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Hygenix cleanroom solutions tailored for pharmaceutical, biotech, electronics, and EV manufacturing industries

INDUSTRIES

We support cleanroom projects in industries where compliance is non-negotiable.

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Each industry we serve operates under its own set of pressures—product timelines, patient safety, audit exposure, and technical precision. But they share a common challenge: cleanroom projects that must be planned, executed, and turned over with structure, clarity, and confidence.

 

Hygenix steps in where standard construction support ends. We ensure every cleanroom project has the documentation, training, and operational framework needed to function—without surprises at startup.

Pharmaceutical Manufacturing

Hygenix designing and constructing GMP-compliant cleanrooms for pharmaceutical manufacturing

Facilities manufacturing oral solid dose (OSD), sterile injectables, APIs, or WFI require full traceability and audit-ready handoff. Every scope decision must align with 21 CFR Parts 210/211, ICH Q9/Q10, and cGMP expectations. Hygenix supports these facilities by embedding structure at every phase of delivery.
 
We help: 

  • Develop URS packages linked to design and CQV

  • Prepare commissioning master plans aligned with validation pathways

  • Draft and deliver SOPs that reflect actual facility use

  • Assemble Enhanced Turnover Packages that support FDA inspections and internal QA audits

Medical Device Production Facilities

Hygenix delivering cleanroom environments for medical device manufacturing with ISO and FDA regulatory alignment

Device cleanrooms operate under ISO 13485, FDA QSR (21 CFR Part 820), and in some cases EU MDR. Cleanliness classifications, traceability, and documentation completeness all impact regulatory submissions and audit outcomes. Hygenix brings regulatory-informed structure from scope to readiness.
 
We help:

  • Integrate project-level QMS and SOP systems aligned with 13485 and QSR

  • Coordinate build decisions with risk-based controls across gowning, cleaning, and classification

  • Train internal and vendor teams on compliance-critical procedures

  • Deliver startup documentation that supports facility registration and QA readiness

R&D Laboratories

ygenix supporting research and development laboratories with custom cleanroom solutions for precise environmental control

R&D and quality control labs support early-stage science, yet they must function with operational precision. Teams often face shifting requirements, evolving headcount, and mixed regulatory exposure, while still needing systems that support inspection readiness and cleanroom control. 
 
We help: 

  • Plan and document layouts for controlled but flexible cleanroom and support zones 

  • Deliver fit-for-purpose protocol and training structures to support startup 

  • Coordinate installation of cleanroom furnishings, gas systems, and support utilities 

  • Ensure documentation and SOPs scale with future cGMP or GLP requirements 

Biotech and Biologics

Hygenix providing turnkey cleanroom solutions for biotechnology research and production facilities

Biotech cleanrooms are built for speed—but fast tracking often creates documentation gaps, protocol misalignment, and turnover delays. Projects must meet GMP expectations under pressure from clinical timelines, process uncertainty, and evolving scale-up plans.
 
We help: 

  • Coordinate facility planning aligned to cGMP and ISPE Baseline standards

  • Build commissioning and SOP structures that flex with process evolution

  • Reduce startup delays with clear turnover deliverables and pre-synced documentation

  • Support facility expansions and fit-outs with planning that protects long-term validation

Diagnostic Laboratories

Cleanroom and controlled environment design by Hygenix for diagnostic laboratory workflows and contamination control

Whether operating under CLIA, FDA, or state-specific oversight, diagnostic cleanrooms and labs demand clarity in both build scope and procedural workflows. These projects often face compressed timelines tied to equipment delivery and go-live windows.
 
We help: 

  • Define cleanroom specifications and layouts aligned with biosafety and cross-contamination control

  • Develop SOPs for personnel flow, environmental monitoring, and sample handling

  • Build safety and EH&S plans aligned to lab-specific hazards

  • Reduce readiness risk by managing protocol delivery and turnover documentation in parallel

Other Regulated Environments 

Custom cleanroom solutions by Hygenix for regulated environments including aerospace, nanotechnology, and metrology labs

We support cleanroom projects in any industry where cleanliness, containment, and compliance intersect. These include advanced manufacturing, specialty chemical processing, nutraceuticals, and battery or semiconductor environments governed by ISO 14644, SEMI, or internal audit protocols. 
 
We help:

  • Align build decisions with operational tolerances and classification requirements 

  • Coordinate vendor protocols, training, and documentation under one aligned framework 

  • Prevent startup surprises by structuring turnover around operational functionality, not just project closeout 

  • Support hybrid cleanroom and process areas with tools built for real-world workflows 

Our Outcome: Facilities That Work on Day One 

Your industry defines the regulatory requirements. We bring the structure to meet them. Hygenix delivers cleanroom projects with traceable planning, compliant execution, and documentation that supports operational readiness on day one. 
 
When you’re ready to go live, we make sure the facility is too. 

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