We guarantee unbeatable Reliability…
For the approval of pharmaceuticals and providing evidence of stability tests, numerous steps must be taken to ensure that the stability test chambers function correctly, e.g. fluctuations in temperature and humidity remain within the stipulated range and this over extremly long periods of time. These requirements are continuously confirmed by our extensive Qualification documentation
The entire system qualification comprises:
FAT – Factory Acceptance Test
DKD – Calibration
DQ – Design Qualification
IQ – Installation Qualification
OQ – Operation Qualification
PQ – Performance Qualification
as well as all the necessary documents, such as circuit diagrams, component lists and certificates, e.g. ISO accreditation, EG conformity declarations or also maintenance recommendations.
Our trained technicians not only carry out on-site qualification on request, but utilize also the extensive measurement and calibration facilities of our accredited DKD laboratory.
In order to fulfil the requirements of the various QM systems, it is necessary that the calibration and monitoring of the test equipment can be traced back to standards that are approved both nationally and internationally. For this reason, Vötsch Industrietechnik GmbH conducts tests for measurable variables, e.g. temperature, dew point temperature and relative humidity in its own DKD calibration laboratory which is accredited to ISO 17025.
International acceptance of the DKD calibration certificate is underlined by the membership of the DKD in the ILAC (International Laboratory Accreditation Cooperation). All member countries of the ILAC must recognize DKD calibration certificates. Our trained calibration technicians perform calibration and spatial measurements of temperature and humidity both in our factory and on site.
Our skilled team of instructors advise you on all questions relating to stability testing, qualification, documentation as well as environmental simulation and heat technology. We offer seminars and work-shops on all current topics relating to our product range and its application both in our in-house-training centre and on site (e.g. FDA 21 CFR Part 11 in practice) This team also qualifies and trains our service technicians in regular training-on-the-job for performing service, maintenance, calibration and qualification.