Process for sterilizing and transferring a solution

Claim 1

A process for sterilizing a solution and thereafter transferring it to a solution container for storage, which comprises the steps of: providing at least one solution container having an inlet; providing a sterilizing filter capable of sterilizing a solution and having a maximum pore size of about 0.22 micron, said filter having an outlet; providing flexible tubing connected to the inlet of said solution container and to the outlet of the sterilizing filter, to provide a fluid path between the filter and the solution container; providing said sterilizing filter, flexible tubing and container as a pre-sterilized unit with a label indicating that said unit is sterile; connecting a source of solution to be transferred to an inlet of said sterilizing filter; sterilizing the solution by transferring it from the source, through the sterilizing filter and to the container via said flexible tubing; determining whether the integrity of the filter, and consequently the sterility of the unit, has been maintained during the transfer process, said determining step comprising the steps of introducing a pressurized gas into the filter and observing through a light-transmissive portion in the sterile unit for gas bubbles, which would indicate a loss of filter integrity and unit sterility.