Sterile IVD Manufacturing Facility Development in 30,000 sq. ft.

PROBLEM STATEMENT

Our client, specializing in personalized cancer diagnostics, engaged D2R Global Consulting to design and develop a 30,000 sq. ft. ISO-compliant cleanroom facility. This state-of-the-art space was required for the sterile manufacturing of in vitro diagnostic (IVD) products, adhering to ISO 14644-1 standards. D2R’s involvement spanned every phase, from initial planning and Auto-CAD design through to validation and facility commissioning, with a strict completion timeline of 8 months.

Our Approach

Comprehensive Planning and Design:D2R developed a fully optimized layout through Auto-CAD designs, incorporating ISO 6, 7, and 8 cleanroom classifications. The team ensured streamlined workflows for men , material movement and sterile workflow, maximizing the 30,000 sq. ft. space.
Comprehensive Documentation Preparation:
HVAC Design and Validation: An advanced HVAC system was installed to meet ISO requirements for air changes per hour and pressure differentials across classifications. HEPA filtration was incorporated to maintain strict contamination controls, with regular air quality monitoring.
Process and Equipment Validation: D2R performed process validation, including equipment and HVAC system verification, to ensure compliance with regulatory standards. Third-party validation was conducted for all equipment, building safety systems and facility protocols to guarantee sterility.
Facility Commissioning and Compliance:Following rigorous testing, the cleanrooms were validated for particle count, bioburden and environmental monitoring, meeting ISO 14644-1 standards. D2R enabled the client to achieve operational readiness and go live with manufacturing within the 8-month timeline.

Outcome

The cleanroom facility was commissioned successfully, achieving ISO compliance and ready for sterile IVD manufacturing. With D2R’s comprehensive support, the client launched operations within the projected 8 months, establishing a robust production environment suited for high-quality cancer diagnostic products and positioned for future growth.

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Sterile IVD Manufacturing Facility Development in 30,000 sq. ft.

PROBLEM STATEMENT

Our Approach

Outcome

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