... really unique

No chance of confusion here

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