In case that the HEPA FILTER in sterilization zone has leak and replaced. So repeat tests for filter only without repeating thermal study or we should repeat all validation
Correct answer. 👍. There are some filters which works on affinity principle or selective chemical binding principle which can separate out endotoxins e.g. Sartobind-Q / Mustang Q filter.
Do we need to monitor particle count monitoring of tunnel for every batch? Or it is only required during routine qualification of the tunnel? Please share the reference also.
Particle count monitoring in depyrogenation tunnels is typically required during routine qualification (e.g., during performance qualification) and not for every batch. For ongoing operations, compliance with established environmental monitoring programs suffices; refer to ISO 14644-1 and regulatory guidelines for specifics.
To disinfect and sanitize the cooling area of a depyrogenation tunnel, use a validated disinfectant compatible with the equipment material, applied through wiping or spraying, followed by wiping with sterile water for injection (WFI) if needed. Ensure the area is allowed to dry completely before operation.
Not clear what exactly you want say. 3 log reduction can be achieved from initial concentration of 10000 EU/vial, 100000 EU/ vial or any other number. 3 log reduction is not only 1000 EU/Vial. definately we can prefer this number for practical feasibility.
Your explanation is so professional and precise.
Thanks for helping me to understand Depyrogenation.
Thank you
Nice sir good information 👍👌
Sir plz depyrogenation tunnel ki fh value calculation ki video bnao na
Ok i will prepare
In case that the HEPA FILTER in sterilization zone has leak and replaced. So repeat tests for filter only without repeating thermal study or we should repeat all validation
Helpful ❤
Thanks
Good information
Thanks 👍
Size of Endotoxins/Pyogens are 0.1 to 0.2ng which can pass through 0.2micron filter so cannot able to remove by filtration process
Correct answer. 👍. There are some filters which works on affinity principle or selective chemical binding principle which can separate out endotoxins e.g. Sartobind-Q / Mustang Q filter.
Because endotoxins limit in usp not more than 0.25 EU/ML then
Noted
Please make vedio
Isolator VHP biodeconatmination cycle
It is already uploaded. Visit injectable playlist in channel and search for Isolator part -1 and part 2.
Do we need to monitor particle count monitoring of tunnel for every batch? Or it is only required during routine qualification of the tunnel? Please share the reference also.
Particle count monitoring in depyrogenation tunnels is typically required during routine qualification (e.g., during performance qualification) and not for every batch. For ongoing operations, compliance with established environmental monitoring programs suffices; refer to ISO 14644-1 and regulatory guidelines for specifics.
how we disinfact and sanitizing cooling area in depyrogenation tunnel ?
To disinfect and sanitize the cooling area of a depyrogenation tunnel, use a validated disinfectant compatible with the equipment material, applied through wiping or spraying, followed by wiping with sterile water for injection (WFI) if needed. Ensure the area is allowed to dry completely before operation.
Brother endotoxins indicator used only for 3 log reduction, 3 log reduction mins 1000 EU/vial
Not clear what exactly you want say. 3 log reduction can be achieved from initial concentration of 10000 EU/vial, 100000 EU/ vial or any other number. 3 log reduction is not only 1000 EU/Vial. definately we can prefer this number for practical feasibility.
Please what's FPM?
Feet per minute