STERILE POWDER LYOPHILIZED VIALS

Sterile Powder Lyophilized Vials

CordenPharma has extensive experience in sterile contract manufacturing with a wealth of lyophilization expertise. In particular, the optimization of the freeze drying process as it relates to cycle times represents a critical attribute for complex parenteral product development. CordenPharma experts support customers’ product development to achieve product stability and improved shelf-life of products destined for clinical or commercial applications. Our fill-finish service for Sterile Powder Lyophilized Vials offers individual filling, suites with lyophilization capacity, along with an intrinsically safe process that enables the use of non-aqueous solvents.

Most notably, our scientists have garnered broad experience in the handling of the growing class of more complex molecules such as Peptides and mABs (mono-clonal Antibodies), in addition to common small molecules.

Sterile Lyophilization Filling currently takes place at CordenPharma Latina and CordenPharma Caponago, where separate and dedicated filling lines exist to handle cytotoxic, cytostatic and non-potent compounds respectively.

The Sterile Oncology manufacturing facility is designed for Category 4 compounds and consists of a sterile liquid filling line equipped with a washing machine, depyrogenating tunnel, filling / capping, sealing, an external washing machine and a glovebox in the dissolution area. The liquid filling machine is also connected to a freeze dryer.

Our cGMP manufacturing facilities have classified areas for aseptic processing to minimize biological contamination. All personnel involved in sterile operations are fully qualified on aseptic techniques and Japanese quality standards.


Manufacturing Suites - CordenPharma Latina

  • >> 2 Filling Lines for Lyophilized Cytotoxic & Cytostatic Products
  • >> Production Suite 1
    • >> 6 Dissolution Vessels (50 - 1,150 L), glass lined & stainless steel)
    • >> IMA (Farmomac) Vial Washer, Depyrogenation Tunnel, Filling & Capping with Isolators
      • >> Production speed of approx. 150 vials / minute (20 R vial)
      • >> Vials: 5 to 102 ml with current tooling
    • >> Lyophilizer I
      • >> Available surface: 37.8m2 (18 shelves)
      • >> Temperature range: -55°C / +80°C
      • >> SIP at every cycle
    • >> Lyophilizer II
      • >> Available surface: 27m2 (15 shelves)
      • >> Temperature range: -55°C / +80°C
      • >> SIP at every cycle
  • >> Production Suite 2
    • >> 2 Dissolution Vessels (120 - 400 L) Stainless Steel
    • >> IMA Vial Washer, Depyrogenation Tunnel, Filling & Capping with Isolators
      • >> Production speed of approx. 300 vials / minute (20 R vial)
      • >> Vials: 10 - 50 ml with current tooling
    • >> Lyophilizer
      • >> Available surface: 27.9m2 (15 shelves)
      • >> Temperature range: -55°C / +80°C
      • >> SIP at every cycle

Manufacturing Suites - CordenPharma Caponago

  • >> Aseptic Filling using Nest & Tub technology & Materials
  • >> Batch Sizes range from 1 - 50 L
  • >> Vials from 2 R - 10 R
  • >> Lyophilizer (1 sqm) with Capacity Range of up to 4,000 vials (2 R) - 1,000 vials (10 R) per cycle.

CordenPharma recently announced capacity expansion with an investment into two new high speed commercial aseptic fill and finish lines, which will become operational in 2Q/2018 and 3Q/2018 respectively in CordenPharma Caponago. The expansion will include the installation of an additional lyophilizer with 5 sqm to handle up to 20,000 vials (2 R) and 8’000 (10 R) per cycle respectively.

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.