In the pharmaceuticals/chemicals industry, safety and quality always have top priority. Marking systems are manufactured in our pharma-suitable production facilities, which meet the most demanding requirements and comply with all quality regulations and the industry's strict standards. This is guaranteed by our complete, extremely efficient quality management system. Naturally, device qualification and documentation according to DQ, IQ, OQ, PQ and MQ, as well as system validation according to GAMP apply here.
We know the typical pharmaceutical requirements, the special procedures and production conditions (e.g. cleanroom/ultra-cleanroom) and the materials used. The experience gained from a large number of projects enables us to develop and produce custom-tailored technical solutions and to integrate them in existing processes at the customer's plant.
A high level of availability, reliability and functionality ensure maximum safety with enormous productivity. Our customers know and appreciate that – and therefore are happy to make use of pharmaceutical know-how and the high-tech brand available from topex.
What you can depend on
topex systems are validated according to the GAMP: "Good Automated Manufacturing Practice Supplier Guide for Validation of Automated Systems in Pharmaceutical Manufacture".
topex systems comply with the following device qualification standards:
DQ Design Qualification – description of the application
IQ Installation Qualification – setup and installation instructions
OQ Operation Qualification – Specification of minimum weight, measuring inaccuracy
PQ Performance Qualification – testing of critical parameters
MQ Maintenance Qualification – cleaning and maintenance measures