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Cleaning & Passivation

Life Science Outsourcing offers precision cleaning and passivation services to remove contaminants and enhance corrosion resistance for medical devices.

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Ultrasonic cleaning of medical components before passivation in a controlled lab environment

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.
Cleanroom setup for medical device cleaning and passivation with ultrasonic cleaners and industrial sinks

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.
Gloved hands holding a sterile medical device in clear packaging.
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How Does Cleaning & Passivation Work?

  1. Pre-cleaning & Inspection: Components undergo an initial inspection to identify contaminants and surface irregularities.
  2. Chemical & Ultrasonic Cleaning: High-precision chemical baths and ultrasonic cleaning remove microscopic debris and contaminants.
  3. Passivation & Verification: Stainless steel components undergo passivation to improve corrosion resistance, followed by quality verification.
  4. 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.

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