STERILE LIQUIDS

Sterile Liquids

Sterile Drug Product manufacturing requires dedicated and specialized capabilities which are in compliance with FDA aseptic guidance and EMA regulatory requirements. CordenPharma has a long track record of experience in manufacturing Parenteral Sterile Solutions and Emulsions in different pharmaceutical forms such as ampoules, vials and pre-filled syringes. Our facilities and equipment design, combined with experienced and trained personnel, are pivotal for success in sterile manufacturing. Currently, two sites of the CordenPharma network are involved in Sterile Liquid Drug Product manufacturing – CordenPharma Caponago and CordenPharma Latina.

CordenPharma Caponago has two main areas of production with a focus on Non-Potent traditional Small Molecules, through its long-standing expertise in Terminal Sterilization, and Aseptic Fill & Finish, through special expertise in the handling of large molecules such as Peptides, Carbohydrates, Oligonucleotides and Biologics.

Terminal Sterilization & Filling

  • >> 3 Separate Process Rooms Equipped with APV High-pressure Homogenizers & Solution Vessels, with batch sizes ranging from 200 L to 1250 L
  • >> 5 Filling Lines (3 for Vials, 1 for Ampoules, 1 for Pre-filled Syringes (PFS) /Cartridge – custom)
  • >> 5 Autoclaves (rotating)
  • >> Container Range 10 – 100 ml (option 5 ml and 150 ml )
  • >> Inspection
    • >> Automatic Inspection Machines for 20 ml & Pre-filled Syringes (PFS)
    • >> Semi-Automatic Inspection Machines for any other vials (50 ml & 100 ml)

Aseptic Fill & Finish

  • >> Aseptic Filling using Nest & Tub Technology & Materials
  • >> Batch Size range from 1 to 50 L
  • >> Vials from 2 to 10 R and PFS from 1 ml (Std or LONG) to 10 ml

CordenPharma recently announced capacity expansion in CordenPharma Caponago with the investment into two new high-speed Commercial Aseptic Fill & Finish Lines which will become operational in 2Q/2018 and 3Q/2018 respectively.

CordenPharma Latina focuses on the manufacturing of complex Sterile Cytotoxic and Cytostatic Drug Products. Their scientific team of experts help overcome technical challenges, including process and formulation development, technology transfer and analytical method development. CordenPharma excels at all phases in the development of solution and freeze-dried dosage forms, for both aqueous and organic solvent solutions.

CordenPharma Latina is comprised of two separate segregated suites with 3 filling lines (2 for vials and one for ampoules) and six dissolution vessels. The production is fully supported by a development group with analytical development and QA/QC functions. The facility is designed with appropriate engineering controls along with a containment culture that allows the safe manufacture of cytotoxic and cytostatic products.

Cytotoxic & Cytostatic Drug Products - Three Filling lines (Two for Vials, One for Ampules)

Production Suite 1

  • >> 6 Dissolution Vessels with a capacity range from 50 to 1,150 L (glass-lined & stainless steel)
    • >> IMA (Farmomac) Vial Washer, Depyrogenation Tunnel, Filling & Capping
      • >> Production speed of approx. 150 vials / minute (20 R vial)
      • >> Vials: 5 to 102 ml with current tooling
      • >> Two Freeze Dryers 38m2 and 27m2 with 18 and 15 Shelves Respectively
      • >> Ampule Filling Line
        • >> Bosch line
        • >> Ampule size 5 to 10 ml

    Production Suite 2

    • >> 2 Dissolution Vessels with a Capacity of 120 and 400 L (stainless steel)
      • >> IMA Vial Washer, Depyrogenation Tunnel, Filling & Capping
        • >> Production speed of approx. 300 vials / minute (20 R vial)
        • >> Vials: 10 to 50 ml with current tooling
        • >> One freeze dryer 29m2 (15 shelves)

      All CordenPharma facilities have been authorized by the main MoH Agencies (FDA, EMA, TGA, ANVISA, Japanese Authority) to distribute products worldwide. Our manufacturing process is highly sophisticated and includes automatic inspection, packaging and serialization.

Integrated Supply

CordenPharma’s ability to develop and manufacture Active Pharmaceutical Ingredients (APIs), Finished Dosage and Packaging in our network of facilities allows clients full access to integrated services resulting in a simplified supply chain, reduced risk and cost associated with technology transfers, and ultimately faster production and delivery timelines.