DELIVERING
We deliver operational readiness—not just a cleanroom.
Too many capital projects focus on construction completion instead of facility activation. But in regulated industries, finishing the build is only part of the challenge. Without complete documentation, trained users, and validated systems, you're not ready to run. You’re just done building.
Hygenix takes capital projects through the final, most critical phase: delivering a facility that’s ready for inspection, startup, and ongoing operations.
We support clients through turnover, documentation control, end-user training, and startup support to ensure the facility functions as intended—without delays, surprises, or compliance gaps.
The Problem: “Done” Isn’t Ready
Life science projects often struggle post-construction because:
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Turnover documentation is incomplete, fragmented, or missing traceability
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End-users haven’t been trained on systems or SOPs
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Protocols don’t match real-world workflows
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Custom furniture and utility systems are delivered late or misaligned
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Cleanroom equipment lacks final validation and integration
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No one owns startup—so critical systems stall under pressure
In FDA-regulated environments, these issues mean more than frustration. They delay product release, revenue, and regulatory inspection readiness.
What We Deliver
Hygenix makes sure your project doesn’t just finish—it works.
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Enhanced Turnover Packages (ETOPs) that are complete, structured, and traceable to URS
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Utility and gas systems installed and tested per spec, with final compliance documentation
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End-user SOPs that reflect real operational flow—not just theoretical procedures
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Custom polypropylene furniture and accessories are delivered to support the workflow—not hinder it
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On-site training that prepares operators, QA, and maintenance for go-live
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Startup support that ensures systems operate under load and meet required performance benchmarks
When regulators arrive, you won’t be scrambling. You’ll be ready.
Our Delivering Services
We tailor our delivery scope to the complexity of the project, the level of regulatory oversight, and the end-user team’s operational maturity. Deliverables often include:
ETOP Development
We assemble all required turnover documentation into clean, indexed, and traceable packages that connect URS, commissioning, and qualification activities.
Final Compliance Documentation
We gather, format, and QA all final documents required for startup, inspection, and long-term retention—no missing links, no placeholders.
Custom Polypropylene Furniture
We design, fabricate, and install compliant polypropylene furniture to meet workflow, cleanroom classification, and ergonomic needs.
End-User Training & SOPs
We deliver SOPs written for actual operators—not just QA reviewers—and provide live training to accelerate readiness and reduce startup errors.
Gas Delivery Systems
We provide system installation and final testing for process-critical utilities, ensuring proper routing, pressure ratings, and compliance with industry standards.
