Checking and controlling apparatus for use in...

Package making – With means responsive to a sensed condition – Separate delivery of incomplete or defective package

Reexamination Certificate

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Details

C053S507000

Reexamination Certificate

active

06327835

ABSTRACT:

DESCRIPTION
The invention relates to machines for packaging metered amounts of medicinal product in hard-gelatine capsules and in particular to machines operating intermittently, for example of the type which comprise at least one carousel with a vertical axis onto which there are fixed, via their body, two groups of hollow-punch volumetric metering devices which are angularly arranged at a distance of 180° and are also vertical and oriented downwards with the open end of the hollow punch itself inside which there is axially movable a piston pushed upwards by a resilient means and provided radially with a lug which projects from the said body through a longitudinal slit and which normally rests against a plate mounted on the axis of the said carousel with micrometric means for adjusting the height. By regulating these means it is possible to lower or raise the piston of the metering devices and therefore decrease or increase respectively the volume of the working chamber of the metering devices themselves and consequently it is possible to vary the weight of the metered amounts of product cyclically formed by the latter. In the machines in question, the carousel with the metering devices is cyclically rotated through 180° first in one direction and then in the other and is raised and lowered in synchronism in order to position alternately the two groups of metering devices in two different workstations. One of these stations contains a store inside which a correct layer of the product to be packaged is maintained such that, when a group of metering devices is immersed into this store, the bottom chambers of their hollow punches are filled uniformly with product. In phase succession, thrusters are lowered with a predefined and constant stroke onto the movable element of the lowered metering devices, said thrusters having the function of pressing the metered amount of product isolated into the said metering devices so as to reduce the volume thereof and in particular ensure that the whole metered amount of product remains by means of friction inside the metering devices when these are extracted from the filling store and transferred into the other station for axial alignment and for positioning above the bottoms of the capsules transported by a carousel for handling the hard-gelatine capsules, which in synchronism rotates stepwise about its vertical axis. In this station the metering devices are lowered and arranged with their openings against those of the capsule bottoms into which they discharge the metered amounts of product following the action of special thrusters on the movable element of the said metering devices. The emptied metering devices, after raising of the associated pistons, are raised and rotated through 180° so as to return into the filling station and repeat the cycle described. The thrusters for pressing the metered amounts of product and those for discharging the pressed amounts are mounted with the possibility of adjustment of the height on a same turret which in synchronism with the movement of the metering-device carousel is raised or lowered with a predefined and constant stroke.
Italian Patent No. 1,268,383 dated Apr. 22,1994 (or U.S. Pat. No. 5,626,171), which is in the name of I.M.A. Industria Macchine Automatiche S.p.A. of Italy (the same Applicant as for this invention), describes how it is possible to adjust automatically the volume of the metering devices of the above-mentioned machines and the heightwise position of the thrusters for pressing the metered amounts of product into the said metering devices, depending on the results of a statistical check as to the weight of the gelatine capsules filled with product by the machine and unloaded from the said carousel for handling these capsules, this check being carried out by means of electronic precision scales pre-programmed with the tare of the empty capsules. This checking system is such that, when it detects inaccuracies, incorrectly filled capsules have already been unloaded into the flow of capsules with a correct weight. When medicinal products, which require extremely precise metering, are packaged in the capsules, the current method used consists in a statistical check as to the weight in order to detect any major repetitive malfunctions of the machine during the whole production cycle and then, when a very precise check is required, all the capsules produced by this machine are checked one-by-one using sets of electronic scales, for example using an apparatus of the type described in Italian Patent No. 1,285,463 dated Feb. 26,1996 in the name of the same Applicant. It is obvious how this solution complicates the capsule production cycle and how it makes it longer and more costly.
Finally it must be pointed out that the packaging machines of the abovementioned type and others of the intermittent type (see below) are often used by the research and development centres of pharmaceutical companies in order to check the machine processability or the so-called “machinability” of the new products, with the aim of providing mixtures which are machinable in an easy, precise and as reliable as possible manner both by the intermittent machines in question and by the faster rotary and continuous machines. For this purpose, the current packaging machines to which reference has been made are unable to provide researchers with the values of all the variables necessary for solving all the problems arising from the various situations.
The invention aims to solve these and other limitations of the known art using the following proposed solution. The thrusters for pressing the metered amounts of product cyclically isolated by the groups of hollow-punch volumetric metering devices have, associated with them, respective main force transducers which are able to emit an electrical signal proportional to the thrust which these thrusters exert on the movable element of the metering devices and therefore on the metered amount of product to be cyclically isolated by the latter, such that, for the same stroke of the said thrusters, it is possible to detect, using a special algorithm, any variations in the density and hence the mass or weight of the metered amounts of product cyclically formed in the metering devices. In this way it is possible to check automatically and rapidly the weight characteristics of all the capsules filled by the packaging machine. In order to allow the operators to detect all the parameters necessary for evaluating the flowability and processability of the product for the metering devices, secondary force transducers are also provided on the thrusters which operate in the station for discharging the metered amounts of product from the metering devices and inserting them into the bottoms of the capsules, so as to generate an electrical signal proportional to the thrust which these thrusters exert during discharging of the metered amounts of product from the metering devices. This signal may be adjusted in the same manner as all the other signals and may, if necessary, be used to perform processing of the signal supplied by the main force transducers.
Downstream of the capsule filling carousel there are provided means which separate, into respective channels, the capsules produced by the various metering devices and which, under the control of the processor which manages the operation of the machine, discard any capsules which may be detected as defective by the primary transducers associated with the pressing thrusters which operate in the station for filling the metering devices. The discarded capsules may be subjected to a statistical weight check by means of electronic scales which are connected to the machine processor so as to signal any anomalies in the functioning of the said main tranducers. The capsules which are considered to have a correct weight finally undergo a statistical weight check by means of the known precision means connected to the processor which is thus able to confirm or interrupt operation of the said primary force transducers. In this latter case, the processor may

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