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Cleaning validation by Testo Industrial Services

Cleaning validation

Merz Group Services GmbH.

Reference

Cleaning validation

at Merz Group Services GmbH, Dessau-Roßlau

Merz Pharmaceuticals is an innovative pharmaceutical company focussed on the research and marketing of pharmaceuticals for treating neurological and psychiatric illnesses. The site in Dessau-Roßlau is used for the manufacture of a parenteral drug with a highly active biological agent.

The aim of this project was the integrated handling of cleaning validation including all development and optimisation activities of the cleaning process in the field of active agent production. Throughout the entire production process, various system components, devices and equipment come into contact with the highly active protein, which necessitated cleaning validation adapted to the process requirements. In the further course of the project, the service life validation was added.

Cleaning validation of biotechnological production of active ingredients

Our scope of services

at Merz Group Services GmbH, Dessau-Roßlau

  • Integrated handling of the cleaning validation project for the production of active ingredients (planning, sampling, and documentation)
  • Implementation of a 2-day workshop on the subject “cleaning validation”
  • Consulting measures
  • Creation of a primary validation master plan
  • Performance of risk analyses (matrixing, calculation of limit values, sampling, and analytics, etc.)
  • Retrospective qualification of the dishwasher (IQ, OQ, PQ)
  • Activities for the service life validation sub-project

Cleaning validation of biotechnological production of active ingredients

The result

at Merz Group Services GmbH, Dessau-Roßlau

The Merz Group Services GmbH was provided with full support in the area of cleaning validation. Thanks to risk-based validation management and cGMP-compliant cleaning validation of the process areas, the facility was ultimately approved by the FDA.

More assurance, better service for your GMP compliance

What set us apart

Expertise

Consulting, measurements, project management – our team with experience of the industry will support you precisely according to your needs

Technology

The use of our extensive test and measuring equipment with more than 4,500 references ensures reliable measurement and test results

Documentation

We will hand over the documentation to you in person upon completion of the order in audit-proven layout or customised to requirements

Testo Industrial Services

Our services at a glance

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