Abstract: The invention relates to a device for filling with high accuracy a finely divided powdered medicament having a particle size smaller than 10 &mgr;m into cavities having a size corresponding to the volume of powder to be filled, wherein said device comprises oscillating and rotating means for breaking down aggregates formed in the finely divided powdered medicament and filling and for compacting it in said cavities. The invention also includes a method of filling with high accuracy of a finely divided powdered medicament having a particle size smaller than 10 &mgr;m and to fill said finely divided powdered medicament into cavities, wherein the finely divided powdered medicament is transported and compacted in said cavities by oscillating and rotating means.

Abstract: A forming roller for manufacturing moulded bodies with the rotary die method comprises a surface which is roughened at least in the region of the forming roller webs. By way of the roughening of the forming roller webs the adhesive friction for the material tapes from which the moulded bodies are manufactured is increased. The roughness of the surface parts of the forming roller is advantageously produced by the processing of the surface with a blast means.

Abstract: A method for producing a package of a fluidized substance is disclosed. The method includes a supplying step in which a prescribed amount of a fluidized substance (103) is supplied onto a first sheet (a first sheet 101′ of continuous length) by use of a metering-applicator (2) for the fluidized substance comprising a metering through-hole (21) having an outer opening and an inner opening. The supplying step comprises positioning the first sheet so as to be brought into contact with the outer opening of the metering through-hole (21), and then supplying the fluidized substance (103) from the inner opening of the metering through-hole (21) via the metering through-hole (21) onto the first sheet while the first sheet is conveyed.

Abstract: A number of spaced apart first and second cavities are continuously formed in first and second thin sheets of material, respectively. Each of the first and second cavities has an edge at an opening thereof. The formed first and second cavities travel in paths that are downwardly inclined from the horizontal and approach each other. A number of first bodies are fed into the first cavities, respectively, where each of the first bodies has a liquid tight interior cavity that contains a volume of a first liquid. This liquid is one that when mixed with a second liquid starts a chemiluminescent reaction. The edge of each of the first cavities is sealed progressively with the respective edge of a second cavity, while injecting the second liquid into one or both of the first and second cavities that are being sealed. This forms a liquid tight second body that contains the first body and a second volume of the second liquid.

Abstract: This invention relates to a method and apparatus for forming soft capsules and provides novel processing flexibility. The apparatus comprises a three-way valve injector wedge. This injector wedge allows for set-up of the encapsulation machine with a placebo fill and quick change over to active fill. This conserves use of the active ingredient.

Abstract: Packaging method and apparatus using multiple packaging material are improved so that multiple packaging filled with goods and sealed may be separated easily to each goods filling section. The multiple packaging material (40, 50) has plural goods filling sections connected in series via adjacent side edge portion (42, 52, 53) between each of the goods filling sections. Goods to be packaged are filled in the multiple packaging material at goods filling portion (12). Multiple packaging so filled with the goods is covered and sealed with sheet coming from master roll (16). The multiple packaging is made separable at the adjacent side edge portion. Overlapped portion of outer peripheral edge portion (41, 51) of the multiple packaging material and the sheet is first sealed at sealing portion (14) and then the adjacent side edge portion is sealed with the sheet at longitudinal sealing portion (21).

Abstract: An injection wedge includes a housing having a first face and a second face. A first tube extends through the housing and is coupled to a first nozzle on the first face of the housing. A second tube extends through the housing and is coupled to a second nozzle on the second face of the housing. The first face of the housing is opposite the second face of the housing. The first nozzle and the second nozzle are angled away from a vertical axis of the injection wedge. The first tube and the second tube are adapted to carry a fill material to the first nozzle and the second nozzle for injection into die pockets formed onto surfaces of a pair of rotary die drums.

Abstract: A device in which a set of capsules previously filled with a specific amount is positioned in a set of cavities arranged in plates, the plates assuming two positions, one for receiving the capsules in correspondence with a capsule-filling device, and the other for unloading these, the second operation being performed with the plates in an extended position in respect of the device frame, and the plates have two parts, an upper one which houses the capsules and a lower one which retains these. In the unloading position the lower plates align with the upper ones, thus allowing the capsules to drop through to arrange the gelatine capsules in blister packs.

Abstract: A capsule filling machine is provided which is characterized in that contents substance m is force fed into a body B accommodated and held in a body pocket 221 using a force feeding screw 33 to fill the contents substance m.

