Classifications

• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B30—PRESSES
  • B30B—PRESSES IN GENERAL
  • B30B15/00—Details of, or accessories for, presses; Auxiliary measures in connection with pressing
  • B30B15/0082—Dust eliminating means; Mould or press ram cleaning means
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
  • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
  • A61J3/10—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of compressed tablets
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B30—PRESSES
  • B30B—PRESSES IN GENERAL
  • B30B11/00—Presses specially adapted for forming shaped articles from material in particulate or plastic state, e.g. briquetting presses, tabletting presses
  • B30B11/005—Control arrangements
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B30—PRESSES
  • B30B—PRESSES IN GENERAL
  • B30B11/00—Presses specially adapted for forming shaped articles from material in particulate or plastic state, e.g. briquetting presses, tabletting presses
  • B30B11/02—Presses specially adapted for forming shaped articles from material in particulate or plastic state, e.g. briquetting presses, tabletting presses using a ram exerting pressure on the material in a moulding space
  • B30B11/08—Presses specially adapted for forming shaped articles from material in particulate or plastic state, e.g. briquetting presses, tabletting presses using a ram exerting pressure on the material in a moulding space co-operating with moulds carried by a turntable
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B30—PRESSES
  • B30B—PRESSES IN GENERAL
  • B30B15/00—Details of, or accessories for, presses; Auxiliary measures in connection with pressing
  • B30B15/34—Heating or cooling presses or parts thereof

Definitions

• the invention relates to the manufacture of tablets, in particular tablets comprising a substance for therapeutic or cosmetic use.
• tablets comprising ibuprofen.
• the ibuprofen molecule has a softening point at 42 ° C and a melting point at 70 ° C. It is known to form ibuprofen tablets from a powder by means of a machine comprising a series of dies and punches between which the tablets are formed. Within the machine, the compression dynamics generate temperature rises, which causes a softening of the raw material used for the manufacture of the tablets. This can cause a problem of sticking of the powder or tablets within the machine, which is detrimental to its proper functioning.
• the document FR-2 440 188 discloses in FIG.
• an installation is provided according to the invention comprising a machine for manufacturing tablets, the machine having at least an enclosure, the installation comprising means for bringing a gas into the enclosure and making it pass through the enclosure.
• the invention can be easily adapted to an existing machine without excessive cost.
• the circulation of gas in the enclosure makes it possible to cool it efficiently without excessive energy expenditure.
• said means are arranged to control a temperature of the gas.
• said means are arranged to control a humidity of the gas.
• the machine may also have at least any of the following characteristics: - said means are arranged to control a temperature of the gas; - Said means are arranged to control a temperature of the gas at a predetermined location upstream of the enclosure to ensure that a temperature of the gas in the enclosure reaches a predetermined value; - Said means are arranged to control a temperature of the gas at a predetermined location upstream of the enclosure, to ensure that the temperature reaches a predetermined value; - Said means are arranged to cool and / or heat the gas; - Said means comprise at least one particle filter; - Said means comprise at least one fan, for example placed upstream or downstream of the enclosure; -
• the enclosure includes organs for shaping the tablets; - the enclosure includes a motor; - the enclosure includes an electronic device; - the enclosures are at least two in number and the machine comprises means for bringing a gas into each enclosure and making it pass through it; • - it comprises gas pipes arranged to supply the enclosures with gas in a parallel arrangement
• a method of manufacturing tablets in which a gas is introduced into an enclosure forming part of a tablet manufacturing machine, and it is made to travel through the enclosure.
• the process may have at least any one of the following characteristics: - a temperature of the gas is controlled; - A temperature of the gas is controlled at a predetermined location upstream of the enclosure to ensure that a temperature of the gas in the enclosure reaches a predetermined value; and - One controls a temperature of the gas at a predetermined location upstream of the enclosure to ensure that the temperature reaches a predetermined value.
