PTB 420 – Automated Tablet Testing Instrument
Contents
1. Display Keyboard Feeder Laser Type Interface Instrument Housing Power Instrument Dimensions Packaging Dimensions Net Weight Gross Weight Certification CE EMC Certification Validation 2 0 300 0N optional 5 0 500 0N Better than 1N 2 00 12 00mm Better than 0 05mm 2 00 30 00mm Better than 0 05mm By connected external Mettler Toledo or Sartorius balance balance not included in standard supply scope 0 0001g 99 9999g Thickness and diameter selectable between millimeter mm and inches IN Hardness selectable between Newton N Kilopond kp and Strong Cobb Sc Selectable between linear force increase and linear speed increase 5 200N sec linear force increase or 5 250mm Min linear speed increase Back lit color LCD Alpha numeric keypad and click wheel Tablet magazine for 10 samples available option Class 1 RS232 serial port to connect a Mettler Toledo or Sartorius analytical balance Parallel port for printer connection USB port for PC connection USB port for firmware updates Stainless steel 804 to meet GLP requirements 110 230 Volt 50 60 Hz Approx 31cm x 48cm x 30cm D x W x H Approx 34cm x 68cm x 36cm D x W x H Approx 14kg Approx 19kg All components certified to USP EP requirements All CE EMC Certification provided All IQ amp OQ documents included We reserve the right to make technical changes without any prior notice PT2. recorded during a test This will show the linear increase of the adjusted force mode PTB CAL15 5 10 15kg adjustable weight set THE GERMAN GRUNDLICHKE T PTAG_29 04000_PTB420_V1 1E Page 8 of 11 onarmdd TEST PTB 420 Automated Tablet Testing Instrument Advantages Some of the highlights the PTB 420 offers are Automated positioning of samples in the testing area by unique alignment jaws Touch less measurement of sample thickness Test up to 10 samples fully automatically by using the tablet magazine optional magazine can be refilled at all times Sophisticated user and method management system included Quick start functionality to start testing with minimal preparation Quick menu navigation by using a large color LCD and a click wheel Select either linear force or linear speed increase dual mode selection Entry of time and date Enter a 12 digit batch number Dual point adjustment of the load cell for the hardness test station Multiple point validation calibration Hardness testing in compliance with the EP lt 2 9 8 gt and USP lt 1217 gt Pharmacopoeia IQ OQ documents included free of charge Features The main features of the PTB 420 are Tablet hardness testing in full compliance to USP lt 1217 gt and EP lt 2 9 8 gt Pharmacopeia 4 results of the same sample thickness diameter hardness and weight via connected external analytical balance Dual force mode instrument with linear
3. CCD sensor by the moving sample dish The Height adjustment screen enlarged ccp height of the sample can be determined form the image on the left 1 1 image on the right side sample s shadow on the CCD sensor Thereafter the sample is automatically moved towards the force jaw to measure the diameter and finally the hardness by breaking it Once the test is finished and the sample is broken the sample dish moves backwards to drop the sample fragments into the removable waste container The results are immediately displayed and may be printed on a connected printer The print out includes each individual result as well as product information date time user instrument serial number and Statistics o THE GERMAN GR NDLICHKEIT PTAG_29 04000_PTB420_V1 1E Page 2 of 11 onarndd TEST PTB 420 Automated Tablet Testing Instrument Operation Principle of the Hardness Measurement The current monographs of the USP and EP Pharmacopoeia define how a tablet hardness testing instrument should work but without establishing data of how to increase the applied force and when to detect a sample to be broken This often causes problems when trying to compare results of the same tablet measured with instruments from different manufacturers The hardness result is directly influenced by the contact speed and force increase rate of testing instrument A faster operated test jaw means a lower reproducibility and often higher absol
4. with a precision of 1N All Pharma Test tablet hardness testing instrument can be statically calibrated over the complete measuring range by the use of different traceable counterweights All instruments support the checking of at least three different points during calibration to prove the linearity of the force sensor PT MT3 Magnetic Test Tablet Furthermore Pharma Test offers the PT MT3 magnetic tablets to calibrate the breakpoint detection of the whole tablet hardness testing instrument force sensor and mechanics of the instrument All Pharma Test tablet hardness testing instruments are fully compliant to the requirements of the current USP Pharmacopeia PTB 420 features an access controlled calibration and adjustment program for the three testing Stations For the thickness and diameter station certified reference blocks are used for both calibration and adjustment Weight sets are used to calibrate and adjust the force sensor load cell of the instrument over the complete measuring range For the two point adjustment zero and reference of the load cell inside the hardness station a certified reference weight of 10 kg is used For validation purposes the use 5 up to 50kg certified weights is recommended The latest calibration and adjustment results are stored on the instrument and can be printed and signed To prove the linearity of the built in load cell during a hardness test the operator can program a print out of the force curve
