DE3430764A1 - METHOD AND DEVICE FOR THE PRODUCTION OF CAPSULES SECURED AGAINST AN UNAUTHORIZED OPENING, AND SUCH CAPSULES - Google Patents

Description

-ΙΟΙ Method and device for producing against a

unauthorized opening secured capsules and such capsules

The present invention relates generally to methods and devices for sealing medical capsules, in particular Processes and devices for friction welding hard gelatine capsule sections with the production of dense, secured against unauthorized opening and indicating such an opening Consumables.

The present invention also relates to medical capsules, in particular hard gelatin capsule sections connected by friction welding, the tight, secured against unauthorized opening and indicating such an opening Form consumables.

Traditional methods of packaging powdered consumer products Such as aspirin, headache powder, and cold remedies include the unit dose packaging of these medicinal products Compounds in telescopically nested tubular capsules made of "hard gelatine" are made. Each such capsule contains a single dose of the respective drug and consists of one upper tubular section, which is pushed onto a lower tubular capsule section with an exact fit, the contains the medicine. Experience has shown that the conventional capsules are very sensitive to them unauthorized or undesired opening by

3Q agreed with the audience while it was on the shelves the retailer are located. Conventional means of preventing such unauthorized opening relate to the use of complicated closures for the medicine bottles. Unfortunately, most, if not so-

gg even all of these so-called indicating unauthorized opening Bottle closures from skilled persons

343076Ä

to be overcome. Even if the bottle closures are difficult to break, the contents of the bottle are then with regard to unauthorized opening by persons who have access to the bottle, if the bottle is at risk is open once. For example, in polyclinics, school clinics and other areas where the The public has general access to such medicaments, the bottle caps indicating an opening does little to prevent unauthorized opening of the capsules once the bottle has been opened.

It is the object of the present invention to provide drug capsules secured against unauthorized opening, in ^ -dem a method and an apparatus for generating such capsules is created. "Capsules secured against unauthorized opening" are to be understood as meaning capsules which offer resistance to opening and which can be viewed whether it is accidental or deliberate opened.

This object is achieved by a method, a device and capsules as described in the claims are.

The integral generated on each capsule according to the invention The seal is so tight that it is necessary to destroy the capsule in order to expose the contents of the capsule. One such destruction clearly indicates to a subsequent user that the capsule has been opened without authorization.

The present invention describes means for sealing the telescopically nested ends individual capsules containing powdered medicinal compositions contain. The invention relates, inter alia, to a combination of a steam jet and friction welding system, which include sealing individual capsules

-12-enables the conditions of rapid mass production.

The present invention includes a method of manufacture of capsules secured against an unauthorized opening or indicating such an opening with two telescoping capsules Capsule halves made of hard gelatin or another thermoplastic material, with the lower half is filled with the consumable product and the upper half is pushed onto the lower half with a precise fit

IQ , wherein the method is the exposure of a contact zone in the overlap area of the two capsule halves, the tackification of the gelatin in at least a part of the exposed zone, the rapid rotation of at least one of the capsule halves relative to the other capsule half and

^ 5 the unification of the capsule halves by renewed complete Includes nesting during their relative rotation.

The device for carrying out said method 2Q comprises an alignment device for arranging the capsules with capsule halves connected by sliding one into the other in a predetermined, preferably vertical arrangement, lower and upper gripping elements for gripping the upper and lower capsule halves, means for partially telescoping them apart the capsule halves, tackifier of a portion of the surface in the region overlapping in telescoped capsule halves, means for rotating the tackified capsule half relative to the other half of the capsule as well as ₃ Q an additional device for re-pushing the capsule halves during the rotation of the rotating means .

The invention is given further advantages and op- embodiments with an explanation of the above terms explained in more detail below with reference to the figures.

Show it:

Figure 1 is a side view of a set of capsule components prior to assembly;

Figure 2 is a sectional side view of an assembled capsule;

Fig. 3 is a sectional side view of a capsule partially expanded in a telescopic manner;

Fig. 4 is a sectional side view of a capsule which

was pushed back together and locked in accordance with the present invention;

5 shows a side view of a device for welding capsules;

Fig. 6 is a plan view of the device of Fig. 5;

7 shows a close-up view of a friction welding station;

8 is a schematic view of the cam assembly of the friction welding device;

Fig. 9 is a schematic view of the alignment construction

group of device;

Figure 10 is a sectional side view of the steam jet assembly the invention;

11 is a schematic flow diagram of the process generator and its tax system;

12 to 14 different views of the vacuum clamping device according to the present invention;

Figs. 15 and 16 show another embodiment of the invention

using an offset source of radiant energy to fuse the capsules;
5

17 shows a further embodiment of the invention with gluing of the capsules to be connected a solution;

Fig. 18 shows another embodiment of the invention with a friction-enhanced friction welding for Fusing the capsule halves;

19 shows an embodiment using Capsules with superficial bumps for

friction welding;

Figures 20 and 21 show a fused embodiment

with a hot wire.

Referring now to FIGS. 1 to 4, these show the various stages in an enlarged sectional view of sliding the capsule halves. Referring to Fig. 1, a gelatin capsule 101 includes a lid or top cylinder 102 and a bottom or lower cylinder 103 which is filled with a powdered drug composition 104 is. The individual capsule parts 102 and 103 may be of the conventional type currently in use. These Capsules consist of a pair of generally cylindrical tubular capsule sections that are in cylindrical circular shape are made of hard gelatin and each have rounded ends. the the two parts are generally very similar in size and form a precisely fitting, tight friction connection. The margin or tolerance of the sizes is just enough for the cartridges to slide over one another

-15-can after they have been filled with the powder.

Fig. 2 shows a conventional cartridge / after it has passed Telescoping has been completely closed. In this arrangement the capsule is inserted into the device according to the invention entered. The present embodiment of the invention is a retrofit or additional system, which can be used with currently used capsule filling devices. According to the invention In other words, the disclosed device is intended for filling at the end of a production line of capsules to be added between the filling system and the bottle filling device. In a particular embodiment it is provided that the present invention is integrated into a filling system, whereby a or two stages of the invention as described in this application can be saved. Even though Thus, reference was made to an integrated system, the present embodiment is in the form of an additional system that can be added to a manufacturer's current equipment. Consequently the procedure is described in terms of the steps involved in making a finished capsule according to Fig. 2 begins. This is then partially separated, after which the capsule is rejoined by friction welding. Thus, Fig. 2 shows a capsule as they are in the invention Device arrives.