Abstract: There is provided a defective capsule removing mechanism characterized in that a defective capsule discharging window 131 is provided for a capsule pocket 11 and the capsule pocket 11 is subject to suction through the discharging window 131 so that a cap or a body of a coupling defective capsule is drawn into the defective capsule discharging window in a rolling manner from one end side directed forwardly and then discharged to the outside of the capsule pocket, and there is also provided another defective capsule removing mechanism characterized in that one end side of a capsule pocket 21 is formed as a cap holding portion 211a having a width smaller than a diameter of the capsule cap and a scraper is inserted in a scraper insertion groove extending transversely to the capsule pocket 21 such that the cap portion of a reverse defective capsule is fitted into the cap holding portion 211a and is not discharged from the capsule pocket at a predetermined location but is further transported, whereafter it is scrap

Abstract: Method and apparatus for providing a precisely controlled amount of dry material to a container. In one embodiment, a system is provided for automated container filling. The system includes a container handling mechanism that includes a container block defining a container receptacle, and a cap carrier defining a cap receptacle. The system also includes a dosing portion having a dosing plate defining a dosing hole. The dosing plate is movable between two positions so that when the dosing plate is in the first position the dosing hole is positioned to receive a dose of powder. When the dosing plate is in the second position, the dosing hole is positioned to dispense the dose of powder into the container receptacle.

Abstract: An apparatus and method for manufacturing soft capsules wherein a filling material, such as liquid medicine, is encapsulated by two gelatin sheets. The soft capsule manufacturing apparatus includes a pair of die rolls that are close to and confront each other, each die roll having capsule pockets in a plurality of rows, and a nozzle segment having an inverse projection for supplying a filling material. The inverse projection has curved faces that are positioned in opposing relation with each other at right and left sides about the lower end central portion thereof the curved faces have nozzle holes. The inverse projection confronts a curved recess that is surrounded by curved peripheral surfaces of the die rolls at the upper sides thereof. The gelatin sheets are supplied between the die rolls from the upper portion thereof to receive the filling material therein corresponding to the capsule pockets of each die roll to manufacture soft capsules.

Abstract: A forming roller for manufacturing molded bodies with the rotary die method comprises a surface which is roughened at least in the region of the forming roller webs. By way of the roughening of the forming roller webs the adhesive friction for the material tapes from which the molded bodies are manufactured is increased. The roughness of the surface parts of the forming roller is advantageously produced by the processing of the surface with a blast means.

Abstract: An apparatus for and a method of manufacturing soft capsules wherein a filling material such as liquid medicine is encapsulated by two pieces of gelatin sheet are provided.

Abstract: A method for producing and coating melt portions includes two sheet strips, which form coating material layers, being continually fed. The melt portions embedded between the sheet strips are cooled and calibrated according to their thickness. The sheet strips are longitudinally and transversely separated in the region of their connection points such that the melt portions become isolated and the sheet strips are connected to each other such that each melt portion is embraced tightly.

Abstract: An apparatus for enrobing tablets in a gelatin layer includes a pair of die assemblies with each assembly including a rotatable, cylindrical die support and a series of die blocks mounted on this support for movement along a circular path. Each block has recesses formed in a top surface thereof and each recess of one assembly cooperates with a similar recess in the other assembly to form a cavity at a nip formed by the two assemblies. Each cavity is dimensioned to receive loosely therein one of the tablets. Two casting drums deliver gelatin strips to the die assemblies and each strip is pulled by one assembly into the nip. A time tablet dispensing mechanism is used to dispense tablets onto one of the strips at a feeding location. The preferred die blocks are made of hard plastics material. In one version of the apparatus, the blocks have substantially enclosed recesses except for their open tops and each block has one or more vacuum applying passageways including one with an open end at one end of the block.

Abstract: A feeding apparatus for delivering tablets or performs to an encapsulating machine includes a number of vertically extending chutes, each capable of holding a number of tablets aligned in a row along the respective chute. A plunger mechanism temporary engages one of the tablets in the chute so as to prevent downward movement of the tablet and all pills located above it in the chute. A rotatable feed roll is located adjacent a bottom end section of the chutes and this roll has a number of tablet cavities, each capable of holding an individual tablet. Pivotable stop members are used to prevent temporarily downward movement of the bottom pill in each chute, this pill being located downstream of the plunger. These stop members move to a pill releasing position when the plungers are engaging their respective tablets in the chutes. Each stop member prevents downward movement of its respective row of pills in the chute past the stop member when the plunger is moved to a position of disengagement.

