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.