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

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.