Area classification is determined basis non viable particle count and ISO 14644, EU Annex-1 and FDA Guidance for Industry September 2004 has defined limits for area classification in non viable particle counts. EU Annex I and FDA guidance also defines limit for viable count as well, which should meet during monitoring
Please sir make video on following equipment Qualification . 1. Water Qualification 2.AHU 1.Autoclave 2.vial washing machine 3. Tunnel 4. Vial Filling machin 5.Lyophilizer in details.
Sir 01 question is that We have 10 operators in line but generally it is not possible to involve all 10 operators in assembling activity as it is completed within 3 or max 4 hous then how can we include all operators in assembling intervention. As may be possible that out of 10 operators any 01 can be required in future commercial production
It depends on how many media fill you are taking in a year. For example, if you are taking two media fills in a year, then try to simulate 5 operators in each media fill. Assembling takes around 2 hours so you can divide activities within operators so all 5 can do some activities in assembling. Remember, on the job training is important before operators goes for media fill so if operators are new, they can be trained by taking water trial or only assembling activity can be simulated to train operators. As per guidance, operators should participate in media fills periodically and once in a year participation is acceptable so two media fills per year sufficient to cover 10 operators. Also, each filling line is different and may have different interventions so unless you can compare both line as equal, you have to simulate operators for each line separately
Sir aap samjhati to shi ho par thoda jor se bola Karo👍
Nicely summarised. Thankyou
Great information sir
Sir can you explain why there is need to do non viable particular count if we are already doing viable particular count
Area classification is determined basis non viable particle count and ISO 14644, EU Annex-1 and FDA Guidance for Industry September 2004 has defined limits for area classification in non viable particle counts.
EU Annex I and FDA guidance also defines limit for viable count as well, which should meet during monitoring
Manitol bhi use karte hai
Great video in Hindi about Media Fill, Must watch
Sawal sir do you make video of OSD products.
I am not making any OSD video now but may make in future
Sir
SCDM or TSB me kya different hai
Ager dono ek hi hai to phir naam alag kyu hai??
hello sir hello sar commercial bich mein product mein growth aati hai batch ko fail Kiya kya mujhe iska answer
Simple way to know "Aseptic Process simulation"
Good sir
Thanks a Lot, kindly also share to your friends and groups and juniors 🎉
Please sir make video on following equipment Qualification .
1. Water Qualification
2.AHU
1.Autoclave
2.vial washing machine
3. Tunnel
4. Vial Filling machin
5.Lyophilizer in details.
Sir
01 question is that
We have 10 operators in line but generally it is not possible to involve all 10 operators in assembling activity as it is completed within 3 or max 4 hous then how can we include all operators in assembling intervention.
As may be possible that out of 10 operators any 01 can be required in future commercial production
It depends on how many media fill you are taking in a year. For example, if you are taking two media fills in a year, then try to simulate 5 operators in each media fill. Assembling takes around 2 hours so you can divide activities within operators so all 5 can do some activities in assembling.
Remember, on the job training is important before operators goes for media fill so if operators are new, they can be trained by taking water trial or only assembling activity can be simulated to train operators.
As per guidance, operators should participate in media fills periodically and once in a year participation is acceptable so two media fills per year sufficient to cover 10 operators.
Also, each filling line is different and may have different interventions so unless you can compare both line as equal, you have to simulate operators for each line separately
thanks sir for such great valuable information
Very knowledge and important information.
Please sir bring such content ..❤
Sir what is difference between septic filling and aseptic filling?
I have not heard word called septic filling. Aseptic filling means filling under Aseptic condition under grade A area
Excellent video on total understanding of Media Fill
Media autocalve wala lenge ya redade ata hai
Ya banaya hua media aata hai
ruclips.net/video/iyoh_dsNg0M/видео.htmlsi=efbIkEkchvKGmDGn
Watch my new video, answer hai isme
Thank you for information sir 👍🏻👍🏻👍🏻
Very grateful video Sir... thanks Sir Ji
Media ka dispensing kaha kar a hoaga
Sterile working person must watch vedio
Thank you so much Dhaval sir
I hope you will continue make this type of sterile content
Thank you so much 🙏
Thanks
Can you help me by sharing the video to all your friends and groups and juniors please
Sure sir
Ap sir micro department pe sare video banaiye sir
Very informative vedio
Waiting for next vedio
Sir, thank you, aap ka explanation ka tarikaah bohot badiya hai.. media fill concept clear kar diya aap ne. Thanks so much brother.
Thanks
Please share to more PHARMA friends
Simply awesome video 😎 Every small details also covered and explained well. Thank you for posting such type of content sir
So nice of you
Nicely explained and very informative
Thanks a Lot, kindly also share to your friends and groups and juniors 🎉
Sir what if media fill fails during commercial operations. Please provide the clarity
Needs investigation, if product sterility impact, then may go up to recall of impacted products
Very good presentation,important content
Thankyou sir itni jankari ke liye
Thank you sir ji 🙏💐
Very nice sir learned a lot today
Nice presentation sir
Very nice information sir
Sir Excellent video
Part by part karek video baniye
Sir why we use 3%SCDM in media fill???
I have prepared a video on this topic, please see in my channel
🙏🙏
👍
Plz make a video in autoclave process and validation ❤❤❤❤❤
Voice is not clear properly some videos but overall good
I will take care and improve 👍🙏
Sir pls make video in Area qualification
Media kitna parcecenateage banana hoga sir ispe video banaiye
Dhs validation sterilization pe video banaye
Sir ispe aur video baniye field media ko kitne temprature par
Scdm media ka dispensing bhi karna hota hai sir
Sir pls explain in english. .
There are 4 videos on this topic in English on my channel
I'm very impressed 👏 someone explaining this topics in hindi language ...keep it up sir
Nice Explanation..sir
Thanks a Lot, kindly also share to your friends and groups and juniors 🎉
Nice information sir
Thanks a Lot, kindly also share to your friends and groups and juniors 🎉
Really very nice video sir
Very helpful 😊👍
Welcome
aap to pharma ke guru ho
Thanks But mai bahot chhota aadmi hu
Just trying to share what I know
Thank you sir
Very useful
Thanks sir
Thanks!
Kitna parsent media use hota hai
3%
thank you doctor for your education videos , please can you make video by english too.I am watching you from abroad
There is a playlist in English on Media Fill videos
ruclips.net/p/PLl7d_zif-t9NcVlqEXSXnrHI703g3DC_Z