Everything that may be involved on creating and increasing the risk of contamination of the products must be strictly controlled and monitored.
Qualipharma can guide you on the process of determination of the status of your compressed air /gas equipment following the ISO 8573 regulation in which is defined the range of the parameters to be controlled according to the different manufacturing process.
Every compressed air/gas equipment involved on your manufacturing process must be considered as a crucial aspect and therefore included on the qualification plan.
Some of the test that we can support you with are:
- Measurement of the hydrocarbon level
- Measurement of the dew point
- Particle count test
- Microbial surface/airborne tests
Through the risk assessment we identify the critical points of your system.