ua-cam.com/video/YCxFlIVvJFQ/v-deo.html How To Develop Terminal Sterilization Cycle? Why Air Removal not required in Terminal Sterilization? Why Vacuum not required in Terminal Sterilization? What is D Value? What is F0 Value based Sterilization Cycle?
After filling and sealing, the product is basically finished product and doesn't need to store in classified area. For terminal stabilizer, CNC (Controlled Non Classified) area is acceptable
European guide: Guideline on the Sterilisation of the medicinal product, active substance, excipient and primary container USFDA: Guidance for Industry Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized By Moist Heat Process
If i use over kill approach of 8log reduction why i consider 121/10min cycle not a Sterilization cycle.and what is the minimum time parameters if I need to change for higher temperature as 134.knowing that f0 is12.... thanks.
Overkill depends upon D value of product, for example if D value is 1, then 121 degree C at 10 minutes will give 10 log reduction, Overkill means 12 log reduction.
Nice lecture sir
ua-cam.com/video/YCxFlIVvJFQ/v-deo.html
How To Develop Terminal Sterilization Cycle?
Why Air Removal not required in Terminal Sterilization?
Why Vacuum not required in Terminal Sterilization?
What is D Value?
What is F0 Value based Sterilization Cycle?
Many many thanks Sir for teaching , gratitude 🙏
Nice video
Many thanks sir
Thank You For Your Appreciation, Kindly also share to your friends and groups and juniors 🎉🙏👍
Useful
Very nice sir
Sir could you please explain about the ventilator cycle in brief please
Sir hindi me sabhi video bano
Hindi me bhi bana do ek video
Which guidelines refer terminal sterilization.???
How to detrmine fo value using bacilus subtilus at 108 degree for 60 min
Nice,My question,what’s area is required for terminal sterilizer,is non class area okay? Please give answers with reference
After filling and sealing, the product is basically finished product and doesn't need to store in classified area. For terminal stabilizer, CNC (Controlled Non Classified) area is acceptable
F0 value development?
How vials are kept inverted or upright during ts
Upright only during terminal Sterilization
Which guidelines is for terminal sterilization please reply
European guide: Guideline on the Sterilisation of the medicinal product, active substance, excipient and primary container
USFDA: Guidance for Industry Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized By Moist Heat Process
Thanks sir
Temperature mapping required in what size containers?
100 ml and above
If i use over kill approach of 8log reduction why i consider 121/10min cycle not a Sterilization cycle.and what is the minimum time parameters if I need to change for higher temperature as 134.knowing that f0 is12.... thanks.
Overkill depends upon D value of product, for example if D value is 1, then 121 degree C at 10 minutes will give 10 log reduction, Overkill means 12 log reduction.
Who will fix F0 value sir.
Nice video