Abstract: An apparatus for enrobing tablets in a gelatin layer includes a pair of die assemblies with each assembly including a rotatable, cylindrical die support and a series of die blocks mounted on this support for movement along a circular path. Each block has recesses formed in a top surface thereof and each recess of one assembly cooperates with a similar recess in the other assembly to form a cavity at a nip formed by the two assemblies. Each cavity is dimensioned to receive loosely therein one of the tablets. Two casting drums deliver gelatin strips to the die assemblies and each strip is pulled by one assembly into the nip. A time tablet dispensing mechanism is used to dispense tablets onto one of the strips at a feeding location. The preferred die blocks are made of hard plastics material. The tablet dispensing mechanism employs vacuum applying members operatively connected to a vacuum source and air cylinder transfer mechanisms for moving these members from a tablet pick-up position to the feeding location.

Abstract: A process for the production of divisible tablets by melt calendering in which two molding rolls are combined together, at least one of which has depressions with at least one bar which extends up to the surface line of the molding roll and forms a score.

Abstract: The machine includes groups of bushes (1) of dimensions suitable for the superposed and aligned containment of a base cover (14), of a tablet (52) and of a lid cover (14).

Abstract: In an apparatus for applying a cover foil to a bottom foil having a containment structure formed therein, the containment structure is formed into sections of the bottom foil in a molding tool through which the bottom foil is moved section-by-section. The bottom foil is then guided over an application roller which has depressions in which the containments formed into the bottom foil are received while a cover foil is applied to the bottom foil. The depressions in the application roller are arranged, in the circumferential direction of the application roller at a slightly larger distance from one another than the containments formed into the bottom foil so that the bottom foil is slightly stretched on the application roller. Means are provided for adjusting the lengths of the bottom foil section moved through the molding tool depending on the position of the cover foil relative to the bottom foil.

Abstract: Methods and apparatus for forming capsules provides novel processing flexibility including dies which are independently movable, even during capsule formation, the ability to vary the speed of the dies even during the formation of a single capsule, independently controlled drums and dies. Advantageously, at least one and most preferably a plurality of independently actuatable pumps are provided for greater control over the dispensing of fill material. For example, the fill rate can be varied during the filling of a single capsule. Preferred embodiments provide electric/electronic signals to actuate the f fill material dispensers, provide for the independent control of rotatable drums, rotatable dies and the dispensers.

Abstract: Rotary die apparatus for producing filled gelatin capsules comprises two cylindrical rollers mounted with their longitudinal axes substantially parallel and defining a nip therebetween, with at least one roller having a plurality of recesses on its outer surface; and means for feeding gelatin ribbon to each roller surface and thereby to the nip. The apparatus includes a metering system for delivering particulate material between gelatin ribbons at the nip; and means for rotating the rollers in synchronism with the metering system such that particulate material is supplied over a recess in said at least one roller, and the juxtaposed ribbon sections close over the particulate material to form a capsule. Air mechanisms may be used to shape the gelatin ribbon into the roller recesses, and such mechanisms can also be used to facilitate the flow of particulate material in the metering system.

Abstract: A continuous solvent free gelatin encapsulation apparatus and process includes an oil roll back assembly (20) for applying a controlled amount of a food-approved lubricant to a first side of the gelatin ribbon and an applicator guide bar assembly (40) for applying a controlled amount of food-approved lubricant to a second side of the gelatin ribbon. Two opposing food-approved lubricant coated gelatin ribbons are then united in a die assembly (50) to form gelatin capsules which are then dried and recovered.

Abstract: An apparatus for enrobing medicine tablets in gelatin and employing a main linked track of die blocks with each block having a number of recesses formed in its top surface. A revolving co-operating die device in the form of another linked track or a cylindrical rotary die is adjacent to and in contact with the main linked track. This device also has a plurality of recesses, each of which is cooperable with a recess of similar size in the main link track to provide an enclosed cavity at at least one point along an upper path traversed by the main link track. This cavity is capable of holding one of the tablets. A first elastic gelatin strip is delivered to the main linked track and positioned for movement along its upper path. A vacuum system causes portions of the first gelatin strip to be pulled and stretched against walls of recesses in the die blocks to form tablet receiving depressions. A tablet dispenser drops tablets into these depressions.