• FIG. 1 is an overall diagram of the installation according to a preferred embodiment of the invention
• - Figure 2 is a schematic plan view of the air handling unit of the installation of Figure 1
• - Figure 3 is a schematic view of part of the air heating and cooling system of the installation of Figure 1
• - Figure 4 is a partial perspective view of the machine of the installation of Figure 1, showing the conduits associated with the compression enclosure
• - Figure 5 is a partial perspective view of the interior of the compression chamber of the machine of Figure 1
• - Figure 6 is a view similar to Figure 4 showing a pipe associated with the engine mount
• - Figure 7 is a perspective view with partial cutaway showing the interior of the engine mount
• - Figure 8 is a view similar to Figure 4 showing the pipes associated with the electronic frame
• - Figure 9 is a perspective view with partial cutaway showing the interior of the electronic frame.
• the installation 2 comprises a machine 4 which is used for the manufacture of tablets, for therapeutic use comprising ibuprofen, this machine being of a type known per se even.
• a machine 4 which is used for the manufacture of tablets, for therapeutic use comprising ibuprofen, this machine being of a type known per se even.
• it conventionally comprises a compression enclosure 6 containing organs for manufacturing tablets, a motor frame 8 comprising in particular a motor actuating the organs located in the enclosure compression, and an electronic frame 10 ensuring the regulation of the machine.
• the compression enclosure, the motor frame, and the electronic frame are contiguous to each other and enclosed in a common casing.
• Such a machine is for example of the type of that disclosed in the aforementioned document FR-2,440,188 and will not be described below in detail in all of its constituent elements.
• the installation 2 in this case comprises means for cooling the machine 4 by blowing cooled air. It includes in particular an upstream supply fan ventilateur. It also includes an air treatment unit 12 in this case ensuring filtration, dehumidification and possibly heating or cooling of the air. It comprises a downstream exhaust fan 14. Finally, it comprises pipes or ducts 16, for example made of stainless steel, bringing the various parts of the installation into gas communication 2. Thus a first common duct 16 extends downstream of the air handling unit and communicates with three other ducts connected in an assembly parallel to the compression enclosure 6, to the motor frame 8, and to the electronic frame 10 respectively. Finally, two sheaths 16 are understood according to a parallel mounting downstream respectively of the motor frame and the electronic frame. They communicate with a common duct 16, itself in communication with the downstream supply fan 14.
• the air is brought in at three points from the compression machine 4. It is all firstly brought into the compression enclosure 6 as close as possible to the manufacturing members to bring frigories making it possible to combat the calories generated by the rapid displacement of the manufacturing turret and friction. Air is also brought into the engine mount 8 in order to minimize the phenomena of heat diffusion towards the adjacent compression enclosure, phenomena due to heating of the mechanical elements of the engine. Finally, and similarly, bringing frigories into the electronic frame 10 makes it possible to minimize the phenomena of heat diffusion towards the engine frame and the compression enclosure, phenomena due to heating of electrical and electronic components.
• the air handling unit 12 is preferably installed in a technical room different from the room receiving the compressor 4. This unit makes it possible to ensure the conditioning of the blown air.
• this power station ensures particulate quality control by filtration, dehumidification, and if necessary heating and / or cooling of the air.
• it is a Hydronic brand CCM20 type power station capable of providing an air flow of 1500 m 3 / hour and offering an available pressure of 350 Pa.
• this power station works in all fresh air, i.e. it does not receive air that has already passed through the machine.
• FIG 2 we will present the different organs constituting this central 12 from left to right, that is to say in the direction of gas flow, the air entering the left end of the central to exit at the right end.
• the plant has a F6 type particle filter 20 (according to standard EN779).
• the power station Downstream of the filter 20, the power station comprises first of all an electric hot battery 22 with a power of 7.8 kW, then a battery 24 operating with chilled water having a temperature between 0 to 5 ° C. a power of 24 kW. It is followed by a second battery of chilled water 26. There is then one. electric hot battery 28 with a power of 15.6 kW.
• the power station comprises downstream of these elements the aforementioned upstream supply fan 9 which in the present example is therefore integrated into the power station and provides a flow rate of 1500 m 3 / hour by providing an available pressure of 300 Pa. these are fitted with an F8 30 particle filter (according to standard EN779) and an H13 32 particle filter (according to standard EN1822).
• All of these filters have the particular function of making the gas "clean", that is to say compatible with pharmaceutical use in order to allow it to come into contact with the tablets.
