WO1998038091A1

WO1998038091A1 - Method and apparatus for manufacturing intravenous solution bags

Info

Publication number: WO1998038091A1
Application number: PCT/US1997/003078
Authority: WO
Inventors: Robert L. Gliniecki; John Kivlehan
Original assignee: Baxter International Inc.
Priority date: 1997-02-26
Filing date: 1997-02-26
Publication date: 1998-09-03
Also published as: AU2138997A

Abstract

An improved apparatus (10) for filling and sealing sterile bags (12) in a sterile enclosure (14) is disclosed. A turntable (16) rotatably mounted within the enclosure suspends two or more bags. Port tubes (22) extend from the bags, and the bags are suspended from the port tubes. One of the bags is filled with sterile solution within the enclosure and the port tube is sealed by vibration welding (26). The turntable then rotates and the sequence is repeated on a new bag.

Description

METHOD AND APPARATUS FOR MANUFACTURING INTRAVENOUS SOLUTION BAGS

FIELD OF THE INVENTION

The present invention relates generally to the art of filling flexible containers or bags with sterile fluids and more particularly to a system of sealing port tubes on such flexible containers and automatically filling such containers within a sterile enclosure.

DESCRIPTION OF THE RELATED ART

In prior practice, flexible containers were filled in a clean room under a hood capable of maintaining sanitary conditions within specified limits. In aseptic filling, bags would initially be sterilized internally and at least partially externally at a very low level of contamination during the filling process. The bags were subsequently re- sterilized after filling to ensure the required sterility.

Prior art IV solution bags have been constructed primarily of vinyl. The principle method of sealing has included radio frequency and ultrasonic sealing. However, it has been found that it is difficult to hermetically seal the port tubes, difficult to provide a strong seal and that the operating parameters of the sealing equipment are narrow and difficult to maintain. Examples include U.S. Patent Number 4,350,649 and U.S. Patent Number 3,920,504.

The filling of IV bags under sterile conditions may be seen in U.S. Patent Nos. 3,269,079 issued on August 30, 1966 to Schmied for "Method of and Apparatus for Sterile Packaging of Sterile Consumer Goods"; 3,376,687 issued on April 9, 1968 to Gewecke for "Method of Preparing a Packaged Parenteral Solution"; 3,466,841 issued on September 16, 1969 to Rausing for "Method of Packaging Sterile Filling Material Under Aseptic Conditions"; 3,538,669 issued on November 10, 1970 to Broman et al . for "Method of Preparing a Packaged Sterile Solution"; 4,045,939 issued on September 6, 1977 to Baurnstingl for "Process for the Production of a Packaging Receiving a Sterile Liquid"; 4,417,607 issued on November 29, 1983 to Scholle et al . for "Apparatus and Method for

Aseptically Filling Flexible Containers"; and 4,964,261 issued on October 23, 1990 to Benn for "Bag Filling Method and Apparatus for Preparing Pharmaceutical Sterile Solutions." The filling equipment usually must also include a mechanism to provide an airtight seal after filling. See, for example, U.S. Patent Numbers 4,530,202 issued on July 23, 1985 to Powell et al . for "Container Filling Machine and Method"; and 4,452,030 issued on June 5, 1984 to Inada for "Contamination-free Method and Apparatus for Filling Spouted Bags With a Fluid."

Several patents recite and disclose steps common to most bag filling systems. See for example, U.S. Patent Number 2,949,712, 3,403,064, 3,514,919 and 3,531,908. Also U.S. Patent Numbers 3,486,295 Raufing et al . for "Methods of Packaging Sterile Liquids." An example of a device utilizing human labor for filling is U.S. Patent Number 3,491,503.

U.S. Patent Number 4,494,363 discloses a machine for filling preformed bags. A bag is secured to the machine and the vacuum head removes a lid covering a tubular fitment from the bag. The engaged fitment, the entire fill chamber, the lid, the lid removing means and the fill tube are all sterilized. Then the fill tube lowers, engages the bag fitment and fills the bag. Thereafter, the lid is heat sealed onto the end of the fitment and the bag is removed. While the previous patents describe various types of sterile packaging systems, it is desirable to improve both the filling and sealing methods of sterile solution containers. Additionally, it has been found difficult to changeover prior art systems to accommodate different sizes of containers.

OBJECTS AND SUMMARY OF THE INVENTION

Accordingly, it is an object of the present invention to provide an apparatus for filling sterile flexible containers, particularly IV bags, which overcomes the disadvantages and limitations of the devices found in the prior art.

An additional object of the invention is to provide an apparatus for hermetically sealing the port tube of an IV bag.

It is an additional object of the present invention to provide an apparatus for filling sterile IV bags which fills the bag, and seals the port tube in a highly automated and efficient manner.

The present invention relates generally to an apparatus for sealing IV solution bags and more particularly to apparatus for filling and sealing flexible thermoplastic bags in a sterile environment. The apparatus includes a substantially sealed sterile enclosure. A turntable rotatably mounted within the enclosure is used for suspending at least two of the flexible bags therefrom. Each of the bags has a port tube extending therefrom. The port tubes are inserted either manually or mechanically into one end of the bag and sealed thereto prior to placement of the bags within the enclosure, with a cap on the distal end of the tube. It should be noted that the port tubes and bag may be sterile when inserted into the enclosure, or may be sterilized within the enclosure. However, in a preferred embodiment, the bags are pre-sterilized by gamma radiation within sealed tray or overwrap bags, then moved into the enclosure.

In a preferred embodiment, in order to suspend the IV bags, a radial flange extends from the distal end of the port tube. The mechanism for suspending the bags comprises a flange support such as an aperture into which the port tube is inserted. The flanges are sufficiently stiff to support the weight of the bag, even in a filled state. A cap is frictionally engaged to the distal end of the flange, sealing the lumen of the port tube . In one embodiment of the invention, a plurality of the flexible thermoplastic bags, contained within overwrap bags, are stored within the enclosure on a multiple level rack. The rack may be used to store bags both before and after filling of the bags with IV solution. In order to manipulate the bags within the sterile enclosure at least two portholes are constructed in the wall of the enclosure. A viewing window is also provided in the wall of the enclosure to allow manipulation of the bags by the user. The window also has a "mousehole" or opening through which filled bags may be removed, while maintaining sterility.

Each of the portholes has a flexible glove which is hermetically sealed at one end about its periphery and which extends into the sterile enclosure. The rubber gloves are used for manually manipulating the flexible bags, port tubes and caps within the enclosure. Alternatively, a conveyor may be used for moving the bags into and out of the sterile enclosure through a tube or passage way at either end thereof, which is also enclosed and sterilized.

Each of the bags is filled within the enclosure through a filling tube which is in fluid communication with a source of sterile liquid such as IV fluid or other medical fluids. A mechanism is provided for inserting the distal end of the filling tube into a port tube. A second mechanism then dispenses a desired quantity of the fluid through the port tube and into the bag. After the bag is filled, the port tube is sealed with the filling tube still in the port tube. A mechanism for withdrawing the filling tube from the port tube is then actuated. In a preferred embodiment the dispensing mechanism includes a syringe pump to dispense the selected quantity of fluid, and a pinch and draw valve contained within the sterile enclosure, which squeezes the flexible filling tube to cut off the flow, and which draws a small quantity of the fluid back from the tip of the filling tube, to limit spillage. To ensure the proper weight of the bag, a check weigher may also be utilized within the enclosure.

After the bag is filled, the port tube is sealed. One of the features of the present invention is the apparatus for hermetically welding closed the port tube using vibration welding. The apparatus includes an anvil located within the enclosure. A sealing head is slidably disposed within the enclosure and is positioned for compression of the port tube against the anvil. The vibration welder is used to vibrate the sealing head against the anvil so as to melt the port tube in a desired configuration. A mechanism for selectively sliding the sealing head towards the anvil and applying pressure is provided outside of the enclosure, as well as a mechanism for retracting the sealing head away from the anvil. In a preferred embodiment these mechanisms utilize an air cylinder. In the mechanism for moving the sealing head, in a preferred embodiment, a pneumatic bladder acts as an air spring in series with the air cylinder. The air cylinder moves the sealing head both toward and away from the anvil depending on the amount of pressure applied and direction in which it is applied. The bladder absorbs a portion of the force applied up to a desired limit, which can be regulated by the amount of air introduced into the bladder. The bladder also spreads the force out uniformly against a plate on the back of the sealing head, so as to apply it more evenly. A limit switch, triggered by the plate, initiates the vibration weld when the desired force has been obtained. A pressure sensor may also be used, if desired, to monitor the pressure applied against the anvil .

In the preferred embodiment, the sterile enclosure further includes at least one pivotable sealable door which is constructed and arranged to allow introduction of bags into the enclosure. A chemical sterilization agent such as Hydrogen Peroxide, or other chemical or/gaseous sterilizing agents may be utilized to sterilize the enclosure and the bags contained therein. Additionally, sterile air is continually forced into the enclosure in order to maintain sterility. The bags are then removed individually from the enclosure by dropping them out the "mousehole" . A chute inside the enclosure connected to the mousehole to prevent contamination.

