Service · Cleanroom Assembly

ISO 7 / ISO 8.
Particle controlled.
Medical & semi.

Cleanroom assembly services for medical devices, semiconductor equipment, aerospace optics, vacuum hardware. ISO 7 (Class 10000) and ISO 8 (Class 100000) clean assembly. ISO 6 (Class 1000) for critical applications.

Cleanroom Assembly Quote Vacuum chamber CNC

ISO 7 / ISO 8 Particle controlled Personnel gowned Documented cleanliness

01 · Cleanroom classes

Cleanroom standards.

ISO 14644-1 specifies cleanroom classes by particle count per cubic meter. Different applications require different classes.

ISO 8 (Class 100000)

3.52M particles/m³

Pharmaceutical preparations, medical device packaging, general clean assembly. Most common cleanroom class.

ISO 7 (Class 10000)

352K particles/m³

Pharmaceutical filling, medical device assembly, semiconductor outer rooms. 10× cleaner than ISO 8.

ISO 6 (Class 1000)

35.2K particles/m³

Sterile pharmaceutical, advanced semiconductor, biotech. 100× cleaner than ISO 8. Limited capability.

ISO 5 (Class 100)

3.52K particles/m³

Aseptic pharmaceutical filling, advanced semiconductor lithography. Specialty — partner facility.

ISO 4 (Class 10)

352 particles/m³

Semiconductor lithography. Very specialty — partner facility for ultra-clean work.

Personnel gowning

Hood + gown + gloves

Operators wear cleanroom gowning. Multiple layers (cap, hood, gown, booties, gloves) per ISO class.

Air filtration

HEPA / ULPA

HEPA filters (99.97% > 0.3 µm) for ISO 8/7. ULPA (99.999% > 0.12 µm) for ISO 6/5.

Particle monitoring

Continuous monitoring

Particle counts continuously monitored. Logged and reviewed. Alarms on particle excursions.

Validation

Periodic certification

Cleanroom certified periodically (annual or per customer requirement). Class compliance verified.

02 · Cleanroom applications

What we assemble in cleanroom.

Medical device assembly

ISO 13485-compatible medical device assembly in cleanroom

Semiconductor equipment

Wafer handling, vacuum chamber assembly with particle control

Aerospace optical

Optical mounts, instrument assembly with controlled environment

Pharmaceutical equipment

Bioprocess equipment subassembly in cleanroom

Implantable medical

Implant device sub-assembly with sterile-ready cleanliness

Disk drive components

Hard drive assembly required ISO 5 cleanroom

Photonic devices

Laser, LED, photonic component assembly

Precision optics

Camera, microscope assembly in clean environment

Vacuum hardware

UHV components packaged in cleanroom

FAQ

Cleanroom Assembly questions.

Yes, our ISO 8 (Class 100000) and ISO 7 (Class 10000) cleanrooms are certified annually per ISO 14644-1. Particle counts monitored continuously. Personnel trained on gowning and clean assembly procedures. Documentation available. For ISO 6 work, we have limited capability — for ISO 5 or higher, partner with specialty facilities.

For ISO 8: cap, gown, booties, gloves. For ISO 7: full hood (head and shoulders), one-piece coverall, booties, gloves, optional face mask. For ISO 6: full sterile-style gowning with face mask. Training on gowning procedure mandatory. Re-gown for each cleanroom entry. Disposable consumables for daily replacement.

All materials entering cleanroom must be cleaned per cleanroom protocol — typically wiped with IPA, double-bagged for staging, single-bag removed at airlock. CNC parts produced for cleanroom use cleaned in our regular ultrasonic clean line, then specially packaged for cleanroom delivery. Ready for installation in cleanroom without re-cleaning.

Cleanroom assembly: 30-100% premium over standard assembly. Justified for medical, semiconductor, aerospace cleanliness requirements. Per-unit cost varies with assembly complexity and time in cleanroom. For simple assembly, premium may be small. For complex assembly, premium more significant.

Cleanroom assembly records: date/time of assembly, operator ID, cleanroom certification status at time of assembly, particle counts during assembly, components used (lot traceable), assembly procedure followed (revision controlled), final inspection results. Records retained per industry requirement (10+ years aerospace, full life + 2 years medical).

ISO 5 (Class 100) required for: aseptic pharmaceutical filling (sterile drugs), advanced semiconductor lithography (sub-10nm features), most-critical aerospace optics, hard disk drive assembly. Our ISO 7 / ISO 8 capability covers most cleanroom work. For ISO 5 requirements, customer is typically already aware and has specific qualified partners.