Catalent Schorndorf GmbH / Modernisation of clean room GMP 1 - 2

Location

Schorndorf, Germany

Project Description

After the extension of the building monitoring system, the system had to be re-evaluated and validated. The building monitoring system monitors the pressure and temperature of the entire production at the Schorndorf site.

Scope of OTTO LSE

Assessment of the scope, preparation of the validation master plan, support in the preparation of the URS, adaptation of the parameters of the system to the URS, preparation of the implementation protocols, execution of the validation and reporting

Time Period

Design: 07/18 - 04/19
Execution: 07/18 - 04/19