One of the features of the present invention is that by suspending the bags from the bag port tube, a variety of different size bags may be utilized without changing the mechanical settings of the device, as long as the bag port tubes themselves are all substantially uniform. In a preferred embodiment, the bags are constructed of 12 - 18% vinyl acetate with the remainder of the material being polyolefins such as Polyethylene, or, alternatively blends of Butyl or Thermoplastic Elastomers.

BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 of the drawings is a front perspective view of an apparatus for sealing intravenous (IV) solution bags within a sterile enclosure.

FIG. 2 of the drawings is a front elevational view of the apparatus for filling IV solution bags within the sterile enclosure of FIG. 1.

FIG. 3 of the drawings is a top view, partially broken away, of the apparatus of FIGS.l and 2.

FIG. 4 of the drawings is a front elevational view of the top portion of a IV solution bag. FIG. 5 of the drawings is the side perspective view, partially broken away, of the apparatus of FIG. 1 showing in particular a turntable for supporting IV solution bags, a filling mechanism for filling the bags and a sealing mechanism for sealing the port tubes of the IV solution bags. FIG. 6 of the drawings is a side view of the enclosure and apparatus of FIGS. 1-3 and 5.

FIG. 7 of the drawings is a side view, partially broken away, of the sealing mechanism of FIGS. 1-3 and 5, showing in particular an apparatus for sliding a sealing head either toward or away from an anvil, for sealing of the port tubes therebetween .

FIG. 8 of the drawings is a front perspective view of a pinch and draw valve including a pair of coaxially aligned air cylinders for dispensing a desired quantity of fluid from a source of sterile liquid through the filling tube of FIG. 5. FIG. 9 of the drawings is a side view, partially broken away, of the air cylinder and pinch and draw valve assembly of FIG . 8 .

FIG. 10 of the drawings is a front perspective view, partially broken away, of a sealing head, anvil, and IV solution container of FIG. 5 having a bag port tubes extending therefrom.

FIG. 11 of the drawings is a side view, partially broken away, of the sealing head, IV solution container, port tube, turntable and bag support mechanism of FIGS. 1-3 and 10.

FIG. 12 of the drawings is a front view, partially broken away, showing a port tube hermetically sealed by means of the apparatus of FIGS. 1-10.

FIG. 13 of the drawings is a side view, partially broken away, showing in particular a fill nozzle actuator which raises and lowers the fill tube into the port tube of FIGS. 1- 3.

FIG. 14 of the drawings is a side view, partially broken away, of the turntable mechanism of FIGS. 1-3.

FIG. 15 of the drawings is a side cut away view of a port tube and port tube cap of the present invention. FIG. 16 of the drawings is a side cut away view of the port tube of FIG. 15, showing in particular schematically the sealing area where the port tube is sealed.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT While the present invention is susceptible of embodiment in many forms, there is shown in the drawings and will herein be described in detail several specific embodiments with the understanding that the invention is not limited thereto except in so far as those who have the disclosure before them are able to make modifications and variations therein without departing from the scope of the invention.

As shown in FIG. 1 of the drawings, an apparatus 10 is provided for filling and sealing, in a sterile environment, ported flexible thermoplastic bags 12. The apparatus includes a substantially sealed sterile enclosure 14. A turntable 16 is provided within enclosure 14. The turntable 16 includes mechanisms 18 and 20, as best seen in FIG. 5, for suspending at least two flexible bags 12 therefrom. A port tube 22 extends coaxially from the distal end 24 of bag 12.

As further shown in FIG. 1, a mechanism 26 for vibration welding the port tube 22 is provided. This mechanism 26 again is best shown in FIG. 5 and will be described in greater detail later herein. FIG. 1 best shows a mechanism 28 for storing the flexible thermoplastic bags 12 within the enclosure 14. In the embodiment shown, the mechanism 28 is a rack 30 having one or more levels 32 and 34 and a plurality of slots 36 formed therein for storage of flexible containers 12 in overwrap 35, or in trays. The enclosure 14 also includes at least two portholes 38 and 40 extending into the enclosure. A glass or plastic viewing window 42 is mounted on one wall 44 of the enclosure and is sealed thereto. Window 42 has a slot 45, (the "mousehole") through which bags 12 may be removed from the enclosure 14. Slot 45, in turn , has a chute 47 extending into enclosure 14 to prevent the back flow of contaminated air when bags 12 are removed. Chute 47 is covered during sterilization. In the embodiment shown, a second window 46 is mounted near rack 30 in wall 44 and a second pair of portholes 48 and 50 are provided for access to the interior of enclosure 14. In a preferred embodiment, portholes 38, 40, 48 and 50 each have flexible rubber gloves 52-58 respectively sealed thereto proximate the forearm portion of the glove. The gloves 52-58 are hermetically sealed to periphery of the portholes 38, 40, 48 and 50 . The gloves 52-58 may be used by the operator of the apparatus 10 to manipulate bags within the enclosure 14.

As further seen in FIG. 1 and FIG. 2, enclosure 14 is constructed of rigid material such as steel which can withstand sterilization. Enclosure 14 is supported by legs 60-66. Enclosure 14 has its walls 44, 71, 72 and 73 as well as windows 42 and 46, floor 70 and ceiling 75 sealed to each other so as to provide a chamber 68 which is substantially sealed to prevent the passage of bacteria and other contaminants into the bags 12. The enclosure is sterilized using hydrogen peroxide. A filtered blower 81 directs sterile air into enclosure 14 so as to provide positive air pressure in order to maintain sterility.

Turning to FIG. 4 of the disclosure, in a preferred embodiment, port tube 22 has a flange 74 extending from its distal end 76. Port tube 22 is preferably molded so that flange 74 is sufficiently rigid for the entire bag 12 to be supported therefrom either in an empty or filled condition.

In the embodiment shown in FIG. 5, the turntable 16 comprises an arm 77 rotatably mounted on a shaft 78. Bags 12 are suspended from the respective ends, first end 80 and second end 82 of arm 77. Flange 74 preferably has a cap 75 press fit therein which is removed after bag 12 is placed on arm 77. (In an alternative embodiment, not shown in the drawings, turntable 16 may simply comprise a conveyor in which the bags 12 are suspended from hooks on a chain and which move in a circular motion about a sprocketed wheel. Similarly, rack 30 may have a conveyor which transports the bags from the rack 30 to the turntable 16 and back again. Shaft 78 in turn is rotated by a rotary actuator 79 such as a FESTO^® Rotary Actuator, by the command of the user.

The mechanism for hermetically welding port tube 22 closed includes an anvil 84, best seen in FIG. 10. Anvil 84, in the embodiment shown, comprises a steel shaft 86 having a flat sealing surface 88 mounted on a ledge 90 which in turn extends from the distal end 92 of shaft 86. Shaft 86 in turn is fixedly mounted to floor 70 of enclosure 14. The sealing head 94 is slidably disposed within enclosure 14 as shown in FIGS. 5 and 6. Sealing head 94 is positioned for compression of port tube 22 against anvil 84 and for sealing of the port tube 22. This operation may best be seen in FIG. 11 of the drawings. The mechanism 96 for selectively sliding the sealing head 94 towards the anvil 84 preferably comprises an air cylinder 98 which, when activated, pushes the sealing head 94 towards the anvil 84 or retracts the sealing head away from the anvil as required. Alternatively, a second air cylinder or other mechanism may be utilized for retracting the sealing head 94 away from the anvil 84. An electronic mechanism 100 is further provided for vibrating the sealing head 94 so as to melt the port tube 22 in the configuration desired. A bag 12 having a port tube 22 sealed at seal 101 is shown in FIG. 12. The sealing of the port tube 22 is best shown in FIG. 11. In a preferred embodiment, sealing head 94 is vibrated at a frequency of 200 Herz to 300 Herz at an amplitude of .070 inches peak to peak, plus or minus .002 inches with a weld time of approximately 1 to 2 seconds, a pressure of 40 to 70 pounds per square inch, a cooling time of 1 second plus or minus a half second and a gap of no less than .004 inches between sealing head 94 and anvil 84 during compression. However, one of the advantages of the present invention is that vibration welding is very forgiving, so that, for example, a weld time of six seconds may be utilized without burning or puncture of the port tube 22. In the embodiment shown, a Branson Series 90 Mini-Vibration Welder is utilized. A copy of the Branson Operators Manual is attached hereto and incorporated herewith. As shown in FIG. 7, in a preferred embodiment, sealing head 94 is mounted on a carriage 102 which in turn is mounted on one or more slides 103 so as to permit extension or retraction of sealing head 94. Positioned between carriage 102 and air cylinder 98 is an air spring bladder 104. In preferred embodiment air cylinder 98 forces plate 105 against bladder 104, which in turn, when sufficiently compressed, exerts force against plate 107, causing movement of carriage 102 towards anvil 84. The air cylinder 98 may move the sealing head 94 both toward or away from the anvil 84 depending on the direction in which air is applied to the air cylinder 98. The bladder 104 absorbs a portion of the force applied up to a desired limit, which can be requlated by the amount of air introduced into the bladder 104. The bladder 104 also spreads the force out uniformly against plate 107 on the back 109 of the sealing head 94, so as to apply it more evenly. A limit switch, (not shown) , triggered by the plate 107, initiates the vibration weld when the desired force has been obtained.