• differential pressure measurements are carried out regularly in order to ensure monitoring of the fouling of these filters.
• the machine sizing calculations were carried out according to different climatic and geographic data. Thus, in summer and winter, we want to maintain a vacuum in the machine from 0 to 30 Pa, a temperature in the compression turret of 25 ° C and a humidity of the supply air less than 5 g of water per kg dry air. Outdoor conditions of -7 ° C with 90% relative humidity were assumed in winter and an outdoor temperature of 29 ° C with 43% relative humidity in summer.
• Each cold battery 24, 26 of the power station 12 is supplied by a common chilled water circuit connected to a refrigeration unit 34 illustrated in FIG. 3. This group is associated with buffer tanks respectively of
• a duct 16 downstream of the central 12, the air is routed through a duct 16 which, as we have seen, is divided into 3 parts: - a duct for blowing the air towards the enclosure compression 6; - a sheath for blowing air to the engine mount 8; and - a sheath for blowing air to the electronic frame 10.
• a blowing register 36a, 36b and 36c On the path of each of these last three sheaths is positioned a blowing register 36a, 36b and 36c. It is a motorized damper 36a on the way to the compression enclosure.
• the registers 36b and 36c on the path to the engine and electronic frames are not motorized.
• the motorized register 36a makes it possible to isolate the compression enclosure in a sealed manner with respect to the air blowing network in the event of the machine stopping. This is a pharmaceutical constraint making it possible to avoid any contamination of the blowing network with powder present in the machine.
• Each of these registers also makes it possible to modify the air flow rate in each of the associated ducts 16 to vary this flow rate between different values of non-zero flow rate, or even to completely shut off the duct.
• the ducts 16 are in this case made of AISI 316 L stainless steel. Each of these three ducts leaves the room receiving the central 12 and ends up in the room housing the compression machine 4. This room has a controlled atmosphere.
• each of these three sheaths 16 has a removable central part, and two respectively upstream and downstream parts located on either side of the removable part and permanently fixed respectively to the room and to the machine.
• the presence of these dismountable sections makes it possible to use the machine 4 in its original configuration if necessary, to have this without blowing the cooled air.
• plugs for example made of stainless steel, are positioned on the fixed sheath sections associated with the machine in order to ensure the basic performance of the machine.
• the sheath 16 associated with the compression enclosure 6 arrives there from above the enclosure. It makes it possible to diffuse the air as close as possible to the compression matrices 39.
• a box or deflector 40 in the shape of a rectangular parallelepiped and made of sheet metal.
• This box receives the air arriving from the sheath 16. It has openings 42 on its vertical lateral faces 44 and 46, as well as on its lower 48 and rear faces (not shown). It allows a good distribution of the air flow in order to ensure a perfect diffusion of the air inside the compression enclosure.
• the front face 49 of the deflector does not have an air outlet opening. In fact, this face faces the inside of the enclosure 6.
• the compression machine is moreover equipped with a system for spraying a pulverulent lubricant which makes it possible to lubricate the dies 39 in a manner known per se and which is a very volatile compound.
• the deflector 40 extends in the upper part of the enclosure 6.
• the downstream sheath 16, aimed at extracting the gas from the enclosure 6, opens in the lower part of the enclosure on a face of this enclosure opposite to the deflector.
• the cooling means of the chamber 8 associated with the engine mount are shown in Figures 6 and 7. The air is fed directly into the engine frame in order to reduce the temperature of the frame 'and minimize the diffusion of heat from the engine frame to the compression enclosure 6.
• a box 50 or deflector, also made of perforated sheet metal, is installed inside the enclosure 8 of the engine mount.
• the deflector is placed on the horizontal lower face of the enclosure 8 and is open on its upper 52, front 54 and vertical lateral 56 faces, having on each of them a network of orifices 42.
• the sheath 16 of outlet air is arranged on a different face from the face of the enclosure 8 receiving the air inlet sheath intended for the deflector.
• the implementation of the cooling of the electronic frame 10 is finally illustrated in FIGS. 8 and 9.
• the air is sent directly into the electronic unit in order to reduce the temperature of this frame and thus minimize the heat diffusion from the electronic frame to the compression enclosure.
