Medical Markets:New Anodizing Technologies

for Re-Usable Equipment

Key Regulatory Requirements

• Aluminum - External use only

• Aluminum Anodizing has a grandfathered status for Class I & II devices

• Fit For Purpose requirement for device design and specification

Emerging Fit For Purpose Requirements

Focuses on three major influences

• “Cleanability”- Manual / Washer Disinfector

• Sterilization - Autoclave & Sterrad

• Marking & ID - Traceability & Use Instructions

Influence One: “Cleanability”

Background

• Each reusable device has a designated cleaning protocolproscribed by manufacturer.

• Process requires removal of biological and other contamination.

• Choice of detergents varies. In Europe, stronger detergents with higher pH are common as they are perceived to be more effective inrespect to prion diseases.

“Cleanability” & Conventional Anodic Coatings

The problem defined

Examples: dull, faded, and/or mottled surfaces; evidence of corrosion.

Key variables: determining rate of failure:

• Chemical agent & pH concentration of cleaning detergents

• Temperature of wash / dry cycle

• Residual chemistry on surface after rinsing

• Exposure time

Conventional Anodizing

• Various strategies employed for conventional anodic coatings - with trade offs: - Heavy metals in seal - Delamination, discoloration, chipping, and tolerance challenges with protective polymeric coatings

• Results in constrained performance space

1 = Poor5 = Excellent

New Technology # 1

MICRO-CRYSTALLINE ANODIC COATINGS

Understanding Failure Modes

• Sulfuric anodizing protects reactive substrate. Corrosion resistance of anodic coatings are enhanced through sealing and seal chemistry. But:

- Pathways to substrate through coating - Varying degree of fissures and coating imperfections

- Chemical dissolution of coating - Conventional coatings are susceptible to chemical attack, especially for hydroxide based chemistries and strong acids.

• Rate of failure has many variables based on application and environment.

Coating Overview

Solution

• A patented anodic coating - Amorphous oxide coating partially phase changed to micro-crystalline structures

• Produced on a modified hard coat anodizing line

TEM ANALYSIS

Molecular Phase Change

Micro-crystalline structures solubilize at a significantly lower rate.

Amorphous Form

Molecules in random arrangement

• Less Stable• Higher Solubility

Molecules packed in a regularly ordered, repeating pattern

• Thermodynamically Stable• Lower Solubility

Crystalline Form

Demonstration

Conventional MICRALOX

0

1

2

3

4

5Decorative

Durability

Corrosion

Resistance

Chemical

StabilityCost

Thermal

Conductivity

Environmental

Impact

Conventional

Micro‐Crystalline

1=Poor

5=Excellent

Performance Space

Influence 2: “Sterilization”

• Autoclave Sterilization: through high temperature steam (121°C). (Most common method for orthopedic and surgical equipment.)

• STERRAD® Sterilization: through hydrogen peroxide gas plasma. (Used for heat and moisture sensitive instruments.)

Sterilization Impact on Al Dyes

The problem defined

• Examples: Autoclave: Dye migration, color mottling and fading, and surface smutting.

• STERRAD: Faded colors

Understanding Failure Modes

• Autoclave: - High pressure steam leads to thermal expansion of anodic pores, expelling residual content and dyes that resettle on surfaces - Heat causes dyes to oxidize and fade

• STERRAD®: - Hydrogen peroxide gas oxidizes organic dyes

New Technology # 2

COLOR FAST DYES & COLORANTSFOR PRINTING & OVER DYE

Dye & Color Overview

Solution

• A Process to eliminate uncontrolled swelling of pores - MICRALOX

• An additional process to protect organic dyes from oxidation

CONTROL SAMPLE (0 cycle)

After 2 cycles

After 10 cycles

After 100 cycles

Influence 3: Marking & ID

Background

• All medical devices are required to be fully traceable by manufacturer.

• Increasing amount of information and design content (i.e., instructions / branding, etc.) on medical devices.

Delamination / Chipping of Print

• Thermal cycles during cleaning & sterilization cause adhesion loss

• Handling leads to chipping

• Biofilms formation in print abscesses are difficult to eliminate

• Sterilization methods may lead to fading.

New Technology # 3

EMBEDDED PRINTING

SANFORD PRINT

The Solution

• Embedded Printing in the Oxide

• Entrapped below seal

• Highly porous substrate leads to intense optical density print

• Colors can be protected from fading due to Autoclave & STERRAD sterilization.

Contact:

Jack Tetrault – President tel: (401) 288 - 5202Mike Sung - Innovations Director tel: (401) 288 - 5223Website: www.micralox.com

About Sanford Process

• Founded 1964.• Global supplier of aluminum anodizing technology, chemistry, and contract R&D services.• Many well known customers and licensees including Raytheon, Calphalon, Samsung, KOST, Apple Computers, Stryker, Synthes, Symmetry, and IMDS.• Subsidiary of Katahdin Industries.

Sanford Licensing

• Low Voltage Rectification Technology• SANFRAN® Electrolyte Additive• Know how & Process Standards• Rights to Patents