Contract manufacturer WuXi STA has invested in a new Blow-Fill-Seal (BFS) aseptic filling line at its Wuxi City site. The introduction of this new line earlier this month, with an annual capacity of 9 million units, is poised to further bolster the company’s sterile platform capabilities.

This BFS aseptic filling line integrates container blow molding, drug filling, and sealing processes within an automated continuous system. The line also operates within a grade A clean air environment, ensuring product sterility within exposure areas, mitigating contamination risks and minimizing human intervention throughout production. Primarily designed for eye drops and inhalants, the line accommodates volumes ranging from 0.1 to 10 mL and boasts a filling capacity of up to 200 units per minute.

With the addition of this latest BFS line, WuXi STA has increased its total of automated aseptic fill-finish lines to three, including a high-potency (HP) sterile injectable line with an Occupational Exposure Limit (OEL) of 10ng/m³. The company’s annual sterile formulation production capacity now reaches 33 million units, accommodating a wide range of dosage forms, including vials (water for injection, lyophilized powder for injection, eye drops, as well as inhalants), pre-filled syringes, and cartridge bottles.

In a move to further fortify its sterile formulation development and manufacturing services, WuXi STA is reportedly also planning to add a Prefilled Syringe (PFS) aseptic filling line at the same site later this year. Previously reported plans are also underway to expand injectable manufacturing capabilities over the next two years at the Couvet site in Switzerland and the facility being built in Middletown, Delaware.