230773 Sotax TD 1 Tap Density Testing
The flexible TD 1 tap density tester with one single measurement station excels in user-friendly operation while complying with all USP, EP, ASTM and DIN EN ISO requirements. The TD 1 has been designed for optimized and efficient operation.
Easy operation allows tests to be run using a pre-defined EP / USP method – reducing setup time to a minimum while ensuring that tests are performed according to specifications.
Operating the TD 1 is simple: The SingleButton™ navigation allows users to quickly start tests and navigate through the menu. Method parameters such as strokes per minute and number of taps can be defined individually or easily set to comply with different standards. Weight measurements before a test are either transferred automatically from a connected standard laboratory balance or alternatively entered manually. To ensure ease of regulatory compliance, the TD 1 automatically compares the test results with regulatory requirements (e.g. acceptance criteria) and automatically guides the user through
the complete test procedure. Test reports including starting volume and tapped volume are conveniently printed
directly from the tester.
Full regulatory compliance :
The TD 1 tap density tester complies with all relevant regulatory requirements:
• USP 1 / 2 (chapter <616>)
• EP 1 / 2 (chapter 2.9.34.)
• ASTM B 527
• DIN EN ISO norm 787-11 and ISO 3953 To ensure ease of regulatory compliance, the device is equipped with various automatic detection, calculation and reporting features.
User-friendly handling
The TD 1 is equipped with only one cylinder station for all test methods – different cylinders can be loaded onto the “easy to lock” holders which allow for free rotation of the cylinders and, hence, horizontal powder surface for clear reading precision. The device also features a builtin sensor that can detect the presence of an adapter piece (spacer) which automatically sets the device to comply with the correct test method (e.g. with adapter → USP 2; without adapter → USP 1).
Operating the TD 1 with the SingleButton™ feature is extremely user-friendly – tests can be started very quickly
and navigating through the menu is simple.
Professional reporting and data management
The TD 1 compiles the results automatically, including method parameters, calculation as Tapped Density, Compressibility index and Hausner ratio. The last 20 reports are saved in the instrument memory and can be printed
out either on a local or network printer. Test data can also be managed professionally with q-doc (optional), a userfriendly PC software for reporting and data management in full compliance with 21 CFR Part 11 requirements. All test data can be stored in a database enabling harmonized and detailed reporting of individual test runs as well as batch results for trend observation. Comprehensive test and batch reports including statistical analysis are automatically generated in formats that are readily
accepted by regulatory authorities. All test results are stored electronically in an SQL database – locally or in a networked environment – and can be retrieved flexibly at any time.
Easy validation and qualification
The qualification procedure is fully menu-guided, stepby-step, and finished off with a printed validation report. The user can also define and set the validation intervals in the TD 1 firmware.
The built-in validation platform simplifies and guarantees a reliable qualification process.
Qualification results are automatically saved in the device and are printable at any time.
