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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

Pricing/Quote

Test Price Request Quote
RMM110 - Residue: Gravimetric Analysis, ASTM F2459 (quantitation), per ext.
Per test1+$375.00
Add
RMM111 - Residue: Gravimetric Analysis, ASTM F2459, extraction efficiency
Per test1+$1,030.00
Add
RMM115 - Residual Manuf. Material, ASTM F2459: Insoluble/Soluble Residue Determination, per filtration
Per test1+$200.00
Add
RMM205 - Residual Manuf. Material: Soap/Detergent Residuals, Validation
Per test1+$775.00
Add
RMM210 - Residual Manuf. Material: Soap/Detergent Residuals, Quant.(UV Vis)
Per test1+$450.00
Add
RMM220 - Residual Manuf. Material: Soap/Detergent Residuals, Analy. (UV Vis)
Per test1+$135.00
Add
RMM701 - Residue: Gravimetric Analysis,add. solvent, per extraction (if >200mL)
Per test1+Quote
Add
RMM110 - Residue: Gravimetric Analysis, ASTM F2459 (quantitation), per ext.
Per test1+$375.00
RMM111 - Residue: Gravimetric Analysis, ASTM F2459, extraction efficiency
Per test1+$1,030.00
RMM115 - Residual Manuf. Material, ASTM F2459: Insoluble/Soluble Residue Determination, per filtration
Per test1+$200.00
RMM205 - Residual Manuf. Material: Soap/Detergent Residuals, Validation
Per test1+$775.00
RMM210 - Residual Manuf. Material: Soap/Detergent Residuals, Quant.(UV Vis)
Per test1+$450.00
RMM220 - Residual Manuf. Material: Soap/Detergent Residuals, Analy. (UV Vis)
Per test1+$135.00
RMM701 - Residue: Gravimetric Analysis,add. solvent, per extraction (if >200mL)
Per test1+Quote

Turn Around Time

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

Code Test TAT
RMM110 Residue: Gravimetric Analysis, ASTM F2459 (quantitation), per ext. 14
RMM205 Residual Manuf. Material: Soap/Detergent Residuals, Validation 14
RMM210 Residual Manuf. Material: Soap/Detergent Residuals, Quant.(UV Vis) 5
RMM220 Residual Manuf. Material: Soap/Detergent Residuals, Analy. (UV Vis) 5
Code TAT
RMM110 14
RMM205 14
RMM210 5
RMM220 5

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.