Aseptic Practices, Media Fill and Sterility Assurance

[@sonic3823]

when he open his mouth,I realize he is an india ,SO GOOD.thank you I learn a lot

[@hitendrakumarshah3718]

Keep Learning !!!

[@sanjay05ish]

Very nice sir

[@hitendrakumarshah3718]

Thanks. Please Keep learning !!!

[@hemantsuryawanshi422]

Real quality content and presentation.
Thank u sir.

[@hitendrakumarshah3718]

Welcome. Please keep learning !!!

[@futurol4177]

Good Training program

[@hitendrakumarshah3718]

Yes

[@AjayKumar-eo6em]

Good lesson.
Please make a lesson on technology transfer of injectable dosage form.

[@hitendrakumarshah3718]

You can go through the recorded session as per link below, ua-cam.com/video/VnnNR1n27kg/v-deo.html

[@AjayKumar-eo6em]

@@hitendrakumarshah3718 I asked for injectable dosage form.

[@rajaramgurung3117]

Please guide us the required basics understanding on Aseptic Practices, Media Fill, Sterility Assurance and SAL value calculation that involve terminal sterilization (Moist heat and EO gas) for medical devices manufacturing.

[@hitendrakumarshah3718]

Sure. We will have separate videos on these topics

[@jankeemistri9054]

Can we use sodium chloride to simulate manufacturing activity for liquid injectable media fill?

[@hitendrakumarshah3718]

I suggest we should not use it. You need to you media supporting growth of microbes.

[@sreedevitv86]

Video required for Autoclave validation

[@hitendrakumarshah3718]

Sure

[@ashishjain412]

Very nicely explained

[@hitendrakumarshah3718]

Thank you so much for your kind comment. Please Keep Learning !!!

[@77santosh1977]

Sir Nicely , Explained.. Great Sir

[@hitendrakumarshah3718]

Thank you

[@77santosh1977]

Great Sir, Nicely explained..

[@hitendrakumarshah3718]

Thank you so much for your kind comments

[@atulsonawane678]

Dear very impressive performance

[@hitendrakumarshah3718]

Thank you dear

[@devanggondaleeya4321]

In one ppt I read that " It is better to validate the integrated line by Media Fill test" here what is the meaning of integrated line ?

[@hitendrakumarshah3718]

Media fill can be done in complete line. and not just filling machine.

[@ramu4138]

Dear Mr Shah, Kindly help me understand through schematic diagrams of usage of 0.22 & 0.45 micron cartridge filters in parentals, injectables and pharma industries

[@hitendrakumarshah3718]

Sure. Will prepare separate video

[@manishgupta3996]

In the upstream you use 0.45 micron filter and in downstream 0.22 micron.

[@ainars1205]

I have one question. If media fill simulation test requires fill 5000 units, does it means that after filling we need to test each unit for sterility according to pharmacopoeia sterile test? 5000 tests for sterility?

[@hitendrakumarshah3718]

You need to incubate and check for growth

[@shahadathossain2509]

All the sample will be incubated for certain period and test will performed by visual inspection

[@ainars1205]

@@shahadathossain2509 It's clear. But if there are used PE white not transparent bottles like for eye drops. How then is possible to perform visual checking?

[@ainars1205]

@@shahadathossain2509 Any comment about not transparent bottles?

[@ainars1205]

@@shahadathossain2509 What about visual inspection for not transparent bottles?

[@pandurangvaidya6576]

Sir pls detils about APQR and Cpv

[@hitendrakumarshah3718]

Thank you for your comment. Will definitely consider this subject.

[@niharranjan157]

Excellent

[@hitendrakumarshah3718]

Thank you

[@jaypalrajput9966]

Sir please thoroughly explain process simulation

[@elayarajav8273]

Useful

[@hitendrakumarshah3718]

Thank you

[@lingarajubannimarad1696]

Good information

[@hitendrakumarshah3718]

Thank you so much for your kind comments

[@77santosh1977]

Sir Nicely , Explained.. Great Sir

[@hitendrakumarshah3718]

Thank you so much for your kind comments