Fig. 3 shows a sectional side view of the cartridge from QQ Fig. 2 after it has been securely in the friction welding device according to the invention and separated a distance labeled "Z" with the remaining telescopic interlocking of the capsule parts in Fig. 3 is denoted by the symbol "E". The ratio of gg separation "Z" to overlap "E" during the friction welding previous step, is about 3 to 2,

343076A

1 or, in other words, the capsule is pulled apart to about 60% of its original overlap. While the Capsule is held in the orientation shown in Fig. 3, the steps described in more detail below are followed the capsule is carried out, and it is reassembled at a predetermined special moment after it treated with a thin jet of steam and friction welded. Figure 4 shows the re-union of the capsule components immediately after the steam jet treatment and friction welding. Fig. 4 thus represents the final sealed configuration of the capsule secured against opening and indicating such an opening represent.

Referring now to Fig. 5, this shows a preferred embodiment of the system for carrying out the present Invention in a schematic view. In Fig. 5, the base 201 comprises a base 202 on which can be rotated a welding wheel 203 and a take-up wheel 204 (Fig. 6) are mounted. On a journal above the welding wheel 203 is a feed device 205 with a mounting pin 206, a ladder conveyor (conveyor belt) 207, a raw product feed trough 208, a slowly rotating felt or padded damper wheel 209, an aligner 210 and a feed pipe 211 is arranged.

A vibrator 213 is attached to the bottom of the trough 208, in order to set this in vibration in order to erleichgo the movement of the capsules downwards to the Dämmrad 209 tern. The wheel 209 is mounted in the trough 208 by means of a pin or shaft 214. In a similar way it is the aligner 210, which includes a set of parallel grooved wheels or "V-disks", on a pin or shaft 215 mounted.

A rotary motion is applied to the rotatable elements of the present Invention transmitted by a drive motor 216, which by a gear reducer 217 with the Pin 206 is coupled. An upper pivot connection 218 is rotatable via the shaft 206 with the drive motor 216 connected and is used to rotate clockwise when viewed from above. A row of upper welding mandrels 219 is attached to the rotary joint 218 with connecting means (not shown). The welding mandrels 219 are in a vertical position Movable to and fro direction, its vertical position being due to the inward-facing action Rollers 220 is determined which engage in a cam slot 221 formed in a stationary cam wheel 222 is. The welding mandrel 219 comprises a bearing-mounted welding head 223 which is rotatable on an elongated Mandrel shaft 224 is mounted, which in turn is from a mandrel transverse shaft 225 hangs down. The mandrel transverse shaft 225 has the already mentioned inner roller 220 and an outer roller 230 which are rotatably mounted at each of its ends. In the specific preferred embodiment Sixty welding mandrels 219 extend from the rotary joint 218 in a uniform arrangement in the radial direction outward.

The upper welding assembly, comprising the parts identified by reference numerals 204-230, is of a Main column base 231 carried, which is arranged centrally below her and extends down to the lower welding assembly extends. The lower welding assembly essentially comprises a welding wheel 203, a lower rotary joint 232, a lower casing 233, a base base 234 and a control console 235. The control console 235, which carries the entire welding device, can be arranged on wheels 236 in order to make the system movable.

A control panel 237 is on the front surface of the console or cell 235 arranged to adjust the

Ι Process control parameters when operating the system enable.

FIG. 6 shows a plan view of the device from FIG. The view of FIG. 5 corresponds to a section 5-5 in FIG. 6. The capsule welding system 201 in FIG. 6 shows a dome cover 240 under which a number of welding mandrels 219 is shown dotted to show its typical placement below the top pivot assembly. A drive system 241 is located in the vicinity of welding stations 219 and includes a driven pulley 242 and a drive pulley 243. A second driven pulley 244 is also in close proximity arranged. A drive belt 245 is stretched over .die three pulleys and arranged so that it is attached to the Thorns 219 on an arcuate section 24 6 rests. This arcuate section comprises about 60 to 70 ° des entire 360 ° circular arc of the upper rotation system. The rotating system 241 is also partially shown in FIG. 5 Sectional side view shown. The drive motor 247 of FIG. 5 serves to drive the drive belt pulley 243 drive and move the drive belt 24 5 around the three pulleys. A housing 252 protects the rotary drive assembly. Fig. 6 also shows the arrangement of a vacuum pump 250 to generate an operating vacuum around the Keep capsules in their proper orientation in the facility. The take-off wheel 204 comprises a circular plate with capsule recesses 251 which are made in its outer wall. An electrical cell 254 is also

QQ is intended as a housing for the electrical components of the present system.

Also in Fig. 6 is a more detailed illustration of the feed system with the conveyor 207, the trough 208, the Wheel 209 and aligner 210 are shown. The trough 208 is provided with a series of parallel elongated channels 255

see formed in or cut into the bottom surface of the trough 208. Each channel is arranged so that the capsules are arranged in a longitudinal direction with respect to the trough 208. At the end of the trough 208 is a soft one padded damper wheel 209 that rotates to pull the capsules into the aligner 210. The organizer 210 comprises a set of six disc-like pulleys 256, each with a profile as generally is shown in FIG. In Fig. 9 is one of the aligner pulleys 256 having a profile with a narrower inner channel 257 and another outer channel 258, which is located next to the inner channel 257 in the radial direction outward. The construction or Orientation of the wheel 256 is such that the lower portions of the capsule when the capsules hit the top of the Aligner 210 pass, rotated inward into the narrower channel 257, creating the upper capsule section is rotated into the top or deck area 258. This is achieved by making the inner channel 257 smaller is performed as the outer diameter of the capsule lid, causing entry of the capsule lid into the lower channel is prevented. Thus, the combination of channels 255 and pulleys 256 serves to get the capsules first in a longitudinal direction and then in terms of their thick and thin ends in a perpendicular direction orientate. The capsules slide from the pulleys 256 into a series of feed tubes 211, each of which one located directly below the lip of each pulley 256. Each feed pipe 211 curves

gQ down into a vertical feed position directly over a capsule cavity in welding wheel 203, as shown in FIG. It should be noted that for reasons For simplicity and clarity, only a single feed tube is shown in Figure 5, although in the preferred embodiment actually six such tubes are used side by side.

