Berkshire Sterile Manufacturing (BSM) has completed the installation and qualification of its IMA Lyomax 3, which is equipped with sterilisation in place (SIP) and clean in place (CIP) capabilities.
This IMA Lyo is connected to BSM’s Fedegari Isolator Line, providing clients with the highest in sterility assurance.
The qualification involved extensive IOQ’s of the equipment, validation of the SIP and CIP and media qualifications that utilised three complete loads.
The validation involved BSM’s Colanar Flexible Filler, capable of filling vials, syringes and cartridges on the same line. BSM completed the isolator qualification with over 12,000 units/run in triplicate with filling duration’s of over 60 hours per run.
“We are pleased to provide to our clients and our future clients the best available technology for their sterile manufacturing requirements”, said CEO Shawn Kinney.
BSM’s plans for 2018 include additional investment in equipment and the addition of a second formulation suite in 2018. The company seeks to purchase another isolator line (currently scheduled to be online in 2020). This line will expand capacity and utilise higher throughput as well as offer larger volume sterile lyo capacity to service commercial needs.