Confidential Modular Aseptic Processing Facility

Our role was to support the owner and ensure the project was built per plan, spec, and owner standards with a heavy focus on quality control and strict adherence to facility good manufacturing practice (GMP) guidelines. That includes supporting as civil, structural, and architectural lead, process piping field engineer, equipment purchasing and procurement lead, and site safety support.

The construction value was roughly $550 million, and the overall facility is 480,000 square feet.

Approximately 50,000 square feet of modular cleanroom space were built to support GMP manufacturing for the product. These rooms are built around ISO classifications ranging from ISO 5 to ISO 7. It consists of lyophilization using isolator technology, formulation, stopper processing, and filling.

CSM Group was responsible for the following activities:

• Inspection of installed work to ensure compliance with standards and GMP requirements.
• Working with design partners to ensure the design met site standards and resolved any design conflicts and/or challenges.
• Worked with equipment manufacturers on customizations and purchasing to meet clients' specifications.
• Supported manufacturer equipment FATs and on-site acceptance tests.
• Reviewed construction materials and compatibility with routine cleaning agents.
• Reviewed systems and ensured serviceability and maintainability.
• Reviewed/witnessed pre-functional testing and documentation.
• Ensured mechanical completion and validated systems for turnover to commissioning and verification teams.
• Ensured that all closeout package documentation was complete.