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Worst case in cleaning validation

Dir sir,
I have an manufactory echipment (drier - granulator) - CIP in for cleaning validation , I want to now an example of worst case in cleaning validation for this manufactory echipment used for vegetal finish products.
For WORST CASE what factors we shuld be take in consideration?
THANKS VERY MUCH!

[quote=MMBACIU]Dir sir,
I have an manufactory echipment (drier - granulator) - CIP in for cleaning validation , I want to now an example of worst case in cleaning validation for this manufactory echipment used for vegetal finish products.
For WORST CASE what factors we shuld be take in consideration?
THANKS VERY MUCH![/quote]

Dear MMBACIU,
in order to evaluate your cleaning process you must first select your worst case product among the products that are involved in the specific production line that the cleaning process refers to.

The selection of the worst case product is based on:
a)API’s solubility of the worst case product (the less soluble the API the more the chances to have traces of the API after the implementation of the cleaning process.
b) Concentration of the API
c) Potency/toxicity (the higher the LD50 of the API the more the chances for selection as worst case product)
d) Excipients solubility - Experience of difficulties in cleaning

Hope this helps.

Feel free to ask if any further questions.

Best regards,

[quote=Gigastorm]Dear MMBACIU,
in order to evaluate your cleaning process you must first select your worst case product among the products that are involved in the specific production line that the cleaning process refers to.

The selection of the worst case product is based on:
a)API’s solubility of the worst case product (the less soluble the API the more the chances to have traces of the API after the implementation of the cleaning process.
b) Concentration of the API
c) Potency/toxicity (the higher the LD50 of the API the more the chances for selection as worst case product)
d) Excipients solubility - Experience of difficulties in cleaning

Hope this helps.

Feel free to ask if any further questions.

Best regards,[/quote]

Dear Gigastorm
thank very much for you repons and promptitude.
Y have other ask because I have an difficult problem too chose the worst case, in this situation for: a) API and excipients solubility is very soluble in solvent(wather)
c) I don’t have the product with toxixity higher the L50
b) The concentration of the API is MAC? Maximum Allowable Carry-Over (MAC)

MY SITUATION IS:
I have for cleaning process determineed duration the 45 minutes, and behain it rested traces visibles of residuu, and i have carry on cleaning process 15 minutes, and it not rested reaces visibles of residuu.
MY ASK IS:
May I have select an worst case a cleaning process the 45 minutes( the minimal time to cleaning)?
And may I alter the time duration of cleaning process, and demostrate it is an worst case?

Apology for my english!

Thank you,

Best regards

[quote=MMBACIU]Dear Gigastorm
thank very much for you repons and promptitude.
Y have other ask because I have an difficult problem too chose the worst case, in this situation for: a) API and excipients solubility is very soluble in solvent(wather)
c) I don’t have the product with toxixity higher the L50
b) The concentration of the API is MAC? Maximum Allowable Carry-Over (MAC)

MY SITUATION IS:
I have for cleaning process determineed duration the 45 minutes, and behain it rested traces visibles of residuu, and i have carry on cleaning process 15 minutes, and it not rested reaces visibles of residuu.
MY ASK IS:
May I have select an worst case a cleaning process the 45 minutes( the minimal time to cleaning)?
And may I alter the time duration of cleaning process, and demostrate it is an worst case?

Apology for my english!

Thank you,

Best regards[/quote]

If all your paramaters to choose the worst case product are similar for the whole group of products involved in the under evaluation cleaning process of the line then YES DEFINATELY the API concentration plays its role in choosing.

It is difficult for me to understand the rest of your question. What I would like to note is that for one thing you are not changing at all your cleaning process duration as this is your base line to evaluate.
Moreover, in order for you to decide the worst case product you can justify by experience the most difficult to clean among all your very soluble products in the line.

I am sorry, I could not understand very well the second part of your question.

Hope this helps.

Best regards,

[quote=Gigastorm]If all your paramaters to choose the worst case product are similar for the whole group of products involved in the under evaluation cleaning process of the line then YES DEFINATELY the API concentration plays its role in choosing.

It is difficult for me to understand the rest of your question. What I would like to note is that for one thing you are not changing at all your cleaning process duration as this is your base line to evaluate.
Moreover, in order for you to decide the worst case product you can justify by experience the most difficult to clean among all your very soluble products in the line.

I am sorry, I could not understand very well the second part of your question.

Hope this helps.

Best regards,[/quote]

I try to explaine my situasion again:
My echipment have an minimal numer of cycles to rince (CIP ) realisable in minimal period of time ( 45 minutes). But the operatores of process have extention this periode of time at 60 minutes for safety.
Questions:
may i consider an situatin the worst case DURATION OF CLEANING PROCESS OF ECHIPMENT?

Best regards,

[quote=MMBACIU]I try to explaine my situasion again:
My echipment have an minimal numer of cycles to rince (CIP ) realisable in minimal period of time ( 45 minutes). But the operatores of process have extention this periode of time at 60 minutes for safety.
Questions:
may i consider an situatin the worst case DURATION OF CLEANING PROCESS OF ECHIPMENT?

Best regards,[/quote]

Dear,
If you evaluate the 60 min duration that you are performing then you are ok. However, if in the future someone decides that this is time consuming and he would like to perform it at 45 min duration then you will be asked to evaluate again.

If now you perform your validation at 45 min you can easily prepare a rational where you will justify the expected theory that since the CIP at 45 is acceptable it will definately be successful for 60 min duration (without providing any data appart probably some bio results at 60 min duration and some TOC tests).

Best regards,

[quote=Gigastorm]Dear MMBACIU,
in order to evaluate your cleaning process you must first select your worst case product among the products that are involved in the specific production line that the cleaning process refers to.

The selection of the worst case product is based on:
a)API’s solubility of the worst case product (the less soluble the API the more the chances to have traces of the API after the implementation of the cleaning process.
b) Concentration of the API
c) Potency/toxicity (the higher the LD50 of the API the more the chances for selection as worst case product)
d) Excipients solubility - Experience of difficulties in cleaning

Hope this helps.

Feel free to ask if any further questions.

Best regards,[/quote]

[quote=Gigastorm]Dear,
If you evaluate the 60 min duration that you are performing then you are ok. However, if in the future someone decides that this is time consuming and he would like to perform it at 45 min duration then you will be asked to evaluate again.

If now you perform your validation at 45 min you can easily prepare a rational where you will justify the expected theory that since the CIP at 45 is acceptable it will definately be successful for 60 min duration (without providing any data appart probably some bio results at 60 min duration and some TOC tests).

Best regards,[/quote]

Thank you very much,
My question is if I may choise this situation for an WORST CASE?
If you select the worst case product based on concentration of the API, what is meens: un active more concentred in a API to compare another API? OR the limit in subsequent product to large based to daily dose of active product?
Best regards