The smoke test is a method of validating a system or piece of equipment to ensure that it is operating correctly, and that there are no leaks or malfunctions that could lead to environmental contamination. This is an important step in the control of contamination in order to develop GMP Annex 1 SCC, whether in a sterile or non-sterile environment. It ensures the safety and efficacy of the products manufactured.
GMP Annex 1 specifies that the smoke test must be carried out before the production environment is put into service, and at regular intervals to verify the stability of the sterile environment. Test results must be documented and retained, so that they can be presented during regulatory inspections.
To carry out a smoke test, you need to ask yourself a number of questions to determine the right conditions for your process, environment and equipment. Intertek can support you at every stage, with its 40 years of expertise in controlled environments:
The different stages of our smoke test intervention:
Stage 1: Technical study of the installation
Our Intertek experts begin by studying the installation to be tested to determine the type of smoke generator to be used (for example, brine or EPPI) and the type of video editing to be carried out. We also gather information for drafting the protocol, including the different sequences to be carried out, the number of operators present during the activities, the location of the shots and the number of shots per sequence.
Step 2: Drafting the protocol in tabular form
Once the information has been collected, Intertek draws up a tabular protocol specifying the various smoke test sequences: type of activity, generation location, shooting location and acceptance criteria.
Step 3: Carrying out the intervention
Two Intertek technicians are mobilized to carry out the smoke test: one generates the aerosol using the smoke generator, while the other films the sequences specified in the protocol. The number of operators is adapted according to the needs of the operation.
Step 4: Video editing
At the end of each day, the raw data is left with the customer after the daily review. Video editing is carried out at the Intertek agency and made available on a secure server, so that our customers can consult and use them to validate their installation.