Media fill or Aseptic process simulation in Pharmaceutical industry l Interview Questions

Media fill or Aseptic process simulation in Pharmaceutical industry l Interview Questions
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1. QMS - Quality Management System in Pharmaceutical industry : • QMS - Quality Manageme...
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3. QC - Quality Control in Pharmaceutical industry : • QC - Quality Control i...
4. OSD - Tablet Manufacturing in Pharmaceutical industry : • OSD - Tablet Manufactu...
5. Injectable processing - Injectable processing or Sterile dosage formulation : • Injectable processing ...
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Questions covered:
Q.1 :What is Media fill ?
Q.2: What is frequency for media fill ?
Q.3: What is purpose of media fill? Or Why media fill is done ?
Q.4: What are the important guidelines used for media fill ?
Q.5: Which media is used for aseptic process simulation ?
Q.6: Why SCDM is used as media in media fill ?
Q.7: Which processes should be covered during media fill ?
Q.8: What is intervention and what are the types of interventions ?
Q.9: What is Population 1 and Population 2 ?
Q.10: For which dosage forms media fill is applicable ?
Q.11: What are the pre-requisites for media fill?
Q.12: What should be the start point and end point of media fill consideration?
Q.13: What should be the duration of media fill ?
Q.14: What is incubation period for media fill vials / bottles ?
Q.15: Why nitrogen is not used in aseptic process simulation ?
Q.16: Media fill is required for terminally sterilized vials or not?
Q.17: What should be the filling speed consideration during media fill?
Q.18: What should be the fill volume consideration during media fill?
Q.19: What should be the leak testing consideration during media fill?
Q.20: How visual inspection of media filled units is done prior to incubation?
Q.21: What are the growth promotion test requirements for media fill units?
Q.22: What should be the acceptance criteria for media fill ?
Q.23: How container closure integrity is performed for media fill units ?
Q.24: Can we abort media fill run ?
Q.25: What are the requirements for media fill recording and review ?
Q.26: What is the destruction procedure for media fill units ?
Q.27: Can we justify the Pass media fill batch with Grade A EM excursion for Batch release?
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Key words to find this video:
media fill trials,media fill guidelines,media run,media simulation,sterile process validation,validation of aseptic processing,media fill,media trials,media fill study,media fill simulation,media fill interventions,aseptic process simulation,aseptic process validation
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[@ap14spt]

Good one

[@PharmGrow]

Thanks

[@shubukaundal1303]

Very good sir ...

[@PharmGrow]

Thanks

[@ranjeetnagarkoti3274]

🙏nice.please expalin about sterility method validation.

[@PharmGrow]

Ok i will post video on this topic very soon.

[@miaburns19333]

👏🏾👏🏾

[@PharmGrow]

Thanks

[@rangarao3828]

Nice

[@PharmGrow]

Thank you

[@jarvish4902]

Thank u sooo much

[@PharmGrow]

Thanks for comment

[@anandjio9093]

Tqq bro

[@sreedevitv86]

Very good

[@PharmGrow]

Thanks

[@nishkarsh8422]

EU GMP ANNEX 1 revised as on 2023 September

[@PharmGrow]

Thanks for update
I have preapared dedicated video on it.

[@kailaskale4333]

Media fill required for nasal ?

[@PharmGrow]

Yes if you claiming it sterile.

[@krishnadesai6953]

Sir for dry powder injection....please share the detail.

[@PharmGrow]

Ok i will prepare.

[@pharmaindustry9399]

sir my question is that when media is batch filling then we take media after 6 months then sir my question is that we take 2 ml, 5 ml, 20 ml, 50 vial If we take then sir, why can't we fill the media in only 2 stools, why do we heal again and again?

[@PharmGrow]

Friend, stool terminology is new for me. Please ask in different words. I will answer

[@vishnuvardhan8889]

Please tell me media PH

[@PharmGrow]

not less than 5.5 and not more than 7.7.Target pH commonly kept at 7 +/- 0.2

[@anuragchaturvedi2208]

4.2

[@DharmendraKumar-sw6yv]

Sir Hindi me bataye to achha hoga kuchh logo ke liye

[@PharmGrow]

Ok

[@krishnadesai6953]

Yes....hindi better.