Qualification approach of depyrogenation tunnel used in sterile injectable facilities
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- Опубликовано: 1 июл 2024
- Qualification approach of depyrogenation tunnel used in sterile injectable facilities
This Video Presented By:
Palash Chandra Das, M.Pharm (Pharmaceutical Chemistry)
Articles link,
COOL ZONE STERILIZING IN DEPYROGENATION TUNNEL: www.slideshare.net/PalashDas1...
About Myself:
I have completed my B.Pharm and M.Pharm in Pharmaceutical medicinal chemistry from WBUT. In the year 2010, I started my journey in the Pharmaceutical Industry. In my career I worked with the F & D, Production and Quality Assurance department etc. I have a good exposure in several Sterile Green field and Brown field projects. Involved in various regulatory audit like CDSCO, WHO, USFDA,TGA,MHRA, GERMAN, UKRAINE, ANVISA-Brazil, INVIMA-Colombia, RUSSIA, IRAN, PMDA-Japan, South Korea etc.
Core Technical Skill:
Sterile Injectable dosages form (SVP and LVP ) with liquid and lyophilized form
Qualification & Validation , Computer System Validation, Sterility Assurance, Quality Management System, Risk Management, cGMP training, Failure Investigation , Auditing
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Share your queries and concern at mail2uscgmp@gmail.com Наука
Very informative..... well explained.....
Very useful information you are sharing 👌🏻👌🏻👌🏻
Informative video
Great work done. Thanks for the presentation 👍
Nicely demonstrated Mr. Palash. Hope you have delivered, all basic elements of Depyrogenation tunnel qualification/Validation. Thank you. Keep going 👍
Thanks
Mr Palash for such a informative video.
Very nice presentation sir
Very much useful
Sir thanks for video to better understand
Sir can give the deep knowledge in tunnel
Great!! It is very useful.
thank you sir...when will come your next vedio
Thanks
As high pressure will be there in infeed zone of filling machine? Possible for air turbulence?
Sir tunnel validation par bhi vedio bano
Is that air from hot zone can go to cool zone? Possibility for Contamination?
Very nice presentation sir, which guidence is telling z value 46.4 and is there any d value for endotoxin
PDA TR-3
Please tell about Fh value limit for depyrogenation at 320
Tunnel me kya kabhi blast ho sakta he kya???
What reason behind maintain 300 degrees only.
Check my video ruclips.net/video/TGTWu-CRg3E/видео.html
Which is temperature controlling sensor
Individual zone (preheating, hot and cool zone) having independent temperature controls.
Sir Hindi Mai samjha do