Application Guide

Aqueous Parts Washers for Medical Device Component Cleaning

Medical device manufacturing operates under some of the most stringent cleanliness requirements in any industry. Implantable components, surgical instruments, device housings, and precision-machined parts must be cleaned to validated standards — free of particulate, machining residue, oils, and process chemicals. Magido's aqueous parts washers, with their all-stainless construction, precise process control, and repeatable cleaning performance, support medical device manufacturers in meeting these exacting requirements.

Cleaning Precision Machined Medical Components

CNC-machined medical components — orthopedic implants, instrument housings, device frames, and precision fittings — come off the machine with cutting oil, coolant, metallic chips, and fine particulate that must be completely removed before downstream processing.

Magido's top-load and front-load spray cabinet washers clean machined medical components effectively, removing cutting fluid residue and metallic fines in a single automated cycle. The all-stainless construction ensures no contamination is contributed by the washer itself — a critical requirement when parts will subsequently undergo passivation, coating, or sterile packaging.

Internal Geometry and Complex Channel Cleaning

Many medical device components have internal channels, cross-drilled ports, and blind bores — features that must be demonstrably clean for regulatory compliance. Spray washing alone cannot reliably clean these features. Magido's Agita immersion washers address this through full submersion with high-energy fluid agitation, driving cleaning solution into and through internal features that spray cannot reach.

For validation purposes, the immersion process is consistent and quantifiable — the same fluid energy is applied to every load, supporting the process characterization required for IQ/OQ/PQ validation activities.

Material Compatibility and Surface Integrity

Medical device components are made from titanium alloys, cobalt-chrome, stainless steel, PEEK, and other materials with specific surface requirements. The cleaning process must not alter surface finish, introduce corrosion, or compromise the material properties that the component specification requires.

Magido's temperature-controlled wash systems, combined with appropriate cleaning chemistry, provide effective contamination removal without mechanical abrasion. The adjustable temperature range (up to 167°F) accommodates different material requirements. All-stainless construction eliminates the risk of galvanic contamination that occurs when dissimilar metals contact cleaning solution.

Supporting Validation and Regulatory Compliance

FDA 21 CFR Part 820 and ISO 13485 require that cleaning processes be validated and controlled. The cleaning step for medical device components is a manufacturing process that must be defined, characterized, and demonstrated to produce consistently clean parts.

Magido washers provide the process control parameters needed for validation: defined and stable operating temperature, adjustable and repeatable cycle time, consistent mechanical energy delivery, and filtration that maintains wash solution quality throughout the production run. These controllable parameters form the foundation of a validatable cleaning process.

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