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Fill and Finish

fill and finish

fig. 1 —
JOINN Biologics

Fill and Finish

JOINN 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 JOINN 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

JOINN 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

JOINN 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

To learn more, please fill out the form below.

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