Mission BPS Outfits Manufacturing Facility with Two Vial Filling Lines

Client: Thermo-Fisher Scientific (Plainville, MA)

Mission BPS was selected to support the design, procurement, and qualification efforts for two vial filling lines at the client’s state-of-the-art Plainville, MA manufacturing facility.

Project Scope

The client required procurement of advanced vial filling technology to yield a 10,000-unit batch production capacity from each of two filling lines, designed to process Ready-to-Use (RTU) container/closure components.

Our role was to drive the project through every stage—from vendor/equipment selection through installation and qualification of the filling lines. With years of experience in isolated vial filling technology, Mission BPS was the ideal partner for this complex and demanding initiative.

Procurement Phase: Securing the Best Equipment to Suit Client Needs

Mission BPS led the procurement process, developing a detailed vendor evaluation matrix for distribution to select filling equipment manufacturers. This process yielded a quantitative comparison of vendor attributes - including their proposed solutions for meeting design requirements, their U.S.-based technical support presence, and most-importantly - their experience and history in deploying the proposed technology to our industry colleagues.

By collaborating closely with selected manufacturers and our extensive network of industry colleagues, our vendor evaluation process yielded a high degree of assurance for cost-effectiveness, sustainability, and quality, ensuring that our clients received the best value for their investment.

Design Phase: Planning for Success

The design phase focused on integrating the selected vial filling lines into the existing facility layout while optimizing for production efficiency and maintaining flexibility for future upgrades.

In this project phase, we meticulously considered every detail—from system cabling and utility piping paths to production process flows and operator ergonomics—ensuring that each system design element would seamlessly work together to meet the specific needs of the client’s intended production environment.

Qualification: Rigorous Testing for Compliance and Performance

The qualification phase is perhaps the most critical part of the project, and one where Mission BPS’s expertise in GxP-critical system validation truly shines. In parallel with vendor-executed commissioning and cycle development activities, we handled the documentation development and protocol execution activities relating to:

• VHP cycle qualifications

• Format-specific filling accuracy and vial handling qualifications

• Format-specific container closure integrity testing (CCIT)

• Development and definition of routine/non-routine intervention methods

• Formal risk assessment of defined routine/non-routine interventions

• Aseptic Process Simulation (APS) bracketing matrix strategy development

• Aseptic Process Simulation (APS) protocol development and execution support

• Post-autoclave sterility hold studies for product-contacting fill line components

• Pos-VHP sterility hold studies for isolator working environment

• Post-filtration media hold studies for bulk product

The testing process was rigorous, verifying that every system functioned according to specifications and regulatory standards. Mission BPS worked closely with the client’s team to ensure that any potential issues were identified and resolved before the systems went live. Our team’s attention to detail and commitment to regulatory compliance helped ensure the client’s operations could continue smoothly without any disruptions.

Ongoing Support: Ensuring Long-Term Success

Even after qualification, Mission BPS continues to support the client by providing ongoing support services, including system troubleshooting and periodic requalification. We understand the complexities of pharmaceutical grade isolators, and that maintaining system operational efficiency and process compliance with evolving regulations is an ongoing effort.

Conclusion: A Proven Partnership for Success

Achieving GMP readiness for these filling lines at our client’s Boston facility highlights Mission BPS’s ability to manage and execute large-scale, complex commissioning and qualification efforts with precision and care. By leveraging our deep expertise in manufacturing process equipment and validation services, we were able to help our client enhance production capabilities while maintaining the highest levels of regulatory compliance and operational efficiency.