Sterile Injectable Manufacturing Process ( Part 2)

[@achyutjagdhane9683]

dear palash , very good clarity on subject , good luck for your journey

[@jirensama1622]

Also in the previous video you mentioned that cleaning of primary packaging materials such as vials is happened in the grade D area whereas now you're saying it's happening in the Grade C area? Can you confirm where it happens?

[@cGMP]

Grade C area will be appropriate for Vial washing.

[@mdimranhossain9495]

Sir, will you please answer my below question. Why ampoule products require sterilization and vial products for depyrogenation. Can we use depyrogenation tunnel for ampoule product

[@cGMP]

Yes, depyrogenation tunnel can be used for Vial and Ampoule both in case of aseptic manufacturing process.

[@mdimranhossain9495]

@@cGMP what is the differences between aseptic & sterile process.

[@jirensama1622]

I just wanted to know - Filteration of the Drug product which is in the holding vessel is happening in the Grade C area with Laminar air flow Grade A? - Terminal sterilization And filteration and sterilization of Drug product which is in the holding vessel is happening in the Grade B area with Grade A laminar air flow - Asceptic sterilization Is this correct?

[@cGMP]

Yes, Grade C under laminar air flow is appropriate for product produce in Terminal Sterilisation facility