Vial filling: integrated line concept from Syntegon for CDMO Alcami

Die neue ARF Isolatorlinie von Alcami ist in Betrieb und ermöglicht es dem Unternehmen, das tägliche Produktionsvolumen in Charleston mehr als zu verdoppeln. / Alcami’s new ARF isolator line is up and running, allowing the company to more than double the daily production volume in Charleston.

Tom Merola, Director Engineering & Maintenance bei Alcami, und Marc Wilhelms, Business Development Director North America bei Syntegon, sind sehr zufrieden mit dem Verlauf des Projekts. / Tom Merola, Director Engineering & Maintenance at Alcami, and Marc Wilhelms, Business Development Director North America at Syntegon, are very satisfied with the successful project.

Die Linie ist mit der bewährten Isolatortechnologie von Syntegon ausgestattet, die Produktionsbereiche und Personal voneinander trennt und so zu höchsten Hygiene- und Sicherheitsstandards beiträgt. / 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.

Das Herzstück der Linie, die ARF Füll- und Verschließplattform, bietet eine vielseitige Lösung auf kleiner Fläche. Für Alcami liegt der größte Vorteil in der Formatflexibilität. / As the line’s centerpiece, the filling and closing platform ARF offers a versatile solution on a smaller footprint. For Alcami, the major benefit of the ARF is the machine’s format flexibility.

Stefan Schuh

Success is a real pacemaker: once it manifests itself as a major milestone like a portfolio expansion or a sales target, the search for the next growth opportunity has already begun. The US-based company Alcami Corporation has done so time and again. As a successful CDMO for the pharmaceutical and biotech industries, Alcami has confirmed its market position through constant adaptations and innovations. One of the latest saw Syntegon support the company with a flexible turnkey vial filling line for increased output.

675,000 square feet is a lot of space – enough to build a strong presence across North America. The impressive number represents the total area operated by the Alcami Corporation, a major pharma and biopharma CDMO. With its headquarters in Wilmington, North Carolina, the company runs facilities across the country, including scientific campuses in Charleston, South Carolina, Research Triangle Park, North Carolina, St. Louis, Missouri, and multiple locations near Boston Massachusetts. The sites provide the much-needed flexibility to serve pharmaceutical and biotech companies of all sizes.

The latter are as diverse as Alcami’s vast network and related services: from customized solutions for analytical development to clinical and commercial sterile fill-finish and oral solid dosage manufacturing, the CDMO covers a wealth of steps along the pharmaceutical value chain. Its comprehensive portfolio makes it one of the country’s few standalone full contract service providers, including packaging, microbiology, environmental monitoring, and pharmaceutical support services.

Pushing the boundaries

This strong market position didn’t come overnight: continuous portfolio expansions and a growing domestic presence have strongly contributed to the corporation’s current success – and keep the company busy in pushing its own boundaries. For over 40 years, Alcami has taken pride in advancing products for its customers. This has led to steady growth and increased demand, requiring a significant expansion of their vial filling capacities for injectable medicines.

Alcami typically provides sterile filling operations for liquid and lyophilized products for a broad range of customers in a variety of containers, including 1 to 3 milliliter prefilled syringes and 2 to 50 milliliter vials. While the two campuses in the Carolinas provide redundancy and additional capacity, the Charleston site required additional capacity and scale to support its growing customer base.

Keeping up with an increasing demand

“Our customers’ products support patients around the globe, and we have supported client projects in over 35 countries to date. We couldn’t have achieved this without continuously reinventing ourselves,” says Sam Trimnal, Senior Director of Quality at Alcami. “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.”

Expectations were high, since customers demand fill-finish operations of the highest quality. For Alcami, this not only meant state-of-the-art equipment, but a solution that would integrate liquid filling and lyophilization technology in one line. Moreover, the entire set-up required 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. “We knew this would pose a considerable challenge to any equipment provider, since we were looking for an especially high level of flexibility and regulatory compliance,” Sam Trimnal explains. “But we also knew there is a company in the market with a great reputation and a unique approach to designing their lines. We decided to embark on that demanding journey with them.”

Support like no other

That partner goes by the name of Syntegon, which has specialized in packaging and processing technology with a proven track record for comprehensive expertise in both sterile filling and isolator technology. The strong global presence of more than 30 locations makes it an exceptionally agile partner. This also showed in the cooperation with Alcami: “It was only logical to turn to a company that could deliver in terms of format flexibility and isolator expertise, while providing on-site support thanks to US-based field service technicians,” 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, 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.

As the line’s centerpiece, the filling and closing platform ARF offers a versatile solution for industrial production of pharmaceutical liquids in vials on a smaller footprint. For Alcami, the major benefit of the ARF is the machine’s format flexibility. The latter 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. “Whichever product or vial size – the ARF enables us to fill different customer products safely, reliably, and easily. We can react to requests faster and implement an increased number of customer projects”, Tom Merola explains.

Safety at all times

Since safe processes are crucial for Alcami, the line comes with proven isolator technology from Syntegon. The barrier system effectively separates production areas and personnel, thus contributing to maintaining the highest hygiene and safety standards. “Our customers’ portfolios include products that require utmost protection – and so do our operators. Thanks to Syntegon’s uniquely designed isolators, we make sure our staff is always safe,” Sam Trimnal says. 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.

Before entering the ARF, the containers pass through an RRN internal cleaning machine for low and medium outputs. Dedicated stainless steel pipes connect its cleaning stations to the cleaning media, leading to a hose-free cleaning area with reduced particle generation. The vials with their particle-free interior are now transferred to the HQL tunnel, which takes care of sterilization and depyrogenation via dry heat. Following filling and capping, a RAN external cleaning machine cleans the vials’ external surface. The design ensures that the vials’ oversealed caps are protected throughout the entire process, maintaining the integrity of the delicate products inside the containers.

Teamwork in Charleston

Despite its complexity and scale, the line was installed smoothly. “During the Covid-19 pandemic, we had to carry out many project steps virtually. At the same time, the U.S. field service staff provided excellent on-site support, when needed. 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. The good cooperation and coordination between the teams were our secret to success – Syntegon knows how to do this and provided the exact solution we needed”, says Tom Merola.

“Syntegon really lived up to their reputation: they delivered an excellent turnkey line including both filling and isolator technology with a small footprint from a single source”, Sam Trimnal adds. 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 ml 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. “This is a step change in Charleston not only for us and our customers, but for patients out there as well. As much as flexibility matters, so do long-term partnerships, which we are happy to take to new heights time and again.”