Returning again to FIG. 10, in a preferred embodiment, sealing head 94 has a thickness at its tip 106 of approximately from .10 to .25 inches, .142 preferred. The tip 106 is approximately .10 to .25 inches long, preferred .125, which is then flared for a length of approximately 1/4 of an inch. The tip 106 is radiused at its edges to prevent punching or cutting the bag 12 during sealing. The main portion 108 of sealing head 94 is approximately 2 1/2 inches long and 5/16" thick. The base 110 of sealing head 94 shown in FIG. 7, is .25 to .5 inches thick and 1 to 2 1/2 inches wide. The sealing head 94 extends from the center of the base 110. A variety of sizes of sealing heads may be used, as seen in the charts incorporated herein. Anvil 84, as shown in FIG. 10, has a sealing surface 88 which is approximately .125 to 1 inches high by 1 to 1 1/4 inches long. This sealing surface 88 is knurled in order to provide improved sealing characteristics of port tube 22. The base portion 112 of anvil 84 is approximately 1 9/16 inches thick, 2 inches high and 2 3/4 to 3 inches long. Obviously other embodiments of a sealing head 94 and anvil 84 may be utilized. In order to test the efficacy of the mechanism 26 for welding port tube 22, a series of tests were conducted varying the parameters for sealing. The results of those tests are as follows :

2ND GENERATION VIBRATION WELDER PROTOTYPE (AIR BLADDER/PNEUMATIC)

Subject BURST TEST STRENGTH OF 18%EVA vs. 18%/l2S 50%-503 BLEND PORT TUBES WELDED WHILE EXTERNAL WEIGHT PULLS ON SEAL. USE WIDE AND NARROW WIDTH HORNS

Weld Parameters : Weld Time 1.6 seconds

Cool Time 1.0 seconds

Knurl Horn and Anvil

Horn/Anvil Gap .004"

Bladder Air Pressure 70 PSIG

Narrow, Long Horn Method:

Dip the port tube in water to wet .

Clamp a Vise Grip plier with auxiliary weight, having a total accumulated weight of 2.2 pounds or 1 kilogram, to the small end of the port tube.

Hang the port tube assembly in anvils' part holding fixture.

Weld fifteen port tubes of 18% EVA Material with the Wide,

Long Horn

Weld fifteen port tubes of the 1%/18% 50%/50% Blend Material with the Wide, Long Horn.

Weld fifteen port tubes of 18% EVA Material with the Narrow,

Long Horn.

Weld fifteen port tubes of the 18%/12% 50%/50% Blend Material with the Narrow Long Horn.

Freeze parts for a minimum of 48 hours. Thaw and burst test . Record the results .

Definitions :

WF WELD FRACTURE The hydraulic pressure of the water has torn through and delaminated the weld.

WFW WELD FRACTURE The hydraulic water pressure has allowed small WEEP capillary flow through the weld; producing water weep.

PD PARTIAL The weld has started to delaminate along the inner DELAMINATION seal but has not fractured through the weld.

SW - SIDE WALL The burst pressure was strong enough to balloon out BURST and burst the side, port tube wall. Sometimes accompanied by Partial Delamination.

SC - SEAL CUT The failure of the port tube wall on the solution side of the seal during burst; due to its' being weakened by the exaggerated penetration of the sharp or serrated, lower edge of the horn. RUN 1

Port Tube Manufacturer: Baxter Healthcare Mold Shop RLT-10

Port Tube Material : Escorene Ultra EVA

Weld Time- 1.6 sec.

Cool Time : 1.0 sec .

Cylinder Pressure 125 PSIG

Bladder Pressure: 70 PSIG

Knurling: Horn and Anvil (did not want to remove anvil knurling for this test) Horn Width: NARROW

Port Initial Actual Port Displayed Rupture No Burst Burst Burst Tube Pressure Pressure Pressure Pressure Pressure No (PSD (PSD (PSD (PSD (PSD

203 203 201 SC

210 210 208 SC

211 211 209 SC

214 214 212 SC

207 207 205 SC

211 211 209 SC

247 247 245 SC

207 207 205 SC

225 225 223 SC

10 232 232 230 SC

11 247 247 245 SC

12 218 218 216 SC

13 232 232 230 SC

14 211 211 209 SC

15 222 222 220 SC

Mean Burst Pressure = 217 mean 217.8 sum x 3267 sum x squared 714337 sample standard deviation 14.103

Port Tube Manufacturer: STEDIM

Port Tube Material: 18%X12% EVA 50%/50%. Blend

Weld Time: 1 6 sec.

Cool Time : 1.0 sec .

Cylinder Pressure: 125 PSIG

Bladder Pressure: 70 PSIG

Knurling: Horn and Anvil (did not want to remove anvil knurling for the 5 test) Horn Width: NARROW

Port Initial Actual Port Displayed Rupture No Burst Burst Burst Tube Pressure Pressure Pressure Pressure Pressure No (PSD (PSI) (PSI) (PSI) (PSI)

1 2 239 239 237 SW

2 2 236 234 234 SW

3 2 251 251 249 SC

4 2 243 243 241 SC

5 2 Damaged in test fixture

6 2 236 236 234 SC

7 2 228 228 226 SC

8 2 240 240 238 SW

9 2 273 273 271 SW

10 2 232 232 231 SW

11 2 218 218 216 SW

12 2 225 225 223 SC

13 2 228 228 226 SW

14 2 232 232 230 SW

15 2 232 232 230 SW

Mean Burst Pressure 234.7 sum - 1286 n 14 sm x squared 77. J546 mean 234.7 samp]:e standard deviation 13.228

Port Tube Manufacturer: Baxter Healthcare Mold Shop. RLT-10

Port Tube Material : Escorene Ultra EVA

Weld Time : 1.6 sec .

Cool Time : 1.0 sec .

Cylinder Pressure: 125 PSIG

Bladder Pressure: 70 PSIG

Port Initial Actual Port Displayed Rupture No Burst Burst Burst Tube Pressure Pressure Pressure Pressure Pressure No (PSD (PSD (PSI) (PSI) (PSI)

203 203 201 SC

210 210 208 SC

211 211 209 SC

214 214 212 SC

207 207 205 SC

211 211 209 SC

247 247 245 SC

207 207 205 SC

9 225 225 223 SC

232 232 230 SC

^~ϊϊ^~ 247 247 245 SC

~Ϊ2~ 218 218 216 SC

^"Ϊ3^" 232 232 230 SC

14 211 211 209 SC

222 222 220 SC

Mean Burst Pressure = 217 8 sum X3267 sum x squared 714337 mean 217.8 sample standard deviation 14.103

Port Tube Manufacturer: STEDIM

Port Tube Material: 18%/12% EVA 50%/50% Blend

Weld Time: 1.6 sec.

Cool Time : 1.0 sec .

Cylinder Pressure: 125 PSIG

Bladder Pressure: 70 PSIG

Knurling: Horn and Anvil (did not want to remove anvil knurling for this test) Horn Width: WIDE

Port Initial Actual Port Displayed Rupture No Burst Burst Burst Tube Pressure Pressure Pressure Pressure Pressure No (PSI) (PSI) (PSD (PSI) (PSI)

240 240 238 SW

251 251 249 SW

239 239 237 SW

236 236 234 SC

240 240 238 SW

239 239 227 SW

239 239 237 SW

10 239 239 237 SW

11 236 236 234 SW

^~IT 243 243 241 SW

13 251 251 249 SW 14 251 251 249 SW

15 239 239 237 SW

Mean Burst Pressure 239.5 sum X 3592 sum x squared 860542 mean 239.5 sample standard deviation 5.194

Results :

Material : Escorene Ultra EVA Horn : NARROW WIDE

Mean Burst Pressure: 284.5 217 .8

100% SC 100% SC

Material: 18%/12% EVA 50%/50% Blend Horn Width: NARROW WIDE

Moan Burst Pressure: 234.7 239 .5

64% SW 93% SW 36% SC 7% SC

VIBRATION WELDER PROTOTYPE (PNEUMATIC/AIR BLADDER)

Subject: STATISTICAL RESULTS - FIRST SCREENING STUDY

Statistical Results from the Applied Sciences Group at Baxter Round Lake - William Graham Building Regarding the First Screening Study using the Short Sonic Horn.

Results :

Goal was to: 1) Maximize Burst Pressure Mean

2) Minimize Burst Pressure Standard Deviation

Key to both above objectives was to: Maximize Total Weld Time i.e. 1.2 seconds

Marginal improvement on Mean and Significant (statistically but probably not practically) Improvement of Standard Deviation by

1) Maximizing Weld Time Proportion > 0.5

2) Maximizing Trigger Pressure, P ex. 70 psi

There is a very marginal improvement of both the mean and SD gained by: Minimizing Trigger Pressure, P

Cool time is not important at all .

