Pharmaceutics International, Inc. (Pii) a contract development and manufacturing organization (CDMO) and Automated Systems of Tacoma, LLC, a provider of flexible aseptic filling systems, have partnered on the new GENiSYS R filling machine for syringes, cartridges and vials. Pii purchased a GENiSYS R system, capable of automated cGMP aseptic small batch processing, and will collaborate with AST on its installation at its Hunt Valley, MD site.
Pii and AST will co-promote the system for clinical and commercial scale products. The GENiSYS R's approach uses flexible robotic automation to process ready-to-fill vials, syringes and cartridges on the same machine. Both peristaltic and rotary piston dispensing systems are available to fill each container directly on an electronic balance to provide up to 100% in-process fill weight inspection. The Electronic Batch Report (EBR) System records critical process information that can be used to create 21 CFR Fkrt 11 compliant batch reports.
"The GENiSYS R is a game-changing solution for any small batch aseptic filling application. Until now manufacturers had no ideal options for rapidly producing products requiring accurate filling in syringes, cartridges and vials in one unit operation in accordance with strict cGMP requirements," said Kurt Nielsen, president and chief executive officer, Pii. "This innovative aseptic filling machine will enable Pii to continue delivering sterile clinical & commercial supplies with very aggressive timelines."
Joe Hoff, president and chief executive officer, AST, said,"AST launched the GENiSYS R platform in 2018 to fill a gap between our GENiSYS C and our ASEPiCELL for automated cGMP aseptic small batch processing. Pii will be AST's first GENiSYS R installation and we are excited to be partnering with such an innovative company."