ERWEKA offers for all its testing equipment Installation Qualification (IQ) and Operation Qualification (OQ) handbooks. These handbooks allow the user to validate/ qualify the equipment by himself by filling the attached forms.
For Qualification Validation Tool Kits (non-certified or certified) are available from ERWEKA specially designed for each unit. This Validation Tool Kits comprise of all needed tools for re-qualification (OQ) of the unit. When purchasing a calibrated tool kit most of the tools have to be re-calibrated each year. This procedure can be done by the purchaser or by ERWEKA (Tool Calibration Service).
To outsource the Validation/Qualification procedure, ERWEKA offers Installation as well as Operation Qualification (IQ/OQ) services at site. Our trained Quality Management staff will come to your location and prepare the comple-te IQ/OQ for you as well as train the users in operation of the equipment. This service guarantees perfect installation and operation of the equipment.
With the new Dissolution Tester generation ERWEKA offers the next step. The units are equipped validation-/calibration- and service interval displays. The user is reminded to re-quality the unit after the USP/EP and FDA proposed interval (6 months).Optional the units check the OQ automatically during the test-run and monitor mistakes by the standard "OQ traffic light". For the Operation Qualification (OQ) no papers have to be filled! The results of the System Suitability Test are entered by the keypad of the unit, a System Suitability Test print-out is created by the unit.