Context and challenges

This client is a leading group in the pharmaceutical industry.

The major challenge for this group is to guarantee the sterility of the medicines it manufactures. To do this, production environments and equipment must remain extremely clean, even sterile.

A highly sophisticated ventilation/extraction/air filtering system has been put in place to achieve this objective. International regulations require it to be tested through the use of fumigants after each modification of the environment or production facility.

However, these Smoke Tests require production to be stopped for sometimes quite long periods and then require a very intensive cleaning of all surfaces, or even a complete blanking of the area.

This client has mandated Assystem to conduct risk studies using its "Virtual Smoke Test" solution in order to best prepare the real smoke tests linked to the installation of a new machine and thus be "just right the first time" to shorten production stoppages.

Project scope

The CFD (Computational Fluid Dynamics) simulations created via the "Virtual Smoke Test" solution enable direct immersion in the virtual environment and real-time observation of aeraulic disturbances, including during an operator's movements under laminar flow.

  • Retrieval / modelling of 3D CAD files of the component and production equipment on the basis of a 3D scan
  • Retrieval of all HVAC related information (device locations, sizes, speeds, etc.)
  • Reconstruction of the production area and the overall HVAC system via Assystem's Virtual Smoke Test Solution
  • Conducting around ten virtual fumigation studies: different points in the room, around open/closed window equipment, with operators moving, inside the machine, around critical areas, during particular aseptic gestures, etc.
  • Conducting additional tests on identified risk situations: gear changes and smoke density, HVAC, object movements, etc.
  • Support in the reflection on quality improvement
  • Delivery of control videos to keep track of the studies and hypotheses tested in order to best prepare fumigation tests on real equipment

Client benefits

  • Reliability of the methodology for preparing smoke tests using the latest innovations in smoke tests
  • Considerable time savings on smoke tests thanks to the promptness of the results without the risk that a detail may have escaped the HVAC experts and therefore the possibility of carrying out a large number of simulations and tests in a short time frame
  • Reduction of risks on smoke tests (and therefore overall improvement of quality) thanks to the ability to analyse in real time the aeraulic impact of different gestures to keep the least risky one
  • Continuity of production and therefore productivity gains thanks to the drastic reduction in production stoppages related to Smoke Tests regulations
  • Anticipation of risks allowing to be "right from the first shot" thanks to simulations well before the tests carried out on the real machine

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