CORDENPHARMA LATINA FACILITY CAPACITIES
Technologies / Processes
- >> Acylation
- >> Hydrolysis
- >> Wittig
- >> Mitsunobu
- >> Friedel-Crafts
- >> Alkylation
- >> Esterification
- >> Pd coupling
- >> Protection / Deprotection
- >> Si-protection / Deprotection
- >> Radical Based Chemistry
- >> Dynamic Kinetic Resolution
Equipment Details
Oral API & Pilot Plant
Reactor Pool
- >> 2 x 500 L, 2 x 500 L, 3 x 3,000 L, 3 x 4,000 L, 2 x 500 L stainless steel reactors
- >> 2 x 6,000 L stainless steel (-80°C to +80°C)
- >> 1 x 8,000 L Hastelloy reactor (-80°C to +80°C)
- >> 2 x 7,000 L glass-lined reactors (-18°C to +120 °C)
Filtration
- >> 2 x 3.9 m2 stainless steel comi-condor centrifuge
- >> 1 x 0.54 m2 tumble filter
- >> 1 stainless steel niagara plate filter (6 m2)
- >> 2 Hastelloy jacketed multi-plate sparkler filters (14 m2)
Drying
- >> 1 x comber stainless steel pan dryer (1,700 L)
- >> 1 x fluid bed dryer (1,300 L)
- >> 1 x turbo dryer
Drug Product Oncology Suite - Oral
Processing Equipment
- >> Granulation (Zanchetta Roto wet 50L and 600L), Milling (5x) Sieving (2x)
- >> Blending (bin, v-blending Bohl, screw mixing PCE)
- >> Tableting (Manesty Betapress & Manesty Dry-cota)
- >> Capsule (Bosch GKF 800 and 2500; Macofar MT20) with metal detector
Packaging
- >> Bottle filling HDPE and glass (Collishan line)
- >> Blistering (Klockner- Hansel CP10L)
- >> Packaging (Bosch Cart 5)
- >> AL (Automatic Line for serialized product both oral & sterile)
Labeling & Packaging Development
- >> Artwork
- >> Package definition
- >> Highly flexible (manual & automated)
- >> Technology transfer & project management
Drug Product Oncology – Sterile
Suite I
Processing Equipment
- >> 6 dissolution vessels (50-1,150 L) capacity, glass-lined and stainless steel
- >> IMA (Farmomac) Vial washer, depyrogenation tunnel, filling & capping with RABS and isolators
- >> Production speed of ~150 vials / minute
- >> Vials: 5-102ml
- >> Ampule filling line
- >> Bosch line
- >> Ampule size 5 to 10ml
- >> Freeze dryer (USIFROID De LAMA SMH 3030)
- >> Available Surface 35,65 m2 (18 shelves)
- >> Temperature range on the shelves - 55°C/+80°C
- >> SIP at every cycle
- >> Freeze dryer TELSTAR
- >> Available Surface 27 m2 (15 shelves)
- >> Temperature range on the shelves - 55°C/+80°C
- >> SIP at every cycle
Suite II
Processing Equipment
- >> 2 dissolution vessels (120-400L) stainless steel
- >> IMA Vial washer, depyrogenation tunnel, filling & capping with RABS and isolators
- >> Production speed of ~300 vials/ minute
- >> Freeze dryer IMA (Lyo Fast 25)
- >> Available Surface 27,9 m2 (15 shelves)
- >> Temperature range on the shelves - 55°C/+80°C
- >> SIP at every cycle
Labeling & Packaging Development
- >> Artwork
- >> Package definition
- >> Highly flexible (manual & automated)
- >> Technology transfer & project management
Drug Product Sterile Cephalosporin
Processing Equipment
- >> Sterile powder filling
- >> Washing machine (LIBRA HYDRA 1800)
- >> Depirogenating Tunnel (LIBRA 1250FLS-95-107)
- >> Filling / Capping (IMA MD300)
- >> Sealing (IMAG 550 8C)
- >> Washing machine (LIBRA HYDRA 300)
- >> X-ray inspection machine (DYLOG DYXIM 24)
- >> Automatic unloading (LIBRA V300)
Labeling & Packaging
- >> Single unit packaging line (FREVILLE)
- >> Flexible semi-automatic packaging line (CAM AV 78)
- >> Multiple units packaging line (FARMORES A)
- >> Semi-automatic line for serialized products
Capacities
- >> 400 m³ reactor capacity, spread over a variety of stainless steel, glass-lined and hastelloy vessels
- >> Dedicated production segments for oral and sterile Penicillin & Cephalosporin manufacturing
- >> Non-Beta Lactams pilot plant & manufacturing plant
Other Specialties
- >> Solvent recovery
- >> Thermal oxidizer
- >> Incinerator
- >> Wastewater treatment Plant
- >> Solid waste management