In addition to the various assemblies and subassemblies above, shown in Figure 6 and associated with the present system is as a key subassembly the process generator 260 should be mentioned, which in the radial direction inwards behind the welding mandrels 219 is arranged opposite the rotary drive 241. The process generator 260 is shown more clearly in FIG includes a steam jet generator with an electric one Rapid heating element 261 in a tubular housing 262 is arranged. The rapid heating element 261 is electrically heated, preferably with a voltage of 220V which is applied to contacts 263. Element 261 is a resistive heating element that comes from a 220V power source is fed and used to flash distilled water, which is supplied through supply line 264 and held in a primary liquid compartment 265. A pair of alternately offset baffle plates 266 and 26 7 are arranged in the tube 262 to prevent that liquid water leaves chamber 265. A narrow exit path shown by flow arrows 268 is formed between the offset plates 266 and 267. The steam can exit through the jet nozzle 269.

An overpressure safety plug 270 is in the steam chamber 271 of the steam generator 260 and adjusted to about 34.5 kPa (5 psi) for a positive pressure to prevent in the generator system. A liquid upper level probe 272 is in the wall of the compartment 265, and a low level probe 273 is in the lower surface of the compartment 265 to indicate a low fluid level. A drain cock 274 is also in the lower Located at the end of the chamber 265 to permit draining of the liquid from the steam generator for maintenance purposes

enable. A temperature probe 275 extends inwardly into the lower end of the chamber 265 from the rear wall thereof 278 ago. A temperature control wire 276 leads from the Temperature probe 275 to the switchboard of the system. It should be noted that the steam nozzle 269 so on Gelatin capsule is directed that the in Fig. 3 and designated "Z" area is hit. The order of steam generator 260 is shown schematically in FIG. 6, as previously mentioned, and is located

IQ extends in the radial direction inside the welding mandrels 219 and the rotary drive 241. The steam jet 269 is directed outwards in the radial direction, so that it hits the capsules held in the welding heads 223. Preferably, a vacuum source is attached to each weld stem 224 to apply vacuum to the head 223 to grip the capsules. Similarly, a vacuum source is connected upwardly through welding wheel 203 to grip the lower portions of the capsule which are held therein.

The operation of the process generator 260 can be ensured in a purely mechanical manner with cam elements, which are operated by cam parts, which one or the other of the rotating elements (203,218,242,243,244 etc.) touch. Alternatively, the process generator can be operated manually through a separate electrical on / off switch be operated. Or it can be in a permanently on arrangement by the power supply contacts 263 are connected to the same switch that supplies motor power to the friction weld assembly, thereby ensuring that steam is generated constantly all the time when the friction weld assembly is switched on.

The process generator 260 is preferably an automated one Control system put into operation using solid state controls. Furthermore, in a preferred embodiment a high-voltage

Steam ionization agent added for better distribution of the impinging steam on the capsules. 11 schematically depicts both a solid state control system and an ionized vapor process represent.

The system disclosed in FIG. 11 consists of the steam generator 260 with the rapid heater element 261, probes and 272 for a low or high liquid level

IQ as well as from the water supply line 264. In addition to these elements already described, the system also includes a sterile water storage tank 212 with a coiled condensate return line 277 therein which is connected to the friction weld capsule assembly area. Of the

j5 tank 212 has a logic probe 282 for low Water level extending through its wall and with a solid state process controller 228 having a electrical line 283 is connected. The process controller also receives signals from probes 272 and 273 for high and low fluid level through lines 284 and 285, respectively.

The heater 261 is a dual element unit with the circuitry in the box 229 which draws its energy from a solid state power controller 238 over lines 286. The controller 238, in turn, is driven by signals from a solid-state temperature controller 239 connected to it by lines 287. An input to the temperature control device

gQ is generated by probe 275 and across the line transfer.

Sterile distilled water is pumped by pump 290 to process generator 260, the pump being over "J. the supply line 289 from the bottom of the tank 212 with Water is supplied. A one-way control valve 291

prevents backflow of liquid from the process generator, when the pump 290 is off. The pump 290 can be activated by a signal from the process controller 228. and switched off, which is transmitted via line 29 2. A 102, 33kPa (15 psi) pressure relief valve is arranged in the steam chamber of the process generator to prevent excessive pressure being created in to prevent this. The temperature probe 27 5 is preferably a "J" type thermocouple.

During operation, sterile distilled water is supplied by the pump 2'90, which is controlled by the process controller 228 in the In accordance with the measurement data controlled by the probes 272 and 273, the steam generator 260 is supplied. The check valve 291 prevents pressurized vapor from flashing back through pump 290. A temperature control of the process generator 260 is accomplished by a closed circuit that controls the temperature 239 and the solid state power supply controller 238. As already described, the baffle plates take care of it 266 and 267 for removing excess moisture from the steam emitted by the gas heater 261 is generated.

The sterile vapor emitted by generator 260 then flows through line 269 to the injector assembly 249, which are electrically controlled by the process controller via an electrical line (not shown) is to shunt steam into return line 277 when the friction welder is not in the operating state. This is the case, for example, when the welding process is started and all parts are only heated to operating temperature.

When the friction welder starts welding the capsules starts, signals the control of the valve assembly

249 to move from shunt to steam injection, and steam is then supplied to metal injector needle 259. A flat earth disk, consisting essentially of a grounded Is a distance G from needle 259. A vacuum source 295 is with a collector 296 in order to prevent the emitted vapor from spraying out and to collect all moisture that does not impinge on the capsules in gap G. A high voltage is applied to the needle 259 via the generator 248, in order to generate an ionized field across the gap G. The vapor sprayed into the ionized field surrounds it Wise the capsule better and will then be attracted to the grounded disc in the vacuum collector. Through this the loss of sterilized steam is greatly reduced and its contamination is prevented, thereby creating a unlimited recirculation of the sterile distilled water becomes possible. A steam / water return line (not shown) from the collector 296 into the tank 212 leads sprayed steam and water, which during the friction welding do not hit the capsules, return to tank 212.

