Injections are prepared under sterile conditions. Injections/ampoules need to be prepared with humidity held in the range of 45% and sterile ampoule powders at 35% RH or lower.
Processing of Dry Injection (RH / Temp Required - 15 + 5% at 21°C)
A tyipcal flow diagram of Dry Injection
Container Preparation --> Vial Washing --> Sterization --> Filling (Tunnel/DHS) --> Sealing --> Inspection --> Packing
The most critical operation in the above process is Filling & Sealing. The filling operation requires conveying of powder and filling the vials with the required amount precisely. The filling operation requires conveying of precisely. The powder must be free flowing and should be dry enough to avoid any lump formation or stickiness.