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