Blow/Fill/Seal

Mastering aseptic packaging for sterile respiratory and ophthalmic 

As the leading sterile liquid delivery brand for the last 25 years, we have the significant capacity and highest-quality support systems to meet all your Blow/Fill/Seal (B/F/S) manufacturing needs. As the catalyst to improve the total performance of your products, we provide customizable, specialty fill-finish solutions that efficiently drive the most effective patient outcomes. Because of our unrivaled expertise in the industry, we are able to provide cost-effective, customized manufacturing options for your most complex treatments, ensuring a reliable global supply and an uncompromising commitment to quality.

Catalent Benefits

• Capacity and flexibility
  • We offer the largest scale and widest breadth of B/F/S contract manufacturing services available:
    • Batch sizes up to 2000L scale
    • Solutions for products that are temperature, light, or oxygen sensitive
    • Capability for complete customization for unit or multi-dose containers without reliance on stock containers 
• Wide variety of sterile and non-sterile liquid pharmaceuticals therapeutic areas
  • Respiratory 
  • Ophthalmic 
  • Biologics 
  • Oral liquids 
  • Topicals
  • Medical devices
• Accurate dosing
  • Capability for complete customization for unit and multi-dose containers without reliance on stock containers
  • Proprietary insertion technology
• Processing efficiencies
  • Highly automated
  • Minimal component handling/pre-sterilization
  • High per-run output 
• Quality/sterility assurance
  • B/F/S is recognized by the USP as an advanced aseptic process for forming, filling, and sealing containers 
  • Minimal operator interface and limited product exposure time

Valuable Product Differentiation

• 

  An extensively customizable range of containers, tailored to meet the unique needs of each customer, across markets such as ophthalmic, respiratory, topicals and biotech
• Scalable capacity to meet customer demand through a network of manufacturing sites 
• Highest quality standards in the industry

How It Works

• An advanced aseptic process, B/F/S technology is a completely automated system with minimal operator interface. 
• The basic concept of the system is the combination of three major processing steps: container molding, container filling, and container sealing. We can mold the container to fit almost any shape.
• The plastic extrusion area and critical fill zone (ISO 5) are designed as a partially isolated area with localized protection.
• There is minimized exposure of the product and container to the environment.
• A sterile boundary sterilized in place eliminates aseptic connections.

Catalent Capabilities

Catalent also has the expertise and capability to support your needs outside of commercial production:

• Fully Functional Pilot Plant
  • 2 pilot scale machines
  • 1 commercial scale BFS-624 machine
  • Pouching and packaging capability
• Feasibility Manufacturing
  • Compatibility test runs
  • Prototype mold development and testing
  • Formulation development
• Clinical Manufacturing
  • Phase I/II/III support
• Registration Manufacturing
  • Process scale-up
  • Submission and stability batches

Facilities

Our facilities in Woodstock, IL offers the following technical capabilities:

• Filling of solutions, suspensions, or emulsions

• Fill volumes range from .3 mL to 1 L

• World-class critical utility systems including water for injection

• Cold-storage capabilities

• Solutions for products that are temperature, light, oxygen or delivery sensitive

• Analytical and microbiology laboratories