Advanced aseptic processing that delivers an innovative glass-free delivery for injectable drugs
ADVASEPT® Technology is an advanced aseptic filling solution for parenteral products. The ADVASEPT® family of products provide a glass-free, primary packaging solution that reduces and even eliminates some of the most pressing concerns associated with traditional glass vials. This technology eliminates glass particulates and surface delamination, reduces foreign particulates by orders of magnitude and decreases protein surface interaction; all while reducing breakage and container weight for transportation and disposal through the use of an ultrapure plastic design.
ADVASEPT® Technology Benefits
The ADVASEPT® Technology leverages a superior manufacturing process that is rooted in the principles of Quality by Design (QbD) to drastically reduce the risk of contamination by minimizing variables, eliminating human intervention and reducing the amount of required class A space. This technology leverages the blow-fill-seal process to automate the container formation and closed filling process to deliver a more efficient, secure and robust injectable solution for your product.
This technology drives at the root cause of many of the manufacturing and quality issues facing todays traditional vial filling processes.
- Provides higher levels of quality assurance through automation and eliminating human intervention.
- Eliminates glass management and removal of variables.
- Because the vial does not exist before the process; there is no cleaning, depyrogenation or handling of vials.
- Drastic reduction of particulates.
- Container is formed, filled and sealed within seconds while in the machine.
- Proprietary filling technology can reduce the chance of particulates even lower.
- Elimination of delamination and glass particles.
- Lower the risk associated with parenteral filling.
- Drastically reduce foreign particulates by > 95%.
- Eliminate delamination & glass particles.
- Lower the cost of shipping and disposable.
- Design freedom and flexibility.
- Processing impact on biologic products.
How It Works
- Advanced Aseptic Process automation requires minimal operator interface.
- The plastic extrusion area and critical fill zone (ISO 5) are designed as partially isolated areas with localized protection.
- Minimized exposure of the product and container to the environment.
- Sterile boundary sterilized in place eliminating aseptic connections.
- Ultimately the technology provides sterility assurance allowing for greater freedom in primary container design.
- Current technologies ADVASEPT® Needle Free and ADVASEPT® Vials.
- Integrated analytical capabilities to support the transition from glass to plastic.
- Formulation and process design expertise.
- Best-in-class quality system and reliable supply.
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.
Catalent also has the expertise and capability to support your needs outside of commercial production:
- Batch sizes up to 2000L scale.
- Capability for complete customization for unit or multi-dose containers.
- Solutions for products that are temperature, light or oxygen sensitive.
- World leader in the field of Extractables and Leachables for primary container closures.
- Expertise in the stability protocols with extensive labs and capabilities to support both activities.
- Integrated services to assist the transition from glass to plastic
- Defined leachable protocol
- Complete extractable studies
- Learn more by reading "Critical Design Strategies for Extractables and Leachables Control"
Our facilities in Woodstock, IL offers the following technical capabilities:
- 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
Container Design Freedom
ADVASEPT® technology offers unlimited potential with an endless number of possibilities, configurations and combinations
- Customizable & flexible delivery solutions with the sterility assurance of this advanced aseptic process.
- Functionality can be added directly into the container with aseptic assurance provided by Catalent’s blow-fill-seal technology.
- Design expertise can provide the features desired in an efficient manufacturing solution.
Our expertise in the blow-fill-seal technology and in-house mold design capabilities can deliver unique primary container designs to provide your brand promise.