After a run of successful Factory Acceptance Tests (FATs) at Solo HQ, this aseptic isolator is ready for shipping and installation
This week has seen a serious of FATs at Solo’s facility in Stockport, Greater Manchester. One of these was an aseptic vial fill/finish line for high potency APIs, as seen below. This was design engineered from our proven aseptic fill isolator design to interface with an automated vial filling and stopping machine (which will sit where the wooden stand is in these pictures). The four chamber design utilises a full wall-to-wall uni-directional airflow system in an easy change flexible film enclosure.
Also testing was an ADC toxin-linker compounding isolator. Developed from our soloADC design, it was designed for small batch production of ADC drugs for fighting cancer. It will be subjected to containment testing to EN689-2018 standards with a pass criteria of 10% of the CPT.
This busy period for Solo has culminated in a bulk transfer isolator, which will permit OEB4 rated API drums to be transferred into an Ezi-dock mini bag system. This utilises the well-proven Solo bag-in/bag-out containment system to enter and exit API drums.
Once again, the Solo engineering team are demonstrating technical leadership in all aspects of flexible film isolators. Be it aseptic processing, HP-API containment or bulk transfer, our Pepper Road facility faces a very busy but satisfying few weeks