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INSTRUMENTATION OF TABLET MACHINES Contents Introduction Isolated punch and die assembly Compaction simulators Single station press Strain gauged punches Poisson arrangement Calibration of instrumentation Multi station press Signal processing Role of instrumentation in production Introduction Provide information on the inherent compaction characteristics of components, effect of additives upon them. Tabletting process involves the utilization of unsatisfied bonds at the solid surface. The process can be enhanced by the generation of large areas of clean surface, if pressed together as might occur if appreciable brittle fracture and plastic deformation were introduced into the system. Behavior on decompression can affect the characteristics of finished tablets because the structure must be strong enough to accommodate the recovery and ejection induced stresses. Ability to monitor ejection forces leads to valuable information on lubricant efficiency. Measurement of punch and die forces , relative displacement of the punches can provide raw data which when suitably processed and interpreted, facilitate evaluation of many of these tabletting parameters. The sensitivity of the formulation being tested to loading rate should be determined by compression at different speeds and by monitoring of any changes in tablet properties. Because of this rate factor several workers have elected to instrument isolated punch and die sets and to carry out compression experiments using these sets in conjunction with a compression/tension testing machine. Isolated punch and die assembly Compaction simulators Recently a sophisticated system has been described, capable of mimicking the precise compression cycle means it has single station tooling and follows rotary press action. The system contains micro processer representing the precise compression cycle of the press, which in turn controls the movements of isolated punches, reproduces the exact loading profile of the press. This assembly facilitate compressional studies at various compressional rates,results in maximum amount of information while using the minimum amount of material and time. They are now often referred to as “compaction simulators”. Single station presses Strain gauge networks as transducers were used for measuring the magnitude of the forces operating during the compression cycle. Resistive gauges are usually preferred. They should be bonded as near to the active site like punch surfaces so as to eliminate the lack of correlation between signals obtained from the remote regions of the machine and actual forces present in tooling. The bonding must be over the entire area of the correctly aligned gauge, at a site where the elastic change in linear dimension of the stress bearing member can be measured. Die wall instrumentation requires machining of die wall to accommodate the gauges and reduce the thickness to a point at which the adequate sensitivity is achieved, original geometry is restored with silicone rubber or similar material. The foregoing procedure necessitate annealing and subsequent rehardening and tempering of the die, and this treatment should not change the precise geometry of bore. Strain gauged punches These assemblies may be connected so as to conform a wheat stone bridge network which is normally energized by an AC amplifier system the attenuated out put giving a DC voltage proportional to the force being applied. The changes in the resistance are small so a full bridge with strain gauges in all four arms is preferable. A stabilized supply is essential since the system is a input voltage dependent, and this arrangement is mounted as Poisson configuration compensation is provided for both temperature and bending of piece. Poisson arrangement Transducers based on piezo electric effect in certain crystals like quartz may be used. When subjected to external forces these materials develop an elctrical charge proportional to the electric force. Transducer is connected to a charge amplifier by a high impedance cable, converts the electrical charge into a directly proportional DC voltage. Disadvantage of such transducers is that the charge is inevitably dissipates with time, and since the difference is being measured they are unsuitable for measuring static forces. Small piezo electric load washers can be easily mounted on upper and lower punch holders of single station presses. Radial die wall measurement has been achieved by means of a special holder for the transducer. Piezo electric die wall instrumentation They may give rise to misleading data because strain gauge equivalents only monitor radial forces over a localized region of the die wall. They have to be sited at same level on the die wall as the region at which the tablet is being compressed. The advantage of piezo electric devices include high sensitivity, robust construction, no bonding to machine fabric which allows easy changing of tooling. Calibration of instrumentation Calibration of instrumentation with punch assemblies was achieved by use of a calibrated load cell which was placed on die table, its signal can be compared with signal from instrumented punches as they are simultaneously loaded. Alternative method was, entire punch assemblies can be removed from the press and mounted in an accurate compression/ tension test press. Calibration using load cell The normal procedure with die wall instrumentation is less straightforward. But the necessary measurements are made by sealing the open ends of the die cavity then pumping in oil at known pressures and noting the response. A close fitting rubber plug or rubber powder in the cavity how ever may be regarded as a perfectly elastic material and therefore can be substituted for oil. The preferred form of transducers for measuring punch displacements is based on the differential inductor principle and is commonly a linear variable differential transformer(LVDT). The movable ferrous core of the transducer is rigidly connected to the punch by mechanical link so that movement unbalances the secondary circuit . The out put is attenuated to produce a DC voltage directly proportional to punch displacement. Typical LVDT circuit Multi station presses Major differences in the instrumentation of multi station as opposed to single station presses is the inherent difficulty in retrieving electrical signals from a revolving turret. This was over came by employing radio telemetry to transmit the force signal from upper and lower punches to external recorders. This was unsuitable for normal production conditions, since only few stations are operative, and only low machine speeds are possible. Ho and co workers how ever overcome this and a significant proportion of the stations remain active as in telemetry system. Other workers have been less reluctant to utilize remote stationary sites on the machine frame in particular the upper and lower compression carrier systems. The response of a strain gauge is entirely a function of the change in linear dimension of the machine part to which it is bonded. Telemetry system There fore such changes must be