Success is a real pacemaker: once they are achieved, major milestone like a portfolio expansion or a sales target trigger the search for the next growth opportunity. The US-based Alcami Corporation has done so time and again. One of the latest innovations saw Syntegon support Alcami with a flexible turnkey vial filling line for increased output.
With its headquarters in Wilmington, North Carolina, the company runs R&D and production facilities across the country. The sites provide the much-needed flexibility to serve pharmaceutical and biotech companies of all sizes. From customized solutions for analytical development to oral solid dosage manufacturing, the CDMO covers a wealth of steps along the pharmaceutical value chain.
This strong market position didn’t come overnight: For over 40 years, Alcami has taken pride in advancing products for its customers. The company typically provides sterile filling operations for liquid and lyophilized products in a variety of containers, including 1 to 3 milliliter prefilled syringes and 2 to 50 milliliter vials. The Charleston site required additional capacity and scale to support its growing customer base.
Keeping up with increasing demand
“When we decided to expand our sterile vial filling capacities to keep pace with demand, we were looking for a flexible line concept that would allow us to easily switch between our broad format range of 2 to 50 milliliter vials and could be extended by further format ranges upon customer requests,” says Sam Trimnal, Senior Director of Quality at Alcami.
For Alcami, this meant a state-of-the-art line that would integrate liquid filling and lyophilization technology and offer latest isolator technology for the highest product and operator safety. Besides producing high-quality injectable drugs, meeting global regulatory standards such as EU GMP Annex 1 is a key pillar of Alcami’s manufacturing strategy.
Support like no other
“It was only logical to turn to a company like Syntegon that could deliver in terms of format flexibility and isolator expertise. Moreover, US-based field service technicians provide on-site support,” Tom Merola, Director Engineering & Maintenance at Alcami points out.
Alcami opted for a complete sterile vial filling line with isolator technology from Syntegon. The solution consists of an ARF filling machine with peristaltic pump filling technology and seven different formats for maximum flexibility on a small footprint, as well as integrated lyophilization and VRT capping technology. An HQL sterilization tunnel as well as upstream and downstream cleaning machines ensure the highest product safety.
Alcami’s new ARF isolator line is up and running, allowing the company to more than double the daily production volume in Charleston.
The ARF’s format flexibility allows to easily switch between seven vial sizes and thus accommodates the CDMO’s changing fill-finish requirements. Single-use filling components contribute to the machine’s flexibility. Optional 100 percent in-process control (IPC) adds to safe and reliable results.
Teamwork in Charleston
The barrier system effectively separates production areas and personnel, thus contributing to maintaining the highest hygiene and safety standards. To this effect, Alcami’s new isolator comprises modern air management and decontamination technology, as well as peripheral systems such as airlocks, transfer equipment and wireless glove testing.
The line comes with proven isolator technology from Syntegon, which effectively separates production areas and personnel, thus contributing to the highest hygiene and safety standards.
Despite its complexity and scale, the line was installed smoothly. “Thanks to Syntegon’s ‘one face to the customer’ approach and a dedicated project lead, everything from the initial quote to the final installation worked out the way we had planned,” says Tom Merola.
Tom Merola, Director Engineering & Maintenance at Alcami, and Marc Wilhelms, Business Development Director North America at Syntegon, are very satisfied with the successful project.
So far, the joint project has proven its worth. Alcami’s new ARF isolator line is up and running, allowing the company to fill 2 milliliter vials at an output of more than 6,000 vials per hour, and more than doubling the daily production volume in Charleston while complementing four sterile fill/finish lines in North Carolina.
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