Qualification of Dissolution Testers and Dissolution Systems is one of the essenial criteria.

For this reason one of the goals of ERWEKA is to offer either Qualification Services or tools and documentation of the Qualification by the operator himself.

In case of outsourcing, ERWEKA offers the know-how of its Quality Control department.

Contacts for installation, qualification, requalification and maintenance are available when required.

Dissolution Tester >> IQ

Installation Qualification can be offered by the Quality Department of ERWEKA.

In case the user wants to do the Installation Qualification himself, ERWEKA offers for DT 600/720/820 and 720-2 Installation Qualification documents which have to be completed.

Dissolution Tester >> OQ

Filling out Operation Qualification (System-Suitability-Test) Documents is past!

DT 720/820 and 720-2 offer a OQ submenu which guides the user through the OQ of each required parameter. The results of the test are entered in the the unit by the numeric (DT 720) or alpha-numeric (DT 820) membrane keypad.

A special OQ-Tool-Kit is available. Optional the OQ tools are equipped with interface to be connected to the OQ-Toll-Interface of the DT 720/820/720-2. In this case the results have not to be entered, they are automatically transferred to the programme of the Dissolution Tester.

On the completion of the OQ the user may print a complete OQ documentation by a suitable printer connected to the Dissolution Tester.

The OQ Interval Display will remind the user for requalification after a period of 6 months optically.

Dissolution Tester >> PQ

Performance Qualification (Calibration of the unit with either USP Calibration Tablets or in-house calibrators) can be performed by the laboratory staff of the ERWEKA Quality Department.

In case the user wants to do the PQ by himself, USP Calibration Tablets are available from ERWEKA.

The PQ Interval Display (Calibration Interval display) reminds the user 6 months after the last calibration that re-calibration is required