FIGS. 12 to 14 describe in more detail a preferred embodiment of the gripping element for holding of the capsules to be welded in the welding wheel 203. In this embodiment, the gripping element is also used for vertical alignment of the capsules. FIG. 12 shows a plan view and FIG. 13 shows a view of the underside of a Gripper system. 14 shows a detailed sectional side view a gripper system. The system, as indicated generally at 301 in Figure 14, includes one insertable subassembly, which consists essentially of an insert body 302, a base insert 303 and an elastomeric Membrane 304 is constructed.

The body 302 generally consists of a lower stepped rim 305 which has a stepped bore

Defined opening 309 into which the base insert is inserted with a precise fit, while a cover plate 306 has a large one Part of the bore opening with the exception of the capsule insertion opening 307 closes. A conical wall transition zone 308 extends from the stepped bore 309 to the capsule opening 307 and further serves as a beveled one Seat for the elastomeric membrane 304, shaped very much like a Belleville washer, and a has tapered conical wall 320 and a flat annular flange 321. The membrane 304 is preferably made of a flexible elastomer such as a silicone rubber or polyvinyl acetate.

A group of eight radial air ports extend through cover plate 306 from a point near capsule opening 307 to a row vertical slots 311 in a circumferential shoulder 312, which is formed around the cover plate 306.

The base insert 303 comprises a stepped cylindrical member with a wide bottom portion 313 and a narrower one upper section 314. A large bore opening 315 is in the Section 313 executed and is in communication with a small bore opening 316 in section 314. One in A substantially hemispherical recess 317 is formed at the upper end of the bore 316 in the upper section 314 and has a pair of opposed slots 318 and 319 cut therein

QQ a vacuum / pressure shunt from bore 316 around the To create recess 317 around.

As previously described, the stepped cylindrical configuration of the base 303 is sized so that a precise mating interaction with the stepped rim 305 of the insert body is obtained. Another ex-

seal between these parts can be achieved by using an elastomeric sealing member (not shown) such as O-ring seals which positioned between the parts, as is well known in the seal art.

The mounting of the base 303 on the body 302 can be done by internal threads on the lower cylindrical portion of the rim 305 as well as a mating external thread formed on the lower cylindrical portion 313 of the base is. A series of four wrench engagement slots 322 are formed in the bottom of the base 303 (Fig. 13) to allow tightening and loosening of the bolted sections.

A capsule gripper is assembled by first inserting the membrane 304 into the insert body 302 so that that the conical section of the membrane rests against the conical section of the insert body. The base section

2Q is then inserted into the body 302 under its rotation, so that the two threaded cylindrical portions of the two elements interlock. If the Base insert 303 is screwed into body 302, the top surface of the base contacts the annular Flange portion 321 of elastomeric membrane 304, thereby retaining that portion of the membrane in the assembly by being wedged between the base and the body.

_or, in the relaxed state, the diaphragm portion 320 retains its outer 'open orientation as a result of engagement with a conical abutment shoulder 323 at which is formed at the top of the base insert 303 to the cavity 317 around. Assembled gripper systems 301

_ocr are then used in complementary recesses,

which are formed in the welding wheel 203 and there on

The usual way, for example by means of set screws, snap rings, threads, etc. held.

The start-up of the gripper system is carried out by applying predetermined air pressure pulses with a vacuum source be reversed. In a typical sequence of work steps, an assembled one is nested Capsule dropped from one of the supply pipes 211 into the gripper system 301, whereupon the lower rounded one End of the capsule fits into recess 317. When the wheel 203 rotates, a vacuum source comes into play, and a vacuum is applied to the bores 315 and 316. This communicates with the underside of the beveled elastomeric sleeve portion 320 via slots 318 and 319, whereby it is pulled down until it grips the capsule in frictional contact and aligns it vertically. At the same time, compressed air can be supplied to the middle section of the capsule via the air passage openings 310 be to increase the pressure difference across the flexible membrane and a vacuum seal in this area at Prevent the capsules from pulling apart. It can also be assumed that the compressed air is pulling the Capsule half supports by equalizing any possible vacuum that would otherwise be formed inside the capsules would if the capsules slide apart, in particular due to a weak infiltration of Air between the two capsules to prevent such a vacuum.

gO When the vacuum in holes 315 and 316 open the diaphragm 304 has pulled close to the capsule so that it is aligned and clamped at the same time, the upper rotatable welding mandrel 219, which is designed for a slightly wedged fit on the upper half of the capsule

gg the interaction of the cam slot 221 with the rollers 220 down until it is close to the capsule.

engages. This ensures a good, tight friction connection between the mandrel and the capsule, since the membrane 304 holds the capsule in the correct vertical direction for receiving the welding mandrel 219. Holding the capsule in the mandrel is further enhanced by a second vacuum source connected to the internal bore of the mandrel via the upper rotary connection structure 218 is connected.

If the rotating elements further its cyclic Ar- IQ beitsschritte through the vacuum to the upper and lower capsule gripping elements is maintained, and the capsule is about 60% of their Uberlappungsbereichs pulled apart, to allow the impact of the steam jet, as elsewhere herein Position is described. As the working cycle continues, the capsule halves are moved back into their original, completely pushed together position simultaneously with the upper welding mandrel, which reaches the desired speed of rotation. The gripping action of the membrane 304 on the lower half of the capsule holds it stationary while the upper half rotates and is pushed back on.

After the friction welding of the collapsed capsule is complete, the air pressure and the Vacuum sources reversed to relax the gripping action of the membrane 304 and the sealed capsule at the same time eject from the upper mandrel when it is moved up through the cam slot 221. The capsule will ο «then easily ejected from the hemispherical recess 317, by attaching to holes 315 and 316 applies upward air pressure.

