Cleaning & Passivation
Life Science Outsourcing offers precision cleaning and passivation services to remove contaminants and enhance corrosion resistance for medical devices.
Life Science Outsourcing offers precision cleaning and passivation services to remove contaminants and enhance corrosion resistance for medical devices.
What is Cleaning & Passivation?
Cleaning and passivation involve removing contaminants, sterilizing components, and enhancing corrosion resistance for medical devices.
- Ultrasonic & chemical cleaning: Ensuring component sterility.
- Passivation for stainless steel: Enhancing corrosion resistance.
- Regulatory validation: Compliance with FDA and ASTM standards.
Who Needs Cleaning & Passivation?
- Medical device OEMs ensuring biocompatibility.
- Implant manufacturers preventing contamination risks.
- Surgical instrument suppliers optimizing durability.
Who Needs Cleaning & Passivation?
- Medical device OEMs ensuring biocompatibility.
- Implant manufacturers preventing contamination risks.
- Surgical instrument suppliers optimizing durability.
How Does Cleaning & Passivation Work?
- Pre-cleaning & Inspection: Components undergo an initial inspection to identify contaminants and surface irregularities.
- Chemical & Ultrasonic Cleaning: High-precision chemical baths and ultrasonic cleaning remove microscopic debris and contaminants.
- Passivation & Verification: Stainless steel components undergo passivation to improve corrosion resistance, followed by quality verification.
- Final Quality Control & Packaging: Post-cleaning inspections and final packaging ensure all components meet required standards for safety and compliance.
What Standards Apply?
- ASTM A967 & A380 – Passivation of stainless steel.
- ISO 13485 & FDA QSR – Medical device cleaning regulations.
Why LSO?
As an FDA-registered and ISO 13485-certified contract manufacturing organization, Life Science Outsourcing (LSO) offers assembly, packaging, sterilization, and specialized capabilities in diagnostics packaging and design. Our unique business model combines comprehensive in-house services and extensive regulatory expertise, allowing us to provide the agility and flexibility needed to expedite market launches while standardizing the supply chain and minimizing risks.
FDA-Registered
Manufacturing Facility
ISO 13485
Certified Quality System
12 Cleanrooms
Class 5–8
125,000+ Sq Ft
Regulated Manufacturing
3 Facilities
CA | NH | Costa Rica
Ready to get started?
Talk to a specialist about cleaning & passivation.