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