In the typical operation of the friction welder, the upper rotational connection, which, as mentioned above, becomes sixty Includes welding stations, clockwise continuously

emotional. As the system rotates, pre-filled capsules are fed via feeder 207 to alignment trough 208, whereupon the capsules roll into channels 255 in longitudinal alignment. The capsules are then from the padded Dämmrad 209 wiped into the parallel grooves of the pulleys 211, which the capsules of a further Subject orientation in an appropriate perpendicular direction with the large end up and the small end down. In this arrangement, the capsules then pass through the top of the aligner 210 and fall into the six feed tubes 211. The feed tubes guide the properly oriented capsules to six adjacent positions of the rotating welding wheel 203, which also rotates at the same speed as the upper rotary joint assembly. To this Thus, the lower rotating welding wheel 203 similarly moves clockwise when viewed from above will. The capsules which are then gripped in the capsule recesses 279 formed in the welding wheel 203 move with the welding wheel on a circumferential line to a point near the bottom edge of Fig. 6. Referring to Fig. 5, it can be seen that the cam slot 221 extends from a topmost point moved near the center. This has the effect of lowering the welding mandrels 219, which are guided in the cam slot 221. When the capsules and the welding mandrels approach the lowest point in FIG. 6, the mandrels move 219 down over the tops of the capsules in welding wheel 203. While the welding mandrels 219 open downwards the upper halves of the capsules as a result of engaging in

QQ lowering the cam slot 221 is simultaneously connected to the Vacuum is applied to weld head 223 to grasp top half 102 of capsule 101. At this point the Roller 220 reaches the lowermost guide point 280 of cam wheel 222. A short time later that's about 10 to 15 degrees of arc of the wire 222, the cam slot 221 rises a distance equal to the displacement "Z" included in the

3 and 4 and shown in Fig. 5 at 281 corresponds. This is used to move the capsule lid 102 by a distance "Z" from the bottom 103 upwards. The welding mandrel moves then through the slit portion 281, with the capsule displaced in this way, around the lower left Quadrants of wheel 203 as shown in FIG. 6. During this part of the movement, the welding mandrels touch the drive belt 245, which, driven by the drive wheel 243, moves continuously. The rotation

IQ speed is in the range of 100 to 300 rpm, and the mandrels rotate on journals 219 and maintain this speed very quickly. As the capsules advance on their arcuate path as a result of the movement of the wheel 203, they come into the vicinity of the pro-

jg zeß generator 260, which produces a steam jet of a diameter from about 2.5 to 7.6 thousandths of a cm (1/1000 to 3/1000 of an inch) with the steam jet the circumference of the lower Capsule part 102 in the area of zone "Z" several revolutions long touched. This makes the gelatin sticky in this area.

When the capsule has passed the process generator under the influence of the movement of the wheel 20 3, moves the cam slot 221 in turn moves from the intermediate level 281 back to the lower level 280 while the capsules continue to be rotated quickly. This puts the upper capsule section back over the lower section of the moves individual capsule until it has again reached the arrangement shown in FIG. As a result of the steam treatment of the lower portion of the gelatin capsule and as a result of the resulting stickiness of the gelatin, the rapid rotation on the tackified surface to a smooth even fusion of the two gelatin capsule areas .

The rapid rotation is then stopped and the capsules continue on their way along the circle until they touch the removal wheel 204 and be sucked into one of the recesses 251. This: the wheel moves against it Clockwise, and preferably moves the capsules through a test station 226 which is one or more of different May include types of test which include, for example, a visual test, an infrared test, An X-ray test, a sonic test, or any other known test should be used to determine the integrity of the device Determine welded connection between the two capsule sections. After the test, the capsules reach the ejection area 227, whereupon the vacuum in wheel 204 is quickly converted to air pressure and the capsule becomes ejected onto a conventional conveyor system that delivers the capsules to the packaging and / or bottle filling area of the manufacturer's works.

In summary, the capsules are passed through the following process steps:

A. Feeding and Registration;

B. Arrangement in the welding wheel;

C. partial separation of the capsule components;

D. rapid rotation of the upper part of the capsule on the lower part;

E. tackifying the lower part by blowing a jet of steam;

F. reuniting of capsule sections during 3Q fast spinning;

G. The capsule is picked up by the ejection wheel; H. Examination of the welded connection of the capsule;

I. Dispensing of the capsule to normal packaging.

It is believed that the combination of tackifying using a thin, low pressure steam jet

with the rotating action of the welding mandrel both serves to create a good welding or fusion medium, as well as to homogenize the sticky substance and to a homogeneous uniform bond between the 5 to widen the upper and lower capsule components. It should be noted that the exact yet very fast operation of the system according to the invention prevents any contamination of the capsules while at the same time a very rapid, economical merger process is effected. Contamination is prevented by that the capsules always remain partially pushed together during operation, so that it never becomes one The contents of the capsule come into contact with the ambient atmosphere or with any part of the welding device. One such precise control is achieved by precisely and precisely cutting the cam slot 221 in the cam wheel as well as the exclusion of any tolerances or play in any rotating parts of the present Received plant. It was estimated that the present system would easily fuse about 120,000 capsules per hour with minimal energy consumption.

FIGS. 15 to 21 show alternative embodiments of the present invention in which the steam jet generator 260 of the previous embodiment is replaced by a melt generator 560 which is located outside of the welding mandrels 219 in the radial direction. This melt generator 560 is shown more clearly in FIGS. ₃ q 15 and 16 and comprises a radiation source 561 which is arranged in a housing 562 which is mounted on a bracket 565. A pair of power supply lines 563 extending from the housing 562 and out can be connected to an available 220V or 440V voltage source O _5. The melt energy source 561 comprises either an ultrasonic generator, an IR

Generator or a laser beam generator. In a particularly preferred embodiment, an infrared was used .impe used as fusion source 561 and over the power supply lines 563 are connected to an electrical power source.

In a second preferred embodiment, an ultrasonic generator 561 was used to generate ultrasonic energy arranged in the housing 562 and connected to a suitable energy source via lines 563.

In a third embodiment of the heat of fusion generator, a laser beam generator in the housing 562 is used to generate a thin laser beam which strikes the gelatin capsules. In these three embodiments, the melt generator 561, which is mounted in the housing 562 and held by the bracket 565, is placed in close proximity to the exposed portion of the gelatin capsule indicated ^{by "z" in FIG.} The top of the capsule is held in mandrel 223 to cause rotation of the lid portion of the capsule. The lower part of the capsule is held by a gripping element which is arranged in the welding wheel 203. The energy source connected to the melt generator 561 can either be intermittent and controlled by mechanical or electrical switching elements on the rotating wheel 203, or it can be a constant energy source which does not produce any switching system dependent on the rotation of the wheel 203.

gO calls.

