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Qualification and calibration in a greenfield project by Testo Industrial Services

Qualification and calibration in a greenfield project

vaccine manufacturer’s.

Reference

Qualification and calibration in a greenfield project

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 (TBE).

The aim of the “greenfield project” was to conduct the qualification and calibration activities on a wide variety of systems and measuring points with the greatest flexibility. Testo Industrial Services was assigned for all activities from the planning of the qualification levels (user requirements/measuring point risk analyses/risk analyses for processing systems/Part11 analyses/DQ/FAT/SAT/IQ/OQ/PQ) through to their processing and implementation of the qualification measurements.

Qualification and calibration in a greenfield project

Our scope of services

at a notable vaccine manufacturer’s

Production building:

  • Ventilation systems
  • Cleanrooms
  • Dishwashers
  • Autoclaves
  • Production tanks (roads), storage tanks
  • WFI and PUW
  • Egg hatches
  • Incubators, refrigerators and freezers
  • Incubator, refrigerated and freezer rooms
  • Scales, PH measuring instruments, tube sealers,
  • LF benches


Warehouse:

  • Incubators, refrigerators and freezers; air conditioned and
  • Storage rooms
  • High bay warehouse


QC laboratories:
 

  • Autoclaves
  • Dishwashers
  • Incubators, refrigerators and freezers
  • Incubator, refrigerated and storage rooms
  • Insulators
  • Diverse systems (including scales, LF benches, egg incubators, and fault indication systems)
  • Production facilities
  • Media supplies
  • Warehouse
  • Quality control laboratories

Qualification and calibration in a greenfield project

The result

at a notable vaccine manufacturer’s

Testo Industrial Services met the special greenfield project challenges to a large extent in terms of project planning, project execution and resource planning. Especially the high level of overall expertise, allowed the complex qualification and calibration activities on various systems and measuring points to be implemented in a project-specific manner.

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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