High Purity media | PW-/WFI-systems
Storage and distribution of high purity media
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).
- Basic engineering: Concept design and layout
- Process analysis for optimising existing systems
- Detail engineering: Project management from
- specification to start-up and production support
- Software engineering in accordance with GAMP (Good Automated Manufacturing Practice) 5
- Monitoring concepts for on-line monitoring and
- batch tracking
- GMP risk assessment
- Preparation of qualification documents and carrying out system qualifications
- Documentation in accordance with internationally accepted standards
- Drawing up of maintenance and calibration requirements as well as SOPs and work instructions
- Change control: Introduction, implementation and maintenance
- Assessment and documentation of maintenance work
- Procurement of spare and wear parts