Qualification and calibration of pharmaceutical production facilities at a well-known vaccine manufacturer
In this project, Testo Industrial Services was involved in the qualification even during the shell construction phase of the building. Qualification documentation was prepared for all trades and completed within a tight time frame.
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.
Testo Industrial Services was involved in the qualification directly after the basic engineering of the building. After the creation of the qualification concept, the qualification measures of the complete manufacturing plant were carried out. This included the execution of FAT's at the plant suppliers and the integration of the SAT documentation as well as the preparation of the qualification documentation.
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- Qualification of plants and utilities: fermenter lines and separators, ultrafiltration, chromatography, inactivation, thermal disinfection, clean-in-place systems, ultrapure water plants, ultrapure steam plants (producers), monitoring systems (rooms), autoclaves
- Cleanroom qualification: filter leak test, determination of recovery times, determination of cleanliness class, volume flow rate and air exchange rate
- Calibration: temperature, relative humidity, pressure, mass flow, level (mass), conductivity, PH value, oxygen saturation, rotational speed
Within a period of three years, the qualification measures of the complete manufacturing plant were carried out, including the execution of FATs at the plant suppliers and the integration of the SAT documentation. The use of a large number of highly accurate measuring systems as well as experienced personnel enabled a high degree of flexibility in the processing of the qualification plans.