High Purity media | PW-/WFI-systems

Wellmann Engineering supplies high quality systems for the distribution of AP ("Aqua Purificata), WFI ("Water for Injection" ) and pure steam.

The cleaned medium is stored and then transported in a distribution system up to the extraction points.

Wellmann Engineering develops individual process systems according to each customer´s requirements always with product safety in focus. We offer solutions for cold and hot storage. The distribution through ring pipe systems (Loops) ensures a turbulent flow and the hygienic design without dead spots prevent the formation of germinals and bacteria.

Our systems are completely made of stainless steel and are orbital welded. In combination with control systems developed by our automation experts a high degree of product safety is ensured.

Scheduled sanitisation of the entire storage and distribution systems is processed either cold (by addition of ozone) or hot (by heating to >85°C).

Storage types

  • Cold storage at about 15-20 "C
  • hot storage at 65-80 ° C
  • Mixed system with hot & cold storage Subloops

Distribution

  • loop systems
  • Parallel cable systems
  • Main & Subleitungssysteme

Properties

  • Ozone-overlay or sanitized at> 85 ° C
  • Compliance with a turbulent final blow (Re> 10,000) at a minimum flow rate of 1 m / s
  • Conductivity <1.1 ĩS & TOC <20 ppb
  • Pipe material stainless steel 316L, 1.4404 or 1.4435, surface roughness <0.8 μ
  • Minimum dead laying of the cable, while maintaining the 3D rule
  • Orbitalgeschweißnähte to achieve a consistently high seam quality
  • Pipeline endoscopy
  • Creation of a database isometry
  • pressure & tightness tests
  • Execution of IQ / OQ test according to GEP
  • PLC controlled by GAMP5, CFR21 / IEC 1131 Part 11 and including removal of management, monitoring and visualization

Reference

  • Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein
  • Rottendorf Pharma, Ennigerloh