Catalent's ADVASEPT Technology

Catalent’s ADVASEPT™ Technology is an advanced aseptic filling solution for clinical or commercial supply demands of biologics, parenteral, respiratory, and other products.

Catalent is able to leverage a superior manufacturing process that is rooted in the principles of Quality by Design to drastically reduce the risk of contamination by minimizing variables, eliminating human intervention and reducing the required class A space.  The technology provides an automated container formation and closed filling process that delivers a more efficient, secure and robust injectable solution for your product.

The process  utilises Blow-Fill-Seal manufacturing to produce a glass-free primary packaging container that reduces, and even eliminates, the main concerns associated with traditional glass vials, such as contamination with foreign or glass particulates and surface delamination. The ultrapure plastic design reduces breakage risks and container weight for transportation and disposal, as well as protein surface interactions. The technology is flexible, to accommodate a variety of product volumes, and can be designed to minimise headspace within the vial, reducing agitation of drug products in transit.

Catalent continues to develop and evolve ADVASEPT technology to increase the safe handling of parenteral drug products, by incorporating an optional needle-free luer lock connection fitting to containers.