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

3M™ Novec™ 72DA replaces AK-225

In the past, many medical device manufacturers, including those producing pacemakers, defibrillators, orthopedic implants (bone screw, hip, joint, knee), catheter and guide wires, were using AK225 HCHC225 solvent for precision cleaning of parts during manufacturing.

Then the U.S. Environmental Protection Agency (EPA) scheduled a phase out of AK225 for January 1, 2015. This caused manufacturers to look for an AK-225 replacement. Many users of HCFC225 planned on stockpiling supplies in light of the phase out, but the EPA reclassified HCFC 225 as a controlled substance, thus banning facilities from even having the solvent in their inventory or transporting it. This reclassification by the EPA placed even more urgency on transitioning to alternative solvent chemistries.

Best Technology is a distributor of 3M™ Novec™ Engineered Fluids and advised all our customers to test and transition to a solvent replacement.

3M Novec 72DA vs. AK225T HCFC 225 Comparison

	3M Novec 72DA	AK-225T HCFC
Composition	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	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	111 °F	129 °F
Flammability	Non-flammable – needed for vapor degreasing equipment	Non-flammable – needed for vapor degreasing equipment
Employee safety	200 ppm (that of the 1,2 trans DCE, HFE is higher; again, higher is better)	50 ppm, ok, but higher is better
Environmental	No ODP, but the 1,2 DCE is a VOC	Ozone depletion potential (ODP) – 0.02, not a VOC
Chemical Stability	Very chemically stable for continued recycling in a vapor degreaser	Very chemically stable for continued recycling in a vapor degreaser
Component Stability	Is a true azeotrope, very stable with minimal composition change over time	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. 3M™ will arrange and pay for waste disposal.	Only if what you clean off your parts is hazardous. You pay for waste disposal.
Cost	Cheaper cost than AK225T	More expensive than 3M Novec 72DA

What are the concerns of medical device manufacturers about 3M Novec 72DA as 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. Testing Parts Cleaning – The 3M™ test center lab in St. Paul, Minnesota is available to test clean your parts. They can provide an FTIR spectroscopy characterizing of residues left on your parts after cleaning.  They can also conduct an FTIR on parts cleaned with your current solvent for a benchmark comparison.
5. 3M™ Novec™ Engineered fluids are currently used and approved by many large medical device companies worldwide.
6. Best Technology has worked with many medical device manufacturers who made the change from using AK225 (HCFC-225) to 3M™ Novec™ 72DA.  We understand the regulatory change process in the medical device industry and can help manufacturers step-by-step to implement changes in solvents due to phase outs.

AGC Chemicals Americas, a wholly owned subsidiary of Asahi Glass Company of Japan, proposed a new alternative to AK-225, called AE-3000. This product has limited information and testing and is made in Japan. Pricing for AE-3000 is higher than AK-225T, which is more expensive than 3M™ Novec™ Fluids.

Back in the 1990s the 3M™ product was not available. Now, however, it is fully defined, tested, approved at many medical manufacturers. 3M™ Novec™ Fluids are made in a production facility in Cordova, Illinois. Best Technology recommends the 3M™ Novec™ product line as the preferred AK-225 replacement solvent for all our customers, including medical device manufacturers.

Learn more about your options for AK-225 replacement with 3M™ Novec™ 72DA on our Solvent Cleaning page. For price and ordering information, contact our chemical sales department using our web contact form, or call 612-392-2414, ext. 2.