The intention of this project was to create a new Pre-Fill Syringe (PFS) filler with isolator suite that is self-contained, including all support spaces. The project includes the design, demolition, construction, start-up and validation (commissioning and qualification) which will be compliant per all site standards and cGMP regulatory requirements. This aseptic processing suite will be designed for commercial use and provide flexible contract manufacturing to fill syringes across a range of 0.5 to 20 mL with formulation fill batch volumes from 5L to 1000L. The line has a filling speed for 1 mL syringes of up to 36,000 syringes per hour.
The project includes the following equipment:
Sterile PFS line with Isolator, glove testing, particle monitoring, debagging, e-beam sterilization, aseptic filling, stoppering, tub coding, and unloading. The machine is designed to provide capability for filling under vacuum or ambient pressure across a range of syringe volumes from 0.5 to 20 mL with flexible stoppering systems including standard mechanical piston placement, standard mechanical piston placement with nitrogen gas overlay, and vacuum stoppering.
Material preparation areas will include an autoclave sterilizer and parts washer/dryer located in the wash room.
Formulation and compounding area with scales, single use pallet tanks, temperature control units and provisions to support future processing in stainless steel vessels (CIP/SIP connections and capability).