Guidance says volume should be sufficient to contact all parts of container and should also provide enough headspace. To comply, we should fill at least half of the container. For small containers like 2 ml, you may have to go like 1.5 ml to have enough headspace oxygen
Sir what about microbial plate exposure in preparation vessel area , holding vessel area and filling machine area should be done before line clearance or after line clearance from QA ? Is there is any guidance for the same ?
Preparation area will be Grade C, Filtration area will be Grade B (if no isolators) and filling area is Grade A Plate exposure will be as per SOP For Grade B and C it will be after QA clearance if SOP says so but no guidance requirement for it, Guidance will say only to monitor For Grade A it will be continuous once you start your assembling, but in some companies they start once they take QA line clearance but again there is no guidance requirement for QA clearance
Then it's Good that you know exact reason but have to understand that why post integrity failed and what needs to be done to prevent it. It can be ensuring filter housing intact or not, gasket damage, How it was handled after pre integrity, What might have gone wrong etc
Hello sir, suppose i have taken 15000 ampoules as my batch size, how do i justify my batch size, like why have i selected 15000 ampoules for media fill validation. Thank you.
You don’t need justification when you take more than 10000 Acceptance criteria remains same for more than 10000 Your media fill protocol should have all simulations related to actual production
Sir, can you please make a video on this same topics based on EU guideline?
EU Annex 1 says zero contamination in media fill batch sizes
How to ఫిక్స్ fill volume? Half of the container? Or how much.
Guidance says volume should be sufficient to contact all parts of container and should also provide enough headspace. To comply, we should fill at least half of the container. For small containers like 2 ml, you may have to go like 1.5 ml to have enough headspace oxygen
Sir what about microbial plate exposure in preparation vessel area , holding vessel area and filling machine area should be done before line clearance or after line clearance from QA ? Is there is any guidance for the same ?
Preparation area will be Grade C, Filtration area will be Grade B (if no isolators) and filling area is Grade A
Plate exposure will be as per SOP
For Grade B and C it will be after QA clearance if SOP says so but no guidance requirement for it, Guidance will say only to monitor
For Grade A it will be continuous once you start your assembling, but in some companies they start once they take QA line clearance but again there is no guidance requirement for QA clearance
@@PHARMAVEN but what are the technical point that decide the above
Sir what if media fill fail during filling due to filter integrity? Pre integrity was pas during filling it's damage.
Then it's Good that you know exact reason but have to understand that why post integrity failed and what needs to be done to prevent it.
It can be ensuring filter housing intact or not, gasket damage, How it was handled after pre integrity, What might have gone wrong etc
Hello sir, suppose i have taken 15000 ampoules as my batch size, how do i justify my batch size, like why have i selected 15000 ampoules for media fill validation. Thank you.
You don’t need justification when you take more than 10000
Acceptance criteria remains same for more than 10000
Your media fill protocol should have all simulations related to actual production