In-Plant Modular Cleanrooms offer the exclusive ability to mix components for both cleanroom and in-plant office solutions allow us to meet cleanroom classification requirements while keeping the benefits of a modular system.
HardWall cleanrooms are the most durable of all modular cleanroom constructions. Suitable for all industries, this style of room will provide you with the structure that you need along with the cleanliness that your product requires. Rest assured, modular cleanroom will meet your needs now and into the future.
RigidWall cleanrooms are the perfect solution for a functional showpiece within a manufacturing environment. The cleanroom features clear acrylic panels and extruded aluminum frame provide a rigid structure to keep particles from the ambient environment out, as well as create an elegant enclosure to showcase your product and process. The RigidWall cleanroom is great for any operation.
SoftWall cleanrooms are the most versatile of all modular cleanroom constructions and these cleanroom enclosures are ideal for any setting. The lightweight extruded aluminum frame allows for fast and easy assembly, and clear vinyl allows for full visibility around the entire room.
Cleanroom Accessories
Many important clean room accessories are available such as HEPA Filters, past-thru walls, many carts, and more. Call our Labs USA reps for a complete list.
Planning a cleanroom project in Utah? Review Cleanrooms in Utah for regional planning context and a path to quote support.
Planning a Modular Cleanroom: Who Does What, Which Class, and What to Send Us
A cleanroom project goes faster when everyone knows their part before drawings start. Most delays we see come from three open questions: who certifies the room, what class it really needs, and which wall system fits the process.
Who does what on a cleanroom project
Labs USA designs, supplies and installs modular cleanrooms and coordinates the independent certifier. Certification itself is performed by that independent certifier, not by us. Our job is to design and build a room that is set up to pass; the certifier’s job is to measure it. Keeping those roles separate gives your quality team an independent report.
For pharmacy compounding rooms, certifiers typically test to the CETA CAG-003 guide. Read more in our cleanroom certification requirements guide.
| Step | Who usually owns it |
|---|---|
| Process requirements: product risk, target class, temperature/humidity, pressure | You (owner, QA or process engineer) |
| Room layout, wall system, filter count and placement, doors, pass-throughs | Labs USA, working with the cleanroom manufacturer |
| Supply and installation of the modular room | Labs USA |
| Building tie-ins: power, HVAC/makeup air, sprinklers, permits | Your facility team or contractors. We coordinate with your mechanical contractor. |
| Classification testing to ISO 14644-1 and tests per ISO 14644-3 (airflow, pressure, filter leak) | An independent cleanroom certifier, coordinated by Labs USA |
| Ongoing monitoring and periodic recertification (ISO 14644-2) | You, with your certifier |
Choosing a classification (or deciding you don’t need one)
ISO 14644-1 defines nine classes by how many airborne particles are allowed per cubic meter. These four cover most projects:
| ISO class | Max particles ≥0.5 µm per m³ | Old “Class” name | Typical use |
|---|---|---|---|
| ISO 5 | 3,520 | Class 100 | Semiconductor and critical work zones, sterile compounding hoods |
| ISO 6 | 35,200 | Class 1,000 | Electronics and optics assembly |
| ISO 7 | 352,000 | Class 10,000 | Medical device assembly, pharmacy buffer rooms |
| ISO 8 | 3,520,000 | Class 100,000 | Gowning/ante rooms, general controlled manufacturing |
Let the rule that governs your product set the class:
Pharmacy compounding
USP <797> sets ISO 5 at the hood, an ISO 7 buffer room and an ISO 8 ante-room. USP <800> adds negative pressure for hazardous drugs. Non-sterile compounding under USP <795> does not require a classified room.
Dietary supplements
FDA’s cGMP rule (21 CFR 111.20) requires cleanable surfaces, separated or defined work areas, and adequate ventilation and filtration, but it does not name an ISO class. Many manufacturers still choose a classified room (often ISO 8) for open-powder steps, or because a customer or auditor expects one. A non-classified, filtered room can be enough for closed or packaging-only steps. Your QA team makes that call; we can lay out both options.
Semiconductor and electronics
The class usually comes from the process owner’s spec, often ISO 5 or better at the work zone.
Also decide the occupancy state for testing: as-built, at-rest or operational. A room that passes empty can still fail with people and equipment running. Our cleanroom classification guide covers the ISO 14644-1 limits in more depth.
Softwall, rigidwall or hardwall
- Softwall: vinyl curtains on an aluminum frame. Fastest to set up and easiest to move, and good for clean zones inside a larger space. Harder to hold tight pressure or temperature.
- Rigidwall: acrylic panels on aluminum. Gives full visibility and better pressure control, and can run once-through or recirculating air.
- Hardwall: insulated, finished panels with a ceiling deck. Best for tighter pressure cascades, temperature/humidity control, multi-room suites and walkable decks for service from above.
Compare them in detail in our hardwall vs softwall guide, or see a finished modular compounding pharmacy cleanroom project.
What to have ready before you request a design
You don’t need drawings to start, but these details sharpen the first layout:
- ✓Room footprint: length, width and clear height to the lowest overhead obstruction (beams, ducts, sprinklers, lights)
- ✓A rough sketch: existing walls, columns, doors, and where people, materials and product enter
- ✓Target ISO class (or “not sure”), and the rule or customer spec behind it
- ✓What happens inside: open powders, liquids, hazardous drugs, heat-producing equipment, number of people per shift
- ✓Temperature, humidity and pressure needs (positive or negative)
- ✓Gowning or ante-room, pass-throughs, and any large equipment that must go in before walls close
- ✓Available power, HVAC capacity and floor condition
- ✓Whether you’re consolidating or relocating existing rooms, and which parts you want to reuse
- ✓Your certifier, if you already have one, plus the occupancy state you’ll certify to
Start a layout in the Cleanroom Configurator, send the details through our contact form, or call (801) 855-8560.
Cleanroom planning FAQ
Can Labs USA certify my cleanroom?
Certification is performed by an independent certifier who tests the finished room to ISO 14644. Labs USA designs, supplies and installs the room so it is ready for that testing, and we coordinate the independent certifier, including talking through the test plan with you and the certifier early.
Do I need a classified cleanroom for dietary supplements?
Not necessarily. 21 CFR 111 calls for cleanable construction, separated or defined work areas, and adequate ventilation and filtration, not a specific ISO class. Many plants classify open-product rooms anyway. Your QA team should set the target, and we can price both options.
I only have building dimensions. Is that enough to start?
Yes. Footprint and clear height let us draft a first layout, and the checklist above fills in the rest.
How often does a cleanroom need retesting?
ISO 14644-2 ties retesting to a written monitoring plan. Reclassification is typically annual unless your monitoring data support a longer interval. Pharmacy rooms follow USP <797> schedules.
Can a modular room be expanded or moved later?
Modular panel systems are designed to be reconfigured. Tell us up front if you expect growth so the layout leaves room for it.
Cleanroom Furniture and Applications
Furniture, storage and modular room options for controlled environments by industry.
Cleanroom project: modular cleanrooms for a compounding pharmacy in Utah · all past projects
