In the presence of potent drug (HPAPI) powders, which exert toxic activity at low doses, it is important to mitigate operator health risks and cross-contamination risks.
Due to poor performances of personal protective systems, the utili-zation of containment systems has become vital.
When operating with HPAPI production machines, blistering machi-nes, transport systems, dedicated areas, filtration systems, washing and waste disposal systems, an assessment is required in order to determine whether the equipment allows for a containment level appropriate to the active substance that will produce.
- Validation Plan design
- Containment evaluation of devices and machines for the phar-maceutical industry in development/update/pre-install/pre-sales and revamping phases.
- Risk assessment of operators potentially exposed to HPAPI (Occupational Safety of operators)
- Verification of containment performances over time
- Validation of cleaning and maintenance operations (air and sur-faces)
- Clean room classifications
- Sampling, analysis and validation of absolute filters and air treatment units
- Microclimate analysis