Fill and Finish

BIOLOGICAL PHARMA CENTER Bio’s Fill and Finish facility brings your drug substance to drug products, and includes:

• Fill/Finish Suite with designated preparation room.
• Dedicated on-site vial washing, pass-through autoclave, and depyrogenation oven.
• Aseptic liquid filling and capping in Grade A environment with Grade B surrounding.
• Inspecting, labeling and packaging of filled drug products.

Benefits of Contracting with BIOLOGICAL PHARMA CENTER Bio Fill and Finish

• Pre-qualified 5mL vials and 13mm stoppers reduce project initiation timelines
• Lot sizes up to 5,000 vials per batch, with 0.7-5.0mL filling volume
• Dedicated storage areas with secure access for filled product
• In process testing and stability of filled product offered through our QC department
• SCADA monitoring for HVAC and equipment process parameters
• Qualified and experienced operators

BIOLOGICAL PHARMA CENTER Bio’s Fill and Finish capabilities are expanding

• Improving the barrier between the filling and capping machines to create a single seamless unit which will meet EU requirements for capping in a Grade A environment
• Parts on order from Bausch + Stroebel to fill ISO 8362 2R (2ml) vials
• Flexibility to order, install, and qualify parts for additional vial sizes within a 4-6 month timeline
• Lyophilization capabilities are in progress
• Secondary, on-site, filling suite has been built; proposals are in progress for state-of-the-art filling lines for RTU vial and syringe processing

BIOLOGICAL PHARMA CENTER Bio Fill Finish Equipment

• Grade A Laminar Flow hood for formulation prep
• Metromatic Vial Washer
• Gruenberg Depyrogenation Oven
• Kuhlman Autoclave
• Bausch + Stroebel Filling and Capping Machines with upgraded barrier panels
• Meissner Accuflux and Sartorius Sartocheck Filter Integrity Testers
• 2x Vial Inspection Stations
• Autolabe 550 semi-automatic label applicator
• ZT411 printer with BarTender software for label design