Measurement technology for the pharmaceutical industry:
In view of the higher demands on quality and product safety from pharmaceutical production, sterile process engineering plays a significant part in the cost-effectiveness and safety of the production processes, in both upstream and downstream areas. Even in the further course of the process chain, up to cleaning and sterilisation, contamination-free processing is a crucial quality factor. From measuring instruments, this demands a combination of the most up-to-date hygienic design and, at the same time, a high measuring accuracy.
GMP compliant:
Measuring instruments from WIKA are manufactured in line with the GMP guidelines (good manufacturing practice). They meet the stringent requirements of, e.g.:
- FDA (Food and Drug Administration)
- EHEDG (European Hygienic Engineering & Design Group)
- 3-A Sanitary Standards, Inc.
- ASME BPE (Bio Processing Equipment)
- ATEX (directive 94/9/EC)
For the proof of conformity within the scope of an FDA approval and national authorities, we have an extensive programme ready-certified. For the ongoing testing of the instruments in the context of quality management, a wide range of calibration equipment and calibration services are available.
Process connections:
WIKA supplies a wide range of industry-standard and manufacturer-specific process connections in hygienic design, for example:
- Clamp connections, Tri-clamp, DIN 32676, ISO 2852, ASME BPE
- Aseptic connections DIN 11864
- NEUMO BioConnect® and NEUMO BioControl®
- VARIVENT®
For toxic, bioactive substances or very sensitive substances, special instrumentation options are available in order to integrate the measuring instruments into the plant without elastomers.