Technical data

158
Services
Installation
Installation of most ERWEKA units (TA/R, TDR,
SVM, ZT, TBH or DT) is easy and can be
achieved by the user himself or an engineer of
the company.
For more sophisticated products such as Disso-
lution Systems ERWEKA offers complete tubing
kits and even pre-configuration. The user or the
engineer has to connect the tubing and plug the
numbered interface cable in the equivalent
numbered sockets only.
For a perfect installation and training of the
user/s, ERWEKA offers a complete installation
service by an ERWEKA engineer. This means
the unit or system will be installed at your site,
the operation will be checked and the user/s
receive a training in the operation of the unit
and (when needed) software.
Qualification/Qualification
ERWEKA offers Installation Qualification (IQ),
Operation Qualification (OQ) and Performance
Verification (PV) documents for all its testing
units.
These documents allow the user to validate/
qualify the equipment independently by follow-
ing the instructions and filling in the attached
forms.
To outsource the Qualification/Qualification
procedure, ERWEKA offers installation as well
as Operation Qualification and Performance
Verification (IQ/OQ/PV) services on site. Our
trained Service performs the complete
IQ/OQ/PV for you as well as training the users
to operate the equipment. This service ensures
perfect installation and worry free operation.
ERWEKA also offers Performance Qualification
(PQ). Our trained engineers will carry out the
PQ test according to your requirements. This
action can even take place on the weekend not
to interrupt your normal laboratory work!
For Qualification Qualification Tool kits (non-
certified or certified) are available from
ERWEKA specially designed for each unit.
These Qualification Tool Kits comprise all nec-
essary tools for re-qualification of the unit.
When purchasing a calibrated tool kit most of
the tools have to be recalibrated each year.
This procedure can be done by the purchaser
or by ERWEKA (Calibration Tool Service).
With the new generation of Dissolution Tester,
ERWEKA offers the next step. The units are
equipped with Qualification-/calibration- and
service interval displays. The user is reminded
to re-qualify the unit after the USP/EP and FDA
proposed interval (6 months). As an option, the
units check the OQ automatically during the test
run and monitors mistakes on the standard “OQ
traffic light”. For Operation Qualification (OQ)
no papers have to be filled in! The results of the
System Suitability Test are entered by the key-
pad of the unit, a System Suitability Test print-
out is created by the unit.