please reply.

Quote:
Originally Posted by ster.yogesh
Dear Sir,
i want to know on which basis expiry of sterilized materials are to be decided.
& if we want to increase the expiry of such sterilized materials what will be the procedure to do so?

thanks & regards,
yogesh

If you are just thinking to enhance or improve the expiry from sterilization point of view then you should also consider the product own stability and degradation profile. All it is based on stability staudies to set a shelf life, which covers both product degradation profile and sterilization intigrity of product in the primary container.


Shahid Ali
Quality Control Manager
Hilton Pharma Pvt. Ltd, Pakistan
Cell: +92217771535

[quote=Shahnawaz]Dear Shahid,
Consideration of product stability or degradation product in sterilization hold time study is out of question because if the material is sterilzed then it should be free from any foriegn material (including product or their degradation products) so just perform bio burden study and establish max holding time of sterilized material.

thanks[/quote]

Material sterilization does not mean that material is also chemically stable or as long as the material is sterilized there will be no degradation. for example Mecobalamin Injection may have impurity hydroxycobalamine with sterilized product. so for the shelf life determination both chemical and bacteriological aspects need to be considered for a sterilized product.

Dear Shahid,

I think you didn’t get Yogesh’s question, He was trying to ask expiry of sterlized materials like sterlized parts, gowns, holding tanks etc, he was not asking the sterile product expiry (shelf life) obviously, so concern about degradation products ( like mecobalamin) is still out of question. So just perform bio burden studies and evaluate the maximum hold time of sterlized material.

My dear friend, It is my strongly advise that please please please, just perform terminally sterilzed those products or materials which are thermal inert and don’t try to do thermal sterlization of thermal labile products, because they may undergo change or breakdown.

Regards,

[quote=Shahid Ali]Quote:
Originally Posted by ster.yogesh
Dear Sir,
i want to know on which basis expiry of sterilized materials are to be decided.
& if we want to increase the expiry of such sterilized materials what will be the procedure to do so?

thanks & regards,
yogesh

If you are just thinking to enhance or improve the expiry from sterilization point of view then you should also consider the product own stability and degradation profile. All it is based on stability staudies to set a shelf life, which covers both product degradation profile and sterilization intigrity of product in the primary container.


Shahid Ali
Quality Control Manager
Hilton Pharma Pvt. Ltd, Pakistan
Cell: +92217771535

.

(Material sterilization does not mean that material is also chemically stable or as long as the material is sterilized there will be no degradation. for example Mecobalamin Injection may have impurity hydroxycobalamine with sterilized product. so for the shelf life determination both chemical and bacteriological aspects need to be considered for a sterilized product.[/quote])

[quote=Shahnawaz]Dear Shahid,

I think you didn’t get Yogesh’s question, He was trying to ask expiry of sterlized materials like sterlized parts, gowns, holding tanks etc, he was not asking the sterile product expiry (shelf life) obviously, so concern about degradation products ( like mecobalamin) is still out of question. So just perform bio burden studies and evaluate the maximum hold time of sterlized material.

My dear friend, It is my strongly advise that please please please, just perform terminally sterilzed those products or materials which are thermal inert and don’t try to do thermal sterlization of thermal labile products, because they may undergo change or breakdown.

Regards,

)[/quote]

Well! thats clear now for the sterilized material but i didnt get your advice (please please please, just perform terminally sterilzed those products or materials which are thermal inert and don’t try to do thermal sterlization of thermal labile products, because they may undergo change or breakdown.) this is in what regard? I mean no body commented to terminally sterilize the the thermolabile product, I dont mind if u want to advise something else which could make sense:)

As per your example of mecobalamin injection impurity may produced on terminal sterilization, one should be well aware that mecobalamin is a thermo liable material, it may afford heat treatment but not sterilized at 121.1 °C. That’s the reason why I advised that initially one should have the basic knowledge of chemistry of molecule regarding its sensitivity towards temperature, light and oxidation. I think mecobalamin example as stated above, somebody may mislead the example and may create wrong perception towards the audience

“Material sterilization does not mean that material is also chemically stable or as long as the material is sterilized there will be no degradation. for example Mecobalamin Injection may have impurity hydroxycobalamine with sterilized product. so for the shelf life determination both chemical and bacteriological aspects need to be considered for a sterilized product”.

This is all what I said in my previous post? Do you see any thing about mecobalamin product terminal sterilization or recommendation to do so? then why do you grasp a wrong perception? ok let me refresh you with the initial discussions I took Yogesh Q? wrongly but I m clear for that now so you had better clear youself for anything about terminal sterilisation, nobody even used the terminology in whole discussions.