WHT 4

Test diameter/length, weight, thickness/height, and hardness of normal, unusual shaped tablets (caplets, oblongs, etc.) fully automatically as well as solid samples. The WHT 4 from PHARMA TEST is used for the fully automated testing of single tablet critical parameters including weight, thickness, diameter and the tablet hardness (in compliance to the European and German Pharmacopoeia for uniformity of mass)

Offering a reliable and reproducible self-contained feeder and measurement station for quality control of samples throughout tablet production and in post-production QA and QC laboratories. The WHT 4 testing instrument do four test parameters of one sample. WHT 4 is a separate unit with an integrated touch screen PC running the WHT32 software. A single/ multiple-batch feeder can be used to separately file the samples into the testing system for entirely automated control of several samples and batches. Using the single feeder WHT 4-SM1 as well as direct connection to a current tableting machine can be done. The multiple batch feeder WHT 4-SM is employed to test up to ten different products unattended and fully automatically.

WHT 4 features

Tablet hardness testing in full compliance to USP <1217> and EP <2.9.8> Pharmacopeia
Whole system of instrument, PC and software
Four results of the same sample: thickness, diameter, hardness and weight (by internal balance)
Multiple point validation procedure for all built-in measurement stations
Dual force mode instrument with linear speed and force increase modes
WHT32 software package features

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
Result data transfer by RS-232 data interface
Batch comparison statistics
Networking capabilities
Robust SQL MS Jet database
Available software IQ and OQ documentation
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.)
Statistical calculations of mean value, absolute and relative standard deviations, minimum and maximum result
User and password and login administration (21CFR part11 option)
Microsoft Excel and LIMS export functionalities

WHT 4 advantages

1. Fully automated operation
2. IQ/OQ documents included free of charge
3. Exceptional flap mechanism to precisely position samples for hardness and diameter test
4. Fully integrated system including integrated PC and software
5. Stainless steel housing to fit well into a production area
6. Standard version of WHT32 software package included and pre-installed in the standard supply
7. No change of tools necessary to handle different tablet shapes
8. WHT32 software package advantages
9. Integrated instrument qualification procedure
10. Direct display and filing of all results
11. Automated flap control for opening and closing angle and adjustable speed
12. Automated speed adjustment for tablet transportation
13. Instant documentation of all results on screen and printer special diameter and hardness test program to run deep concave tablets which tend to” stand up” while moved for hardness and diameter testing
14. Software controlled display, data entry and calculation facilities
15. Gel Capsule weight control program
16. Special transport adjustment options for “rolling” samples, like caplets
17. Graphical display of results either as a chart diagram or variation curve
18. Calibration and validation procedures for all integrated stations