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Cleaning validation of pharmaceutical process systems by Testo Industrial Services

Cleaning validation of pharmaceutical process systems

B. Braun Melsungen AG.

Reference

Cleaning validation of pharmaceutical process systems

at B. Braun Melsungen AG, Melsungen

B. Braun supplies the health market worldwide with products for anaesthesia, intensive care, cardiology and extracorporeal blood treatment. An independent pharmaceutical pilot plant was built for the development and production of new innovative products. State-of-the-art technical facilities, which represent production in the subsequent series production, are used for the development and small series production (“small scale production”) of new innovative products.

The aim of this project was the integrated handling of cleaning validation including all development and optimisation activities in the field of cleaning processes.

Cleaning validation of pharmaceutical process systems

Our scope of services

at B. Braun Melsungen AG, Melsungen

  • Consulting in the field of cleaning validation
  • Creation of a cleaning validation concept
  • Project management of cleaning validation of new pilot plant
  • Consulting during analytical method validation
  • Structuring of the cleaning validation activities in a primary master plan
  • Creation of the risk analysis for cleaning validation
  • Process development in the optimisation studies for cleaning complex process plants and a dishwasher
  • Development and structuring of the sampling strategy

Cleaning validation of pharmaceutical process systems

The result

at B. Braun Melsungen AG, Melsungen

The integrated support provided by Testo Industrial Services in the field of cleaning validation included the implementation of risk-based validation management and the cGMP-compliant cleaning validation of the process plants and the dishwasher. Processing of the requirements was flexible, fast and project-specific.

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

Your contact

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