Do we need to perform media hold time study (to simulate the actual production).
Suppose i am having 7 days hold time of the product. Do we need to simulate the same during media fill by keeping the prepared media for 7 days.
Regards
Anup Sharma
Yes, you must prove that the sterile substances that are stored in those containers or vessels will be intact for the specified number of days.
In vaccine manufacturing the vessels will have the blended vaccine or some times only the attenuated or toxin which is sterilised will be held for 14 days.In such casses they will perform this study with SCD medium.
[quote=anup_s82]Do we need to perform media hold time study (to simulate the actual production).
Suppose i am having 7 days hold time of the product. Do we need to simulate the same during media fill by keeping the prepared media for 7 days.
Regards
Anup Sharma[/quote]
Dear Anup,
Media hold time & product hold time are separate studies. Product hold time studies are conducted on Product not on media. In this study all the critical parameters like assay, sterility etc (As per product specification) are considered during study. Objective of media hold time during media fill is to establish the hold time period of Equipment after Sterilization.
Regards,
Avinash Tomer
[quote=avinash]Dear Anup,
Media hold time & product hold time are separate studies. Product hold time studies are conducted on Product not on media. In this study all the critical parameters like assay, sterility etc (As per product specification) are considered during study. Objective of media hold time during media fill is to establish the hold time period of Equipment after Sterilization.
Regards,
Avinash Tomer[/quote]
Dear Avinash,
I am not agree with you, you have to validate hold time for media as hold time of product in manufacturing process. This will prove that your product remains sterile after holding it for such time as suggested by Durga Sir. Assay, impurities & other product specification these are product based for that you have to perform process validation. In Product process validation you are able to prove your products remains stable after keeping such time after manufacturing prior to filling. In media fill you have to simulate all possible intervention thay may contaiminate your product. Mr. Anup you have to follow what Durga Sir suggested, for a succesful Media Fill.
Why you carry a Media Fill Validation?
This process ensures that the whole line of unit operations or sub process or subsystems or the chain of activities are properly sterilized and this whole good during the enitre process.
Why one must carry out a Hold time study?
During the processes it is necessary to hold sterile Drug substances(drug substances are those prior to formulation) and or Drug products( those are formulated and ready for fill operation) for various reasons like a campaign production or intermittent storage or they hold vaccines so that antigen binds the adjuvant properly when incubated at a prticular temperature or when there is a sudden repair or error in sterilization process.
You cannot prove always with your Drug substance or Drug product as it is expensive to prove. If any one of these two fail its an expense for organization for reprocessing or throwing out that product as waste with waste management procedures.
In such events when its is required the regulators always guided the organization to take a proper media that can be sterilized by required methods and stored in the containers used to store Drug substance or Drug product longer times with out losing its Sterility. This process gives the Sterility assurance in two way. It proves sterility and also it proves that in the process there are no slow growing species like spore form which normally show up after 6 or 7 days. The media used generally selected to support most of the vegitative forms and also spore which traditionally grow when proper environment comes into play.
Regards