White paper: decommissioning strategy of water for injection loops (WFI) in pharmaceutical industry

WFI (Water For Injection) loops are used in pharmaceutical industry to distribute high quality water in process area. When the installation is for example too aged, it may be needed to replace it, the current must be then decommissioned.

As the WFI loop is used during daily production, the removal can only be performed during shutdown. This period is often short, so the decommissioning activities can be divided in two parts:
-    The activities that have a potential impact on routine,
-    The rest of the activities.
The first type of activities will be performed during the shutdown and their results will be summed up in an intermediate report to allow the restart of production at the end of the shutdown. Once the other activities are performed, a final report with all results will be released. The activities without quality impact will be performed in a concurrent way (…)

INTRODUCTION

DECOMMISSIONING STRATEGY

DECOMMISSIONING TESTING
Prerequisites
Mechanical and electrical
Automation
Documentation

CONCLUSION

This white paper has been created by Sébastien, Validation Engineer at Nalys.