Qualification of a new vaccine production factory
In order to be able to launch large-scale clinical trials (phase 3) of a new vaccine,one of the ten international pharmaceutical industry giantshas invested in the construction of a new production site inBelgium.ALTEN has been entrusted with theresponsibility of qualifying equipment performance(PQ) anddrafting the operating instructions.
In order to meet the customer’s business priorities, ALTEN’s technical division dedicated to the pharmaceutical industry has rapidly set up aservice centreto independently lead theintegration and validationof:
- All equipment (e.g. cleaning, autoclave, disinfection systems, etc.)
- All clean fluids (water, compressed air, steam, etc.)
- All C and D class areas
This organization has enabled ALTEN to draft and carry outmore than 80 performance qualifications(PQ) andmanage the related deviations, demonstrating its ability to upscale rapidly with regard to高度先进的工程标准l expertise.