Qualification and calibration in a greenfield project at a well-known vaccine manufacturer
Testo Industrial Services carried out the entire qualification process for the customer - from the planning of the various qualification stages to their processing and execution of the qualification measurements.
The plant is the "Centre of Excellence" for cell culture based vaccines and viral vaccines for this renowned customer from the pharmaceutical industry. The main products produced at the site are influenza vaccines, tetanus/pertussis/diphtheria/rabies vaccines and vaccines against tick-borne encephalitis (tick-borne meningoencephalitis): TBE) produced.
The aim of the "Greenfield Project" was to carry out qualification and calibration activities at a wide variety of plants and measuring points with a high degree of flexibility. Testo Industrial Services was commissioned for all activities from the preparation of plans for the qualification stages (user requirements/measurement point risk analyses/risk analyses of process plants/Part11 analyses/DQ/FAT/SAT/IQ/OQ/PQ) to their processing and execution of the qualification measurements.
Your advantage: Our competence
- Qualification of production buildings and media supply:
Ventilation systems, clean rooms, dishwashers, autoclaves, production tanks (lines), storage tanks, WFI and PUW, egg locks, incubators, refrigerators and freezers, incubators, refrigerators and freezers, scales, PH measuring equipment, hose welders, LF benches.
- Warehouse qualification:
Incubators, refrigerators and freezers, air-conditioning and storage rooms, high-bay warehouses
- Qualification of QC laboratories:
Autoclaves, dishwashers, incubators, refrigerators and freezers, incubation, refrigeration and storage rooms, isolators, various equipment (including scales, LF benches, egg incubators, fault indicator room).
- Calibration of production plants
- Calibration of media supplies
- Warehouse calibration
- Calibration of the quality control laboratories
Testo Industrial Services met the special challenges of a greenfield project in terms of project planning, project execution and resource planning to a high degree. Particularly due to the high overall competence, the multi-layered qualification and calibration activities at various plants and measuring points could be implemented in a project-adapted manner.