VIBRATION WELDER PROTOTYPE (PNEUMATIC/AIR BLADDER)

Subject: BLADDER GAGE PRESSURE VS. FORCE PRODUCED

MEASURED BLADDER LENGTHS

Measured Uncompressed Bladder Length - 2-7/16" - 2.4375" Measured Compressed Bladder Length = 2-3/16" = 2.1875"

CONSTANT PRESSURE CHARACTERISTICS (taken from Data Sheet on Air Spring Model IS3-013)

Bladder Calculated

Height Bladder Pressure Force Produced Cross-sectional Area

2 2

1 5 " 20 lb/in 125 lbs 6.25 in delta = 10 delta = .5 2 2.0 " 20 lb/in 115 lbs 5.75 in

Operating Range delta = 10 delta = .5 2.5 " 20 lb/in 105 lbs 5.25 in delta = 15 delta = .75

Interpolated Force over the linear range at a Bladder Pressure of 20 PSI .

Bladder Calculated

Height Bladder Pressure Force Produced Cross-sectional Area

2 2

2.0 " 20 lb/in 115 lbs 5.75 in 2 2

2.1 ' 20 lb/in 113 lbs 5.65 in 2 2

2.2 " 20 lb/in 111 lbs 5.55 in

2 2

2.3 " 20 lb/in 109 lbs 5.45 in

2 2

2.4 " 20 lb/in 107 lbs 5.35 in

2 2

2.5 " 20 lb/in 105 lbs 5.25 in

* Given Values from Data Sheet . y- intercept = 155 lbs slope = -20 Force at 2.1875" height = 111.25 lbs

Force = -20 (height) + 155

Bladder

Height Bladder Pressure Force Produced

2.0" 30 psi 180 lb

2.5" 30 psi 170 lb

2.0" 40 psi 230 lb

2.5" 40 psi 220 lb

2.0" 50 psi 290 lb

2.5" 50 psi 290 lb

Height Bladder Pressure Force Produced

2.0" 60 psi 345 lb

2.5" 60 psi 335 lb

Drive cylinder behind Bladder as FESTO Typo DNN-50-50-PPV-A-S2

Double-Acting Cylinder 50mm Bore 50mm Stroke Max 180 PSI Series E041 Adjustable Cushioning Acid-Resistant

50mm BORE CYLINDER = 1.9685039" DIA

Shaft Diameter = .786"

2 Cylinder Bore Cross-Sectional Area = pi * .98425" = 3.0434234 sq. in.

2 Cylinder Shaft Cross-Sectional Area = pi * .353" .4852 sq.in.

Working area of cylinder = Bore Area - Shaft Area

= (3.0434 - .4852) Sq. in.

= 2.5582 sq.in.

Pressure Force

125 PSI 320 LB

120 PSI 307 LB

115 PSI 294 LB

110 PSI 281 LB

100 PSI 256 LB

95 PSI 243 LB

90 PSI 230 LB

85 PSI 217 LB

80 PSI 215 LB

75 PSI 192 LB

70 PSI 179 LB

65 PSI 166 LB

60 SI 153 LB

55 PSI 141 LB

80 PSI 120 LB

45 PSI 115 LB

40 PSI 102 LB

35 PSI 90 LB

25 PSI 77 LB

20 PSI 51 LB

15 PSI 38 LB

10 PSI 26 LB

NEW CYLINDER (changed Drive Cylinder on 2/23/95)

Drive Cylinder behind Bladder is FESTO Type DNN-63-60-PPV-A Double-Acting Cylinder 63 mm Bore 60 mm Stroke .MAX 150 PSI Series 0690400 Adjustable Cushioning Acid-Resistant

60 mm STROKE = 2.362"

63 mm BORE CYLINDER 2.4803149" DIA

Cylinder Bore Cross-Sectional Area = pi * 1.2402"

= pi * 1.538096 = 4.832071 sq. in.

Pressure Force

125 PSI 604 LB

120 PSI 578 LB

115 PSI 556 LB

110 PSI 532 LB

100 PSI 256 LB

95 PSI 243 LB

90 PSI 230 LB

85 PSI 217 LB

80 PSI 215 LB

70 PSI 192 LB

65 PSI 166 LB

60 PSI 153 LB

55 PSI 141 LB

50 PSI 128 LB

45 PSI 115 LB

40 PSI 102 LB

35 PSI 90 LB

30 PSI 77 LB

25 PSI 64 LB

20 PSI 51 LB

15 PSI 38 LB

10 PSI 26 LB

SUBJECT: BRANSON MINIWELDER LIFT TABLE PRESSURES APPLIED TO PART

Information obtained from Kevin Buckley at Branson Plastic Joining in Henrietta, New York on 2-8-95

Miniwelder has a 4" BORE CYLINDER

The following was determined through the use of a strain gage load cell.

25 PSIG = 130 LBS.. ON PART 50 PSIG = 430 LBS. ON PART 80 PSIG = 800 LBS. ON PART

To make a good weld you want an applied force of 250 to 300 lbs per square inch of welding area.

2 4" Bore Cvlinder Cross-Sectional Area = 12.566 m

Pressure Force

100 PSI 1257 LB

95 PSI 1194 LB

90 PSI 1131 LB

85 PSI 1068 LB

80 PSI 1005 LB

75 PSI 1005 LB

70 PSI 879 LB

65 PSI 817 LB

60 PSI 754 TB

55 PSI 691 LP

50 PSI 628 LP

45 PSI 565 LB

40 PSI 503 LB

35 PSI 440 LB.

30 PSI 377 LB

25 PSI 314 LB

20 PSI 251 LB

15 PSI 188 LB

10 PSI 126 lb.

Note: Force on part = Force of cylinder - Weight of lift table And, Weight of lift table - 150 lbs

Checking the Load Cell measurements for accuracy: Therefore,

Force on part = Force of cylinder - 150 @ 25 PSI 3141b - 1501b = 1641b VIBRATION WELDER - FINAL DESIGN Page 1 (AIR BLADDER/PNEUMATIC)

Subject: FINAL DESIGN TESTING WITH KNURLED HORN AND ANVIL PRISM FEEDBACK VOLTAGE MEASUREMENTS

Port Tube Material is the Ultra Escorene EVA BSG-913 RL-2-10-95A 5-D

PRISM operating voltage: 451vac 3 phase 50Hz incoming power.

Gap: .004"

Trigger Distance: 2.320"

Bladder Pressure: 70 PSIG

Cylinder Pressure: 100 PSIG

Welded on 5-21-95

Wet

Weighted 1kg (2.21b)

No freeze

Burst Tested on 5-24-95

Weld Time: 1.6 sec

Cool Time : 1.0 sec

Horn/Anvil Alignmen . Radius to Radius mirror image on lower edges .

Setup 1 Uses tne Final Long Horn - Wide width Radiused and Knurled Final Design Anvil - Radiuseα and Knurled.

Setup 2 Uses the Welded version of the Long, Wide Area Horn that has been stepped down at the horn tip to make it equivalent to a Narrow, Radiused, Knurled horn.

Setup 3 Uses the same configuration as in Setup 1 for a repeat condition after physical breakdown and regapping.

Page 2

Setup 1 Long, WIDE, radiused, knurled horn

Voltage feedback on Pickup Coil consists of a sinewave signal where every other cycle alternates at a different peak to peak level . Major peak to peak swing = 25 vp-p Minor peak to peak swing = 21 vp-p Period = 3.4 msec Frequency = 294.1Hz

Initial

Port Displayed Rupture No Burst Burst Actual

Tube Pressure Pressure Pressure Pressure Pressure

No (PSI) (PSI) ( (PPSSII)) ( (PPSSII)) ( (PPSSII)) Reason

1 -7 269 269 276 SW

2 -7 302 302 309 B+S

3 -7 320 320 327 SW

4 -7 306 306 313 B+S

5 -7 305 305 312 SW

6 -7 280 280 287 B+S

7 -7 305 305 312 SW

8 -7 283 283 290 SW

9 -7 290 290 297 B+S

10 -7 283 283 290 B+S

Page 3

Setup 2 Long. NARROW. Radiused. Knurled Horn

Voltage feedback on Picxup Coil consists of a sinewave signal wnere every other cycle alternates at a different peak to peak level.

Major peak to pea swing = 26 vp-p

Minor peak to peak swing - 21 vp-p

Period = 3.4 msec

Frequency = 294.1Hz

Initial

Port Displayed Rupture No Burst Burst Actual

Tube Pressure Pressure Pressure Pressure Pressure

No (PSI) (PS ) (PSI) (PSI) (PSI) Reason

-7 319 319 SW

-10 301 301 SW

-10 319 319 SW

-10 294 294 B+S

-10 319 319 SW -10 286 286 SW

•10 305 305 B+S

-10 286 286 B+S

-10 272 272 B+S

-10 305 305 SW

Setup 3 Long, WIDE, radiused, knurled horn

Voltage feedback on Pickup Coil consists of a sinewave signal where everv o-n-r r r_iP alternates at a different peak to peak level. " ~ ^<-^J"-^Le:

Major peak to peak swing = 26 vp-p Minor peak to peak swing = 21 vp-p Period = 3.4 msecs Frequency = 294.1Hz

Initial

Port Displayed Rupture No Burst Burst Actual

Tube Pressure Pressure Pressure Pressure Pressure

No (PSD (PSD (PSI) (PSI) (PSI) Reason

-10 282 282 292 B+S

-10 290 290 300 B+S

•10 273 273 283 B+S

-10 272 272 282 B+S

-10 265 365 275 B+S

-10 290 290 300 B+S

-10 305 305 315 B+S

-10 286 286 296 B+S

-10 272 272 282 B+S

10 -10 235 235 245 B+S

VIBRATION WELDER - FINAL DESIGN Page 1 (AIR BLADDER/PNEUMATIC)

SUBJECT: Port Tube Bursting Test with Varying Bladder Pressures on the Final Design.

