Pharmaceutics International, Inc. (Pii) has announced the expansion of its aseptic filling capacity and capabilities with the addition of a new, fully robotic filling line.
Pii has installed a GENiSYS® R filling machine from Automated Systems of Tacoma, LLC (AST), which processes pre-sterilized, ready-to-fill vials, syringes, and cartridges on a single machine specifically designed for small to medium scale aseptic manufacturing under cGMP. Integration of proven isolator-barrier and automated technologies provides a balance of flexibility and advanced system features, enabling processing of aseptic, toxic, and cytotoxic drug products.
“This automated solution enhances system productivity and controls contamination risk by minimizing operator intervention to the greatest extent possible, while providing unrivaled flexibility for aseptic filling of medium-sized clinical and commercial batches,” Samuel Chia, Director of Aseptic Manufacturing, said.
Automated bag and tub opening, statistical and 100% in-process fill weight verification, and vial capping completely automate the aseptic fill-finish process. Operations downstream can include lyophilizer loading and unloading and vial capping, depending on product and application requirements.
The new line, installed with assistance from Automated Systems of Tacoma (AST), will be fully qualified to support vial and syringe operations by the end of Q1 2020, just one year after the initial purchase order was placed. Multiple programs in early to late-stage development have already been identified as candidates for transition to the new line.
“The new innovative aseptic filling machine will enable Pii to continue delivering aseptic products on very aggressive timelines,” said Dr. Kurt Nielsen, Pii's President and CEO.