5. 0 features a large back lit color LCD Menu navigation is done by use of a click wheel similar to the ones used in many car navigation systems This allows the user to rapidly scroll through the menus to make his selections Quickly create methods by entering the nominal test information for thickness diameter hardness and weight via the aloha numerical keyboard and select the unit to measure mm in Kp N Sc It is also possible to use the quick test functionality to work without creating a method first and without entering any nominal values When creating a method it is also possible to disable certain measurements for example to only test the hardness of a tablet The angle of the operation panel can be adjusted freely to guarantee optimal visibility whether the user is sitting in front of the instrument or operating it from a standing position cco iii Sa AT To perform a test with PTB 420 either insert the samples into the tablet magazine or drop the individual samples into the unique sample positioning station for a automated correct alignment inside the combined Revs tuto thickness diameter and hardness test station 1 463 mm HB 1 211 mm A class 1 laser beam is used for the touch free measurement of the sample thickness The beam is used to illuminate a CCD sensor on the other side of the measurement area The sample is scanned by the ESC exit laser beam while simultaneously being moved in front Noss bindow of the
6. AG_29 04000_PTB420_V1 1E THE GERMAN GRUNDLICHKE T Page 11 of 11
7. gazine can be refilled at any time to allow the testing of larger batches in one test run As the tablet magazine can easily be removed from the PTB 420 it may be used to collect samples directly at a tablet press In this case it is possible to use several magazines one for each tablet press for example The PTB 420 features a RS232 interface to connect a Mettler Toledo or Sartorius analytical balance of 0 1mg accuracy This way it is possible to test either the individual weight or average weight of all samples prior to the test of the physical parameters of thickness diameter and hardness The samples are placed manually from the balance either directly into the testing station of PTB 420 or into the tablet magazine o THE GERMAN GRUNDLICHKE T PTAG_29 04000_PTB420_V1 1E Page 4 of 11 B TEST PTB 420 Automated Tablet Testing Instrument Example Print Outs Pharma Test Tablet Testing System PTB420 Serial No 19075 Department PTAG 28 01 2014 Product Placebo Batch No 1234ABCD Procedure Lin Force Setting Weight g Thickness mm aye eae 5149 s5189 5199 5172 5174 s5163 Weight g Thickness 5149 0 5241 0092 average 5192 SD av 0029 Performed by Confirmed by Example Result Report Print Out PTAG_29 04000_PTB420_V1 1E Page 5 of 11 Time 13 03 Time 13 03 THE GERMAN GRUNDLICHKEIT onarmdd TEST PTB 420 Automated Tablet Testing Instrume
8. nt Pharma Test Tablet Testing System PTB420 Serial No 19075 Department PTAG User ADMINISTRATOR Print Date 28 01 2014 Hardness Calibration Static Measurement of Reference Weights ad 02 02 Performed by ADMINISTRATOR 28 01 2014 Confirmed by Date 28 01 2014 Approved by Date 28 01 2014 Example Hardness Calibration Report PTAG_29 04000_PTB420_V1 1E Page 6 of 11 15 16 THE GERMAN GR NDLICHKEIT re gt TEST PTB 420 Automated Tablet Testing Instrument Fharma Test Tablet Testing 5ystem PIBAZ2O0 l Ver 01 00 Serial Wo Department User Logged out QUICK TEST Print Date 11 12 2015 Time 10 50 Product TESTPLACERO Batch Wo Procedure Quick Test Setting 20 0 N a Break Det 13 3 N Touch Force 5 0 N Init Gap 0 02 mm Shape Tablet No Weight g Height mm Diameter mm Hardness H 2 n a 9 47 9 54 a4 2 40 0N 20 0N l J 0 08 2 0 4 0 The gradient is calculated at 50 and 90 of t Fmax 1 84 5 dF 31 5 N 17 7 W Z emmnme 18 7 N 7B Example Print Out of Force Curve THE RMAN CR NDLICHK IT PTAG_29 04000_PTB420_V1 1E Page 7 of 11 onarndd TEST PTB 420 Automated Tablet Testing Instrument Calibration and Adjustment The current USP Pharmacopeia requires the force sensor of a tablet hardness testing instrument to be calibrated periodically over the complete measuring range or the range used for measuring samples
