At SUNAURA Machinery, medical device customers have been asking for years for a single-source supplier that can deliver both medical-grade silicone keypads and medical snap domes assembled and tested in one controlled environment. Today we are glad to report that the answer is on the floor.
Our Qingdao plant has commissioned a dedicated Class 100,000 (ISO 8) cleanroom assembly line, purpose-built for medical input devices. The line brings together dome cap picking, PET dome sheet array lamination, silicone key over-molding inspection, and final membrane switch assembly under one HEPA-filtered roof.
Why a medical cleanroom changes the supply picture
For patient-facing devices - infusion pumps, bedside monitors, handheld diagnostic readers - any particle on the contact path can become a field-return failure. Traditionally, buyers split the bill: they bought metal domes from one stamping house, silicone keys from another, and assembled everything at their own plant or at a membrane switch integrator. Each hand-off added dust, ESD risk, and quality documentation that had to be reconciled.
The new line shortens that chain. We now deliver a semi-finished input module that arrives already tested for actuation force, contact resistance, and visual inspection - ready to drop into your enclosure. Combined with our existing metal dome technical specifications guide, this lets OEMs treat the input stack as a single qualified subassembly rather than three separate components.
What the line can build today
- Triangular and medical snap domes in stainless steel SUS301, gold-plated on the contact area, with cycle life certified to 500,000 actuations.
- Silicone keypads molded from medical-grade platinum-cured silicone (Shore A 30–60), with laser-etched legends and optional EMI shielding.
- PET dome sheet arrays pre-cut to customer Gerber files, adhesive on 0.1mm PET, die-cut to ±0.15 mm tolerance.
- Finished membrane switches with FPC tails, LEDs, and optional flexible printed circuit integration.
Documentation you actually receive
Every batch ships with a lot-specific COC, actuation-force histograms sampled from every reel, and a 48-hour salt-spray report for the contact plating. For customers working under 21 CFR Part 820 or ISO 13485, we can also provide PPAP-style approval documentation on request. Our engineering team is already supporting several European and North American Class II device programs.
This is not a marketing story about a bigger machine - it is a quiet operational upgrade that lets medical buyers consolidate two suppliers into one, shorten qualification lead time, and get traceability they can actually audit. If you are currently qualifying a new input module or re-sourcing an existing one, send us your drawing and we will come back with a feasibility review within two working days.
SUNAURA Machinery has been making metal domes, dome sheet arrays, and medical silicone keys from Qingdao for over a decade. The cleanroom line is the next step in that same commitment.
