US 3376687 A
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Description (OCR text may contain errors)
April 1968 T. H. GEWECKE 3,376,687
METHOD OF PREPARING A PACKAGED PARENTERAL SOLUTION Filed Jan. 7, 1966 Wanda} AT T'YS United States Patent 3,376,687 METHDD 0F PREPARING A PACKAGED PARENTERAL SOLUTION Theodore H. Gewecke, Milledgeville, Ga. 31061 Filed Jan. 7, 1966, Ser. No. 519,308 3 Claims. (Cl. 53-14) This invention relates to a method of preparing a packaged parenteral solution, and, more particularly, to a method utilizing unique conditions of sterilization.
Historically, parenteral solutions have been packaged and sterilized in either of two ways. The first type of packaging employed glass bottles and utilized heat sterilization. This procedure was advantageous in having available the advantages of batch techniques wherein the bottles were filled as a group and then only representative samples checked for sterility. A later development in packaging, and one deemed more desirable from the standpoint of transportation, marketing, etc., is that of using plastic bags. Two outstanding advantages of plastic bags were ability to absorb shock without breakage, and relatively minor disposal problems. However, such plastic bags are severely damaged by the normal method of heat sterilization of the complete units. The plastic material undergoes shrinkage and distortion and the heat also causes leeching of impurities from the bags into the solution. The rate of discards experienced is much higher than can be tolerated commercially. For the reasons, the packaging of intravenous solutions in plastic bags has never become a practical commerical reality in spite of the great desire for such units by hospitals and the armed forces.
Gas sterilization of the filled units is not possible since the solution itself cannot be gas sterilized. Sterile fill techniques have been considered but they would not make available the advantages of batch techniques, particularly insofar as checking sterility is concerned, and the provision of a sterile fill technique which does have available this significant advantage constitutes an important object of the invention.
Other objects and advantages of the invention may be seen in the details of construction and operation set down in this specification.
The invention is explained in conjunction with the accompanying drawing, in which- FIG. 1 is a schematic perspective view of apparatus for developing the plastic bag utilized in the practice of the invention; and
FIG. 2 is a schematic perspective View of apparatus for sterile filling of the partially-formed bags developed by the apparatus of FIG. 1.
In the illustration given and with particular reference to FIG. 1, the numeral designates generally webbing which is-seen to include an upper web 13 derived from a first parent roll 11, and a lower web 14 developed from a second parent roll 12. As the webs are unwound from the respective parent rolls, they are cleaned of occluded impurities by vacuum cleaning hoods or shoes 15. Thereafter, the unwound webs 13 and 14 pass through a sealing station generally designated 16. Provided as part of the electronic heat-sealing station 16 is a transversely retractable mandrel designated 17 which is adapted to be positioned between the upper heat-sealing shoe 18 and the lower heat-sealing shoe 19. The shoes 18 and 19 are recessed as at 18a and 19a, respectively, to accommodate the receipt of the mandrel 17 on which is ensleeved an outlet fitting such as is depicted at 20, immediately to the left of the heat-sealing station 16. The fitting 20 can be seen in greater detail in my copending application Ser. No. 493,760, filed Oct. 7, 1965.
The numeral 21 designates a printing mechanism which is arranged to overprint the upper web 13 (now united along the near longitudinal edge to the lower web 14) as the now-joined webs index forward under the action of a progressive motion pull-through mechanism 22, or other advancing mechanism such as driven rollers.
The numeral 23 designates a pressure switch arranged to activate a take-up roller 24 which provides the partially united web in reeled form.
A further practice of the invention contemplates utilizing the apparatus generally designated 25 in FIG. 2 which is employed for sterile filling and is seen to include a generally box-like enclosure. The lower portion of the enclosure is designated 26 and includes an airtight storage receptacle for filled bags, the receptacle being collapsible for sterilization. At the extreme upper righthand portion of FIG. 2 the numeral 27 designates an arbor upon which the reeled, partially-formed webbing is mounted, the webbing as it is unwound being designated 28. Suitable powered unwind means such as pull rolls may be employedthese being omitted for clarity of presentation. The numeral 29 designates a supply pipe which delivers parenteral solutions, i.e., glucose, saline, etc., from a sterile tank (not shown), but wherein the solution can be quickly sterilized by heat so as to prevent caramelization. The numeral 30 designates a valve interposed in the line 29, the line 29 being seen to be equipped with an elbow 29a fitting into the open side of the webbing 28 so as to deliver liquid solution between the webs 13 and 14. The opposite longitudinal margins (to those already sealed and equipped with the outlet 20) are sealed by means of a solenoid operated die 31 which operates intermittently to seal the opposite sides together.
The progressive die mechanism, also solenoid operated, is generally designated 32 and is seen to operate a transverse sealing mechanism 33 in addition to the longitudinal sealing mechanism 31. The mechanism 33 also functions to control the volume of solution in the bags by adjusting the squeeze given to the filled bag or web just prior to sealing. The numerals 34 and 35 indicate ports controlling the flow of sterile air in and out of the system, maintaining the same under suitable pressure.
In the practice of the invention, the reel of partially formed bags is mounted on arbor 27 and arranged so that the pipe 2 9 is interposed between the confronting Webs 13 and 14. Thereafter, the entire enclosure is sterilized by being subjected to ethylene oxide or like sterilizing gas for -a suitable period. Thereafter, the valve 30 is opened and the already heat-sterilized solution delivered to the enclosure 25, the mechanism 32 operating to simultaneously longitudinally and transversely seal the webbing 28 by actuating the solenoids 31a and 33a, associated with the dielectric dies 31 and 33 which are suitably connected to a dielectric generator (not shown). This results in a series of filled bags 36, as are seen in the lower central portion of FIG. 2.
Through the practice of the invention, the parenteral product is now provided in batches which can be tested in the advantageous batch fashion not heretofore available in prior art teachings. Further, the invention makes use of transparent plastic material of substantial thickness so as to stand up in the usual parenteral solution application. The material is strong and heavy and is subjected to dielectric sealing on an intermittent basis, as outlined above. The resultant bag 36 is immediately ready for coupling to the usual parenteral administration set and by adding additional heat-sealing equipment within the enclosure 25, suitable hangers can be provided on each bag 36. Fluid height, both maximum and minimum, can be controlled by photocells 37 adjacent the tube 28 for regulating the setting of valve 30.
While in the foregoing specification a detailed description of an embodiment of the invention has been set down for the purpose of illustration, many variations in the details herein given may be made by those skilled in the art without departing from the spirit and scope of the invention.
1. A method of preparing a packaged parenteral solution, comprising sequentially installing outlet fittings longitudinally along elongated thermoplastic webbing, reeling said webbing, installing said reeled webbing in apparatus coupable to a source of [heat] sterilized solution, gas sterilizing said apparatus and reeled webbing, and there after introducing heat sterilized solution into said web- 4 hing while said webbing is formed into bags and while said apparatus is maintained under sterile conditions.
2. The method of claim 1 in which said webbing includes a pair of webs arranged in superposed relation with aligned longitudinal edges, said webs being edgeunited incident to installing said fittings.
3. The method of claim 1 in which said bag forming is achieved through intermittent dielectric heat-sealing of transparent plastic materials to allow ready visual inspection.
No references cited.
TRAVIS S. MCG EHEE, Primary Examiner.
R. L. SPRUILL, Assistant Examiner.