Media fill hold time study

Dear All,

How we can validate media hold time study?or we need to conduct with product itself!!


Choose the maximum batch size of product and note down the process completion time and validate this time with media fill hold.

Thanks Mr. Manoj
Regarding Unfiltered media or unfiltered product how will you conduct hold time study.

Also could you explain what should be the maximum allowable time for bulk media for filteration and how we should conduct it?!! Bioburden levels?! any reference and guideline…

are you using non sterile media or product?

Yes, basically for eyedrops as aseptic filteration technique…

Eye drop is sterile product so why u r asking about unfiltered product? Do you not filter the solution for eye drop? what method are you using for sterilization of solution for eye drop?

Media fill validation is not required for non sterile product.

I m awaiting your reply

Dear Mr. Manoj,

Yes eye drops are sterile product,
Method: Asceptic filteration.(0.2micron)- 2 filters in series
Bulk product is transfered to storage vessel from manufacturing vessel through motor pump.

for example, if you have not yet filtered the Bulk solution and you have encountered, some un avoidable delay/problem i.e any maintenance work or any major breakdown in filling machine after manufacturing of eye drops, then upto how much time period we can keep this manufactured unfiltered Bulk?.How to develop this hold time study same as liquid or?

For filtered product ok we can say that, maximum allowable time is —same as media fill filling.


Hold time of different product may be perform hold time study of each product during process validation.take the sample of bulk solution at different interval and check bioburden.


You can consider maximum hold time of product for media fill.

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Thank you,

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