• the air is brought in from below an electrical cabinet 60 of the electronic frame 10.
• a deflector or box is provided for the introduction of air within the enclosure 10.
• the deflector is installed in the lower part of the enclosure after dismantling the fans generally located in the lower part of the cabinet.
• the box is open on its upper face by presenting several networks of openings 42.
• This system allows a good distribution of the air flow in order to ensure a perfect diffusion of the air inside the electronic frame.
• the upstream sheath 16 introducing the air into the enclosure 10 is located in the lower part of the cabinet while the downstream sheath 16 extracting the air from this enclosure is located in the upper part of the engine mount.
• the two sheaths are associated with the same side wall 64 of the cabinet. As can be seen, the air is extracted via the ducts 16 only at two points on the machine, namely the motor frame 8 and the electronic frame 10. This extraction is carried out by means of the extraction fan 14.
• the two downstream ducts 16 associated with the engine and electronic frames are provided with motorized extraction registers 70 which make it possible to seal the extraction network from the blowing network in a sealed manner in the event of the machine stopping.
• This pharmaceutical constraint makes it possible to avoid any contamination of the blowing network by contaminated air having circulated within mechanical and electronic elements.
• the machine includes means for controlling the air blowing system, making it possible in particular to adjust the various parameters and operating modes.
• This system could include a terminal built into a room partition fitted with a control screen. This terminal allows entry of instructions and monitoring of operating parameters. It also allows you to manage alarms.
• it will include means for recording the entire history of the operation of the installation.
• the installation includes an automatic on / off control between the air blowing system, the compression machine and the vacuum cleaner associated with it.
• the first one that we can call manual mode includes the step of entering a target supply air temperature.
• This setpoint temperature is chosen by the operator within a predetermined range, for example from 5 to 15 ° C.
• the minimum blowing temperature at 5 ° C makes it possible to avoid condensation phenomena which can appear below this temperature.
• This setpoint is naturally associated with a tolerance range (for example between 9 and 11 ° C) for the oscillation of the temperature around this setpoint.
• the installation controls the temperature of the gas leaving the power station 12 by means of a sensor 80 located on the sheath 16 communicating directly downstream with the latter.
• the installation therefore controls the central unit 12, in particular its heating and cooling batteries, so that the temperature measured at the sensor 80 remains as close as possible to the set temperature, here 10 ° C.
• the probe 80 continuously reads the air temperature at this point. If this temperature changes, the installation will control the central unit to ensure temperature regulation.
• This operating mode makes it possible to lower the temperature in the engine mount and the electronic mount.
• the temperature of the air blown into these two zones is identical to that of the air blown into the compression enclosure.
• the moisture content of the gas is controlled by means of a probe 82 located next to the temperature probe 80 downstream of the plant 12.
• the flow rate provided in the compression enclosure 6 is 150 m 3 / hour.
• the flows in the engine mount and the electronic mount are each planned at 700 m 3 / hour.
• the flow rate of 150 m 3 / hour at the level of the compression enclosure is regulated as a function of the vacuum prevailing in the compression enclosure.
• this enclosure is connected to a vacuum cleaner 69 ensuring permanent dusting of the machine in a manner known per se.
• This vacuum cleaner eliminates excess lubricant present in the machine. It draws a flow of 190 m 3 / hour. The vacuum cleaner sucks more than the system blows in the compression enclosure, there is a permanent vacuum in the compression enclosure located between 0 and 30 Pa.
• This vacuum allows to contain the dust, and to avoid excessive dusting of the machine and a powder leak in the room.
• the air flow entering the enclosure 6 is regulated to maintain the vacuum. This regulation is done via the blowing fan9 located in the control unit 12. This regulation is necessary because the vacuum cleaner becomes dirty as the operation progresses, thus generating a reduction in the suction flow rate.
• the compression enclosure 6 is associated with a differential pressure transmitter 84 simultaneously measuring the pressure inside and outside the enclosure. The differential pressure measurement provided by this sensor allows the machine to control the fan9. Pressure measurements are also carried out permanently by means of two sensors 86 and 88 respectively located downstream of the central 12 and upstream of the extractor fan 14.
