High quality components
Usually quite simple functions are requiring highest demands on design, materials, surface finishing and quality assurance to be suitable for processing liquid pharmaceutical products. The aim of these efforts is, that your valuable products can be completely discharged, and the cleaning cycles can be processed effectively.
To ensure the necessary compatibility to other components a multitude of partially standardized industry-specific standards have been established. Therefore we offer our full support to choose the right product of our portfolio to fit into your application.
The materials used, requiring a 100% safety in contact with the product, and the resistance to the cleaning and sterilization media resp. temperatures. The issues about "extractables/leachables" has been seriously debated in recent months with authorities in many audits. Only with a sophisticated quality assurance system we can prove that the required specifications are met, with traceable certificates.
Our manufacturers are highly specialised on the pharmaceutical branch so that all your concerns can be answered satisfactorily. The demand for the following certificates is widespread:
- cGXP (general good manufacturing praxis)
- 3-A "sanitary standard
- PED-European directive for construction of pressured devices
- ISO 9001 (Quality management system)
- CE-certificate of conformity to European standards
- Ex-suitable to be installed within ATEX (atmosphere explosive) areas
- FDA CFR 21, 177.2600 (f. e. silicone; EPDM) 177.1550 (f. e. PTFE)
- ADI animal derived ingredient free
- Cytotoxicity tested
- USP class VI
- 3.1B (acc. EN10204)
- surface-roughness Ra
for any question or further informations. call: +43 1 587 29 47