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home Best Technology / Precision Cleaning Chemistries, Solvents, & Fluids / Medical Device AK 225 Replacement with 3M Novec Engineered Fluid Solvent

Medical Device AK 225 Replacement with 3M Novec Engineered Fluid Solvent

Most medical device manufacturers including those producing: pacemakers, defibrillators, orthopedic implants (bone screw, hip, joint, knee), catheter and guide wires are using AK225 HCHC225 to precision clean parts during manufacturing.

As some may be aware, the EPA has scheduled a phase out of AK225 for January 1, 2015.  This is causing manufacturers to look for an AK 225 replacement. Many users of HCFC225 planned on stockpiling supplies in light if this upcoming phase out, but more recent releases from the EPA have indicated that after January 1, 2015, HCFC 225 will be considered a controlled substance thus banning facilities from even having the solvent in their inventory or transporting it.  This latest news release from the EPA has placed even more urgency on initial testing and transition to alternative solvent chemistries planning.

Best Technology is a distributor of 3M Novec Engineered Fluids and advises all our customers to start initial testing, transition, and DCE solvent replacement planning soon.  3M laboratories are open for customer testing, just contact us and we can get you scheduled into the lab.

AK225T HCFC 225 and 3M Novec 72DA Comparison

AK-225T HCFC composition and properties:

  • 87% 225ca/cb HCFC blend – non flammable inerting properties and limited oil solvency
  • 10% cyclohexane- to increase oils solvency-
  • 3% ethanol- for polar emulsifier soils removal
  • Boiling point- 129F
  • Non-flammable- needed for vapor degreasing equipment
  • Employee safety- 50 ppm, ok, but higher is better
  • Environmental- ODP- 0.02, not a VOC
  • Very chemically stable for continued recycling in a vapor degreaser
  • Component stability- not an azeotrope, but very stable with minimal composition change over time
  • Hazardous waste from the degreaser?  Only if what you clean off your parts is hazardous.  You pay for waste disposal.

3M Novec 72DA composition (AK 225 replacement due to 2015 phase out):

  • 30% HFE7200 blend- non-flammable inerting properties only, no solvency for oils
  • 68% 1,2 trans DCE (chlorinated solvent with inhibitors)- excellent high solvency for non-polar oils from your swiss machining equipment, true oil removal, PCB cleaning, etc
  • 2% Isopropanol- for polar emulsifier soils removal
  • Boiling point 111F
  • Employee safety- 200 ppm (that of the 1,2 trans DCE, HFE is higher-again, higher is better)
  • Non-flammable– needed for vapor degreasing
  • Environmental- No ODP, but the 1,2 DCE is a VOC
  • Very chemically stable for continued recycling in a vapor degreaser
  • Component stability- Is a true azeotrope, very stable with minimal composition change over time
  • Hazardous waste from the degreaser?  Only if what you clean off your parts is hazardous.  3M will arrange for and pay for waste disposal.
  • Cheaper cost that AK225T

IMPORTANT: What are the concerns of medical device customers on a solvent replacement?

  1. Will it affect pyrogens/bioburden? No change.  Testing has shown none of the components contribute to bioburden growth/residues
  2. Will it clean oils/soils as well? Yes, actually much better KB (Kauri-butanol value) value, higher solvency for non-polar oils, faster, more complete cleaning
  3. Will it leave any residues?  Both solvents have very low NVR (non-volatile residue) <10 PPM
  4. Part Clean Testing- the 3M test center lab in St. Paul, MN is available to test clean your parts and they can provide an FTIR spectroscopy characterizing of residues left on your parts after cleaning.  They can also conduct and FTIR on your present AK-225T cleaned parts for a benchmark and comparison.
  5. 3M Novec Engineered fluids are currently used and approved by many large medical device companies worldwide.
  6. Best Technology has converted many of our medical device customers using AK225 (HCFC-225) to 3M Novec 72DA.  We understand the regulatory change process in the medical device industry and can help you step by step to implement the change due to the phase out.

AGC Chemicals Americas, a wholly owned subsidiary of Asahi Glass Company of Japan, new proposed alternative, AE-3000, has limited information and testing, will be made in Japan.  Best Technology has been informed it will likely cost about 30-40% more than the present AK-225T solvent which is more expensive than 3M Novec Fluids.

