Manufacturing of sterile parenteral products
A sterile preparation section usually consists of one or more compounding vessels where the solution is prepared, a filtration line where the prepared solution is filtered through 22 µm filters to ensure the sterility of the output liquid, and a storage or receiving vessel, where the aseptically filtered liquid is stored for further filling in ampoules, vials or syringes.
TRAC has designed and developed several automation systems for preparation lines. The least complex system consisted of one mixing vessel, filter line, and receiving vessel. In contrast, the most complex system consisted of 6 mixing vessels, 8 filtering lines, 5 receiving vessels, 3 special aseptic units, and 2 auxiliary vessels.