9. onarma TeST PTB 420 Automated Tablet Testing Instrument PTB 420 Automated Tablet Testing Instrument The automated tablet testing instrument PTB 420 is a dual test mode instrument to determine the diameter thickness and hardness of tablets The instrument is made in strict compliance with the EP lt 2 9 8 gt and USP lt 1217 gt Pharmacopoeia Prior to testing the hardness of the tablet the PTB 420 can measure sample thickness or height and diameter or length The thickness is detected automatically by an optical system The samples are automatically pe by means of the patented movable alignment jaws The behaviour of the Pharma Test Apparatebau AG Siemensstr 5 63512 Hainburg Germany PTAG_29 04000_PTB420_V1 1E jaws movement is adjustable to accommodate many different shapes of tablets and oblongs The instrument can be set to either linear force or linear speed increase mode for the tablet hardness test Furthermore PTB 420 allows the connection of a Mettler Toledo or Sartorius analytical balance to measure the weight of the samples as well PTB 420 offer two modes for the weight measurement either weigh each sample individually before placing them into the tablet magazine or weigh all samples together P 49 6182 9532 600 F 49 6182 9532 650 info pharma test de www pharma test com Page 1 of 11 onarmd TEST PTB 420 Automated Tablet Testing Instrument and calculate the average weight PTB 42
10. speed increase and linear force increase modes Steppless adjustment of the linear force or speed increase rate Document all results on external printer Multiple point validation procedure for all measurement stations built in Programmable print out of force increase curve Standard Scope of Supply The PTB 420 comes ready to use with the following standard scope of supply PTB 420 instrument A set of 3 5 and 10mm reference blocks Comprehensive documentation folder including User manual QC DQ testing certificate Q documentation OQ documentation Conformity Declaration CE EMC Declaration Instrument logbook THE GERMAN GR NDLICHKEIT PTAG_29 04000_PTB420_ V1 1E Page 9 of 11 onarmndd TEST PTB 420 Automated Tablet Testing Instrument Options In addition to the standard scope of supply Pharma Test offers a broad range of accessories and options including Tablet magazine for 10 samples Extended hardness range of up to 550N PTB 420 500 model Adapter to connect USB PCL 5 printers THE GERMAN GR NDLICHKEIT PTAG_29 04000_PTB420_V1 1E Page 10 of 11 onarndd TEST Technical Data PTB 420 Automated Tablet Testing Instrument Parameter Specification Hardness Testing Range Hardness Accuracy Thickness Testing Range Thickness Accuracy Diameter Testing Range Diameter Accuracy Weight Measurement Weight Testing Range Measuring Units Force Mode Force Rate
11. ute results In order to offer the possibility to select an operating mode which will offer you similar results to other instruments you may already use PTB 420 allows to set the force mode by selecting between linear force increase or linear speed increase and the set the force rate When the instrument detects that the sample has been touched it switches to the measuring mode and starts to increase the force applied to the sample Another adjustable parameter the break detection force to test softer samples as well as gel capsules Often samples such as soft gel capsules do not break but become smaller in diameter deformation To increase the sensitivity of the instrument and to get a result without just squashing the sample the total testing distance of the jaw after contact with the sample can be programmed Which Force Mode to Select Since more than 10 years ago all Pharma Test tablet hardness testing instruments offer the possibility to select either linear force or linear speed increase Linear force increase offers the most accurate control as the rate of increase is directly controlled by the electronic load cell used to read the force Also it is quite simple to validate the correct and linear operation as a tablet with for example 100N hardness will be broken within 5 seconds when 20N s had been set as force increase rate Linear speed increase can also be used here the driving speed of the stepper motor is kept linear Actuall
12. y as long as the touching force is kept low there is not too much difference in the results between the two modes but validation of this mode is reasonably difficult and requires specific equipment In general results obtained with the linear speed increase mode are less PTB 420 mechanics showing the measuring reproducible than the ones with linear force increase area force sensor and alignment jaws mode Therefore Pharma Test recommends using linear force increase The test of soft tablets often requires an increase of the standard force setting otherwise the sample gets deformed only but does not break We will continue to offer both modes of operation in order to offer the possibility of comparing results of different instruments by setting the same parameters of operation THE GERMAN GR NDLICHKEIT PTAG_29 04000_PTB420_ V1 1E Page 3 of 11 ouarmdid TEST PTB 420 Automated Tablet Testing Instrument Optional Equipment The optional tablet transport magazine holds 10 samples with a maximal diameter of 22mm anda maximum width of 30mm The magazine is connected to the PTB 420 instrument by means of a magnetic coupling which is connected to the drive inside the PTB 420 The transport belt moves forward to drop one sample directly into the alignment jaws in the testing station of PTB 420 Once the test has finished and the broken sample is released into the waste container the next sample is supplied automatically The ma
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