Abstract: An apparatus for packaging granular materials, wherein the granular material flows vertically through various components, wherein the apparatus comprises a frame, a plurality of servo driven packaging payout means, a plurality of packaging material alignment means, granular material filler means, sealing means, and severing means. The apparatus further comprises a computer controlled coordination means for controlling and coordinating the operations performed by the components of the apparatus.

Abstract: In a method and an appliance for manufacturing a blister pack having a carboard inlay (blister cardboard pack) a blister pack is provided as an endless tape having the products sealed in blisters. At a unification station a cardboard inlay having recesses for the blisters of the blister pack and having in the direction of conveyance of the blister pack substantially the length of a blister cardboard pack, is placed true-to-size on the blister pack tape, the recesses of the cardboard inlay surrounding the blisters of the blister pack. By a feed pawl, a holding collet and outfeed rollers the blister pack tape is fed to the unification station incrementally and further conveyed incrementally after placement of the cardboard inlay. In a sealing station the cardboard inlay is sealed to the blister pack tape. Subsequently the individual blister cardboard packs are separated from the blister cardboard pack tape in a cutting station.

Abstract: A medicine tablet is described as a new article of manufacture. The tablet is enrobed in a gelatin coating formed by application of respective layers of elastic gelatin film to opposite sides of the tablet. The applied gelatin layers conform tightly to the tablet surface, bond securely to the tablet, and are sealed together in essentially edge-to-edge manner at a seal line which extends around the tablet at a desired place on the tablet. The gelatin layers can be colored differently from the tablet and differently from each other. A range of formulations are described for film which can be peelable from a tablet or other product core, and for films which bond to the core. A presently preferred formulation for producing tablets having a bonded tamper-evident coating comprises a water-based gelatin preparation having about 45% gelatin and about 9% plasticizer (glycerin and/or sorbitol) by weight. Method and apparatus for producing such new products are also described.

Abstract: The invention relates to providing a medicinal rod with a shell. The shell is formed from a hose, which is expanded by pressurizing its inner space. The medicinal rod is pushed into the expanded hose, after which the pressure is relieved. The hose tightens over the rod after the pressure relief.

Abstract: Apparatus for manufacturing a subcutaneous capsules filled with a selected medicine comprising: a tube cutting mechanism which cuts a continuous length of tubing into a plurality of tubular capsules, each capsule having an open top end and an open bottom end; a capsule support mechanism which holds the capsules in a predetermined array, the bottom open ends of the capsules being sealed by a sealing mechanism; a plurality of spring mechanisms insertable into the open top ends of each capsule held in the array, each spring mechanism receiving a selected quantity of medicine for each capsule, each spring mechanism being rotatable and delivering the selected quantities of medicine into each capsule by insertion of the spring mechanisms into the open top ends of each capsule and rotation of the spring mechanisms.

Abstract: Apparatus for filling a plurality of capsules with a selected medicine, the capsules each having a closed lower end and an open top end and being mounted in the apparatus for filling the medicine into the capsules through the open top end, the apparatus comprising a dosing mechanism which separately measures a selected quantity of the medicine for input into each capsule; a capsule filling mechanism comprising a plurality of funnels each having an axis, the funnels each receiving a measured quantity of medicine and funneling the received medicine to an open delivery end of the funnels; the capsules being mounted such that the open top ends of the capsules are disposed at the open delivery ends of the funnels for receipt of the measured quantities of medicine; the filling mechanism further comprising a plurality of spiral spring mechanisms, the spiral spring mechanisms being insertable through the open top ends and removable from the capsules, the spiral spring mechanisms further being rotatable simultaneously

Abstract: An apparatus and methods of manufacturing flexible containers are disclosed. The containers typically enclose fluid absorbing polymers so that fluid contacting the containers can migrate through their outer fabric and be absorbed by the polymers.

