fig. 1 —JOINN Biologics 乐彩彩票客服微信
- 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.
- 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
- 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
- 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