EPSILON Pharmaceutical Engineering & Processing Systems B.V.

EPSILON is a pharmaceutical engineering Design Authority delivering regulated engineering services, fabrication governance, and system integration for GMP-driven pharmaceutical facilities, supporting both end-user manufacturers and EPC(M) organizations.

Core System Portfolio

• Aseptic and Sterile Production Systems
• Bioprocessing Equipment and Engineered Process Skids
• Clean Utilities – PW, WFI, Pure Steam (Generation, Storage & Distribution)
• Mobile and Fixed CIP/SIP Systems
• Sterile Filtration Architectures with PUPSIT (Pre-Use Post-Sterilization Integrity Testing) Integration
• Dedicated Temperature Control Units (TCU) for critical and bioprocess applications

Engineering Authority & Governance Framework

• Lifecycle-Controlled Engineering (Conceptual → FEED → Detailed → C&Q)
• Risk-Based and Contamination Control Strategy (CCS)-Driven Design
• Clearly Defined System Boundaries and Interface Governance
• Full URS–Risk–Design–Test–IQ/OQ Traceability Architecture
• Validation-Integrated and Inspection-Prepared System Delivery

All EPSILON systems are engineered to be applicable, measurable, repeatable, and fully traceable — audit-proof by design and resilient under regulatory inspection — ensuring predictable performance and controlled compliance throughout the entire lifecycle.

EPSILON Pharmaceutical Engineering & Processing Systems

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EPSILON Pharmaceutical Engineering & Processing Systems

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Teams

Offices

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