Engineered Containment. Based on Risk, Not Guesswork.
Handling highly potent compounds requires more than equipment. It requires a science-based containment strategy.
At Gonvert, in partnership with a leading European containment technology provider, we develop containment solutions aligned with OEL/OEB bands, SMEPAC guidelines, and current GMP expectations.
We start with an exposure risk assessment and process analysis. Then we define the appropriate containment level and technology for both new facilities and brownfield upgrades. Our focus is on integrating containment into the process with minimal impact on workflow while maximizing operator safety and product protection.
For existing facilities, we assess current operations and retrofit targeted containment solutions to close GMP and safety gaps. For new projects, we engineer containment from process design through verification.
The result: a compliant, safe, and operable manufacturing environment for HPAPI and other highly potent compounds.
Key Areas of Containment Strategy & High Potent Compound Handling Expertise:
- Exposure Risk Assessment & OEL/OEB Strategy – defining required containment levels per SMEPAC
- Containment Technology Selection – Isolators, RABS, SBV, Downflow Booths, Glove Boxes
- Process & Facility Containment Design – for new facilities and GMP upgrades
- Technology Integration & Retrofit – minimizing disruption to existing operations
- Containment Performance Verification – smoke studies, tracer testing, and qualification
- Cross-Contamination Control – product and personnel protection strategies
- Lifecycle Support & Training – procedures, maintenance, and compliance sustainability
