Medical Parts Cleaning

Our deep understanding of medical parts cleaning and passivation
provides the best solution for you - no guesswork, just results.

Medical Device Passivation & Cleaning Processes

Jayco has been delivering certified cleaning and passivation systems for over 15 years to some of the leading OEM and Tier 1 medical device manufacturers in North America.

  • Citric or Nitric Passivation
  • In-Process Cleaning
  • Final Cleaning
  • Data Management per FDA 21 CFR Part 11
CleanRoom Line
medical parts cleaning

Medical & Dental Devices

Jayco has experience with providing proven cleaning solutions for the following devices.

  • Surgical instruments
  • Orthopedic implants
  • Vascular implants
  • Dental tools and instruments
  • Custom additive manufactured
  • Guidewire & endoscopic

Manufacturing Soils

We've cleaned practically all traditional and emerging manufacturing process soils used to produce medical devices.

  • Rouge and buffing compounds
  • Machining oils, EDM fluid, FPI solution
  • Particulate
  • Additive manufacturing powder
  • Polymer debris
medical device parts cleaning

Featured Customer


Norman Noble (Medtech Manufacturing)

Norman Noble chose Jayco to invest in a fully automated & validated final cleaning processes including passivation.

Our new Elma cleaning line and shareable validation reports help simplify our customers’ submission and compliance with Regulation (EU) 2017/745 of the European Parliament and are designed to meet the requirements of Annex II.

Frequently Asked Questions

What medical cleanliness specifications do you meet?
  • In-vitro cytotoxicity test acc. to DIN EN ISO 10993-5
  • Bioburden determination acc. to DIN EN ISO 11737-1
  • Endotoxins acc. to LAL test USP 85
  • Total Organic Carbon - TOC acc. to DIN EN 1484
  • Total Hydrocarbon - THC acc. to DIN EN 14039
  • Particulate cleanliness acc. to DIN ISO SCP Klassen ISO 14644-9 or VDI guideline 2083 sheet 21
  • Passivity of stainless steel surfaces e. g. acc. to ASTM A0967
Can I have cleaning and passivation in the same system?

Yes, with the Elma X-TRA ultrasonic system you have the capability of having the cleaning and passivation within the same system. Some customers also have separate tanks for using both citric and nitric acid passivation chemistries in the same system. Because the Elma system is modular, you have the capability of adding tanks to your line at any time. Your tank line can change as your needs change.

What is the process for passivation of medical devices?

Stainless steel parts are processed according to ASTM A0967.

What types of medical data tracking do you offer?

User-friendly system visualization and quality assurance through:

  • Data logger
  • Error prevention with barcode and RFID systems
  • Connection to ERP and MES systems
  • User administration and audit trail according to FDA CFR 21, Part 11
Are Jayco systems FDA 21 CFR Part 11 compliant?

Yes, Jayco medical parts cleaning system support FDA 21 CFR Part 11 compliance.  We can help you through the process and full validation.

Does Jayco offer aqueous parts cleaning and passivation chemistries for medical?

Yes, Jayco Chemical Solutions provides MedTech with a line of aqueous chemistries designed specifically for cleaning of medical and dental devices. The chemistries are highly effective and provide excellent materials compatibility.