• a possible speed variation of the ventilator 9 generated by the sensor 84 results in a change in the pressure measured by the sensor 86 at the outlet of the central and in the pressure measured by the sensor 88 in the extraction network.
• the installation therefore acts on the fan 14 for this purpose.
• the vacuum cleaner 69 generating an air vacuum inside the compression enclosure is provided with a pressure switch measuring the differential pressure at the inlet of the vacuum cleaner and outside the machine. It thus measures the fouling rate of the vacuum cleaner. When this rate reaches a critical threshold, an alarm warns the operator that unclogging the filter is necessary.
• the machine then goes into default, the upstream register 36 of the compression enclosure and the downstream registers 70 are then closed to isolate the machine to be compressed.
• the other operating mode of the process can be called automatic mode.
• the operator provides as data to the installation a gas temperature setpoint in the compression enclosure 6, for example 25 ° C., here again with a certain tolerance.
• the system controls the central unit 12 in order to blow air into the enclosure 6 and ensure that the temperature of the gas in the enclosure reaches the set value.
• the machine comprises a temperature sensor 90 disposed in the enclosure. This sensor continuously measures the temperature in the enclosure.
• the installation controls the central unit 12, in particular the heating and cooling batteries, in order to heat or cool the air to return to the set temperature.
• This operating mode also ensures a lowering of the temperature in the engine 8 and electronic 10 frames.
• These zones are not directly controlled in temperature but are subject indirectly to the set point associated with the compression enclosure 6.
• the humidity level is regulated in the same way as in manual mode. The same is true for the regulation of pressure differences.
• the installation and the method according to the invention make it possible to avoid the phenomena of sticking of the tablets.
• the invention generally consists of blowing pre-treated air (heating, cooling, filtration and treatment of the relative humidity of the air) within the machine in three suitably chosen places.
• the blowing of cold air within these last two frames makes it possible to cool these elements and therefore to minimize the phenomena of heat conduction towards the compression enclosure.
• By blowing cold air as close as possible to the compaction zone it is possible to reduce the temperature rise phenomena generated by the friction forces combined with the kinetic energy of the moving compression turret. Since the compression machine can be located in a room in which the renewal of the air is controlled, like aerolic flows, the invention has the advantage of avoiding disturbing these flows.
• the regulations implemented by the invention for controlling the temperature and the flow make it possible not to disturb the possible recommendations of the manufacturer of the basic compressor (viscosity of the lubricating oil of the different parts, temperature of operation of motors and electrical components, etc.).
• the invention can be easily implemented by adapting an existing compression machine because it minimizes the modifications to be made. Indeed, it will suffice to pierce the casing and add the corresponding deflectors.
• the invention requires relatively large auxiliary technical organs, namely an air handling unit, a cold group and preferably insulated pipes as well as automatic means for controlling the system.
• the invention allows temperature control at a relatively low cost.
• many modifications can be made to the invention without departing from the scope thereof.
• the tablets may include a substance for therapeutic or cosmetic use other than ibuprofen.
• substance for therapeutic use means a substance which can be administered for preventive or curative purposes.
• the compression machine could include at least one enclosure which is not associated with the gas blowing system. A system for humidifying the air entering the compression machine can be provided.

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• Engineering & Computer Science (AREA)
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• 2003
  • 2003-07-07 FR FR0308268A patent/FR2857253B1/fr not_active Expired - Lifetime
• 2004
  • 2004-07-07 WO PCT/FR2004/001764 patent/WO2005004784A2/fr not_active Ceased
  • 2004-07-07 JP JP2006518289A patent/JP2007525252A/ja active Pending
  • 2004-07-07 DE DE602004018318T patent/DE602004018318D1/de not_active Expired - Fee Related
  • 2004-07-07 AT AT04767599T patent/ATE416749T1/de not_active IP Right Cessation
  • 2004-07-07 CN CNB2004800225508A patent/CN100420431C/zh not_active Expired - Fee Related
  • 2004-07-07 US US10/563,614 patent/US20060157878A1/en not_active Abandoned
  • 2004-07-07 EP EP04767599A patent/EP1648372B1/de not_active Expired - Lifetime
  • 2004-07-07 CA CA002531514A patent/CA2531514A1/fr not_active Abandoned

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