Abstract: The invention relates to an equipment for manufacturing subcutaneous capsules. The capsules are produced by cutting from a silicone tube lengths in excess of the final capsule length. The lengths are arranged into rows including a defined number of them and in these rows they are filled and sealed. One end of the capsules is first sealed by glue dosaged into their openings. The material for the capsules is dosaged by an aperture disc glidable on a plane surface. By sweeping the upper surface of the disc the dosage volume is limited to the volume defined by the aperture. To regulate the packaging density of the material vibration may be used during the filling of the apertures. The dosaged material is conveyed to the capsule via a feeder funnel, through which a rotatable spiral spring, functioning as a filling screw, is inserted into the capsule to be filled.

Abstract: This invention relates to a method and apparatus for filling a powder, lipid or granule into a soft shell capsule employing a flat linked track of cavity blocks to prevent spillage.

Abstract: A formed or molded body, a manufacturing method and a manufacturing apparatus therefor, wherein several equal or different active ingredients in suitable, equal or different carrier substances are filled at the same time side-by-side without a partition into a uniform enclosure or envelope to provide a formed or molded body with uniform outer appearance and with separate inner regions.

Abstract: In a system for filling granular material into hard gelatin capsule wherein the granular material is portioned to a predetermined quantity by volume in a metering chamber and the portioned granular material mostly gravitates to a body of the hard gelatin capsule positioned beneath the metering chamber, an artificial force is exerted by a pusher rod on the granular material remaining in the metering chamber after the beginning of the gravitation. There also is an improved system for adjusting the capacity of the metering chamber. The improvements result in a greatly increased number of capsules which may be handled and filled at a time, a reduction in time required for the process and correspondingly in area occupied by the machine, and a remarkable improvement in the productivity. The uniformity and accuracy in the quantity of the granular material actually filled in the capsule are also remarkably improved.

Abstract: Apparatus for manufacturing gelatin capsules and method therefor are provided. The apparatus comprises a gelatin sheet forming mechanism which includes a rotatable cooling drum, a gelatin capsule forming mechanism which includes a pair of die rolls and a gelatin capsule recovery mechanism. The inner space of the cooling drum is provided with a coolant. The thickness of the gelatin sheet and the gap between the die rolls are numerically indicated respectively. The driving mechanism for the gelatin capsule recovery mechanism is independent from the other driving mechanism provided in the apparatus.

Abstract: Methods are provided for producing flexible packages and particularly transdermal medication patches. The method includes the continuous and rapid production of a plurality of such packages while continuously treating one portion of the laminate forming the package by corona discharge in order to modify the surface adhesion properties thereof to provide, simultaneously, a proper seal of a transdermal membrane in the laminate forming the package, while maintaining the desired medication dispensing properties thereof.

Abstract: A blister packaging apparatus comprises a blister forming part for forming a plurality of blisters in a thermoplastic resin sheet, an automatic material supplying part for automatically supplying materials into the blisters of the thermoplastic resin sheet, a metal foil member adhering part for adhering a metal foil member to the thermoplastic resin sheet so as to cover openings of the blisters accommodating the materials, a half-cutting part comprising at least one circular blade which is fixed in a non-rotational state and has a blade formed on an entire circumference thereof for forming a half-cut line in the thermoplastic resin sheet for facilitating separation of the blisters, and a curl reforming part for reforming a curl in the thermoplastic resin sheet on which the metal foil member is adhered.

Abstract: The loading apparatus of our invention comprises a filling shoe for input of small products, particularly pharmaceutical products, into a plurality of receptacles of a package component moving by and below the filling shoe. The filling shoe is provided with at least one feed chamber for receiving and dispensing the product which has a mouth opening below to the package component. A product duct for feeding the products one after the other is connected to and ends in the feed chamber. Each feed chamber is connected to at least one vacuum passage which is connected to and communicates with a vacuum source. The front side of the feed chamber in the motion direction of the package component may be formed as a guide slope running slantedly downward toward the package component opening in or to a vacuum passage with the feed chamber and to the package component. Vacuum slots may be provided running in a wall of the product duct and ending in the feed chamber to augment the vacuum effect in the product duct.

Abstract: Methods and apparatus are provided for the continuous and rapid production of a plurality of flexible packages containing a non-solid substance such as an ointment, by continuously forming and vacuum sealing the packages from two webs of material in the nip of cooperating roller surfaces. The packages each contain a precise quantity of medication which may be, for example, the kind of medication which is self-administered by the user by transdermal application. The method and apparatus herein joins together two specially prepared webs of material continuously drawn from supply rolls while at the same time incorporating and vacuum sealing a desired quantity of the medication therebetween.

