- FAMAR has installed the MG2 FlexaLAB OEB5 continuous motion capsule filler at its R&D unit, enhancing its high-potency active pharmaceutical ingredient (HPAPI) capabilities.
- The new system supports clinical, registration, and small-scale commercial batches, compliant with EU and US GMP standards.
FAMAR, a contract development and manufacturing organisation (CDMO), has upgraded its high-potency capabilities with the installation of the MG2 FlexaLAB OEB5 continuous motion capsule filler at its R&D facility. The system is designed to meet OEB5 containment requirements and is fully GMP compliant, enabling the production of clinical, registration, and small-scale commercial batches for EU and US markets.
The encapsulation system features an OEB5 containment isolator with negative pressure ventilation and HEPA filtration, a wet-in-place cleaning system for safe product changeover, and a dosator-type powder dosing unit for accurate filling. It operates at 3,000 capsules per hour, offering precise small-scale production with robust control and data integrity systems.
The MG2 FlexaLAB incorporates a PLC Omron control system, touchscreen HMI, and data backup, and is designed in accordance with FDA 21 CFR Part 211 and EU 2006/42/CE standards. These features support FAMAR’s contract manufacturing services by maintaining high levels of safety and accuracy in handling HPAPIs.
This investment reinforces FAMAR’s focus on innovation, flexibility, and safe handling of high-potency active ingredients throughout the development and commercialisation stages.
