Pii and AST Partner On GENiSYS R Aseptic Small Batch Filling & Closing Machine
HUNT VALLEY, MD and TACOMA, WA (April 2, 2019) - Pharmaceutics International, Inc. (Pii), a Contract Development and Manufacturing Organization (CDMO) and Automated Systems of Tacoma, LLC (AST), a leading provider of flexible aseptic filling systems, announce their partnership on the new GENiSYS® R filling machine for syringes, cartridges and vials. Pii has 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 location. Furthermore, Pii and AST will co-promote the innovative, flexible, compact system for clinical and commercial scale products. The GENiSYS® R’s adaptive 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 accurately fill each container directly on an electronic balance to provide up to 100% in-process fill weight inspection. The integrated Electronic Batch Report (EBR) System records critical process information that can be used to create 21 CFR Part 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. This innovative aseptic filling machine will enable Pii to continue delivering sterile clinical & commercial supplies with very aggressive timelines,” said Dr. Kurt Nielsen, Pii's President and CEO.
“AST launched the innovative GENiSYS® R platform in 2018 to fill a gap between our highly successful 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 and grateful to be partnering with such an innovative company,” said Joe Hoff, AST’s President and CEO.
About Pharmaceutics International, Inc.
Pii is a privately held CDMO providing dosage form development and cGMP manufacturing services to the global pharmaceutical industry. Headquartered in Hunt Valley, Maryland USA, Pii’s services include pre-formulation development, and clinical and commercial cGMP manufacturing of parenterals, liquid solutions and oral solids, including soft gels, tablets and capsules. In addition, the Company offers containment suites to handle potent drugs and Schedules I-V controlled substances. For more information, please visit www.pharm-int.com.
About Automated Systems of Tacoma, LLC
AST is a privately held company that revolutionized the cGMP aseptic small batch fill/finish industry with the ASEPTiCell® over 10 years ago. Using robotics and advanced automation, this system was the industry’s first multi-format cGMP aseptic fill/finish machine capable of processing ready-to-use vials, syringes and cartridges using a single machine. Today AST is recognized as an industry leader in flexible aseptic filling and offers an extensive range of products that support drug product development, clinical and commercial needs using AST’s GENiSYS® Lab, GENiSYS® C, GENiSYS® R, and ASEPTiCell® product lines. AST will be unveiling its latest multi-format robotic filling system, the GENiSYS R, at Interphex April 2nd-4th. Stop by Booth #3853 to experience this latest in AST’s advanced aseptic system. For more information, please visit www.ast-inc.com.