Abstract: A method and apparatus for making a porous laminated sheet product having upper and lower web members connected about their periphery and having at least one compartment formed therein, and containing a predetermined quantity of inner product within such compartment. In a preferred embodiment, the apparatus includes a pouch-forming surface having at least one inner product loading area formed therein which further includes a cavity surrounded by peripheral land areas, a passageway adapted to place the product loading area cavity in fluid communication with a vacuum source such that suction can be selectively applied to the cavity, and one or more apertures formed through the peripheral land areas and adapted to be selectively placed in fluid communication with a source of pressurized air whereby outward air flow can emanate from the peripheral land areas.

Abstract: Apparatus and method for forming sealed pharmaceutical capsules containing precisely compacted charges of a powdered material. A pair of substantially cylindrical sealing rolls are arranged in nipping relationship for directing a pair of webs of gelatin material along predetermined paths between the nip of the sealing rolls. For each sealing roll there is provided a powder supply hopper which contains a supply of powdered material and a cylindrical roll rotatably mounted adjacent the supply hopper. The cylindrical roll has chambers extending radially inwardly from the surface thereof for receiving therewith powdered material as the cylindrical roll rotates past the supply hopper. A compaction mechanism is associated with each cylindrical roll for compacting the predetermined charge of powdered material in the chambers so as to form a compacted slug.

Abstract: A method and apparatus is disclosed for packaging articles in two portions of film which are fed between outer and inner annular film clamping mechanisms with the outer clamping mechanism firmly clamping the film portions while stretching the film over the article. The inner annular clamping mechanism then clamps the periphery of the film portions together immediately inward of the seal area, and the outer clamps release the film allowing an annular hot knife to seal and sever the film portions in a relaxed area. A low inertia film drive system is also provided with the film supply rolls on one side of the clamping mechanisms being continuously driven while brush rolls on the other side of the clamping mechanisms are intermittently driven. The low inertia film drive system also includes components for assuring that the film is stressed longitudinally and transversely to remove wrinkles therefrom, and to assure that the film portions are sealed and severed in a completely relaxed area.

Abstract: A machine is proposed for filling and closing hard gelatine capsules, in which the powder to be filled into the capsules is located in a filling product container, the base of which is a revolving dispensing disc. The dispensing disc has openings into which the powder is pressed with the aid of filler punches. A ring is firmly connected with the dispensing disc and has openings for receiving upper capsule portions. Curve controlled elements having openings for receiving lower capsule portions are pivotably disposed on the underside of the ring. The pivoting movement of the elements is effected via a stationary curve and a curved roller. The curve is embodied such that the elements can be moved both outward, that is, beyond the circumference of the ring, and inward, that is, underneath the openings in the dispensing disc.

Abstract: A method of packaging and machine capable of continuously forming an array of packages from a double web film. A first web is fed over a rotating thermoforming drum which vacuum forms a plurality of pouches for receiving a product to be packaged, and a second web, maintained under constant pressure, is progressively disposed in sealing relation to the peripheral edges of the formed pouches in the first web as the pouches approach a vertical position while the product is simultaneously introduced into the progressively formed package at a rate not exceeding the volume of the package as it is formed.

Abstract: A packaging device for sealingly closing an upper foil and a lower foil utilizing a framelike constructed welding device which has a separate drive for welding together the lower and the upper foil, of which at least the lower foil is formed into containerlike segments and is moved, held by a chain at the sides thereof, through the packaging device. The packaging device has an evacuating chamber which is formed of two boxlike halves, of which one half is stationary and the other half is vertically movable. One of the halves has a framelike welding device embodied therein.

Abstract: Pharmaceutical dosage forms comprising an edible web having deposited thereon or at least partially thereon a particulate medicament, the webs being thereafter fabricated and finished to pharmaceutically elegant solid dosage forms having no medicament exposed on an exterior surface. The dosage forms have a consistency of release of medicament which can be controlled to exacting specifications. The disclosed solid dosage forms are prepared by high speed automated equipment and the process by which they are made is characterized by non-destructive quality control analysis and performance evaluation both conducted on-line and integrated into the manufacturing operation. Included in the scope of the disclosed invention are certain apparatus and methods of manufacture.