Electropolishing & Passivation Process

Our electropolishing and passivation processes have been validated in accordance with Quality Management Systems-Process Validation Guidance authored by SG3 and endorsed by The Global Harmonization Task Force.

While our medical device customers will require their electropolishing vendors to perform process validation, our diligence in addressing this benefits our customers in all industries, as the steps taken have helped to ensure that while operating within our specified parameters, we have demonstrated that our process will consistently yield product that will meet the requirements of our customers.

Documented & Validated

Able has completed its validation protocol and performed the validation for its electropolishing and passivation processes including:

  • Installation Qualification
  • Operational Qualification
  • Performance Qualification

Able Electropolishing began the process by first outlining our process in a detailed flow chart, which helped define a FEMA. The potential failure modes outlined in the FEMA provided a basis to design a validation protocol that would encompass the three aspects of the process validation.

All process equipment was tested in accordance with operation manuals, and our preventative maintenance scheduled was integrated into our ISO-quality system to ensure that critical process equipment remains calibrated.

Able then identified the process variables that determine electropolishing and passivation outcomes, and defined operating ranges, and verified that all coupons processed within these ranges were indeed within appropriate criteria (dimensionally, aesthetically and for passivity).

Upon verification of this data, Able re-ran these tests, obtaining SPC data that showed statistically the consistency of our process over an extended period of time.

Able Electropolishing continues to improve its quality management systems, and considers our recent efforts to perform process validation in a manner consistent with ISO:13485 to be an advantage to our customers who are looking to provide world-class metal components to their customers.

Contact us to learn more about electropolishing and passivation

Electropolishing Blog

Electropolishing for Finishing Rescue Device Parts

When a marine and rescue hardware manufacturer started developing parts for rescue harnesses in 2018, they knew they needed to find a metal finishing partner with uncompromising standards and no tolerance for error: lives, literally, hang on the line.

Electropolishing for Food Processing Blades

From exposure to salt and acids and near constant moisture, industrial food processing blades must stand up to a wide variety of potentially corrosive ingredients without losing their edge. Such blades must also meet strict requirements regarding quality and cleanliness…

Grow Your Reach, Shrink Lead Time with Trusted Supplier Network

The process of finishing critical metal parts for our clients in industries that include aerospace, medical device design, semiconductor manufacturing, pharmaceutical production – and many others – is incredibly precise. Success can be measured in ten-thousandths of an inch.

What Can and Can’t Be Passivated?

Passivation is a widely used chemical finishing process to remove contaminants and improve the corrosion resistance of metal parts, including stainless steel and alloys like Nitinol and titanium. While passivation can be effective for many parts, for certain parts and…