Facility Upgrade for Continuous Manufacturing – Delivering Innovation in an Active GMP Environment
Background
AVS Life Sciences delivers cutting-edge engineering, projectmanagement, automation, validation, and clinical solutions to clients in the pharmaceutical, biotech, medical device, and diagnostic industries. Our team goes beyond execution—we build lasting partnerships and ensure full traceability in every service we provide, from utilities support and preventive maintenance to installation and documentation.
We are proud of our 100% success rate across FDA, EMA, and PIC audits, a testament to our rigorous quality and compliance standards.
In this case study, we detail a complex, multi-year collaboration with a major pharmaceutical manufacturer to repurpose an underutilized room within an activeGMP facility—ultimately enabling a new continuous direct compression manufacturing process.
Background
AVS Life Sciences delivers cutting-edge engineering, project management, automation, validation, and clinical solutions to clients in the pharmaceutical, biotech, medical device, and diagnostic industries. Our team goes beyond execution, we build lasting partnerships and ensure full traceability in every service we provide, from utilities support and preventive maintenance to installation and documentation.
We are proud of our 100% success rate across FDA, EMA, and PIC audits, a testament to our rigorous quality and compliance standards.
In this case study, we detail a complex, multi-year collaboration with a major pharmaceutical manufacturer to repurpose an underutilized room within an active GMP facility, ultimately enabling a new continuous direct compression manufacturing process.
The Challenge
Our client needed to transform an existing multiproduct space, originally designed for open processing, into a modern, continuous direct compression manufacturing suite. While the room had never been qualified for use, it presented unique constraints:
- Fixed ceiling height and limited airlock configurations
- An overhead interstitial space filled with mechanical systems
- The need to integrate equipment from five separate vendors, some of whom were competitors
- Execution within a live GMP environment, requiring zero disruption to ongoing operations
AVS was selected to serve as the Owner’s Representative Project Manager, responsible for delivering a full turnkey solution, from design, construction and equipment procurement to installation, commissioning, and qualification.
Our Approach
AVS divided the challenge into four major workstreams:
1. Design a Compliant Facility Layout: Meet the utility and process equipment requirements while overcoming physical constraints.
2. Vendor Coordination: Manage the design and integration of process equipment across five competitive suppliers.
3. Construction in a Live GMP Environment: Execute ceiling modifications and equipment installation without disrupting operations.
4. Commissioning & Qualification (C&Q): Ensure full compliance through rigorous documentation and traceability.
Integrated Project Management
We began by collaborating with our client, architectural partners, and engineering teams to develop a viable facility redesign. The most critical hurdle was the ceiling height, additional space was required to accommodate the new vertical equipment. The solution involved strategic demolition and rework of the interstitial mechanical space, all while preserving system functionality elsewhere in the plant.
Managing Competing Vendors
AVS facilitated equipment procurement and coordinated technical integration across five vendors. To manage confidentiality and ensure productive collaboration, we implemented tailored NDAs and hosted weekly design coordination meetings. Factory visits ensured physical compatibility prior to site delivery.
On-Site Execution
The project’s execution phase required precision. Because the GMP facility remained operational, construction teams accessed the manufacturing room via a rooftop hatch. A crane was used to carefully lift and lower equipment sections, which were then assembled on-site. AVS supervised every phase of the process, including ceiling modifications and utility upgrades.
Commissioning & Qualification
Our team led all C&Q activities for the facility, utilities, and equipment, ensuring alignment with the client’s quality systems and internal change control processes. All validation protocols were generated and executed in accordance with regulatory standards and project-specific requirements.
The Results
AVS successfully delivered a multi-year, CAPEX lifecycle project that was on time and within budget, despite its complexity.
Key accomplishments included:
- Seamless integration of five vendor systems into a cohesive continuous direct compression line
- Ceiling modifications and equipment installation in a live GMP environment without operational disruption
- Full traceability across design, construction, and C&Q phases
- Robust project tracking with monthly KPI reporting and stakeholder alignment
Our efforts enabled the client to launch a flexible, high-efficiency manufacturing process that significantly enhances production capacity and supports the delivery of life-saving medicines.
Conclusion
This project showcases AVS Life Sciences’ commitment to delivering complex solutions with agility, compliance, and care. By aligning engineering, construction, and regulatory execution within a live GMP environment, we empowered our client to expand capacity and future-proof their operations.
Let’s Talk
Whether you need support with facility upgrades, new manufacturing processes, or turnkey project execution, AVS is ready to help. Contact us to learn how we can support your next initiative.