Qualification of Tablet Compression Machine.pptx

Qualification of Tablet Compression Machine.pptx

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  Department of PharmaceuticalQuality Assurance Smt. B. N. B. Swaminarayan Pharmacy College, Salvav–vapi Presented by:- Machhi Dhruvi A. 2nd sem M.Pharm.
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   Tablet CompressionMachine  Principle of Tablet Compression Machine  Construction of Tablet Compression Machine  Working of Tablet Compression Machine  Qualification of Tablet Compression Machine  Installation Qualification  Operational Qualification  Performance Qualification  References 2
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   Tablets arebeing formed by compressing the granules using the compression machines.  A tablet formation takes place by the combined pressing action of two punches & a die. 3 Tablet Compression Machine
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   The basicprinciple behind the tablet compression machine is hydraulic pressure.  This pressure is transmitted unreduced through the static fluid.  Any externally applied pressure is transmitted via static fluid to all the directions in the same proportion. It also makes it possible to multiply the force as needed. 4 Principle of Tablet Compression Machine
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  5 Construction of TabletCompression Machine
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  1. Filling: Itinvolves the transfer of granules into position for compression. 2. Metering: involves removal of excess granules from the cavity. The weight is controlled by height of lower punch in die which is controlled by metering cam. 3. Compression: Top & bottom punch come together by pressure within die to form a tablet. 4. Ejection: involves removal of tablet from lower punch die station. 6 Working of Tablet Compression Machine
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   IQ checklist:  Compare all specification & write the observation.  Machine height- measure with measuring tape  Overall dimension- measure with measuring tape  RPM of turret - check by tachometer.  Hopper : i. Conventional hopper- by visual check ii. MOC(master of construction )-using Molybdenum iii. Height- Measure with measuring tape  Number of station- visually count number of holes on turret  Type of tooling- using venire caliper check the die hole diameter  Feeder- by visual check. 7
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   Following shouldbe checked by visually.  Required utilities-electricity  Thickness & weight of controller cam  Main drive: i. Potentiometer ii. Selector Switch iii. Emergency switch iv. ON indicator  Dust extraction & exhaust system  Lubrication i. Oil pressure gauge ii. Select switch for auto/manual 8
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   Verify alarmcontrol.  Perform calibration according to the manual or established by the validation team.  Operate the equipment at low, medium & high speed as per operation manual to verify the operation control.  Verify that all switches & push buttons are functioning properly  Establish procedures for operation, maintenance & calibration  Establish training program for relevant staff  Run one pilot batch for each product 9 Operational Qualification
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   OQ CheckList: 1. Main switch- check visually by operating the main switch of the machine. 2. Start push button- illuminated green switch : by pressing start button the green switch glows & the main drive motor should start 3. Stop push button- illuminated red switch : By pressing stop button the red switch glows & the main drive motor should stop 4. Turret RPM challenge test- set in the digital table counter : by rotating the knob, check by tachometer 5. Rotation direction (clockwise)- by visual check 6. Emergency switch by visual check . 7. Tablet thickness & Hardness controls : By turning the swing lever to right/left thickness increased /decrease & vise versa 10
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  7. Machine speedadjustment : Release the locking knob & rotate the hand wheel anticlockwise /clock wise- increased speed/decreased speed 8. Main upper punch entry: Remove the bolt & rotate the perforated segment to right/ left - upper punch penetration increases/ decreases. 11
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   It isan Evaluation of compression capabilities & tablet characteristics. The compression capabilities & tablet characteristics are: 1. Content uniformity 2. Thickness 3. Hardness 4. Friability 5. Weight variation 6. Disintegration test Above parameters should be investigated & result should fall under acceptance criteria . 12 Performance Qualification
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  References 1. http://www.slideshare.net/JadhavAnkushJadhav/qualification-of- manufacturing-equipments?from_m_app=android 2. SubrahmanyamCVS, Setty JT, Sarasija S & Devi VK in “ Pharmaceutical Engineering- Principles & Practices”, Vallabh Prakashan, New Delhi, 2001, 390-391, 397-399. 3. http://www.slideshare.net/YashMenghani2/qualification-of-tablet- compression-machine-capsule-filling-machine?from_m_app=android 4. Ankur Choudhary, “ Working and Principle of Tablet Compression Machine”. https://www.pharmaguideline.com/2016/02/principle-of- tablet-compression- machine.html?m=1#:~:text=The%20basic%20principle%20behind%20t he,multiply%20the%20force%20as%20needed. 13
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  5. Reddy, B.Venkateswara, et al. "A Review On Qualification Of Autoclave, RMG, FBD, Cone Blender, Tablet Compression Machine." Journal of Global Trends in Pharmaceutical Sciences,2014, 5(1), 1450-1459. 6. http://www.slideshare.net/YashMenghani2/qualification-of-tablet- compression-machine-capsule-filling-machine?from_m_app=android 14
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  Thank you 15