Catalent Benefits      Valuable Product Differentiation      How It Works
Catalent Capabilities      Facilities

Blow-Fill-Seal (BFS) is an advanced, aseptic liquid packaging technology, whereby product containers are formed, filled and sealed in a matter of seconds through a continuous and automated process. BFS technology significantly reduces the likelihood of microbial contamination relative to traditional bottling and provides a valuable, preservative-free option to patients. BFS is commonly used in the ophthalmic and respiratory areas, but can be utilized for a wide variety of applications:

• Ophthalmic
• Inhalation
• Biologics
• Topicals
• Oral liquids
• Medical devices
• Other

As one of the leading providers of sterile liquid delivery for over 30 years, we have the expertise, production capacity and stringent quality systems needed to handle the most demanding BFS projects. The Catalent Blow-Fill-Seal Center of Excellence, located in Woodstock, Illinois, specializes in handling complex formulations for suspensions, emulsions and large molecule products. Because of our unrivaled experience in the industry, we are able to provide cost-effective and customizable, specialty fill-finish solutions, to ensure a reliable global supply and optimize patient outcomes.

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CATALENT BENEFITS

Flexibility and Capacity

• Batch sizes from 5L to 2,000L
• Fill volumes from 0.25mL to 250mL
• Over 30 machines from clinical to high-volume commercial
• Solutions for temperature, light and/or oxygen-sensitive products
• Support for highly-potent APIs, through category 4
• Sterile and non-sterile manufacturing
• Unit or multi-dose container options
• Variety of closure options and hermetically-sealed tip/cap assemblies or stoppers
  • Specialized insertion technology
• Standard or unique/customizable container designs
• Various clear and tinted resin options:
  • Low-Density Polyethylene (LDPE)
  • High-Density Polyethylene (HDPE)
  • Polypropylene (PP) resin material

Formulation Expertise

• Specialized in handling complex formulations
• Optimization of solutions, suspensions and emulsions
• Large and small molecule formulation
• Expertise in protecting highly-sensitive molecules

Scalability and Commercial Optimization

• Scalable capacity for programs anywhere in the development process
  • GMP filling suites for piloting, R&D and early-phase clinical
  • GMP filling suites for late-phase, regulatory submission and commercial manufacturing
• Development to commercial machines available through a network of manufacturing sites
• Dedicated scale-up machinery

Broad Registration, Accreditations and Certifications

• Registered for drug, device and food manufacturing with the U.S. Food and Drug Administration (FDA)
• Holds a state license for wholesale drug manufacturing and distribution
• Maintains certifications through EU-competent authorities
• Manufacturing accreditations for Japan, Australia, Canada and Brazil
• Potent material handling Safebridge 1-4
• ISO 13485:2003 Certification

Quality and Sterility Assurance

• BFS is recognized by the USP as an advanced aseptic process for forming, filling, and sealing containers
• Minimal operator interface and limited product exposure time
• Highest quality standards in the industry
• Exceptional regulatory performance

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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

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HOW IT WORKS

An advanced aseptic process, BFS 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.
• Minimal exposure of the product and container to the environment.
• An in-place sterilized boundary eliminates aseptic connections.

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CATALENT CAPABILITIES

Catalent Pharma Solutions has the expertise and capability to support your needs from development through commercial production:

Formulation Expertise

• Pre-formulation and formulation development
• Dosage form selection and device/technology assessment

Characterization and Analytical Capabilities

• Material characterization and compendial analysis
• Stability testing
• Method development, optimization and validation
• Extractable & leachables support
• Finished product and release testing
• Additional in-house analytical services

Fully Functional Pilot Plant

• 2 pilot scale machines
• Pouching and packaging capability

Feasibility Manufacturing

• Compatibility test runs
• Prototype mold development and testing
• Formulation development
• Suspensions and emulsions

Toxicology materials

Clinical Manufacturing and Support

• Phase I/II/III support
• Packaging and clinical supply services
• Clinical trial materials
• Comparator sourcing
• Placebo development and manufacture

Registration Manufacturing

• Process scale-up
• Submission and stability batches

Commercial-scale Manufacturing

Flexible warehousing services

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FACILITIES

Our facility in Woodstock, IL ffers the following technical capabilities:

• Filling of solutions, suspensions, or emulsions
• 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
• Catalent BFS Center of Excellence