In typical operation, the energy supplied via lines 563 is converted into a form of energy which hit the area "Z" of the lower half of the capsule gt- can and is suited to the surface of the lower capsule to soften. Whether the energy is in the form of infrared heat,

Ultrasonic waves or a laser beam is supplied, is insofar as the energy has been adjusted so that just enough energy is supplied to soften the outer surface of the capsule structure. After the welding wheel has been rotated the capsule out of the range of the melting generator 560, the rotating mandrel is placed in operation 223, and simultaneously, the cam slot 221 serves one above the other to push the capsule halves again, thereby rotating upper half of the capsule with de ^m softened region "Z" the lower half comes into contact and a fusion of the two capsule halves is achieved.

In another embodiment of the invention, which is shown in 17, a source of fluid 360 is provided using either vacuum or pressure atomization is used to deliver an atomized pulse jet of fluid from atomizing spray nozzle 361. Preferably, a mechanical cam lobe 362 is attached to the lower end of the wheel 203 with a feeler lever 363 cooperates, which extends from the bottom portion of the solution generator 360 downwards. In one embodiment becomes a tank of a solvent such as water, which is the preferred solvent for a gelatin capsule is pressurized and the solvent is supplied to an atomizing spray nozzle 361. So if that Wheel 203 rotates sufficiently, the feeler lever 363 hits the cam 362, thereby supplying the pressurized Liquid is opened to the spray nozzle 361 where it

OQ atomized into a spray of very small droplets and hits the exposed area "Z" of the lower half of the capsule. In an alternative embodiment, instead of using a pure solvent such as water for the gelatin capsule,

qc a solvent mixture provided, which in sterilized Water contains dissolved gelatine to reduce the sticky

to further increase the ability of the lower half of the capsule. The nozzle

361 and generator 360 may be parts of any conventional one commercially available atomization systems, such as a spray device of the paint spray type, as it is commonly used to apply paint. Although the cam and feeler mechanisms 362, 363 Similarly, as shown, an alternative embodiment would be a constant-release spray that on the capsules. It should be pointed out that a cam member 362 may be placed at the location of each capsule in wheel 203 to provide one for each capsule Creating spray cycle. It should also be noted that a sensing element (not shown) is associated with each capsule recess in 203 can be linked to the presence or

• ■ ε to determine the absence of a capsule in this recess, and this sensing element can with the cam part

362 are operatively connected to withdraw the part when the capsule is missing. That prevents them from being given away a spray jet in the event that an empty capsule recess passes the spray nozzle 361.

Figures 20 and 21 illustrate a further embodiment the device for welding the capsules, in which the melt generator 460 a heated contact wire for

2g direct application of heat to the melting area of the capsule includes. The contact wire can be heated either by induction heating or direct resistance heating. The wire is preferably made of a tack-free material such as polytetrafluoroethylene (PTFE)

_on known as Teflon, coated. In Fig. 20, the melt generator 460 includes a main bracket 461 having electrical insulators 462 and 463 mounted thereon, on which in turn a heating wire 464 is mounted. A pair of electrical leads 46 5 and 466 is. with the heating wire

_orr 464 connected through the center of insulators 462. The whether

Heating wire 464 is arranged above wheel 203 so that

a direct tangential contact with capsules is made, which are arranged in the recesses of the wheel 203 are.

Fig. 21 shows a schematic side view of the heating wire 464 showing how it covers the area "Z" of an expanded capsule touches. In operation, one or more of the heater wires 464 in tangential arrangement to one or more of the capsule

IQ positions can be provided in wheel 203. As the wheel rotates continuously, the capsule sections are brought into contact with the heating wire 464. Although not shown in Figure 21, it is preferred that a rotation system be used in the lower portion of the capsule,

jg to turn the capsule on the heating wire and to obtain a sticky surface on the whole circumference. Further, although not shown, it is clear that A pair of parallel heating wires can also be used, which are simply arranged in parallel on insulators

2Q 462 can be attached.

In a typical operation of the embodiment of Fig. 20 and 21 are welded similarly to the previous embodiments, i.e. the wheel 203 is brought together

2j- tangential capsules arranged in it during its rotation Contact with the heating wire 464, and when the capsule contacts the heating wire it can be set in rapid rotation to create a 360 ° contact surface with the heating wire or any such contact area,

_or . which is sufficient to firmly connect the capsule halves

tie. After the capsule half has passed the area of contact with the heating wire, the upper capsule section becomes pushed back over the overlap area "Z", wherein either the cover part, the bottom or

",. both halves rotate relative to each other to make the sticky

made surface between the two capsule halves homogenize.

In addition or as an alternative to the systems for tackifying as described above and heating or that Provide spraying a solution, further measures for fusing the capsule halves together can be provided , whereby it is ensured that the surface between the capsule halves has an increased friction. The fig. 18 and 19 show two embodiments of this concept. In Fig. 18, the lower capsule half 103 was in one cross-shaped pattern in the area of the exposed overlap zone "Z" sanded or scratched to create a roughened surface for increased frictional contact to be generated in the upper capsule half 102. In a preferred embodiment, the capsule halves 103 sanded before they were fed to the filling system.

In a separate further embodiment (not shown), a simple grinding system can be provided on wheel 203 which is connected to the rotating system of the dome 219 and / or the rotating system in the wheel 203 in order to grind or roughening the capsule half 103 immediately prior to rapid friction weld rotational contact with the capsule 102 to effect. In any case, there is the increased frictional resistance between the upper and lower capsule halves due to the surface "Z" with increased friction, sufficient to cause the To effect gelatin sections, so that these are connected to one another when the mandrel 219 rotates.

19 shows an alternative embodiment for increasing the frictional resistance between the capsule halves, in which case the lower capsule half 103 has raised friction ribs 103a formed on its outer surface were formed in the contact zone "Z". These ribs can only be vertical, exclusively be executed horizontally or in any combination of horizontally and vertically, for example in a checkerboard shape or helical. The pressing of the upper

Capsule half 102 on the lower capsule half 103 leads to a very close interaction with the ribs 103a, so that the rotation of the capsule half 102 results in rapid heating leads into the rib area 103a, as a result of which these areas become sticky and become rib-shaped or point-shaped Weld the lower half of the capsule to the upper half of the capsule.

