top of page
Cleanroom Consulting Services | Hygenix

Move from Construction to Production—Without Delays

We take cleanroom projects from concept to compliant operations so you can start producing without waiting. 

Capital projects stall when planning breaks down, vendors misalign, and protocols fall behind. We fix that. 

Hygenix leads cleanroom-intensive capital projects for regulated industries. We start early, manage every phase, and stay engaged until your facility is fully operational.

 

  • ​We write the documents that keep design and execution aligned 

  • We manage trades to hit compliance milestones and critical dates 

  • We deliver cleanrooms that are validated, usable, and revenue-ready 

 

We don’t consult. We execute. 

Our Services

Cleanroom project planning meeting for GMP-compliant facility design

Planning

We define scope, align documentation, and structure the execution. URS, SOPs, CMPs, EH&S plans—compliant, traceable, and built for regulatory scrutiny. 

Cleanroom project management team overseeing construction and compliance milestones

Managing

We oversee vendors, enforce protocols, and keep construction execution on track. We lead protocol training, control changes, and actively manage project risk. 

Turnkey cleanroom solutions delivered to support operational readiness and regulatory compliance

Delivering

We bring your project to startup-ready. Turnover packages, SOPs, startup support, custom polypropylene furniture, and gas systems—clean, complete, and usable. 

Who We Serve

Engineers and facility managers in pharmaceutical and cleanroom environments Hygenix supports

We support regulated operations where startup readiness is mission-critical. 

​

Our clients operate in high-stakes environments where delays cost time, money, and compliance risk. Hygenix delivers cleanrooms that start-up on time, pass inspection, and get into production—fast. 

We understand FDA inspections, ISO classifications, QMS integration, and regulated controlled environments that feel the urgency of getting to production. 

Why Trust Hygenix

We don’t just support cleanroom projects—we manage them to operational readiness. Our projects succeed where others drift because we bring deep industry insight, disciplined execution, and full transparency from planning through production.

Hygenix cleanroom specialists with deep expertise in GMP regulations and controlled environment projects

We Know Regulated Facilities 

From cGMP pharma suites to ISO-classified device assembly, we bring deep experience in regulated cleanroom environments. We understand the pressures of FDA inspections, documentation requirements, and production readiness—and we plan accordingly. 

How We Work

Every project starts with expertise and ends with operational readiness. Here’s what you can expect from partnering with Hygenix.

Hygenix team applying regulated expertise to cleanroom construction for GMP and FDA-compliant environments

Regulated Expertise

We bring deep industry knowledge to every project—anticipating compliance needs and sequencing protocols with FDA expectations in mind.

Hygenix leading cleanroom construction execution with full ownership of schedule, budget, and compliance outcomes

Execution Ownership

From first scope to final turnover, we lead the process—not just advise it. We manage trades, enforce standards, and keep the project aligned from day one.

Turnkey cleanroom delivery with traceable project documentation for GMP and FDA compliance

Turnkey and Traceable

We deliver cleanrooms with complete, structured documentation—so your team is ready to operate, train, and scale without delays.

Hygenix cleanroom services tailored to client goals, facility constraints, and compliance needs

Aligned to
You

We work like part of your team—transparent, responsive, and focused on getting your cleanroom producing faster, safer, and more reliably.

Trusted by Regulated Operators Across Industries

TFS 369x86.png
Evonik 397x103.png
Pfizer 258x105.png
Fermilab 396x73.png
Lilly 188x103.png
Artelon 282x107.png
bottom of page