Closed, sterile, aparogenic set, made of plastic, providing a controlled, closed flow system between containers. The kit must bear the CE marking.
The set complies with Annex 1 to IWPS.46.5.2022.MPIA- Requirements and guidelines for containers used in the plasma production process for fractionation of the Chief Pharmaceutical Inspectorate.
The Ordering Party allows containers in which, shortly after the end of the production process, there are single drops of liquid that is a remnant of sterilization.
Quadruple containers up-down for collection and preparation of blood with in-line filter for KKCz