PTB 330
5-in-1 Tablet Testing Instrument
PTB 330
5-in-1 Tablet Testing Instrument
The 5-in-1 tablet testing instrument PTB 330 is a dual test mode instrument to measure five different parameters of one sample. Hardness, diameter (or length), thickness, width and the weight of tablets can be determined here. The instrument is operated via a large 7” backlit color touch screen. The instrument is made in strict compliance with the EP <2.9.8> and USP <1217> Pharmacopoeia.
Measurement of Five Different Parameters
PTB 330 features one testing station to determine the thickness, width, diameter (or length) and the hardness of tablets. Furthermore, PTB 330 allows connecting a Sartorius or METTLER TOLEDO analytical balance to measure the weight of the samples as well. PTB 330 offer two modes for the weight measurement: either weigh each sample individually, before placing them in the testing station or weigh all samples together and calculate the average weight.
Changeable Sample Support
The sample support of the test station is changeable. You can use version with a groove for optimal positioning of oblongs or other samples which tend to move during the test procedure. The measuring units can be selected from mm or inch and KP (Kilopond), N (Newton) or Sc (Strong Cobb).
User Interface
PTB 330 features a large, 7” backlit color touch screen with a state-of-the-art graphic user interface (GUI).
Running A Test
Quick Test or Method
There are two ways to start a test with PTB 330 – start a quick test immediately after powering on the instrument without logging on or login to start a test using a defined method.
Select Sample Shape
When running a test, you first select the approximate sample shape (round, oblong or capsule). This determines which parameters can be measured subsequently. Afterwards, select which parameters to measure, enter a batch number and start the test.
Insert Sample
Place the tablets one by one into the test station and orientate them according to the parameter to be tested next. The instrument gives clear instructions including pictures to the user at every step.
Test Procedure
Weight Measurement
In case a balance is connected to the PTB 330, the weight of the tablet (or tablets) is measured and directly transferred to the instrument. Take the tablet from the balance dish and place it into the testing station of the PTB 330.
Measurement of Dimensions and Hardness
First place the tablet in an upwards position towards the wall and start the thickness measurement. The force jaw moves forward to measure the thickness. Next the sample is rotated for the (optional) width measurement. The sample is rotated a final time for the combined diameter and hardness measurement (breaking force).
Automatic or Manual Restart
Clear on-screen instruction will lead the user through every step of the test either in an automatic restart mode, where the test procedure continues automatically after an adjustable interval, or manually where the user confirms the correct position of the tablet before each step.
Result Display
All results of the current sample are always displayed during the test. Once the test of one sample is finished, the tablet can be discarded into the removable waste container. Then a result overview of all results obtained during this test run can be displayed. Once a test run is finished, the results including statistics can be printed directly on the integrated printer, printed on a connected printer or transferred to a LIMS system or other external system via a serial interface
Printing of Results and Statistics
When printing directly via an internal or a connected ticket printer or a ticket printer the data including each individual result as well as product information, date, time, user, instrument serial number, statistics are added to this information.
Test Using a Method
The instrument includes a method management system. In the method the nominal values and number of samples to be tested are defined. It is also possible to define tolerances here, which will be indicated on the result overview on screen as well as in the result reports.
Three Tolerance Levels
PTB 330 support three tolerance levels: T1, T2 and Invalid. These can be defined as absolute values or in percentages. Performing the actual test then is similar to the procedure described above for the quick test.
Activating or Deactivating Testing Parameters
It is always possible to activate or deactivate separate testing stations. This way it is possible, for example to just test the hardness of a tablet without measuring any other parameters. For this, deactivate the other parameters like thickness simply by leaving the field for the nominal value empty.
Operating Principle
In the existing USP and EP monographs there is no standard force setting or force increase mode established, but it is recommended to use a linear force increase rate of 20N/s. Different force settings usually cause problems when comparing results received by different supplier’s instruments when testing the same tablet. The hardness result is directly influenced by the contact speed and force increase rate.
About Force Modes
A faster moving force jaw generally leads to lower reproducibility and often to higher test results. To offer the possibility to select an operating mode which will produce results similar to instruments you may already use, select the same force mode, linear force or linear speed increase and select the same or a similar rate. Also touch and detection force may be altered to suit the sample design specification. When the sample is touched the instrument switches to the selected mode and linear increasing rate. The instrument offers also the option to test capsules with the help of a special procedure, which allows the instrument to just touch the sample, compressing, but without breaking it.
Which Force Mode Should Be Selected?
Since decades 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.
If 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 reproducible than the ones with linear force increase mode. Therefore, Pharma Test recommends using linear force increase. We will continue to offer both modes of operation to offer the possibility of comparing results of different instruments by setting the same parameters of operation.
User Management
PTB 330 features a user management system. Users can be defined with username and password and a combination of rights can be assigned to them: run tests, edit methods, perform calibrations, perform service and change settings, edit users.
