Analyses of packaging materials and cleaning in Isolators
SKAN AG · Stefan Schäfer
Your Challenges:
-Development of a suitable cleaning strategy with risk assessment
-How does the active substance spread inside the isolator, depending on setups and installations?
-What is the recovery from different materials?
-How effective is the applied cleaning procedure?
-Airbourne contamination during product change over measurable?
Our solutions:
-Determination of the mechanical transfer of contamination by the use of a fluorescent surrogate
-Simulation of process malfunctions like vial crashes
-Definition of worst-case positions
-Customer support for risk assessment
-Determination of the recovery rate of a surrogate substance on different materials, present inside the isolator
Different Test methods to underline these solutions will be shown.Agenda
- Material resistance to H2O2 and contamination
- Trace analysis
- Contamination mapping
- Risk analysis
- Cleaneaness check