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Cleaning Validations for Newly Manufactured Devices Overview

Cleaning Validations for Newly Manufactured Devices Overview

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 Laboratories 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

Test Options

Standard turn around times (TAT) are listed below. Ask an expert for a specific consultation on your product. If you are ready to submit your samples for testing, click here to fill out the Sample Submission Form.

Code Test TAT (days) Request Quote
BIO220 Bioburden - Aerobic bacteria and fungi 10 Add
CTX110 Cytotoxicity: MEM elution, 48 hr inc., triplicate L929, 24 hr ext (non-implant) 10 Add
LAL110 Bacterial Endotoxin Test: Kinetic Turbidimetric Method 3 Add
PAR110 Particulate Analysis: Device Extraction (Automatic, HIAC ROYCO) 7 Add
RMM300 Gravimetric Quantitation no FTIR (polar extraction standard test) ASTM F2459 14 Add
RMM305 Gravimetric Quantitation no FTIR (nonpolar extraction (not hexane) standard test) ASTM F2459 14 Add
TOC105 Total Organic Carbon (TOC), O.I, device extraction, each 6 Add
BIO220 - Bioburden - Aerobic bacteria and fungi
TAT: 10 days
CTX110 - Cytotoxicity: MEM elution, 48 hr inc., triplicate L929, 24 hr ext (non-implant)
TAT: 10 days
LAL110 - Bacterial Endotoxin Test: Kinetic Turbidimetric Method
TAT: 3 days
PAR110 - Particulate Analysis: Device Extraction (Automatic, HIAC ROYCO)
TAT: 7 days
RMM300 - Gravimetric Quantitation no FTIR (polar extraction standard test) ASTM F2459
TAT: 14 days
RMM305 - Gravimetric Quantitation no FTIR (nonpolar extraction (not hexane) standard test) ASTM F2459
TAT: 14 days
TOC105 - Total Organic Carbon (TOC), O.I, device extraction, each
TAT: 6 days

Sample Specifications

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.

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 Laboratories can help you design a cleaning validation package. Click on the tests below or contact us for additional information.
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