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TRANSCRIPT
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