Back in the 1990’s the 3M product was not available, however, now it is fully defined, tested, approved at many medical customers. 3M Novec Fluids are made in a production facility in Cordova, Illinois.   Based on this information, Best Technology feels the 3M Novec product line is a much preferred choice going forward for all our customers including medical device manufacturers.

 

Latest News & Products from Best Technology

Semi-Automated Inline Citric Passivation Solution with Data Tracking

For one medical device manufacturer, the design of a citric passivation solution faced two major challenges: The manufacturing process required performing a water-break test after cleaning parts, before proceeding to passivation. This meant that they could not use a fully automated passivation solution. The system had to have data tracking for quality control purposes. Semi-Automated […]

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Best Technology Inc.
14040 23rd Avenue N.  
Minneapolis, MN 55447
612.392.2414   |   763.519.1460  
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  • Industrial Parts Washers
    ✛
    • Agitated Immersion Heated Parts Washers
    • Inline Conveyor Wash-Rinse-Dry Parts Washers
    • Immersion Inline Parts Washer
    • Spray Cabinet Parts Washers
      ✛
      • Front Load Spray Cabinet Parts Washer
      • Top Load Spray Cabinet Industrial Parts Washer
    • Vertical Door Pass Through Parts Washer
    • Rotary Drum Parts Washer
    • Powder Coat Prep Equipment
    • Phosphating Lines
    • Pipe Washing Equipment
  • Precision Cleaning Systems
    ✛
    • Applicable Articles
    • How clean is clean?
    • How Do Ultrasonic Cleaners Work?
    • Ultrasonic Benchtop Parts Cleaner
    • Benchtop Ultrasonic Parts Cleaning Multi-Tank Systems
    • Ultrasonic Cleaning Consoles
    • Automated Ultrasonic Parts Cleaning Equipment Wash-Rinse-Dry
    • Large Scale Automated Precision Aqueous Cleaning for Cellular Manufacturing
    • Agitated Immersion Ultrasonic Parts Washer
    • Machine Shop Parts Washer for Swiss and CNC Precision Parts
    • Immersible Ultrasonic Transducers
    • Vapor Degreasers
  • Passivation Equipment
    ✛
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    • What is Passivation? How Does It Work?
    • Nitric vs. Citric Acid Passivation
    • CitriSurf – Citric Acid Passivation
    • Benchtop Ultrasonic Passivation Equipment
    • Ultrasonic Automated Passivation Equipment
    • Automated Ultrasonic Passivation System for Medical Device Parts
    • Passivation Wet Bench for Citric / Nitric Acid
    • Cleanroom Space Saving Automated Passivation System
    • Heated Polypropylene Acid Passivation and Rinse Tanks
    • Agitated Immersion Multi-Tank Passivation Systems
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    ✛
    • Alodine Lines
      ✛
      • What is Alodine / Chem film / Chromate Conversion Coating?
      • Alodine Chem Film Tank Line
    • Mass Finishing Machines
      ✛
      • Centrifugal Barrel Finishing Machines
      • Spin Dryers / Chip Wringers
      • Vibratory Bowl Polishers
    • Titanium Anodizing Equipment
  • Wet Benches
    ✛
    • Citric / Nitric Passivation Wet Bench for Stainless Steel & Titanium
    • Electropolishing Equipment in a Wet Bench / Fume Hood
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    • Quick Dump Rinse Tank
  • Specialty & Custom Industrial Process Systems
    ✛
    • Contents Restoration
    • Vapor and Dryfilm PTFE Coating Systems
    • Heated Hot Air Parts Dryer
    • Solvent Recovery Equipment
  • Precision Cleaning Chemistries, Solvents & Fluids
    ✛
    • Why Use a Parts Cleaning Solvent?
    • 3M Novec Engineered Fluids, Fluorinert Liquids, Solvents & Chemicals
    • Solvent Cleaning with 3M Novec Engineered Fluids
    • Thermal Management / Heat Transfer with 3M Novec and Fluorinert Fluids
    • 3M Novec 72DA 73DE Solvent Vapor Degreaser For Medical Device Instruments
    • Solvent Phase-outs
      ✛
      • AK225 HCFC-225 Phase Out and Replacement with 3M Novec HFE Engineered Fluids
      • Medical Device AK 225 Replacement with 3M Novec Engineered Fluid Solvent
      • nPB Replacement
    • Aqueous Cleaning Chemistries
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