TD1 Tap Density 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.

The TD 1 also has a built-in 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).

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.

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.