Calibration and Validation
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) with a precision of 1N. All Pharma Test tablet hardness testing instrument can be statically calibrated over the complete measuring range using different traceable counterweights. All instruments support the checking of at least three different points during calibration to prove the linearity of the force sensor.
For the thickness, width and diameter (length) 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 30kg certified weights is recommended. All adjustment and calibration results can be printed and countersigned.
To prove the linearity of the instrument, the operator can program a print-out of the force curve recorded during a test. This will show the linear increase of the adjusted force mode. Also, different weights, like the PTB-CAL15 and PTB-CAL30 weight sets which include 5, 10, 15kg and 30kg (PTB-CAL30) using two additional 10kg weights for total 50kg, may be placed onto the load cell or the PT-MT3 and can be used to validate the linearity. Using the RS232 COM port, a Matrix or PCL5 printer can be added, and all results can be transmitted to software running on a computer system.
Features
- Tablet hardness testing in full compliance to USP <1217> and EP <2.9.8> Pharmacopeia
- 5 results of the same sample: thickness, width, diameter (length), hardness and weight (via connected external analytical balance)
- Dual force mode instrument with linear speed increase and linear force increases modes
- Statists including mean value, absolute and relative standard deviations, minimum and maximum
- Easy to use graphical touch screen user interface with clear operator instructions
- Multiple point validation procedure built-in
- Set to test tension strength of oblongs and caplets available
Advantages
- Select either linear force or linear speed increase (dual mode selection)
- Stepless adjustment of the force or speed increasing rate
- User and method management system
- Entry of time and date
- Quick start to start testing with minimal preparation
- Automatic re-start facility to speed up the testing sequence
- Directly connectable to LIMS or other external systems
- Validation and calibration program for the measurement station
- Dual point adjustment of the load cell for the hardness test station
- Multiple point calibration (calibration)
- Test program for soft gelatin capsule testing
Technical Specifications
| Parameter | Specification |
| Hardness testing range | PTB 330: 2.0 – 300.0 N
PTB 330-500: 5.0 – 500.0 N PTB 330-1000: 10.0 – 1,000.0 N |
| Hardness accuracy | Better than ±1 N |
| Hardness resolution | 0.1 N |
| Thickness testing range | 2.00 – 35.00 mm, expandable to 70mm |
| Thickness accuracy | Better than ±0.02 mm |
| Width & diameter testing range | 2.00 – 35.00 mm, expandable to 70mm |
| Width & diameter accuracy | Better than ±0.02 mm |
| Thickness, width & diameter resolution | 0.01 mm |
| Weight measurement | By external METTLER TOLEDO or Sartorius balance (balance not included in standard supply scope), individual or average weight |
| Measuring units | Thickness, diameter and width selectable between millimeter (mm) and inches (IN); Hardness selectable between Newton (N), Kilopond (kp) and Strong Cobb (Sc) |
| Force mode | Selectable: linear force increases or linear speed increase |
| Force rate | 5 – 250 N/sec. (linear force increase); 1 – 5mm/sec. (linear speed increase) |
| Display | 7” color LCD, backlit |
| Data entry | Touch screen |
| Number of users | Up to 100 |
| Number of methods | Up to 100 |
| Number of tests per run | Up to 200 tests in one run |
| Interfaces | 2 x RS-232 serial port to connect a PT-Node network adapter, an Epson TM-U220B ticket printer, or a balance, 1 x USB-C port for data export and firmware updates |
| Instrument housing | Stainless steel (304) to meet GLP requirements |
| Power | 100-240 Volt AC, 50/60 Hz |
| Installation requirements | Ambient Temperature 15-35 °C
Relative Humidity 15-80 %rH Desk with at least 50 kg working load. All around the instrument at least 10 cm free distance to walls or other equipment. Free access to the mains power plug and switch. |
| Instrument dimensions | Approx. 260 x 500 x 260 mm (Length x Width x Height) |
| Packaging dimensions | Approx. 310 x 660 x 420 mm (Length x Width x Height) |
| Net / gross Weight | Approx. 9,5 kg / 12,5 kg (without optional accessories) |
| Certification | All components certified to USP / EP requirements |
| CE / EMC certification | All CE / EMC Certification provided |
| Validation | All IQ & OQ documents included |
Features are subject to change due to ongoing development. We reserve the right to make technical changes without any prior notice.
Standard Scope of Supply
The PTB 330 comes ready to use with the following standard scope of supply:
- Broken sample collector
- Integrated printer
- Comprehensive documentation folder including:
- User manual
- QC/DQ testing certificate
- IQ documentation
- OQ documentation
- Conformity Declaration
- CE/EMC Declaration
- Instrument logbook
Options
In addition to the standard scope of supply Pharma Test offers a broad range of accessories and options including:
- 500N (PTB 330-500) and 1,000N (PTB 330-1000) extended force range
- Full range of certified validation tools available
- Different splints for tablet guidance in test station via exchangeable bottom plates
- Set of recommended spare parts
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