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Question added by Deleted user
7 years ago

How would you validate the cleaning process after producing Anthrax in a fermenter if you plan to follow it with a non spore forming product?‎

This scenario is where only one batch is produced in two to three years and building a separate facility as per GMP guidelines is not financially viable.‎

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Answer added by  Muntakhib khatib , Executive , Biocon
9 years ago

Yes i agree with the concept. Because when harmless antigen is administered into human body, antibody produces against that particular antigenic structure. In the process ... See More

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Answer added by  Shawal Hameed
6 years ago

First of all we need to define validation for cleaning process. that is nothing but ask yourself Are we performing right clenaing process? Now we need to identify the obj ... See More

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Answer added by  Mohamed Elhibishy, QA Manager, Pioneer Co. For Pharmaceuitical Industry
6 years ago

This really hard Question , for my self , I did not work in biotechnology field but if you need brainstorming , We need to agree at first that m.o not like chemicals , no ... See More