Bausch & Stroebel Filling Line EM Upgrades

Client: Thermo-Fisher Scientific (Cambridge, MA / Lexington, MA)

Project Scope

This ambitious initiative involved upgrading three critical filling lines across two of the client’s Boston-based manufacturing facilities to enhance passive/active-viable and total particulate sampling coverage, while incorporating Ready-to-Use (RTU) tray staging and de-bagging fixtures to facilitating significant aseptic technique enhancement during normal production filling operations.

Creative Strategies

Leveraging my deep expertise in isolated filling technology, I worked closely with stakeholders and system manufacturers to ensure the seamless integration of both hardware and software upgrades. Due to constraints in the Client's manufacturing schedule, the project was divided into two phases to ensure minimal disruption to operations.

Phase I focused on laying the groundwork while maintaining compliance with the Client's change management system. This phase primarily involved cabling and hardware installation to achieve a rough-in state. The infrastructure was put in place, but final process connections and wiring terminations were deferred. This approach preserved the validated state of the system and ensured uninterrupted functionality of the isolator/filler.

Phase II involved the completion of the project. The scope included:

• Final connection of the roughed-in cabling and hardware

• Installation of the upgraded isolator chamber flange

• Updates to the isolator software program

• Comprehensive return-to-service testing, including IQ/OQ/PQ protocols

Project Outcome

By adopting the phased installation strategy, I was able to effectively safeguard the equipment's validated state to the greatest extent possible while efficiently progressing towards project completion. This careful planning ensured that each phase built seamlessly upon the previous one, ultimately delivering a successful outcome.