PTB-M100

Portable Tablet Hardness Testing Instrument

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PTB-M100

Portable Tablet Hardness Testing Instrument

PTB-M100 is a portable, manual hardness testing instrument for tablets. The instrument is made in strict compliance with the EP <2.9.8> and USP <1217> Pharmacopoeia. PTB-M100 is very easy to use. The force and break point are measured by a precise force sensor and the result is immediately displayed on the large color touchscreen.

PTB-M100 – the new generation of portable tablet hardness testers with an intuitive operation via touchscreen


Password Protection

Important settings, such as date and time are protected by a password. The password can be changed. Calibration and adjustment of the instrument also require the password.

Build Quality

The instrument is solidly built and yet perfectly portable, making it ideal for use in a production department, for example. The integrated rechargeable battery lasts for approximately two hours of operation.

Operation Principle

Touch Screen
The instrument is operated using a 3.5” color touch screen. During a test the hardness value is displayed live in either Newton (N), Kilopond (Kp) or StrongCobb (Sc). The instrument is powered by a rechargeable battery using a standard USB-C charger. The test results can be documented by connecting a ticket printer or by using the Pharma Test PT-Node network adapter. When starting a new test run, a batch number (alpha-numeric) can be entered using a software keyboard.


Manual Handling
Simply place the sample on the testing platform and manually rotate the knob. This moves the jaw and applies force to the sample. The result is immediately displayed. All results of a current measurement run are then shown in a scrollable table. Incorrectly measured samples can be discarded here. These results are still documented on the result report but are not included in the statistics. The results of the latest test run are stored in the instrument memory and can be printed repeatedly. Starting a new measurement run discards the results of the previous run.


Settings
The settings menu is password protected. This password can be changed. The instrument keeps date and time (date and time are not lost when the battery is empty) and supports 12- and 24-hour time formats and US and European date formats. All printouts contain date and time of performance and date and time of the printing.


PTB-M100 with Extended Measurement Range for Larger Samples
PTB-M100 is also available in an extended measurement range version. In this instrument variant, the mechanics have been extended to be able to test larger samples than the standard model. This is useful for certain veterinary products or other, non-pharmaceutical applications.


Measurement Ranges

PTB-M100 is available with the following extended measurement ranges:

Part No. Sample Min. Diameter Sample Max. Diameter Hardness Max.
29-01660 30mm 60mm 300N
29-01665 30mm 60mm 500N
29-01690 60mm 90mm 300N
29-01695 60mm 90mm 500N
29-01620 90mm 120mm 300N
29-01625 90mm 120mm 500N

Calibration and Validation

PT-MET Mechanical Tablets
For daily verification, PTB-M100 is compatible with the Pharma Test PT-MET mechanical tablets. PT-MET are available with four different nominal hardness values (50, 100, 150, 200N). They can be purchased individually or as a complete set. They come with a certificate of calibration, operating instructions and can be returned to us for re-calibration.


PTB-CAL 15 Weight Set
Using the certified PTB-CAL15 weight set, adjustment and calibration of PTB-M100 can be carried out on site and requires only a few minutes. 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 using different traceable counterweights.


PT-Node Network Adapter for Printing and Data Transfer
PT-Node is an adapter that connects up to two Pharma Test instruments simultaneously to a network using a wired LAN connection. This way you can print test results from the instrument via your web browser on any local or network printer. Furthermore, it is possible to transfer the test results from the instruments to external systems in the same network. PT-Node supports PTB-M100.


Setup of the PT-SV110 Instrument
The instrument design consists of a solid baseplate, a stand to carry the funnel and baffle box, a stainless steel receiving cup. The height of the funnel and of the baffle box can be adjusted freely up and down and locked into place without a risk of twisting and without using any tools. After a test the baffle box can be swiveled to this side to allow easy access to the receiving cup.

The instrument includes a powder collecting tray, which can be easily removed for cleaning. The base plate with integrated spirit level can be adjusted via three points to ensure a level installation. A suitable balance is required to calculate the apparent density.

Result Reporting
Usually there should be a series of at least three tests to provide a basic statistical set of results and to avoid any sample anomalies. Samples should be of a uniform nature and as such should be representatively sampled. This can be achieved by coning and quartering or by the use of suitable riffling device, either electronic or manual. When the test is finished you need to prepare a test report which should include product descriptive information such as batch number, specification, method of drying (if it has been dried).



Features
  • Fully USP <1217> and EP <2.9.8> compliant
  • Hardness Range: 5N to approx. 300N (500N optional)
  • Test tablet sizes of up to 28mm diameter (extended measurement range models available)
  • 5” color LCD touch screen
  • Date & time (printed on all reports)
  • Connect ticket printer or PT-Node network adapter to document the results (optional)
  • Calibration and adjustment programs included


Advantages
  • Very easy to use via color touch screen, get immediate results
  • Solidly built and yet compact, portable instrument
  • Powered by an integrated rechargeable battery using a standard USB-C port
  • Features the same high quality force sensor as other Pharma Test hardness testers
  • Important settings such as date and time are password protected
  • Select result display unit from Newton (N), Kilopond (Kp) or StrongCobb (Sc)
  • Documentation of all results using the optional ticket printer or PT-Node network adapter
  • Calibration and adjustment programs and printing of reports included
  • Date and time are included on all reports

Technical Specifications

Parameter Specification
Display 3.5” color LCD
Data entry Touch screen
Standard force range 5.0 to approximately 300N (500N optional)
Hardness accuracy 1N
Hardness resolution 1N
Maximum number of tests 100 in one test run
Maximum sample size 28mm diameter (extended measurement range models available)
Battery capacity 2x 1.100mwh NiMH AAA battery cells (approx. 2 hours of working time, can be used and charged simultaneously)
Printer Serial printer port to connect ticket printer
Interface RS-232 COM port supporting PT-Node network adapter
Calibration program 3-point calibration program including report
Adjustment program 2-point adjustment program including report
Instrument dimensions Approx. 27cm x 9cm x 9cm (Length x Width x Height) w/o printer
Packaging dimensions Approx. 40cm x 30cm x 21cm (Length x Width x Height)
Net / gross weight Approx. 2kg / 3kg
Certification All components certified to USP / EP requirements
CE / EMC Certification All CE / EMC Certification provided
Validation All IQ & OQ documents included

We reserve the right to make technical changes without any prior notice.


Standard Scope of Supply
The PTB-M100 comes ready to use with the following standard scope of supply:
  • USB-C power adapter
  • 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 extended force range
  • Extended measurement range to test larger samples of 30-60mm, 60-90mm or 90-120mm diameter
  • Ticket printer to document results
  • PT-Node network adapter
  • Recommended spare part set
  • Full range of certified validation tools available



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Pharma Test Instruments India Private Limited
Pragathi Nagar, Medchal Dist. Hyderabad - 500090, Telangana. T: +91 40 48591800 E: c.neelam@pharma-test.in




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