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Single Use Medical Devices, Implants & Instruments Cleaning & Sterilization Validation

We know that ensuring cleanliness of single use devices, such as implants, is critical for manufacturers to guarantee patient safety. Which is why Lucideon offers its specialized cleaning validation service for medical devices to be delivered in the sterile state (single use).

If you're looking to:

  • Implement a new cleaning procedure to gain regulatory approval
  • Ensure continual cleanliness of your manufacturing and cleaning processes
  • Identify the presence and source of contaminants
  • Develop effective cleaning protocols for products (including ALM devices)
  • Determine why residue limits are being exceeded, and set appropriate limits
  • Verify and validate that a process change has not negatively affected cleanliness
  • Perform residue analysis of detergents and manufacturing lubricants.

Then we can help. 

With Lucideon’s VALIDATA program you get a complete validation service for your medical devices to determine the effectiveness of your cleaning process and environment on an on-going basis.

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Resources

  • White Paper

    Additive Manufacturing - A Metallurgical Perspective
    pdf (4.98 MB)

  • White Paper

    Medical Devices - Cleanliness Validation
    pdf (793 KB)