Salt-Spray & Bioburden: Finishing Aluminum Medical Housings

By Haijiang Lai

Owner at YongZhu Casting

As a supplier of aluminum casting for over 20 years, my purpose in discussing this topic is to talk with you about the growth of aluminum casting in this industry, and if you have a project you need to get off the ground, Contact us today receive a solution, or Mail: yongzhucasting@gmail.com

Table of Contents

See corrosion loads, salt-spray tests, low-bioburden finishes, and proof files you need before FDA or MDR review.

Disinfectants, perspiration, and coastal shipping mists attack bare aluminum, while bacteria counts can delay product clearance. A finish that lasts 1 000 h in salt-spray yet cleans down to ISO 11737 limits safeguards both warranty risk and regulatory filings.

Why Medical Aluminum Faces Extra Corrosive Loads

Hospital equipment meets saline aerosols from ventilators, harsh chlorine wipes during turnover, and long sea voyages to global clinics. Warm storage rooms accelerate galvanic action, so housings corrode faster than general-industry castings.

Salt-Spray Testing 101

ASTM B117 and ISO 9227 place samples in 5 % NaCl fog at 35 °C. Medical handhelds often need 720 h resistance; fixed gear such as imaging frames targets 1 000 h. Evaluation looks at blister width, coating creep, and visible pits rather than total red rust area.

Bioburden Basics for Medical Housings

Regulators cap viable microbes on reusable surfaces. ISO 11737 calls for low colony counts, while roughness below Ra 0.8 µm hinders adhesion. The finish must also survive EtO gas, gamma radiation, or autoclave steam without flaking.

Finishing Options & Their Trade-Offs

FinishSalt-Spray Life (h)Bioburden Clean-offSterilization FitCost Index
Type II Clear Anodize336GoodEtO / GammaLow
Hard-coat Anodize + PTFE≥ 1 000ExcellentAutoclave 1 000 cyclesMedium
Antimicrobial Powder Coat960ExcellentEtO; autoclave limitedMedium-High
E-Coat + Clear Seal720GoodGamma onlyMedium

Design Tips to Boost Finish Life

A few millimeters in CAD prevent months of field returns.

  • Chamfer external corners ≥ 0.5 mm so anodize builds evenly.
  • Add drain holes in pockets to stop standing disinfectant.
  • Use ribs for strength instead of thick walls to keep film uniform.

Validation Roadmap

  1. 5 % NaCl spray—target 720 h or 1 000 h, record creep.
  2. 1 000 autoclave cycles at 134 °C / 2 bar.
  3. ISO 11737 plate count after triple disinfectant wipe.
  4. Cross-hatch adhesion (ISO 2409) post-aging.
  5. CT scan to verify no base-metal pitting.

Documentation Needed for MDR / FDA Files

  • Salt-spray, adhesion, and leachables reports in the Design History File.
  • Alloy chemistry sheets showing RoHS / REACH compliance.
  • ISO 14971 risk log covering finish crack or delamination events.

Case Snapshot — Ventilator Housing Upgrade

A ventilator maker moved from chromate-sealed anodize to PTFE hard-coat:

  • Salt-spray life rose 480 h → 1 200 h.
  • Post-wipe bioburden fell by 1.3 log.
  • Field corrosion complaints dropped 45 % in 18 months.

Balancing corrosion control with sterility starts at the finish line and ends with solid test data. Need sample reports or bulk pricing? Email yongzhucasting@gmail.com and receive a reply within one business day.

Quick FAQ

Does hard-coat anodize darken after many autoclave cycles?
Minor shade change appears after roughly 500 cycles; hardness and salt-spray life remain stable.

Can antimicrobial powder survive 1 000 h salt-spray without chalking?
Yes, if the resin system uses high-durability polyester and the cure profile is verified.

What Ra surface target eases FDA cleaning validation?
Aim for Ra 0.8 µm or below; smoother walls shed protein and reduce detergent dwell time.

Searching for High-Quality for Cast Aluminum Parts Supplier?

You’ve come to the right place! Yongzhu Casting is a certified die casting manufacturer with over 20 years of expertise in the industry.

We have successfully completed numerous die casting projects for Aluminum casting parts, particularly in your industry.

casting machine

Zhejiang Yongzhu Casting Technology Co., Ltd.

Location: Zhejiang, China

Company type: Manufacturers, Producers, Wholesalers

Year Founded: 2004

Main Products: Aluminium die castingMold MakingDie CastingSand CastingGravity Casting

Leading Chinese producer Yongzhu Casting is formerly known as Hangzhou Higer Metal Products Co., Ltd., was established in 2004.

With 20 years of experience in the industry, we are a specialized manufacturer in Aluminum casting and Machining.

Our products are widely used in various applications such as AutomotiveEnergyLightingMedicalHome FurnishingsMachinery & Equipment etc. Below are our advantages:

Design Review & DFM Support

Our professionals will evaluate your designs and provide suggestions for cost savings. Additionally, we offer Design for Manufacturing (DFM) assistance and conduct mold flow analyses to facilitate efficient production.

State-of-the-Art Manufacturing Equipment

Our facility is equipped with advanced hot-chamber and cold-chamber die casting machinery for aluminum and zinc production.

We also utilize high-precision CNC machines in a temperature-controlled workshop, featuring 3-Axis, 4-Axis and  5-Axis setups to manage any project you have.

Rigorous Quality Control Measures

Our dedicated quality control team ensures that all parts meet the highest standards of quality and consistency. We employ high-accuracy measurement instruments, including CMM, spectrometers, and X-ray detectors.

Comprehensive Surface Treatment Options

We provide a variety of surface finishing techniques for your precision die casting components. Our in-house services include cleaning, polishing, anodizing, shot blasting, and painting.

Flexible Project Acceptance

While larger manufacturers often shy away from low-volume projects, and smaller ones may struggle with quality, Yongzhu Casting stands apart. We prioritize customer satisfaction and willingly accept high-mix, low-volume projects like yours.

Yongzhu Casting Established in 2004, has become a leading name in the die-casting industry. We use die-castingsand-castingprecision casting and gravity casting, to cater various industries such as AutomotiveEnergyLighting, and Home Furnishings.

Contact us today to discuss your needs and explore tailored solutions. Mail: yongzhucasting@gmail.com

Hey, I’m LAI HAIJIANG the author of this article. 

Ready for professional aluminum castings for your project? Get in Touch with Yongzhu Casting today! Our casting experts will guide you through the entire process from mold to logistics, ensuring your aluminum castings arrive on time and exceed expectations.

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