Cleanroom Manufacturing.
ISO Class 6 & 7. 20,000+ Sq. Ft.
Medical device assembly under your regulatory framework, sensitive electronics, precision optics, and life sciences — Class 1,000 and Class 10,000 environments. ISO 9001 + 14001 certified. Canton, Michigan, USA.
Contract Cleanroom Manufacturing:
Dual-Class Cleanroom, Full-Service Floor
Most cleanroom operators only do cleanroom work. Lotus runs a 20,000+ sq. ft. dual-class cleanroom inside our 300,000 sq. ft. contract manufacturing facility in Canton, Michigan, USA — so your product moves from controlled assembly into testing, packaging, warehousing, and shipping without leaving the building, with the cleanroom dropping in wherever your process needs it.
ISO 9001:2015 and ISO 14001:2015 certified. Full batch and unit traceability.
- 20,000+ sq. ft. total cleanroom space
- Both ISO Class 6 and ISO Class 7 environments available (Class 1,000 and Class 10,000)
- Integrated with assembly, testing, warehousing, and fulfillment
- ISO 9001:2015 and ISO 14001:2015 certified quality management
ISO Class 7 & ISO Class 6
Two cleanroom classes, under one roof. Choose the environment your product demands — or use both across production stages.
ISO Class 7
≤ 352,000 particles / m³
Typical Applications
- Consumer electronics assembly
- Light medical device builds
- Optical component handling
- General contamination-sensitive work
ISO Class 6
≤ 35,200 particles / m³
Typical Applications
- Medical device sub-assembly
- Sensitive electronics
- Precision optics and photonics
- Life sciences final assembly
Not sure which class your product needs? Talk to our engineering team about your contamination requirements.
Cleanroom Applications
From medical device sub-assembly to sensitive optics — applications that demand contamination control.
Medical Device Assembly
Contamination-controlled medical device assembly — disposables, instruments, and sub-assemblies built under your regulatory framework. Full documentation and traceability.
Sensitive Electronics
Component-level assembly and integration for electronics where airborne contamination compromises function or longevity. ISO Class 6 (Class 1,000) available.
Optical Component Assembly
Lens assembly, precision optics, and optical system integration. Contamination-controlled with environmental monitoring.
Life Sciences Packaging
Contamination-controlled packaging, labeling, and final assembly for life sciences products.
Precision Sub-Assembly
Contamination-sensitive sub-assemblies feeding larger systems built elsewhere in our facility. Cleanroom and standard assembly under one roof.
Controlled Testing & Inspection
Final inspection, functional testing, and documentation in the same cleanroom as assembly — no contamination between build and test.
Gowning, Validation, Documentation
A cleanroom is only as good as the process inside it: gowning protocols, environmental monitoring, and documented procedures at every step. “Probably clean” isn’t a standard.
Our post-sale service team supports cleanroom-built products with warranty and repair from the same facility.
- Full gowning protocols (bunny suits, gloves, hairnets, booties)
- Environmental monitoring (particle counts, temperature, humidity)
- Documented SOPs for every cleanroom process
- Full batch traceability and documentation for every product
- Regular validation and recertification of cleanroom environments
Sq. Ft. Cleanroom
Years Manufacturing
Industry Partners
Industries We Serve
Our cleanroom supports clients in industries where contamination control isn't optional — from medical device sub-assembly to precision optics.
Beyond the Cleanroom
Contract Manufacturing
Cleanroom-assembled components integrate directly into our full assembly lines.
ExploreWarehousing & Distribution
Cleanroom products move directly to storage and shipping in the same building.
ExploreCertifications & Quality
ISO 9001, ISO 14001, and the quality systems that govern our cleanroom operations.
ExploreCleanroom Manufacturing FAQ
A cleanroom is a controlled-environment manufacturing space where airborne particulate, temperature, humidity, and contamination are actively monitored and limited to defined thresholds. Cleanrooms are classified by maximum allowable particle counts per cubic meter — the lower the class number, the cleaner the room. Manufacturing inside a cleanroom is required for products where airborne contamination would compromise function, longevity, or regulatory compliance: medical devices, sensitive electronics, optical assemblies, semiconductors, and life-sciences packaging.
ISO Class 7 (formerly Class 10,000) allows up to 352,000 particles 0.5 microns or larger per cubic meter — suitable for general medical device assembly, sensitive electronics, optical work, and most contamination-controlled manufacturing. ISO Class 6 (formerly Class 1,000) is ten times stricter at 35,200 particles per cubic meter — suitable for tighter medical device assembly, precision optics, and applications where particulate-driven failure rates matter. Lotus operates both ISO Class 6 and ISO Class 7 environments in the same 20,000+ sq. ft. cleanroom complex, so programs can move between classes without changing facility.
No. Lotus is ISO 9001:2015 and ISO 14001:2015 certified. We are not currently ISO 13485 (medical device QMS) certified. We support medical device contract manufacturing programs by performing assembly, testing, and packaging under your regulatory framework — your ISO 13485 / FDA QSR / 21 CFR 820 systems govern the program, and Lotus operates as the production partner inside that framework. If you need a contamination-controlled assembly partner without rebuilding your own QMS audit trail, this is the standard arrangement.
Lotus performs cleanroom assembly, testing, and packaging for non-implantable medical devices and components — diagnostic equipment, home monitoring devices, durable medical equipment (DME), instrument sub-assemblies, and life-sciences packaging — under your regulatory framework. For implantable, sterile-fill, or other work that calls for our own ISO 13485 certification, talk to us about your program and timeline.
Lotus operates both ISO Class 7 (Class 10,000) and ISO Class 6 (Class 1,000) cleanrooms, totaling over 20,000 sq. ft. of controlled environment manufacturing space. These rooms are validated and maintained for particulate control, temperature, and humidity.
Our cleanrooms support assembly, testing, and packaging of medical devices, electronic components, optical assemblies, LCD/display panels, and sensitive consumer electronics. Any product requiring particulate-controlled manufacturing can be accommodated within the boundaries of our certifications and your regulatory framework.
All cleanroom personnel follow strict gowning procedures including full cleanroom garments, gloves, booties, and hair/beard covers. We maintain airlock entry systems, regular particulate monitoring, and documented cleaning and validation schedules.
Yes. Our 20,000+ sq. ft. of cleanroom space allows us to add lines and shifts to match your production volume. We can also move between ISO Class 7 and ISO Class 6 environments (Class 10,000 and Class 1,000) based on your product requirements.
Yes. Our cleanrooms are within our 300,000 sq. ft. Canton, Michigan, USA facility. This means cleanroom-assembled products can move seamlessly to testing, warehousing, and shipping without leaving the building.
The cleanroom operates under our ISO 9001:2015 and ISO 14001:2015 systems with full traceability documentation, gowning protocols, particulate monitoring, and validated cleaning schedules. If you run an ISO 13485 or FDA-regulated program, you maintain your own QMS umbrella; Lotus performs the contamination-controlled assembly inside your framework.
Need a cleanroom manufacturing partner in Michigan?
Our team responds within one business day.