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WHT 4 Fully Automated 4-in-1 Tablet Testing Instrument

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Code: #22325

Supplier: Pharma Test Apparatebau AG

4-in-1 tablet hardness testing with multi-batch feeding option

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rightMORE INFORMATION

  • Test weight, thickness (or height), diameter (or length), and hardness of regular tablets, odd shaped tablets (caplets, oblongs etc.) and other solid samples fully automatically. Use the WHT 4 for the fully automated testing of single tablet critical parameters including weight (in compliance to the European and German Pharmacopoeia for uniformity of mass), thickness, diameter and the tablet hardness also according to the European EP <2.9.8> and USP <1217> Pharmacopoeia.
     
    Features
    The main features of the WHT 4 instrument are:
    Tablet hardness testing in full compliance to USP <1217> and EP <2.9.8> Pharmacopeia
    4 results of the same sample: thickness, diameter, hardness and weight (via internal balance)
    Complete system of instrument, PC and software
    Dual force mode instrument with linear speed increase and linear force increase modes
    Multiple point validation procedure for all measurement stations built-in
    The main features of the WHT32 software package are:
    Product dependent method description including number of tests to be done within each testing station, T1 and T2 tolerance classification, plausibility rejection, selectable measuring units and adjustable measuring parameters
    Statistical calculations of mean value, absolute and relative standard deviations, minimum and maximum result
    Batch comparison statistics
    Networking capabilities (optional)
    Features a robust SQL MS Jet database
    User and password and login administration (21CFR part11 option)
    Audit trail and data path selection (21CFR part 11 option)
    Calibration programs for each testing station (requires calibration tools, such as reference blocks, weights etc.)
    Result data transfer via RS-232 data interface
    Microsoft Excel and LIMS export functionalities (optional)
    Software IQ and OQ documentation available

  • Parameter

    Specification

    Number of Testing Stations

    4 (Hardness, Thickness, Diameter and Weight)

    Hardness Testing Range

    5.0 – 500.0 N (optional 2.0 – 300.0 N, 10.0 – 1,000.0 N)

    Hardness Accuracy

    Better than 1N

    Thickness Testing Range

    1.00 – 20.00mm

    Thickness Accuracy

    Better than ±0.02mm

    Diameter Testing Range

    2.00 – 30.00mm

    Diameter Accuracy

    Better than ±0.02mm

    Weight Measurement

    By internal Sartorius balance cell

    Weight Testing Range

    0.0001g – 200.0000g

    Weight Accuracy

    0.1mg

    Force Mode

    Selectable between linear force increase and constant speed

    Force Rate: lin. force

    5 – 250 N/sec. (linear force increase)

    Force Rate: constant speed

    5 – 250 mm/Min. (constant speed)

    Industrial PC (IPC)

    Integrated high resolution color touch screen PC

    Sample Handling

    Semi- or fully automated using single or multi-batch feeder

    Testing Speed

    10 to 15 tests per minute depending on sample hardness

    Flap Control

    Flap speed and opening angle steplessly adjustable

    Number of Tests

    Up to 250 tests in one test run

    Measuring Units

    Thickness and diameter selectable between millimeter (mm) and inches (IN)

    Hardness selectable between Newton (N), Kilopond (kp) and Strong Cobb (Sc)

    Calibration Procedure

    Using certified 1-30 mm reference blocks, 50g (for balance) and 5 to 50kg (for load cell) reference weights

    Break Force Validation

    Using the PT-MT3 magnetic tablet at 10 to 480N

    Interfaces

    2x USB, 2x LAN, RS232, DVI, Bluetooth

    Printer Support

    Supports any Windows compatible printer via USB or LAN

    Instrument Housing

    Stainless steel (304) to meet GLP requirements

    Power

    110/230 Volt, 50/60 Hz

    Packaging Dimensions

    Approx. 90cm x 65cm x 75cm (D x W x H); approx. 118cm x 76cm x 70cm incl. WHT 4-SM

    Net / Gross Weight

    Approx. 45 / 70 kg

    Net / Gross Weight

    Approx. 73 / 105 kg incl. WHT 4-SM

    Certification

    All components certified to USP / EP requirements

    CE / EMC Certification

    All CE / EMC Certification provided

    Validation

    All IQ & OQ documents included

  • Some of the highlights the WHT 4 instrument offers are
    Fully automated operation
    Fully integrated system including integrated PC and software
    Unique flap mechanism to precisely position samples for hardness and diameter test
    No change of tools necessary to handle different tablet shapes
    Stainless steel housing to fit well into a production area
    Standard version of WHT32 software package included and pre-installed in the standard supply
    IQ/OQ documents included free of charge
    Some of the highlights the WHT32 software package offers are:
    Integrated instrument qualification procedure
    Automated flap control for opening and closing angle and adjustable speed (depends on sample size and thickness)
    Automated speed adjustment for tablet transportation
    Special transport adjustment options for “rolling” samples, like caplets
    Special diameter and hardness test program to run deep concave tablets which tend to ”stand up” while moved for hardness and diameter testing
    Software controlled display, data entry and calculation facilities
    Gel Capsule weight control program
    Immediate display and filing of all results
    Graphical display of results either as a chart diagram or variation curve
    Immediate documentation of all results on screen and printer
    Calibration and validation procedures for all integrated stations

 

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