With 25 years of FillFinish experience, Pii's experts are uniquely qualified to take on your complex formulations. Key to this process is Pii’s specialized vial filling equipment.

The Bosch FWR 4020 highspeed vial filler is one of four aseptic filling lines at Pii. The Bosch filler is perfect for handling large commercialization batches, up to 200,000 vials.

Vials from a 2mL with 13mm neck finish to a 100mL with a 20mm neck finish are easily supported on the Bosch line. For a 3mL vial, the system can fill 150200 vials per minute.

The flexibility of the filler accommodates both Ready to Use (RTU) and Ready to Sterilize (RTS) vials. Ready to Use vials can be placed directly on the Bosch line while Ready to Sterilize vials go through an extensive sterilization process.

Pii deploys unique sterilization technology. First, a 1,000 liter stainless steel tank handles all compounding for the Bosch line. The jacketed tank regulates temperature, and checks for headspace and weight as raw materials are added.

There is also a 1,000 liter disposable tank system is specifically for sterilizing singleuse disposable technology. This tank is equipped with bottom magnetic mixer to precise mixing.

A washer and tunnel are integrated into Bosch line and feed onto turntable that opens onto the filling line. Vials are escorted via conveyor for filling. The Bosch features 8 filling heads and rolling diaphragm pumps to ensure filling accuracy. Filling speed is dictated by the nature of the solution.

Once filled, the vials go to stoppering station. Nitrogen overlay in the vial before stoppering is possible for oxygensensitive products to ensure stability.

Filled and stoppered vials then move to Pii’s M&O Perry machine for capping under GradeA air conditions. The vials are then loaded onto trays for storage and visual inspection according to USP guidance.

Pii can accommodate your QC testing and analysis as well as secondary packaging needs before batch release.

Pii scientists understand that accurate vial filling is critical for commercial success, and most importantly, the impact on patient’s life. Our stateoftheart technology ensures we keep our promise to our customers to “get right first time.”

Pharmaceutics International, Inc. (Pii) is a USbased contract development and manufacturing organization (CDMO) located in Hunt Valley, Maryland. Visit us at: https://www.pharmint.com/