We design and carry out Smoke Studies with multi-camera video footage optimised in all aspects (angles, lighting, depth of field, contrasting backgrounds) in order to supply a clear and documented representation of the air flows and sterile operations, in accordance with Good Manufacturing Practices (GMP).
Over 20 years’ experience in controlled-contamination environments, with constantly evolving techniques and methodologies in keeping with regulatory developments and international best practices.
Project co-ordinators and specialised operators work alongside the production departments in all phases of the test, guaranteeing accurate feedback on the conditions encountered and the actions required to achieve the required standards.
Smoke Studies provide a visual documentation of the behaviour of air flows and their interaction with operators, equipment and materials in controlled environments (such as clean rooms and isolators).
The tests are carried out in four operational modes: As Built, At Rest, Dynamic At Rest and In Operation, depending on the specifications of the systems and required conditions, both at rest and in operation, with or without operators.
Each session is structured to precisely identify any interference or turbulence, and to support targeted actions to improve the performance and safety of the processes.
Our experience in the field allows us to work with Production and QC departments to offer highly qualified support. From preventive evaluation of the layouts and analysis of the results through to the design and approval of systems, we guide companies through the most critical phases of the production cycle.