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Cleaning Validations for Newly Manufactured Devices

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.

ASTM F2847 Standard Practice for Reporting and Assessment of Residues on Single Use Implants outlines 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. 

Applicable Standards

  • ASTM F2847

Test Options

Standard turn around times (TAT) are listed below. Ask an expert for a specific consultation on your product.

Code Test TAT (days) Request Quote
RMM110 Residue: Gravimetric Analysis, ASTM F2459 (quantitation), per ext. 14 Add
RMM111 Residue: Gravimetric Analysis, ASTM F2459, extraction efficiency Add
RMM115 Residual Manuf. Material, ASTM F2459: Insoluble/Soluble Residue Determination, per filtration Add
RMM205 Residual Manuf. Material: Soap/Detergent Residuals, Validation 14 Add
RMM210 Residual Manuf. Material: Soap/Detergent Residuals, Quant.(UV Vis) 5 Add
RMM220 Residual Manuf. Material: Soap/Detergent Residuals, Analy. (UV Vis) 5 Add
RMM701 Residue: Gravimetric Analysis,add. solvent, per extraction (if >200mL) Add
RMM110 - Residue: Gravimetric Analysis, ASTM F2459 (quantitation), per ext.
14 days
RMM111 - Residue: Gravimetric Analysis, ASTM F2459, extraction efficiency
Standard TAT not available for this product
RMM115 - Residual Manuf. Material, ASTM F2459: Insoluble/Soluble Residue Determination, per filtration
Standard TAT not available for this product
RMM205 - Residual Manuf. Material: Soap/Detergent Residuals, Validation
14 days
RMM210 - Residual Manuf. Material: Soap/Detergent Residuals, Quant.(UV Vis)
5 days
RMM220 - Residual Manuf. Material: Soap/Detergent Residuals, Analy. (UV Vis)
5 days
RMM701 - Residue: Gravimetric Analysis,add. solvent, per extraction (if >200mL)
Standard TAT not available for this product

Sample Specifications

RMM110: At least one sample set per solvent type (Samples may be pooled or tested individually)
RMM210: At least one sample set + ~1 gram of detergent being analyzed (Samples may be pooled or tested individually)
RMM220: At least one sample set + ~1 gram of detergent being analyzed (Samples may be pooled or tested individually)

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.