Key principles.
Drain everything
Avoid crevices, dead corners, hidden cavities. Design fully drainable.
Cleanable Ra
Ra 0.4-0.8 µm typical for cleanability. Electropolished for highest tier.
No sharp corners
Internal corners radiused 3-5 mm minimum. Bacteria collect in sharp corners.
No gaps
Sanitary welds — orbital TIG, smooth profile. No discontinuity for bacteria.
No recessed slots
Minimize fastener heads with recesses. Use button-head, smooth caps. Or bonded assemblies.
Cleaning agents
Materials resistant to medical cleaning agents (alcohol, chlorhexidine, hydrogen peroxide).
FAQ
Defined per: ISO 17664 (sterilization processing), ISO 13485 (QMS), AAMI standards. Application-specific.
Reusable: must withstand 100s of cleanings without degrading. Disposable: lower cleaning burden.
Steam autoclave 121°C: most metals OK, most plastics struggle. Gamma radiation: most materials but check polymer effects.
Ra ≤ 0.8 µm general medical, ≤ 0.4 µm sterile applications. Electropolished for biopharm.
Silicone or Viton standard. Avoid gasket types that absorb fluids.
Yes — design for disassembly between uses. Snap fits or thumbscrews enable user disassembly.
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