All operations are in these alternative embodiments of the device as in the previous embodiments according to FIGS. 1 to 14, as far as the setting the capsule halves for the fusion and rotation of the capsule halves and their ejection from the welding machine are affected.

Although specific preferred embodiments are described in greater detail in the present specification The description is not intended to limit the invention to the specific embodiments, since these partly serve only for illustration, but do not imply any restriction. It is clear to the person skilled in the art that in particular numerous modifications with regard to the tackification of the surface and the specific design of the device possible are. For example, although a particular type of feed and registration system is described it will be apparent that other types of conveying and aligning means can be used in which for example air pressure, negative pressure, sense wires and other device elements can be used. How

3Q already mentioned, means the description of the device as an add-on to a conventional filling station does not mean that the method and the device of the invention do not can also be integrated into the filling line.

It should also be noted that although the present invention is described with regard to hard gelatin capsules

However, the term "thermoplastic material" should be considered as a more comprehensive term for hard gelatin and that the method and apparatus of the present invention are also used for fusing nested Capsules formed from other types of thermoplastic materials can be designed. So For example, these methods and apparatus can be used to replace thermoplastic polymers of hard gelatin capsules to fuse. It should also be noted that in place of the steam generator described herein also other means or devices for tackifying the overlapping area of the nested Capsule halves can be used. For example For tackifying the overlapping areas of caps can be made of a thermoplastic material a spray jet a solvent for the respective thermoplastic material can be used. When the capsule halves are fused For example, a thermoplastic polymer could be a hydrocarbon solvent for the Polymers are used. A solvent can also be used with a solution when fusing gelatin capsules the gelatin in water or another gelatin solvent can be used as an adhesive. In such a Trap can the steam generator shown here by a Solvent dispensing device can be replaced with either positive or negative pressure spraying can be done in a manner known per se. It is also envisaged that the gelatin used for the capsules in The solvent dispenser can be used by adding such gelatin in any available suitable solvent is dissolved. In one embodiment it is provided that the gelatin in sterilized water is dissolved to form the adhesive surface between the capsule halves. Sterilized water is

gc preferred to the integrity of the inside of the capsule to ensure the consumable product located.

■ 3430784

Further means of tackifying the area of overlap of the capsule halves include the arrangement of heating elements in close proximity to each of the capsule halves and the heating of the local peripheral area between this. Such heating elements include electrical resistance heaters, radiant heaters, laser heaters, induction heaters, Plasma jets, ultrasonic generators, radio frequency heaters, microwave generators and flame heaters. Other heating means known to those skilled in the art can replace the tackifying means described above be used.

Additional means for homogenizing the tackified surfaces between the capsule halves comprise, in addition to the above rotary homogenizing step, the step of homogenizing by axially oscillating the capsule halves in their pushed-together state. Oscillations in the range from about 20 to about 20,000 Hz can be used for this homogenization step. This is ^{quite advantageous in comparison to} the above rotary homogenization, which takes place at a speed of approximately 20 revolutions per minute to approximately 2,000 revolutions per minute. It is thus declared that the present invention embraces all changes and modifications to any specific example disclosed for purposes of illustration with equivalents familiar to those skilled in the art or falling within the scope of the present invention.

Claims (28)

