| 摘要 |
<p>PROCESS AND APPARATUS FOR TRANSFERRING AND STERILIZING A SOLUTION A process and apparatus for the transfer of a parenteral solution into an extensible plastic bag and the sterilization of that solution during such transfer. The apparatus include a hydrophilic, bacterial organism retentive, sterilizing filter, such a bag, and tubing connecting same, which have been combined and sterilized as a unit, which unit is labeled for sale as being sterile. A container holding the solution to be transferred and tubing associated therewith are provided for delivery of the solution to the sterile unit. A vacuum chamber is also provided by which the solution may be rapidly drawn through the filter, as it is sterilized, and into the bag upon the creation of a pressure differential between the inside and outside of the bag in the vacuum chamber. A transparent portion of the sterile unit provides a means by which the sterility of the transfer process can be determined. The process includes delivering the solution to the sterile unit, transferring the solution through the filter for sterilization and into the bag by creating the pressure differential, terminating solution transfer and directing a gas through the unit, observing the transparent portion for the presence of gas bubbles, which would indicate a loss of filter integrity, and consequently sterility of the unit, and hermetically sealing off the bag, if no such bubbles are present.</p> |
