We are members of various pharmaceutical professional associations and organisations, meaning that we always have our finger on the pulse of important market developments and technological innovations. We are involved in the committees as engineers, qualifiers and QA representatives and work to enhance patient safety in everything we do.
All EnviroFALK PharmaWaterSystems solutions are planned, designed, manufactured, commissioned and qualified according to stringent quality standards to comply with the specifications of the pharmacopoeia and all GMP/GEP criteria. We place great emphasis on safety. – safety is the focal point of your project from the outset: Production & Precision
QUALITY & KNOW-HOW
We know what matters
An established, successful quality management system
Risk workshops for operators and comprehensive risk analysis
Consistently hygienic design
Reliable standby concepts
Hot water sanitisation of all system components as well as other sanitisation measures (UV, ozone, etc.)
Comprehensive qualification package (DQ, IQ, OQ, FAT and SAT) and documentation
Automation tools: Siemens controller (Simatic S7) with Siemens HMI concepts (TIA Portal), compliant with CFR 21 Part 11, with appropriate computer validation and categorisation according to GAMP 5
Continuous and ongoing development
