Component Selection Equates to Successful Sterile Fill-Finish Manufacturing

As a contract manufacturer, Alcami provides experience in all aspects of the manufacturing process, including fill volume accuracy, plunger placement, material compatibility, and reduction in line loss. “Many of the prefilled syringe products in the contract manufacturing space are high value, low volume, so assessment of manufacturing capabilities with components selected by the client during the device design process is critical to ensuring our success during an individual manufacturing run or campaign,” says Jacquelyn Uribe, Vice President of Quality Operations at Alcami.

She says engineering runs are the most comprehensive way to approach this assessment. “Because they are performed on equipment used at scale, this allows us to assess additional considerations associated with the introduction of a new process/components that may have been lost if this was conducted in a laboratory setting.”

Alcami’s focus on filling services is two-fold: to ensure component offerings align with current client demand, and to ensure filling technology can support a variety of product types. The company’s site in Morrisville, NC offers 1mL long, 1mL standard, and 2.25mL and 3mL syringe capability with a variety of needle configuration options. The filling technology on the syringe line currently utilizes a positive displacement pump technology that can fill high viscosity products with planned expansion for peristaltic filling to support more shear-sensitive formulations.

Excerpted from Drug Development & Delivery's Special Feature Section titled, "Prefilled Syringes & Parenteral Manufacturing: Innovations, Challenges & Solutions." To read the full article, please visit Drug Development & Delivery's website.