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
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
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.
Modular immersion cleaning tanks with multi-frequency ultrasonics, HEPA drying, and automation.
Space-saving design for aqueous cleaning which includes our patented cleaning and drying under vacuum.
Frequently Asked Questions
- 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
