Optima Filling Line Procurement, Commissioning, and Qualification

Client: Thermo-Fisher Scientific (Plainville, MA)

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.

My 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, I was the ideal partner for this complex and demanding initiative.

Procurement Phase

I led the procurement process by 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 my network of industry colleagues, the vendor evaluation process yielded a high degree of assurance for cost-effectiveness, sustainability, and quality, ensuring that the client received the best value for their investment.

Design Phase

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 Phase

The qualification phase is perhaps the most critical part of the project, and one where My 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. I worked closely with the client’s team to ensure that any potential issues were identified and resolved for timely execution of Aseptic Process Simulation (APS), and subsequent release of the lines for GMP use.

Ongoing Support

Even after qualification, I continue to provide ongoing support services, including APS program development, regulatory gap assessment, and periodic requalification activities.