Executive Summary

The client was bringing a refurbished building, Salvarcar 2, online for medical-device manufacturing. Before production could begin, 162,000 sq ft of facilities, mechanical areas, and external utilities had to be commissioned and qualified to ISO Class 8 standards, with documented turnover the end-user could rely on.

Objectives

• Qualify 85,000 sq ft of ISO Class 8 cleanroom space against design requirements
• Commission mechanical areas and external utilities equipment
• Deliver a documented, risk-based turnover package to the end-user
• Hand over a safe, functional environment ready for manufacturing

BEPC's Role

BEPC owned the commissioning and qualification (C&Q) workstream end-to-end, planning the risk-based approach, managing startup and turnover of facilities, equipment, and systems, and qualifying the environment against the established design requirements.

Scope & Approach

• Risk-based C&Q planning across facilities, equipment & utility systems
• Cleanroom qualification to ISO Class 8 across 85,000 sq ft
• Commissioning of mechanical areas and external utilities equipment
• Managed startup and structured turnover to the end-user

BEPC applied a planned, risk-based approach to startup and turnover, sequencing commissioning so that facilities, equipment, and systems were verified against design requirements before being released to the end-user, resulting in a safe, functional environment with no surprises at handover.

Outcomes

The refurbished Salvarcar 2 facility was commissioned and qualified on plan. BEPC turned over a validated 162,000 sq ft environment, including 85,000 sq ft of ISO Class 8 cleanroom, ready for medical-device manufacturing, with a complete risk-based documentation trail.

Metricas clave

• Cleanroom area qualified: 85,000 sq ft (ISO Class 8)
• Total facility commissioned: 162,000 sq ft (Full turnover)
• C&Q scope delivered: $1.2M (On plan)

Evidencia visual (descripcion)

• Mechanical area and utilities equipment commissioned alongside the cleanrooms.
• Pre-construction state and the completed cleanroom, same footprint, qualified to design requirements.

Trust & References

BEPC turned a refurbished shell into a qualified, production-ready facility on plan. Their risk-based turnover gave us confidence at every handover, and we walked into a validated environment with no surprises.

Ultima revision: June 2026