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Qualification and calibration of pharmaceutical production facilities by Testo Industrial Services

Qualification and calibration of pharmaceutical production facilities

vaccine manufacturer’s.

Reference

Qualification and calibration of pharmaceutical production facilities

at a notable vaccine manufacturer’s

For the renowned customer from the pharmaceutical industry, the factory is the “centre of excellence” for culture-based vaccines and viral vaccines. The main vaccines produced at the site are influenza vaccines, tetanus/pertussis/diphtheria/rabies vaccines and vaccines against tick-borne encephalitis (in short: TBE).

In this project, Testo Industrial Services was involved in the qualification straight after the basic engineering phase and through the structural works phase of the building. After the qualification concept had been drawn up, the qualification measures for the entire manufacturing facility were carried out. This included the implementation of FATs at the system suppliers, the integration of the SAT documentation as well as the preparation of the qualification documentation.

Qualification and calibration of pharmaceutical production facilities

Our scope of services

at a notable vaccine manufacturer’s

  • Fermenter lines and separators
  • Ultra-filtration
  • Chromatography
  • Inactivation
  • Thermal disinfection
  • Clean in place systems
  • Ultra pure water systems
  • Ultra steam systems (generator)
  • Monitoring systems (rooms)
  • Autoclaves
  • Filter leak test
  • Determination of recovery times
  • Definition of the purity level
  • Volume flow and air exchange
  • Temperature
  • Relative humidity
  • Pressure
  • Mass flow
  • Fill level (mass)
  • Conductivity
  • PH value
  • Oxygen saturation
  • rpm

Qualification and calibration of pharmaceutical production facilities

The result

at a notable vaccine manufacturer’s

Within a period of three years, the qualification measures of the entire manufacturing facility were carried out, including the implementation of FATs at the system suppliers and the integration of the SAT documentation. The use of a large number of highly accurate measuring systems and experienced staff enabled a high degree of flexibility in the processing of qualification plans.

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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