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Residual Manufacturing Materials

Cleaning Validations for Newly Manufactured Devices

Cleaning validations examine the overall surface cleanliness of newly manufactured medical devices and single-use implants, targeting contaminants remaining from the manufacturing and cleaning processes. It’s important to keep in mind that just because a device is sterile, it doesn’t mean that it is necessarily clean.

Test methods are available to quantify the amount of residuals (i.e., oils, lubricants, polishing compounds, detergents, and passivation residuals) on the device or implant. To give a comprehensive view of cleanliness, you can also include a cytotoxicity assessment and tests to examine the microbiological contamination.

The standards ASTM F3127 (Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices) and ASTM F2847 (Standard Practice for Reporting and Assessment of Residues on Single Use Implants) outline a variety of test options that can be included in a cleaning validation. Nelson Labs offers a package of tests that can be used together for this purpose.

A new ISO standard, ISO 19227 Implants for surgery – Cleanliness of orthopedic implants – General requirements, is currently in development. This standard is expected to require a total hydrocarbon (THC) analysis be included in a cleaning validation. As an alternative to the Gravimetric nonpolar method, Nelson Labs also offers a THC via gas chromatography method (Nelson test code HDO105). This method is compliant with ISO 9377-2, Water quality – Determination of hydrocarbon oil index – Part 2: Method using solvent extraction and gas chromatography, as specified in ISO 19227.

Applicable Standards

  • ASTM F3127
  • ASTM F2847

Separate sets of samples are required for each test method. Refer to specific test method pages in the Study Outlines below for specific information by test.

Testing Locations

  • Salt Lake City, UT, USA

Study Outline

A cleaning validation may include any of the tests listed below. Depending on the contaminants of concern, a specific combination of tests will be appropriate to assess surface cleanliness. Nelson Labs can help you design a cleaning validation package. Click on the tests below or contact us for additional information.

  • Quantification of Extractable Residue by Gravimetric Analysis

For more information on the Gravimetric test options, please see our supplemental test guide.

  • Organic Carbon
  • Detergent Residuals
  • Particulates
  • MEM Elution (Cytotoxicity)
  • Bioburden
  • Endotoxin

If you have additional questions about Residual Manufacturing Materials testing, or would like to consult with the experts at Nelson Labs, just send us a request or call us at (801) 290-7500.