A cleanroom is a controlled environment engineered to keep airborne particles, temperature, humidity, and pressure within strict limits — classified by ISO 14644 — so that pharmaceutical, biotech, cosmetic, and medical-device products can be made without contamination. Paul Industries designs, builds, and validates modular and stick-built cleanrooms for manufacturing facilities across the US East Coast, self-performing the HVAC, HEPA filtration, wall systems, and IQ/OQ/PQ under a single contract.
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How a cleanroom works
A cleanroom controls contamination by continuously supplying HEPA- or ULPA-filtered air, maintaining positive (or, for containment, negative) pressure relative to surrounding spaces, and using smooth, cleanable, non-shedding surfaces. Air changes per hour, airflow pattern (unidirectional/laminar vs. turbulent), and room pressurization are engineered to the ISO class the process requires. The cleaner the class, the more filtered air, the tighter the envelope, and the more rigorous the gowning and controls.
Paul Industries engineers the full system as one package: the HVAC and HEPA filtration that set the class, the wall, ceiling, and flooring systems that hold it, the pressure cascade between rooms, and the controls and monitoring that keep it in a validated state — then certifies performance against ISO 14644.
ISO 14644 cleanroom classifications
ISO 14644-1 classifies cleanrooms by the maximum allowable particle count per cubic metre. Choosing the right class is a balance of product risk and cost — over-classifying wastes capital and energy, under-classifying risks the product.
| ISO Class | Max particles ≥0.5 µm/m³ | ≈ FED STD 209E | Typical use |
|---|---|---|---|
| ISO 5 | 3,520 | Class 100 | Aseptic filling, sterile compounding |
| ISO 6 | 35,200 | Class 1,000 | Sterile prep, sensitive assembly |
| ISO 7 | 352,000 | Class 10,000 | Aseptic background, medical device |
| ISO 8 | 3,520,000 | Class 100,000 | General pharma / cosmetic packaging |
Modular vs. stick-built cleanrooms
Both approaches can meet any ISO class; the right choice depends on speed, flexibility, and your building.
| Modular (panel) | Stick-built | |
|---|---|---|
| Speed | Faster — prefabricated panels | Slower — built in place |
| Flexibility | Reconfigurable / relocatable | Permanent |
| Best for | Fast timelines, changing needs | Fixed, fully integrated suites |
| Finish | Cleanable panel systems | Custom architectural finishes |
Our cleanroom services
- Design & engineering — ISO-class selection, airflow and pressure-cascade design, HVAC and HEPA sizing.
- Construction — modular panel or stick-built walls, ceilings, cleanroom flooring, doors, and pass-throughs.
- HVAC & filtration — air handlers, HEPA/ULPA terminals, humidity and temperature control.
- Controls & monitoring — pressure, particle, and environmental monitoring for cGMP records.
- Certification & validation — ISO 14644 certification plus IQ/OQ/PQ.
- Process integration — high-purity water, process piping, and equipment tie-ins under one contract.
Industries we serve
We build cleanrooms for pharmaceutical and biotech manufacturing (aseptic filling, cell and gene therapy, WFI suites), sterile compounding pharmacies under USP <797>/<800>, medical-device assembly, and cosmetic and nutraceutical production where product protection and regulatory compliance matter.
Standards & compliance
- ISO 14644
- The international standard that classifies cleanrooms by airborne particle concentration and defines how performance is tested and certified.
- cGMP / 21 CFR 211
- FDA current Good Manufacturing Practice requirements that drive the environmental control, monitoring, and documentation a pharma cleanroom must maintain.
- USP <797> and <800>
- Standards governing sterile and hazardous-drug compounding environments, which set airflow, pressurization, and classification for compounding cleanrooms.
- IQ / OQ / PQ
- Installation, Operational, and Performance Qualification prove the cleanroom was built to design, operates within its parameters, and holds its class in production.
Why Paul Industries
Cleanrooms fail at the seams between trades — the mechanical contractor, the panel installer, the controls integrator, and the validation firm. Paul Industries self-performs across those trades, so one team owns the airflow, the envelope, the controls, and the certification, and there is a single point of accountability for the class you’re paying for. With 30+ years building process environments on the US East Coast, every project is documented for cGMP traceability. Where client confidentiality limits public references, we provide capability statements and certification deliverables on request.
Frequently asked questions
What ISO class cleanroom do I need?
Is a modular or stick-built cleanroom better?
How long does cleanroom construction take?
Do you handle the HVAC and HEPA filtration?
Do you certify and validate the cleanroom?
Do you build cleanrooms in New Jersey and the East Coast?
Get a cleanroom project quote
Tell us about your facility, product, and target ISO class — a Paul Industries engineer will follow up to discuss scope, standards, and timeline.
Request a Project Quote or call 201-450-8280