US3538669A - Method of preparing a packaged sterile solution - Google Patents

Description

Nov. 10, 1970 c. R. BROMAN ET AL 3,538,669

v METHOD OF PREPARING A PACKAGED STERILE SOLUTION Filed 001:. '7. 1968 [NV/5N! ()RS' CYRUS R. BROMAN THEODORE H. GEWECKE United States Patent O 3,538,669 METHOD OF PREPARING A PACKAGED STERILE SOLUTION Cyrus R. Broman, McHenry, 11]., and Theodore H.

Gewecke, Milledgeville, Ga. 31061; said Broman assignor to said Gewecke Filed Oct. 7, 1968, Ser. No. 765,576 Int. Cl. B65b 61/00 U.S. Cl. 53-14 Claims ABSTRACT OF THE DISCLOSURE In the method, an elongated tube is compacted, gas sterilized, filled with a sterilized solution to elongate the same and then selectively partitioned into discrete units.

BACKGROUND AND SUMMARY OF THE INVENTION This invention is an improvement on the prior U.S. Pat. No. 3,376,687 of Theodore H. Gewecke. In that patent, a method was disclosed which was useful in the preparation of sterile solutions, particularly those employed for parenteral purposes. The art in this area, as well as in sterilized solutions in general, makes use of involved apparatus and procedures which are primarily an outgrowth of the older methods employing glass bottles. The invention here is a departure from the established art and in one embodiment makes use of a novel filter and manifold arrangement to substantially lessen the complexity of equipment and procedure for the preparation of sterile solutions.

DETAILED DESCRIPTION The invention is described in conjunction with an illustrative embodiment in the accompanying drawing, in which FIG. 1 is a fragmentary perspective view of a tube employed in the practice of the invention, i.e., the bag providing means at an intermediate stage of manufacture;

FIG. 2 is a perspective view of the apparatus used for sterile fill in an early stage of usage;

FIG. 3 is a fragmentary perspective view of the apparatus of FIG. 2 but at a subsequent stage of operation; and

FIG. 4 is a perspective view of an individual unit sterile filled according to the teachings of the invention.

In the illustration given and with particular reference to FIG. 1, the numeral designates generally an elongated tube which is advantageously constructed of flexible, transparent plastic material. Depending upon the usage, many materials may be employed. For example, polyvinyl chloride, polyethylene, vinyl vinylidene chloride, nylon, etc. may be used. The tube 10 is seen to be relatively elongated and equipped at longitudinally spaced points with outlets as at 11 and hanger holes as at 12. One end is closed by a transverse seal or union as at 13 and the other end is equipped with an inlet fitting as at 14.

Following the preparation of the tubing 10, the element is compacted, i.e., rolled upon itself as shown in FIG. 2 and generally designated 15. Alternatively and equally as advantageous in some instances, other compacting arrangements may be employed such as reverse folding, arranging the same in a serpentine configuration,

3,538,669 Patented Nov. 10, 1970 ice etc. In FIG. 2, two such units are illustrated but it will be appreciated that a lesser or greater number may be utilized. Coupling theunits 15 to amicrobiological filter 16 is a manifold 17. Thefilter 16 advantageously may be of the construction provided by Millipore Corporation of Bedford, Mass. Thefilter 16 is equipped with aliquid inlet 18 and the manifold 17 is equipped with valved couplings as at 18, 19, and 20. The valve couplings 18-20 permit the rapid separation of discrete units or portions of the assembly seen in FIG. 2.

In the practice of the invention, the assembly seen in FIG. 2 is subjected to gas sterilization in anenclosure 21 depicted schematically. Any conventional gas sterilization unit may be employed using, for example, sterilizing gas such as ethylene oxide disclosed in the earlier issued patent.

Following sterilization of the assembly seen in FIG. 2, the assembly is placed partly on a platform 22 (see FIG. 3), with theunits 15 placed on a slopingconveyor 23. Theinlet 18 of thefilter 16 is coupled to a source of solution (illustrated schematically as at 24) and solution is'caused to flow into theunits 15, causing them to unroll to the configurations designated 25 in FIG. 3. After theunits 25 have been filled, thediscrete bags 26 are developed by simultaneously separating out discrete portions of the fluid and transversely heat sealing or otherwise uniting opposing walls of the tubing making up theunits 25.

We claim:

1. In a method of preparing a package solution comprising sequentially installing outlet fittings at longitudinally spaced points along elongated webbing, forming said webbing into an elongated tube with one end closed, coupling the other end of said tube to a microbiological .filter, gas sterilizing the assembled filter and tube, coupling said filter to a source of solution and filling the tube, and cross sealing intermittently the elongated tube to provide discrete units having a predetermined volume of fluid therein.

2. The method of claim 1 in which a plurality of tubes is provided with a manifold interposed between said filter and each of said tubes.

3. The method of claim 1 in which said tube is initially compacted.

4. The method of claim 3 in which said tubes are initially rolled to provide the compacting thereof and thereafter unrolled incident to filling.

5. In a method of preparing a packaged solution comprising sequentially introducing outlet fittings at longitudinally spaced points along an elongated webbing, forming said webbing into an elongated tube with one end closed, compacting said webbing, gas sterilizing the assembled tube, coupling the other end of said tube to a source of sterilized fluid, filling said tube, and cross sealing the tube intermittently to provide required volumes.

References Cited UNITED STATES PATENTS 3,011,293 12/1961 Rado 53-29X 3,376,687 4/1968 Gewecke 53-180X THERON E. CONDON, Primary Examiner E. F. DESMOND, Assistant Examiner U.S. Cl. X.R. 53-29

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