Port tube material is the Ultra Escorene EVA BSG-913 RL-2-10-95A 5-D

PRISM operating voltage 45lvac 3 phase 50Hz incoming power.

Gap .004"

Trigger Distance 2.320"

Bladder Pressure: Will be varied from 20 to 60 PSI in 10 psi increments.

Cylinder Pressure: 100 PSIG

Welded on 7-25-95.

Wet

Weighed

No freeze

Burst tested on 7-31-95.

Weld Time 1.6 seconds

Cool Time 1.0 seconds

Horn/anvil alignment: radius to radius mirror image on lower edges

Horn Description: Long, wide, internally knurled face with a 1/16" radius along the lower edge.

Anvil Description: Wide, final design with internal, knurled diamond pattern and 1/16" radius along lower edge of face.

page 2

Bladder Pressure 30 PSIG

Port Initial Rupture No Burst Burst Actual Tube Pressure Pressure Pressure Pressure Pressure No (PSI) (PSI) (PSI) (PSI) (PSI)

1 -10 240 240 250 SW

2 -10 258 258 268 SW

3 -10 247 247 257 SW

4 -10 254 254 264 SW

5 -10 257 257 267 BS

6 -10 269 269 279 SW

7 -10 272 272 282 SW

8 -10 269 269 279 SW

9 -10 250 250 260 SW

10 -10 280 280 290 SW page 3

Bladder Pressure 30 PSIG

Port Initial Rupture No Burst Burst Actual Tube Pressure Pressure Pressure Pressure Pressure No (PSD (PSI) (PSD (PSD (PSI)

1 -14 239 239 253 SW

2 -14 261 261 275 SW

3 -14 239 239 253 SW

4 -14 243 243 257 W

5 -14 269 269 283 SW

6 -14 243 243 257 BS

7 -14 239 239 253 SW

8 -14 251 251 265 SW

9 -14 232 232 246 BS

10 -14 257 257 271 BS

Bladder Pressure 40 PSIG

Port Initial Rupture No Burst Burst Actual Tube Pressure Pressure Pressure Pressure Pressure No (PSD (PSD (PSI) ( SI) (PSI)

1 -14 261 261 275 SW

2 -14 261 261 275 SW

3 -14 272 272 286 SW

4 -14 247 247 261 sw

5 -14 239 239 253 SW

6 -14 261 261 275 sw

7 -14 269 269 283 sw

8 -14 232 232 246 BS

9 -17 247 247 264 sw

10 -17 254 254 271 W

Bladder Pressure 50 PSIG

Port Initial Rupture No Burst Burst Actual Tube Pressure Pressure Pressure Pressure Pressure o (PSI) (PSI) (PSI) (PSI) (PSI)

-17 261 261 278 SW

-17 257 257 274 SW

-17 239 239 256 BS

-17 251 251 268 SW

-17 239 239 256 BS

-17 254 254 271 SW

-17 280 280 297 SW

-17 254 254 271 BS

-17 246 246 263 SW

10 -17 282 282 299 BS

Bladder Pressure 60 PSIG

1 -17 265 265 282 BS

2 -17 286 286 303 SW

3 -17 239 239 256 BS

4 -17 257 257 274 BS

5 -17 250 250 267 BS

6 -17 282 282 299 BS

7 -17 254 254 271 BS

8 -17 250 250 267 SW

9 -17 243 243 260 BS

10 -17 239 239 256 BS

VIBRATION WELDER PROTOTYPE (AIR BLADDER/PNEUMATIC)

Subject: STATISTICAL RESULTS OF SCREENING STUDY NO 2

PROJECT NAME KIVALT.ECP

Created: Tue Apr 18 16:01 55 1995

"xxxxxxxxxxxxx Coefficients for response 'Mean-logit'

Centered continuous variables

COEFFICIENTS SD CONDITION TERM

-1.52619 0 CONSTANT

17.3166 0. .384504 0. ,0000 0.706 1 Weld-Time-Tot

1.80716 0. 954332 0. ,791 0.260 2 Weld-Time

0.0250475 0. ,0086903 0. .0121 0.248 3 Trig-Press

-0.0145366 0. .00807536 0. .0934 0.246 4 Trig-Press2

-0.444243 0. .111825 0, .0014 0.973 5 Cool -Tine

0.000549966 0. .0122511 0. .9648 0.791 7 Weld-Time-Tot*Trig

Press

-0.0118983 0. .0115285 0. .3195 0.819 8 Weld-Time-Tot*Trig-

Press2

-2.15134 0. .570482 0 .0021 0.963 9 Weld-Time-Tot-Cool-

Time

0.0521895 0 .0323042 0 .1285 0.264 10 Weld-Time*Trig-Pressl

-0.0070417 0. .01048 0. .5126 0.780 11 Weld-Time*Trig-Press2

-0.000391146 0 .000275724 0 .1779 0.238 13 Trig-Press*Trig-

Press2

N trials = 26

N terms = 12

Residual SD = 0.276687

Residual DF = 14

Residual SD used for tests

Replicate SD = 0.271336 Replicate DF = 5

R squared = 0.997, P=0.0000 ***

Adj R Squared = 0.994

Maximum Cook-Weisberg LD influence (scaled 0-1) = 0.915

- This term may be eliminated xxxxxxxxxxxx Coefficients for response 'SD-BURST'

Log e transformation used Centered continuous variables

COEFFICIENTS SD CONDITION TERM

1.68562 0 CONSTANT

8.76468 0. .254351 0. .0000 0 . 706 1 Weld-Time-Tot

-1.38569 0. .631294 0. .0455 0 .260 2 Weld-Time

-0. .00554859 0. .00574866 0. .3508 0 . 248 3 Trig-Press

-0 .00485027 0. .00534188 0. .3793 0 .246 4 Trig-Press2

0 .0866238 0, .0739728 0, .2611 0 . 973 5 Cool-Time

-0 .0209489 0 .00810414 0. .0216 0 . 791 7 Weld-Time-Tot*Trig-Press

0 .0141208 0 .00762615 0. .0853 0 . 819 BWeld-Time-To *Trig-Press2

( 3.303637 0, .377376 0. .4345 0 . 963 9 Weld-Time-Tot*Cool-Time

-0 .0440941 0 .0213694 0. .0581 0 . 264 10 Weld-Time*Trig-Press2

0 .0144737 0. .00693256 0. .0556 0 . 780 11 Weld-Time*Trig-Press2

0.0002510540 0 .00182392 0 .1903 0 . 238 13 Trig-Press*Trig-Press2 N trials = 26

N terms = 12

Residual SD = 0.183030

Residual DF = 14

Residual SD used for tests

Replicate SD = 0.150857 Replicate DF = 5

R Squared = 0.995, P=0.0000 ***

Adj R Squared = 0.990

Maximum Cook-Weisberg LD influence (scaled O-l) = 1.000

- This term may be eliminated

Parameters : Weld-Time = 0 . 500000 Trig-Press = 10 . 000 Cool -Time = 1 . 00 mean - logit Mean 1 + 315 e Burst = mean - logit 1 + e

Weld-Time=1.2 Cool-Time=l . 000

Value Low Limit High Limit 1 . 89 1. 13 2 . 65

Mean

Burst 273.789 238.333 315.0707

Important variables to maximize Mean Burst

Weld-Time-Tot = 1.2 seconds Cool-Time = 1 second Trig-Press = 10 PSIG

Parameters: Weld-Time = 0.500000 Trig-Press = 10.000 Cool-Time = 1.00

Weld-Time-=1.2 Trig-Pre=10.00

Value Low Limit High Limit 28.01 16.53 47.01

Important Variables to minimize Standard Dev. Burst

Weld-Time-Tot = 1.2 seconds Trig-Press = 10 PSIG Weld-Time = 0.5 seconds

Best setting found for Trig-Press2 = 10 PSIG But not important.

