Cleanroom Frequently Asked Questions

We deliver turnkey design/build services for non-sterile and sterile (FDA-compliant) and industrial-controlled environments (ISO Classifications, dry rooms and other clean facilities), covering applications in pharmaceuticals, IV compounding pharmacies, electronics, aerospace, food manufacturing, biotech and more.

Our turnkey approach means handling everything end-to-end — consultation, design and engineering, permitting, construction, commissioning, certification support, and after‑sales maintenance — so you can focus on your operations, not the build.

Our engineers design to meet all applicable ISO Classifications, FDA (503A/503B), cGMP (503B), USP (<795/797/800/825>), and other standards. We also coordinate third-party certification and guarantee performance through rigorous commissioning and testing.

We serve a broad range of clients, including pharmacies, hospitals, IV-compounding facilities, semiconductor, optics, nanotech, and battery dry rooms, as well as food processing, aerospace, automotive, life science and biotech labs.

Yes — we often assist clients during the site selection phase. Selecting the right location can significantly impact project success. We evaluate factors like existing infrastructure, HVAC and power capacity, structural limitations and potential compliance risks.

By involving us early, you can avoid costly retrofits or regulatory surprises down the line. We'll help you assess whether a site can support the cleanroom environment you need — or identify what upgrades would be required. It's a smart way to mitigate risk in your investment before plans are finalized.

Absolutely. We frequently collaborate with in-house facilities managers, architects, engineers, and project stakeholders. Our goal is to integrate seamlessly with your team — bringing cleanroom-specific expertise while respecting your existing processes and priorities.

Whether you need us to take the lead or complement internal resources, we ensure smooth communication, aligned goals, and minimal disruption. It’s all part of delivering a cleanroom that works for your people, your facility and your long-term strategy.

Yes. Alongside conventional stick-built rooms, we offer modular and pre-engineered systems, including cleanroom-ready walls and ceiling grids, to suit project timelines and budgets.

General contractors have the skills to handle standard construction, cleanrooms involve highly specialized design and integration challenges. Airflow dynamics, contamination control, pressure balancing, filtration systems, and regulatory compliance (such as ISO, USP or cGMP) all require in-depth expertise.

Using a cleanroom specialist like CE Cleanrooms ensures that:

• Your room meets all required standards from day one
• Mechanical and electrical systems are properly designed for clean environments
• Certification and inspections go smoothly with no costly rework
• You avoid downtime or compliance risks after the handover

Cleanrooms are mission-critical spaces. Working with a specialist reduces risk, saves time, and protects your investment in the long run.

1. Consultation – discussing your needs, workflow, and site suitability
2. Design and engineering – drawings, permits, approvals
3. Construction and installation – full project management
4. Commissioning – verifying systems and airflow performance
5. Certification – readying for inspections and tests
6. After‑sales support – repairs, expansion or recertification by a professional third party.

Absolutely. We provide ongoing services for recertification, maintenance, remodeling and redesign, upgrades, expansion and responsive support to evolving contamination or compliance needs.

Yes. We have specialized expertise in sterile and non-sterile IV-compounding environments designed to USP and FDA standards, serving pharmacies, health systems and hospital groups across the US.

Our team of architects, designers and engineers brings decades of hands-on experience in the controlled-environment construction industry.

CE Cleanrooms offers deep experience, specialized knowledge, and a turnkey approach that makes complex projects more manageable. Clients choose us because:

• We speak your language – Whether you’re in pharma, microelectronics, or biotech, we understand the regulatory and operational challenges you face.
• Turnkey delivery – From concept through commissioning, we handle design, permitting, build-out, and certification support—so you don’t have to coordinate multiple vendors.
• Performance you can count on – We design for compliance and long-term reliability, and our work is backed by decades of successful projects across regulated industries.
• Tailored solutions – No cookie-cutter builds. Every cleanroom is custom engineered to match your workflow, facility, and compliance requirements.
• Long-term partnership – After your facility is up and running, we’re here to support you with upgrades, maintenance and recertification.

We combine technical precision with practical insight — and we’re easy to work with.

Reach out via phone (800‑283‑3720), email (Info@CECleanrooms.com), or the contact form on our website. We'll schedule a consultation to discuss your requirements, goals and project scope.