Medical Device Cleaning & Passivation
Precision Cleaning Services to Support Quality from the Start
At Cretex Medical | QTS we provide medical device cleaning and passivation services that ensure components meet your cleanliness requirements before they ever reach the cleanroom for assembly or packaging. We can either adopt your product into our existing cleaning processes to optimize speed to market and validation costs, or our experts can design and validate customized cleaning processes tailored to your device materials, regulatory needs, and production timeline.

Tailored Cleaning for Critical Components
Our flexible approach to cleaning means we recommend the right method for your materials and product requirements, minimizing contamination to support regulatory compliance and product performance.
Our cleaning capabilities include:
- Ultrapure DI (deionized) water systems
- Detergent cleaning with alkaline and neutral pH options
- Ultrasonic cleaning
- Automated equipment with continuous monitoring for temperature, conductivity, time, and agitation intensity
- Custom cleaning process design
- Isopropyl alcohol (IPA) wipe or dip
- Cleaning process validation studies
- Validations for product families
Our cleaning services are performed entirely within an ISO class 8 cleanroom. Cleaned products are then transferred directly to the ISO Class 7 cleanroom without interim packaging or leaving the cleanroom environment.

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Passivation Services
For stainless steel and other corrosion-resistant components, we offer passivation services per ASTM A967 and ASTM F86 standards. Our capabilities include:
- Citric acid passivation
- Nitric acid passivation
Our team follows current industry best practices and regulatory guidance to ensure consistent, repeatable outcomes.
Passivation can also be an effective bioburden and bacterial endotoxin reduction tool. When passivation and all downstream operations are performed in a controlled environment, this step can be effective in establishing control of bioburden prior to radiation sterilization, as required per ISO 11137-1.
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Collaborative Planning for Your Project
Choosing the right cleaning and passivation methods, along with the appropriate testing, can be complex. Our experienced engineers work closely with your team to:
- Identify the most appropriate cleaning method based on your product
- Ensure alignment with regulatory requirements
- Reduce contamination risk and keep your project on schedule
We’ll help you make confident, informed decisions from the start.

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Start Your Project with Confidence
We’ll work together to build a cleaning plan that meets your needs and helps you get your products to patients.
Contact us to speak with a QTS representative and get started.