VIBRATION WELDER PROTOTYPE

Subject: 2ND SCREENING STUDY GROUPED RESULTS

WT=WELDTIME CT=COOLTIME

PI = FIRST BLADDER PRESSURE P2 = SECOND BLADDER PRESSURE

PR = PROPORTION RATIO OF THE TIME SEGMENT AT THE FIRST BLADDER PRESSURE TO THE OVERALL WELD TIME

S = SMALL HORN WIDTH

L = LARGE HORN WIDTH

N = NO KNURL PATTERN ON HORN OR ANVIL

H = KNURL PATTERN ON HORN, NONE ON ANVIL

B = KNURL PATTERN ON BOTH HORN AND ANVIL

Mean

Burst VARIANCE Horn Horn

5 PORT GROUPS T CT PP. PI P2 Pressure Lo Hi Width Knurl

RUN 1 TRIAL 1.4 -. , .5 40 70 278.2 -4.2 +24.8 S N

RUN 2 TRIAL 1 1 1, .5 70 70 38.8 -23.8 +44.2 S N

RUN 3 TRIAL 22 1 1, .5 40 40 24.0 -8.0 +17.0 S N

RUN 4 TRIAL 23 1.4 1, .5 40 40 267.2 -51.2 +31.8 S N

RUN 5 TRIAL 4 1.4 1, .5 40 70 278.4 -4.25 +16.75

RUN 6 TRIAL 13 1.4 1, .5 70 70 s N

278.25 -27.25 +16.75 S N

RUN 7 TRIAL 36 1 1, .5 40 70 27.2 -4.2 +15.8 S N

RUN 8 TRIAL 27 1 1, .5 55 55 21.8 -10.8 +4.2 S N

RUN 9 TRIAL 1 1 1, .5 70 70 20.8 -1.8 +5.2 S N

RUN 10 TRIAL 26 1.4 1, .5 55 55 298.6 -20.6 +33.4 L N

RUN 11 TRIAL 2 1 1, .5 40 70 78.0 -64.0 +61.0 L N

RUN 12 TRIAL 20 1.4 1, .5 40 70 321.4 -29.4 +27.6 L N

RUN 13 TRIAL 3 1.4 1, .5 40 40 48.4 -37.4 +34.6 L N

RUN 14 TRIAL 14 1.4 1, .5 40 40 282.4 -15.4 +16.6 L N

RUN 15 TRIAL 19 1 1, .5 70 70 23.8 -8.8 +24.2 L N

RUN 16 TRIAL 2 1 1, .5 40 70 40.0 -25.0 +47.0 L N

RUN 17 TRIAL 40 1.4 1, .5 70 70 297.6 -23.6 +23.4 L N

RUN 18 TRIAL 3 1 1, .5 40 40 38.4 -27.4 +73.6 L N

RUN 19 TRIAL 9 1.4 1, .5 40 70 275.2 -12.2 +16.8 L H

RUN 20 TRIAL 8 1 1, .5 40 70 15.4 -8.4 +13.6 L H

RUN 21 TRIAL 21 1.4 1, .5 70 70 271.0 -26.0 +9.0 L H

RUN 22 TRIAL 39 1.4 1, .5 40 40 268.0 -30.0 +6.0 L H

RUN 23 TRIAL 17 1 1, .5 70 70 18.6 -5.6 +10.4 L K

RUN 24 TRIAL 43 1.4 1, .5 55 55 277.8 -14.8 +10.2 L H

RUN 25 TRIAL 15 1 1, .5 40 40 17.6 -2.6 +1.4 L H

RUN 26 TRIAL 36 1 1, .5 40 40 28.6 -17.4 +21.6 S H

RUN 27 TRIAL 25 1 1, .5 55 55 44.6 -22.6 +60.6 S H

RUN 28 TRIAL 29 1 1, .5 40 70 30.2 -4.2 +6.8 N 29 TRIAL 51. 1 1, .5 70 s H

RU 70 237.0 -200.0 +65.0 H

RUN 30 TRIAL 37 1 1, .5 70 s

70 29.8 -11.8 +10.2 31 TRIAL 10 1.4 1, .5 s H

RUN 40 40 298.2 -17.2 +7.8 H

RUN 32 TRIAL 42 1.4 1, .5 55 s

55 295.4 -17.6 +14.6 S H

RUN 33 TRIAL 35 1.4 1, .5 40 70 297.4 -27.4 +23.6

1.4 1, .5 70 s H

RUN 34 TRIAL 5 70 306.2 -32.2 +21.8 s H

RUN 35 TRIAL 7 1.4 1, .5 40 70 275.6 -15.6 +16.4

1 s B

RUN 36 TRIAL IB 1, .5 40 70 26.0 -8.0 +11.0 S B

RUN 37 TRIAL 11 1 1, .5 40 40 19.8 -4.8 +6.2 38 TRIAL 33 1.4 1, .5 s B

RUN 40 40 258.8 -20.8 +11.2 S B

RUN 39 TRIAL 16 1 1, .5 70 70 30.0 -15.0 +35.0 S B

RUN 40 TRIAL 28 1 1, .5 55 55 19.0 -8.0 +7.0 UN 41 TRIAL 34 s B

R 1.4 .5 70 70 268.8 -19.8 +9.2 UN 42 s B

R TRIAL 41 1.4 .5 70 70 254.4 -17.4 +40.6 L B

RUN 43 TRIAL 6 1.4 τ_ .5 40 40 251.2 -13.2 +28.8 L B

RUN 44 TRIAL 30 1.4 -. , .5 40 70 271.2 -12.2 +33.0 L B

RUN 45 TRIAL 32 1.4 1, .5 55 55 260.8 -8.8 +13.2 L B

RUN 46 TRIAL 24 1 1, .5 70 70 24.6 -17.6 +55.4 L B

RUN 47 TRIAL 12 1 1, .5 40 70 70.8 -60.8 +31.2 L B

RUN 48 TRIAL 31 1 1, .5 40 40 79.4 -72.4 +28.6 L B

One Second Weld Group Organized fay Pressure

Mean

Burst VARIANCE Horn Horn

5 PORT GROUPS WT PR PI P2 Pressure Lo Hi Width Knurl

RUN 3 TRIAL 22 1, 1, 40, 40 24.0 - 8.0 +17.0 WF

RUN 18 TRIAL 3 1, 1, .5, 40, 40 38.4 -27.4 +73.6 WF

RUN 25 TRIAL 15 1, 1, .5, 40, 40 17.6 - 2.S + 1.4 WF

RUN 37 TRIAL 11 1, 1, • , 40, 40 19.8 - 4 8 + 6.2 WF

RUN 26 TRIAL 36 1, 1, .5 , 40, 40 28.6 -17 4 +21.6 WF

RUN 48 TRIAL 31 1, 1, .5, 40, 40 79.4 -72 4 +28.6 WF

Avg Mean 18

RUN 7 TRIAL 36 1, 1, .5, 40, 70 27.2 - 4.2 +15.8 WF

RUN 11 TRIAL : 1, 1, .5, 40, 70 78.0 -64.0 +61.0 WF

RUN 16 TRIAL 2 1, 1, .5, 40, 70 40.0 -25.0 +47.0 WF

RUN 20 TRIAL 3 1, 1, .5, 40, 70 15.4 - 8.4 +13.6 WF

RUN 28 TRIAL 29 1, 1, .5, 40, 70 30.2 - 4.2 + 6.8 WF

RUN 36 TRIAL 18 1, 1, .5, 40, 70 26.0 - 8.0 +11.0 WF

RUN 47 TRIAL 12 1, 1, • s , 40, 70 70.8 -60.8 +31.2 WF

Avg Mean 41.1

RUN 8 TRIAL 27 1, 1, .5 , 55, 55 21.8 -10.8 + 4.2 WF

RUN 27 TRIAL 25 1, 1, 55, 55 44.6 -22.6 +60.6 WF SW PD

RUN 40 TRIAL 28 1, 1, .5, 55, 55 19.0 - 8.0 + 7.0 WF

Avg Mean 28.5

RUN 9 TRIAL 1 1, 1, .5, 70, 70 20.8 - 1.8 + 5.2 WF

RUN 2 TRIAL 1 1, 1, • 5, 70, 70 38.8 -23.8 +44.2 WF

RUN 15 TRIAL 19 1, 1, .5, 70, 70 23.8 - 8.8 +24.2 WF

RUN 23 TRIAL 17 1, 1, .5, 70, 70 18.6 - 3.6 +10.4 WF

RUN 29 TRIAL 3 1, 1, .5, 70, 70 237.0 -200.0 +65.0 SW.PD,WF

RUN 30 TRIAL 37 1, 1, .5, 70, 70 29.9 -11.8 +10.2 WF

RUN 39 TRIAL IS 1, 1, -5, 70, 70 30.0 -15.0 +35.0 WF

RUN 46 TRIAL 24 1, 1, • 5 , 70, 70 24.6 -17.6 +55.4 WF

Avg Mean 32 . 6

1. Second Weld Group Organized by Pressure

Mean Burst VARIANCE Horn Horn

5 PORT GROUPS WT CT PR PI P2 Pressure Lo Hi Width Knurl

RUN 4 TRIAL 23 1.4, 1₁ .5 , 40, 40 267.2 -51.2 +31.9 SW WF

RUN 13 TRIAL 3 1.4, .5, 40, 40 48.4 -37.4 +34.6 WF *?