Ch.Dr. Steffen D »Pi.-pnys.D <eter f, 2 Aug. 1, 1984 Note: COSDEN TECHNOLOGY, Inc. Wilmington, Delaware, V.St.A. Az: 246 / AS / as Method and device for the production of capsules secured against unauthorized opening, as well as capsules of this type 1. A process for the production of capsules which resist an unauthorized opening and which indicate such an opening, with two nestable capsule halves made of hard gelatine or another thermoplastic material, the lower half being filled with the consumable product and the upper half being pushed onto the lower capsule half with a precise fit, characterized in that it comprises:
Exposing a contact zone in the overlap area of the two capsule halves; Tackifying the gelatin in at least a portion of the exposed zone; Rotating at least one of the capsule halves relative to the other half of the capsule; and The capsule halves are united by sliding them completely into one another during their relative rotation. 2. The method according to claim 1, characterized in that it comprises: Arranging a capsule vertically in an opening in a rigid housing component, this housing component being a contains flexible, pressure responsive circular membrane; Applying a pressure differential across said membrane in such a direction that said membrane after flexing internally against said capsule in the housing; and Removal of said pressure difference after the said capsule has been friction welded. 3. The method according to claim 2, characterized in that it also includes the additional step of ejecting the Capsule from the housing in that the direction of said pressure difference is reversed, whereby said membrane is relaxed and the capsule is blown out of said housing component. 4. The method according to any one of claims 1 to 3, characterized in that the step of applying a pressure differential is applying a vacuum to the lower part of said capsule and at the same time to the underside of said membrane. 5. The method according to any one of claims 1 to 4, characterized in that the step of applying of a pressure difference also the level of 3Q applying an air pressure to the central part of said Comprises capsule and the top of said membrane. 6. The method according to claim 1, characterized in that the tackifying step also includes exposure encompassed by heat from external energy input. 7. The method according to claim 1, characterized in that that it includes: Forming a surface with increased friction in at least one area of the contact zone in the overlap area of the nested capsule halves on at least one of these capsule halves; wherein this stage is the grinding of the said surface with the formation of a rough surface or the shaping comprises at least one discrete, elevated point of friction on the surface during manufacture of the capsules. 8. The method according to claim 1, characterized in that it comprises: Exposing a region of the contact zone in the overlap region of the two capsules pushed one inside the other; Spraying a tackifying liquid on said portion of the exposed zone; and Pushing the capsule halves together while rotating at least one of the halves relative to the other, whereby the two capsule halves are fused together homogeneously. 9. The method according to claim 8, characterized in that the tackifying liquid is water, dissolved in water Gelatin or steam. 10. Apparatus for producing an unauthorized opening resisting and indicating such an opening Capsules with two nested capsule halves made of hard gelatine or another thermoplastic Material, the lower half being filled with the consumable product and the upper half fitting precisely on the the lower half of the capsule is pushed on, characterized in that it comprises: an aligner for arranging capsules connected by sliding one into the other in a predetermined, preferably vertical arrangement;
upper and lower gripping means for gripping the upper and lower capsule halves, respectively; Means for partially opening the capsule halves; Means for tackifying a portion in the area of overlap of the nested capsule halves; Means for rotating the tackified capsule half relative to the other capsule half; and additional means for pushing the two capsule halves into one another together with the means for rotating. 11. The device according to claim 10, characterized in that that they have a plurality of lower and upper gripping devices in a perpendicular direction to each other having opposite arrangement. 12. The device according to claim 10, characterized indicates that it comprises a gripping and aligning assembly comprising an insert body with a central bore (309), a base insert (303) insertable into said bore (309) and a flexible gripping membrane (304) which is clamped between the body (302) and the base (303) and has a wall portion which can shift from a relaxed, non-gripping position to such a position under the influence of a pressure differential across the diaphragm (304), that disposed in the body (302) ^is gripped capsule · 13. Apparatus according to claim 12, characterized in that said membrane (304) is an elastomeric one has conical wall portion with a through opening which has such a size that the wall portion in a relaxed state, loosely around a gelatine -δ- Ι capsule is arranged around, and which is designed so that, under the influence of a pressure difference in only one predetermined direction on the conical wall section, it rests tightly against a capsule and holds it in place. 14. The device according to claim 12, characterized in that that the base insert (303) comprises a part having a central bore (315,316) which is connected to a hemispherical recess (317), in which at least one pressure bypass slot (318) is executed, communicates. 15. Apparatus according to claim 12, characterized in that that it includes: a rigid housing element with a substantially central arranged capsule container with a cup-like Floor; a flexible elastomeric gripping sleeve in the aforesaid Housing element above the cup-like bottom with a central passage opening for a capsule; this membrane being arranged to be under gripping a capsule, which is arranged in the capsule passage opening, under the influence of one on the membrane acting pressure difference is bent towards the capsule; and Through openings in said housing element, the communicate with the membrane to create a pressure differential. 16. Device according to .Anspruch 15, thereby marked-OQ shows that the passage openings have an air passage opening which communicates with the cup-like bottom, and at least one pressure bypass slot (318) around the cup-like bottom. 17. The device according to claim 15, characterized in that the housing element has one with an edge provided, hollow insert body (302) with a central capsule opening (307) therein and a base insert (303) with a central recess (317) with a through hole (315,316) which communicates with this, where- in the case of the base insert (303) being inserted with a precise fit in the body (302) provided with an edge. 18. The device according to claim 15, characterized in that the membrane has a tapered conical portion made of a flexible elastomer which is attached to a flat annular flange portion, and that this membrane is secured in said housing assembly by the flange portion between the insert body (302) and the base insert (303) ^is clamped · 19. The apparatus according to claim 15, characterized in that the means for tackifying a jet nozzle ⁿ for spraying a jet of a tackifier include a said capsule half, said nozzle a steam generator, for example. 20. The device according to claim 10, characterized in that that the limiter has at least one cam stop and at least one cam follower element, which cooperates with the cam extension and is in operative connection with one of the gripping elements. 21. The device according to claim 10, characterized in-QQ draws that the gripping element and the device for rotating an upper rotatable capsule wheel, a lower rotatable capsule wheel and at least one fast-speed rotatable mandrel (219) which is rotatable is mounted in one of the rotatable capsule wheels, woge a drive device (241) is provided which drives the rotatable mandrel (219) and selectively with it can be coupled. 22. The device according to claim 10, characterized in that that at least one of the capsule wheels can be reciprocated in the vertical direction and with said Cam elements is in an operative connection and is moved back and forth by these. 23. Device according to one of claims 7 to 22, characterized characterized in that the lower gripping elements are mounted on a rotatable plate (203), and that the - ^ q upper gripping elements to back and forth in the vertical direction moveable and rapidly rotatable mandrels (219) connected to the cam follower, mounted are. ■ Lg 24. Apparatus according to claim 19, characterized in that said steam jet generator system for generating a steam jet impinging on the capsule comprises:
a hollow, closed generator housing with an 2Q connection for the liquid supply and a connection for the steam outlet; an electrical heating element arranged in the housing with electrical contacts which are sealed by the housing wall extending outward; To remove excess moisture ₂ c arranged in said housing baffles from the generated steam; Probes for a highest and lowest water level; and OQ a temperature probe in the flow area of the steam in the housing having a signal line extending outwardly through the wall of the housing. 25. The device according to claim 24, characterized in that it also pressure relief means and includes manually operable drain means in the wall of the housing. -δι 26. Device according to one of claims 24 or 25, characterized in that it comprises: a hollow closed housing with a connection for the liquid supply and a connection for the vapor outlet; an electrical heating element arranged in the housing with electrical contacts extending from the housing to extend outside; a probe for a low liquid level in the lower part of said housing with a signal line which extends outwardly from the housing; a temperature probe arranged in the housing with a signal line, extending outwardly from the housing; a storage tank for sterile water with water inlet and Water outlet connections and a condensation coil arranged in it; a low water logic probe extending into the tank and having a signal line extending therefrom;
a pump connected to the water outlet connection with a control line for switching the pump on and off; a control device for the power supply, which is connected to the electrical contacts and enables vary the energy input to the heating element; a temperature control device associated with the aforesaid Temperature probe and the control device for the energy supply is connected and the a temperature signal from of the probe and controls the heating element via the control device for the energy supply in order to produce a in the generator maintain predetermined desired temperature; and a process controller, who is responsible for the line of the logic probe for low water, the control line of the pump, the line the probe for high liquid level and the conduit connected to the low-level probe and which is designed in such a way that a pre- - ΟΙ the given liquid level is maintained and the also generates a signal to shut down the system when a low water signal is received from the tank. 27. A capsule resisting an unauthorized opening and indicating such an opening, characterized in that, that the upper and lower capsule halves are tackified by friction welding a partially pulled apart Capsule are interconnected. 28. A capsule resisting an unauthorized opening and indicating such an opening, characterized in that, that it was obtained by the process according to any one of claims 1 to 9.