Containment Solutions
Containment Solutions
Safety for human and the environment.
Highly-active substances demand particularly safe production processes. The use of Containment and WiP (Wash-in-Place) systems safeguards the health of operators. Product changeovers can be carried out significantly faster using WiP. Equipping a WiP machine with a Containment package permits entirely new possibilities when processing highly-active granulates.
Containment Guide.
The manual describes the fundamentals and the framework conditions of a systematic measurement procedure and outlines the process for recording a tableting system's relevant statuses. This system allows us to reliably determine a system's retention capacity.
Containment Guard. Maximum safety and optimal efficiency.
Absolutely reliable containment is of increasing importance in the pharmaceutical production of Highly Potent Active Pharmaceutical Ingredients (HPAPI). The aim is to reliably protect patients from the risks of cross-contamination and to eliminate any risk for operators of the machine when handling highly-active substances. We developed the Containment Guard to meet these challenges while simultaneously safeguarding your efficiency during manufacturing. The system comprises:
- A test process in accordance with the measurement criteria of the SMEPAC Guideline (Standardized Measurement Particulate Airborne Concentration)
- The basis for technical development of containment solutions in tableting
The measurement process. Precise with little effort.
The measurement method is based on the SMEPAC Guideline. It is supplemented by the Containment Guard to include other practical aspects:
- Positioning the measurement probes
- Location of operators
- Number of samples
- Machine operating modes
- System performance during faults or errors
- Calculation of total system performance including process equipment
This makes it possible to achieve a reproducible evaluation specially for containment tableting systems.
Certificate based on the OEB level
Fette Compacting conducts this test in special test rooms in the customer center in Schwarzenbek. Successful testing is followed by the plants receiving the Containment Guard certificate. The certificate levels are based on the OEB levels and/or the corresponding PDE values.