RUN 14 TRIAL 14 1.4, • 5, 40, 40 282.4 -15.4 +16.6 SW PD

RUN 22 TRIAL 39 1.4, 1, .5, 40, 40 268.0 -30 +16.0 WF SW PD

RUN 31 TRIAL 10 1.4, • 5, 40, 40 298.2 -17.2 + 7.8 SW PD

RUN 38 TRIAL 33 1.4, 1 • 5, 40, 40 258.8 -20.8 +11.2 WF SW PD

RUN 43 TRIAL 6 1.4, 1, • 5, 40, 40 251.2 -13.2 +28.8 WF

Avg Mean 239.2

RUN 12 TRIAL 20 1.4. τ_ .5, 40, 70 321.4 -29.4 +27.6 SW PD

RUN 1 TRIAL 4 1.4. • 5, 40, 70 278.2 - 4.2 +24.8 SW PD

RUN 5 TRIAL 4 1.4 1 • 5 , 40, 70 278.4 - 4.2. +16.75 WF SW.PD

RUN 19 TRIAL 9 1.4. 1 .5, 40, 70 275.2 -12.2 +16.8 WF SW PD

RUN 33 TRIAL 35 1.4. • 5, 40, 70 297.4 -27.4 +23.6 SW PD

RUN 35 TRIAL 7 1.4, 1 • 5, 40, 70 275.6 -15.6 +16.4 WF SW

RUN 44 TRIAL 30 1.4, 1 .5, 40, 70 271.2 -12.2 +33 WF SW

Avg Mean 285.3

RUN 10 TRIAL 26 1.4, .5, 55, 55 298.6 -20.6 +33.4 SW WF

RUN 24 TRIAL 43 1.4, 1 .5, 55, 55 277.8 -14.8 +10.2 WF

RUN 32 TRIAL 42 1.4, _ • 5, 55, 55 295.4 -17.6 +14.6 SW PD

RUN 45 TRIAL 32 1.4, .5, 55, 55 260.8 - 8.8 +13.2 WF SW PD

Avg Mean 283.2

RUN 6 TRIAL 13 1.4, .5, 70, 70 278.25 -27.75 +22.25 WF SW PD

RUN 17 TRIAL 40 1.4, .5, 70, 70 297.6 -23.6 +23.4 SW PD

RUN 21 TRIAL 21 1.4, 1 70, 70 271.0 -26.0 + 9.0 WF SW,PD

RUN 34 TRIAL 5 1.4, 1 .5, 70, 70 306.2 -32.2 +21.8 SW PD

RUN 41 TRIAL 34 1-4, . .5, 70 70 268.8 -19.8 + 9.2 SW PD WF

RUN 42 TRIAL 41 1.4, _]_ • 5, 70 70 254.4 -17.4 +40.6 WF SW PD

Avg Mean 279.4

1.4 Second Weld Groups Organized by Horn Pattern

Mean

Burst VARIANCE Horn Horn

5 PORT GROUPS WT CT PR PI P2 Pressure Lo Hi Width Knurl

RUN 4 TRIAL 23 1.4, 1, .5 , 40, 40 267.2 -51.2 +31.8 S N SW WF

RUN 1 TRIAL 4 1.4, .5, 40, 70 278.2 - 4.2 +24.8 S N SW PD

RUN 5 TRIAL 4 1.4, 7, .5, 40, 70 278.4 - 4.25 +16.75 S N WF SW PD

RUN 6 TRIAL 13 1.4, 1, • 5, 70, 70 278.25 -27.25 +16.75 S N WF SW PD

Mean Avg 275.5

RUN 31 TRIAL 10 1.4, 1, .5, 40, 40 298.2 -17.2 + 7.8 S H SW PD

RUN 33 TRIAL 35 1.4, 1, .5, 40, 70 297.4 -27.4 +23.6 S H SW PD

RUN 32 TRIAL 42 1.4, 1, .5, 55, 55 295.4 -17.6 +14.6 S H SW PD

RUN 34 TRIAL 5 1.4, 1, .5, 70, 70 306.2 -3L.2 +21.8 S H SW PD

Mean Avg 299.3

RUN 38 TRIAL 33 1.4. 1, .5, 40, 40 258.8 -20.8 +11.2 S B WF SW PD

RUN 35 TRIAL 7 1.4. 1, .5, 40, 70 275.6 -15.6 +16.4 Ξ B WF SW

RUN 41 TRIAL 34 1.4. 1, .5, 70, 70 268.8 -19.8 + 9.2 S B SW PD WF

Mean Avg 267.7

RUN 13 TRIAL 3 1.4, 1, .5. 40, 40 48.4 -37.4 +34.6 L N WF

RUN 14 TRIAL 14 1.4, τ_ • 5, 40, 40 282.4 -15.4 +16.6 L N SW PD

RUN 12 TRIAL 20 1.4, 1, • 5, 40, 70 321.4 -29.4 +27.6 L N SW PD

RUN 10 TRIAL 26 1.4, 1, .5, 55, 55 298.6 -20.6 +33.4 L N

RUN 17 TRIAL 40 1-4, 1, • 5, 70, 70 297.6 -23.6 +23.4 L N

Mean Avg 249.68 With Outlier

Mean Avg 300.00 Without Outlier

RUN 22 TRIAL 39 1.4, 1, .5, 40, 40 268.0 -30.0 + 6.0 L H

RUN 19 TRIAL 9 1.4, 1, • 5, 40, 70 275.2 -12.2 +1D.8 L H

RUN 24 TRIAL 43 1.4, 1, .5, 55, 55 277.8 -14.8 +10.2 L H

RUN 21 TRIAL 21 1.4, 1, _> 5 70, 70 271.0 -26.0 + 9.0 L H

Mean Avg 273.00

RUN 43 TRIAL 6 1.4, 1, .5, 40, 40 251.2 -13.2 +28.8 L B

RUN 44 TRIAL 30 1.4, 1, .5, 40, 70 271.2 -12.2 +33.0 L B

RUN 45 TRIAL 32 1.4, 1, .5, 55, 55 260.8 - 8.8 +13.2 L B

RUN 42 TRIAL 41 1.4, 1, • 5 , 70, 70 254.4 -17.4 +40.6 L B

Mean Avg 259.4 Results :

In the prior Screening Study No. 1, it was indicated that a .8 second weld resulted m weld^" fractures.

A 1.2 second weld resulted n s dewall bursts.

Cool Time was not significant and could be held constant at the minimum tested (1 second) .

The bladder pressure proportion of .5 seemed to achieve slightly higher mean burst pressures and is well constant m this experiment.

These welds were done with the short sonic horn having a knurl patters in the horn and a blank relief of .050" on the lower edge. The anvil was also knurled.

Bladder pressures below 40 pounds resulted in very poor burst pressures.

In this Screening Study, No. 2, it was thought to test the area around 1.2 seconds to see if going longer on weld time would improve burst strengtn. The range of weld time oecomes l to 1.4 seconds and we test these limits.

Changes from the previous experiment are:

1) Long Horn instead of short.

2) Symmetrical Chisel to the line of center.

3) Large and Small width versions of the long horn.

4 ) Start with Blank Faced Horns and Anvil ,- knurl progressively horn and then both horn and anvil; do experiments after each transition.

From the tables above, all 1 second weld times resulted in weld fractures. These port tubes were delaminated on one or both sides of the weld pattern wnen thawed from the freezer.

The weld fracture pressures indicated above for these tubes were, m fact, the initial driving pressure indication of the burst testing machine. These ports will weep at lower pressures .

The burst pressures for 1.4 second weld resulted in a mixture of Weld Fractures and Side Wall Bursts.

As best in FIG. 5 of the drawings, in a preferred embodiment apparatus 10 includes a filling tube 114 for filling bags -L2 through port tube 22. A supply of sterile liquid such as intravenous solution is contained in a sealed receptacle 115 which is in fluid communication with filling tube 114. The flow of the solution through filling tube 114 is controlled by a syringe pump 117 and by a pinch and draw valve 116, as shown in FIG. 8. Filling tube 114 lies in a track 119 in block 121. Liquid within the filling tube 114 is drawn from the sealed receptacle 115 by the syringe pump 117 in a desired quantity. In order to dispense liquid pinch and draw valve 116 must be open. Valve 116 has two valve heads 118 and 120 which compress tubing 114. Opening and closing of valve heads 118 and 120 is accomplished by air cylinders 122 and 124. When air cylinders 122 and 124 are actuated, they causes valve heads 118 and 120 to close. Conversely, when air cylinders 122 and 124 cause valve heads 118 and 120 to retract, fluid is allowed through the distal end 126 of filling tube 114 and into port tube 22. By closing valve head 118 first, and valve head 124 next, fluid in filling tube 114 at distal end 114 is drawn back slightly into the tube 114. This allows liquid to be dispensed without dripping from the filling tube 114 after dispensing. A second view of pinch and draw valve 116 is shown in FIG. 9 in which air is provided at first end 132 of air cylinder 124 so as to cause shaft 134 to be withdrawn into air cylinder 124, thereby opening a passage for fluid into filling tube 114.

In order to raise and lower filling tube 114, a fill nozzle actuator 127 is provided, as shown in FIG. 13. Fill nozzle actuator 127 is mounted on shaft 128 which in turn is raised or lowered by air cylinder 130 thereby causing filling tube 114 to be raised and lowered toward or away from bag 12. Port tube 22 is preferably sealed while distal end 126 of fill tube 114 is within port tube 22. In an alternative embodiment, not shown, bag 12 mounted on a conveyor may be passed under filling tube 114 and filling tube 114 lowered into bag port tube 22 for filling. Turning again to FIG. 3, in a preferred embodiment, enclosure 14 has a plurality of pivotable sealable doors 136. The doors are mounted on hinges 138 and are constructed so as to allow introduction and removal of the bags 12 from the enclosure 14 if required. However, bags 12 are usually removed individually through slot 45. A sterilizing agent such as Hydrogen Peroxide, Ethylene Oxide or other chemical or gaseous sterilization agents commonly known may be used for resterilizing the bags. In order to maintain sterility, sterile air is forced into the enclosure 14 under pressure from filtered blower 81 and continually replaced so as to keep a positive air pressure within sterile enclosure 14.