sufficient to induce an adequate change in gauge resistance while not exceeding elastic limit. Cast iron components are unsuitable because of variability in their modulus of elasticity and Poisson ratio, so parts only constructed with steel should be selected. More popular arrangements on modern high speed presses is to attach strain gauges or to incorporate piezo electric load cell into one of the tie rods. Instrumenting the normal ejection cam on a rotary tablet machine by attaching strain gauges to its bolts is of limited value, because the resulting signal is a summation of the effects of the several lower punches on it at any instant. The solution adapted by Wray employed a two part cam so that the region responsible for tablet ejection is separate and in the form of a beam fixed at one end. But this method necessitated minor modifications to other parts of the machine and there is no affect on the normal operation. Flexure of beam caused by lower punches during ejection was monitored by strain gauges and was found to mimic the ejection response of an instrumented lower punch. Alternatively, the normal cam can be cut into three sections each clamped to the frame by a bolt, two of which are fitted with a piezo electric load washer for instance. The division should be such that there is only one punch on each section at a time. The first transducer then monitors the force to initiate ejection and the second monitors the force necessary to push the tablet clear of the die. This arrangement minimizes the fulcrum effect as the punches move over the cam surface toward and then away from the actual transducer location. Certain aspects like sticking of the lower punches due to frictional effects can also be detected by sensitive instrumentation of this type. Mitrevej and Augsburger have recently described a system to measure the adhesion of tablets to the lower punch face by attaching strain gauges to a small cantilever blade mounted on the feed frame in front of the sweep off attachment. They found that the force of adhesion did not necessarily reflect the ejection force or the lubricant activity of the formulation but system did appear to be sensitive to batch variations in the anti adherent quality of magnesium stearate. Instrumentation to measure sweep off force Regardless of selection of remote site for instrumentation the response should always be checked periodically against signals obtained from directly instrumented tooling over the whole working range of the machine to ensure constancy in response relation ships. Signal processing Instrumentation described here are usually DC voltages and can therefore be retrieved, stored, processed. Displaying the signals on a cathode ray oscillograph(CRO) enables the instant visualization of instrumentation out put. Displays were often photographed to provide permanent record but UV oscillographs provide better definition of traces and can facilitate large number of simultaneous recording channels. Signal processing Inexpensive microcomputers that are currently available can remove much of the tedium in reducing raw data from the recorders previously described there fore they are the method of choice. The analog signals(DC voltages) can be fed by an A to D (analog to digital) convertor to memory locations in the computer. This digital data can be recalled, manipulated and outputted in a wide range of graphic or tabular formats. So that active compounds and excipients can be fingerprinted for their compactional characteristics. I.T.M micro processor linkage Role of instrumentation in production Tablet production department seeks innovation because of the trend toward direct compression methods, availability of machines with increased out put and to reduce tablet to tablet variations. Design of instrumentation that exercises some degree of control over the tabletting process is an attractive goal because it reduces labor involvement. Attempt to limit weight and hardness deviations based upon the premise that compressional force is directly proportional to tablet weight provides 1. The formulation is homogeneous(i.e., has uniform density). 2. The compressional force/ tablet weight function is constant. 3. The volume of die cavities at the point of maximum compression is constant. The third supposition is valid only when over all length of punches and tip geometry are constant , the die bores are uniform and the pressure rolls are perfectly cylindrical and mounted centrally. The out put from the electronic unit of most force measuring systems is a DC voltage which produces series pulses of short duration each proportional to the weight of an individual tablet. Signals can be conditioned to provide a wide range of monitoring and control facilities of increased complexity. The individual compression pulses can also be used to drive counting mechanisms and to provide a reliable figure for the number of tablets made. These devices are uncomplicated, inexpensive, and there is a desire to extend the signal conditioning system to control the process to some extent. ex: one can set upper and lower limits for acceptable tablet weight and then distinguish pulses from tablets lying out side these thresholds. When the frequency of these out of specification tablet exceeds some present value a relay can be tripped to activate an alarm and the machine can automatically stopped. Machines can be fitted with mechanical accept/reject gates at machine out let so that individual out of specification tablets can be diverted to separate container. This function requires a high level of sophistication because the defective tablets must be memorized until they reach the outlet. A second approach is to take the amplified out put signals and feed them into an averaging network. This average DC voltage is compared with reference voltage and any difference is converted into an AC signal which was amplified and used to drive a two phase servomotor. The motor can be connected to the weight or pressure adjustment control of the press so that any change in the average compressional force is reflected in an adjustment of either the weight or force control. Regardless of which transducer system, sites, forces selected it is essential to ascertain that the response of instrumentation is a direct function of the property needing to be monitored. The work of Wray and his colleagues is important in that it establishes that stresses generated in certain parts of machine frame are directly proportional to the punch forces which in turn are related to compressional weights. Machine out puts are now exceeding 12,000 tablets per minute which means the frequency of force pulses is approximately o.1kHz. Since the detection of small differences in individual pulses may be necessary all units should have flat responses well beyond this level up to approximately 1.0kHz. Instrumented tablet machine technology is advancing rapidly. Useful for better under standing of the tabletting process, in turn will assist in formulation development and batch quality control . References The theory and practice of industrial pharmacy by Leon lachman, Hebert A.leiberman THANK U