As best seen in FIG. 3 of the drawings, vibration sealer mechanism 26 extends from outside enclosure 14 to within enclosure 14. The electronic apparatus 100, (Branson Model Series 90 Mini- Vibration Welder No. 109-130-001) sits outside the enclosure 14 and an air cylinder 98 is utilized for extending or retracting the sealing head 94 within the enclosure 14. Extension is caused by inserting air into the proximal end 140 of air cylinder 98 and retraction is caused by providing air under pressure into the distal end 142 of air cylinder 98.

As mentioned previously, in a preferred embodiment arm 77 has at its first end 80 and second end 82, apertures 144 and 146 which are open sufficiently to allow passage of port tube 22 with flanges 74 extending therefrom. Flanges 74 then rest upon the first and second ends 80 and 82 of arm 77 and port tube 22 is frictionally engaged within apertures 144 and 146 so as to be retained therein, thereby supporting bag 12. As a result one of the features of the present invention is that, as shown in FIG. 5, because of the suspension of bags 12 from arm 77, a variety of sizes of bags may be utilized without mechanical changes to the apparatus .

In a preferred embodiment, means of monitoring the pressure applied by sealing head 94 may be provided by a pressure sensor 148 proximate anvil 84, which monitors the pressure being applied and controls the volume of air being directed to air cylinder 98 thereby precisely maintaining the desired pressure for the desired period of time. As an additional feature of the invention, a check weigher may be provided either attached to arm 77 or as a separate station within enclosure 14 which allows precise control of the weight and therefore the volume within filled bags 12. Port tube 22 is preferably constructed of a blend of EVA and Ethylene. In a preferred embodiment, Escorene^® UL00218MED random Copolymer of Vinyl Acetate and Ethyl (EVA) from Exxon Chemical is utilized. Port tube 22 is constructed of Escorene^® having a range of 12 - 18 percent EVA and a 50/50 blend of Polyethylene to the EVA. It has been found that the pressure and dwell times previously enumerated utilizing this blend provide strong hermetic seals of port tube 22, as shown in the charts found on pages 12 to 39 herein. Alternatively, bags 12 may be constructed of blends of Polyolefins and Butyl rubbers or thermoplastic elastomers such as Kraton^® in a 50/50 blend, as known in the prior art .

Claims

CLAIMS What is claimed is:

1. An apparatus for filling and sealing, in a sterile environment, flexible thermoplastic bags having a port tube extending therefrom, said apparatus comprising: a substantially sealed sterile enclosure; a turntable rotatably mounted within said enclosure, said turntable including means for suspending a plurality of said flexible bags therefrom; means for filling said bags through said port tube; and means for vibration welding and hermetically sealing said port tubes .

2. The apparatus of Claim 1 wherein said port tube includes a flange radially extending therefrom, and said means for suspending said flexible bags comprises: flange support means for suspending said flexible thermoplastic bags from said flange.

3. The apparatus of Claim 1 and further comprising: means for storing said flexible thermoplastic bags within said enclosure before sealing of said port tubes.

4. The apparatus of Claim 1 and further comprising: at least two portholes extending into said enclosure; and a viewing window into said enclosure; and at least two flexible glove members each hermetically sealed to said porthole members and extending therethrough, said flexible gloves being constructed and arranged to allow manual manipulation of said flexible bags within said enclosure.

5. The apparatus of Claim 4 wherein said viewing window further comprises: a slot member within said window for removal of said bags from said enclosure without contamination thereof.

6. The apparatus of Claim 5 wherein said slot member further comprises : a chute connected thereto for prevention of backflow into said enclosure when said bags are removed therefrom.

7. The apparatus of Claim 2 wherein said means for storing said flexible containers comprises: a rack member having one or more levels and a plurality of slots formed therein, said rack member being constructed and arranged for the storage of said flexible containers within said enclosure .

8. The apparatus of Claim 1 wherein said turntable comprises: a circular conveyor.

9. The apparatus of Claim 7 wherein said rack further comprises : a rack conveyor for transporting said plurality of bags to and from said rack member.

10. The apparatus of Claim 1 wherein said means for hermetically vibration welding said port tube comprises: an anvil within said enclosure; a sealing head slidably disposed within said enclosure and positioned for selective compression of said port tube against said anvil; means for selectively sliding said sealing head towards said anvil and applying pressure against said port tube and said anvil so as compress said port tube; means for vibrating said sealing head so as to melt said port tube sufficiently to hermetically seal said port tube; and means for slidably retracting said sealing head away from said anvil.

11. The apparatus of Claim 10 wherein during sealing, said sealing head is vibrated at a frequency of 200 herz to 300 herz, peak to peak, at an amplitude of .070 inches + .020

12. The apparatus of Claim 1 wherein said means for filling said bags through said port tubes comprises : a filling tube in fluid communication with and connected to a source of fluid; means for selectively inserting the distal end of said filling tube into said port tube; and means for selectively dispensing a desired quantity of said fluid through said port tube and into said bag; and means for withdrawing said filling tube from said port tube.

13. An apparatus for filling and sealing flexible thermoplastic bags having a port tube extending therefrom said apparatus comprising: a substantially sealed sterile enclosure; means for suspending a plurality of said flexible bags within said enclosure; and means for filling said bag through said port tube; and means for vibration welding said port tubes within said enclosure.

14. The apparatus of Claim 1 wherein said sterile enclosure further comprises: means for introduction and removal of said bags from said enclosure while maintaining sterility; and means for introducing and retaining a chemical sterilization agent in said enclosure.

15. The apparatus of Claim 14 wherein said chemical sterilization agent comprises hydrogen peroxide.

16. The apparatus of Claim 1 wherein sterile air is continuously forced under pressure into said enclosure.

17. The apparatus of a Claim 1 wherein said anvil has a width of approximately 1 1/4 inches +, % and a height of ^XA inches ┬▒ 1/4 and said sealing head has a width of % inches +_. 1/4 and a height of 1/4 inches ┬▒ 1/16.

18. The apparatus of Claim 16 wherein said sealing head has a height of 2.5 - 4.5mm.

19. The apparatus of Claim 8 wherein said sealing head is compressed against said anvil with a minimum 40 pounds of force when sealing said port tube.

20. The apparatus of Claim 1 wherein said means for suspending a plurality of said flexible bags comprises: means for accepting and supporting a plurality of bags of different sizes without alteration of said turntable.

21. The apparatus of Claim 1 wherein said means for suspending a plurality of said flexible bags comprises: an arm member having one or more forked apertures thereon, said apertures being constructed, sized, arranged, and positioned for reception of and support of said port tubes, thereby supporting said bags.

22. The apparatus of Claim 10 wherein said means for selectively sliding said sealing head toward said anvil comprises : an air cylinder for movement of said sealing head and for selectively application of a desired force against said sealing head.

23. The apparatus of Claim 22 and further comprising: a pressure sensor for monitoring the pressure of said sealing head applied against said anvil.

24. The apparatus of Claim 22 and further comprising: a pneumatic bladder positioned between said air cylinder and said sealing head for controlling the amount of force applied against said sealing head, said bladder being inflatable and deflatable to regulate said force.

25. The apparatus of Claim 24 wherein said bladder absorbs a selected amount of force applied against it by said air cylinder, said amount of force being regulatable by inflating or deflating said bladder.

26. The apparatus of Claim 12 wherein said means for selectively dispensing a desired quantity of said fluid comprises : a pinch and draw valve for dispensing a desired amount of fluid without dripping of said filling tube after dispensing said desired amount of fluid.

27. The apparatus of Claim 1 wherein said flexible bag comprises 12-18% ethyl vinyl acetate and the remainder is polyethylene.

28. The apparatus of Claim 1 wherein said flexible bag comprises 12 - 18% ethyl vinyl acetate and polyolefins.

29. The apparatus of Claim 1 wherein said means for sealing said port tube comprises a port cap which frictionally engages and seals the distal end of said port tube.

30. A flexible container for medical solutions, said container comprising: a thermoplastic bag having a port tube extending therefrom; and a vibration weld for hermetically sealing said port tube.

31. The bag of Claim 30 wherein said bag comprises:

12-18% Ethyl Vinyl acetate and a blend of polyolefin and butyl rubber.

32. The bag of Claim 21 wherein said port comprises: 12-18% Ethyl Vinyl Acetate and a blend of polyolefin.

33. A method of filling and sealing sterile medical solution bags, each having a port tube extending therefrom, said method comprising the steps of : suspending said bags from a conveyor in a sterile enclosure; filling said bags on said conveyor through said port tubes; and vibration sealing said port tubes.

34. The apparatus according to Claim 1 in which said means for vibration welding comprises: a sealing head extending horizontally into said enclosure; an anvil within said enclosure; means for selectively sliding said sealing head towards said anvil; and means for vibrating said sealing head positioned outside said enclosure so as to allow operation thereof without contamination of said sterile enclosure.

35. The apparatus of Claim 12 wherein said means for dispensing a desired quantity of fluid comprises a syringe pump.