Cleaning validation

Nelson Laboratories offers a full range of services to evaluate reusable devices, including inoculation, sterilization, disinfection, cleaning, AAMI TIR 12 and TIR 30 evaluations, and post-reprocessing biocompatibility tests.

As part of a reusable device validation, product inoculation is an important component. The method of inoculation is dependent on the product. Clients should consult their FDA reviewer or regulatory consultant for their specific product and test requirements.

With the increased awareness of the potential dangers of residual manufacturing materials on medical devices, the FDA often requests documentation of a thorough validation of the cleaning processes used to remove residual materials from newly manufactured devices.

Optional Tests for Cleaning validation

Cleaning validation (AAMI TIR 12, AAMI TIR 30) AAMI TIR 30, AAMI TIR 12

The risks associated with reprocessing medical devices are (a) disease transfer from one patient to the next and (b) the risk of inadequate or unacceptable device performance after reprocessing.  Cleaning of the devices is therefore critical to remove microorganisms, soil, organic and inorganic materials, lubricants, etc. from both the inside and outside of the devices.  Cleaning methods may include manual techniques or mechanical aids in conjunction with water and detergents to remove foreign matter.

 

Study Outline

AAMI TIR 12

Includes: Product inoculation, device cleaning and bioburden (triplicate plating)

AAMI TIR 30

AAMI TIR 30 guidance recommends that device reprocessors perform a range of tests dependent on the device type/use. It is the responsibility of clients to contact their FDA reviewer to confirm the appropriate test plan.  We offer the following tests for TIR 30:  Bioburden, detergent residuals, TOC, LAL/pyrogen, protein, hemoglobin, cytotoxicity (MEM), biocompatibility, and carbohydrate.

Sample Requirements

The total cost of a cleaning or disinfection validation is dependent on the device (type, size), cleaning or disinfection requirements following the manufacturers intended instructions for use (IFUs) or internal procedures, and test materials required (organisms, soil, etc). Contact the Sales Department at sales@nelsonlabs.com for a specific quote on your product cleaning or disinfection validation.

Nelson Experts:

• Alpa Patel 801-290-7857, 800-826-2088
• Emily Mitzel 801-290-7899, 800-826-2088
• Julee Barrett 801-290-7859, 800-826-2088

Sample Requirements

The total cost of a cleaning or disinfection validation is dependent on the device (type, size), cleaning or disinfection requirements following the manufacturers intended instructions for use (IFUs) or internal procedures, and test materials required (organisms, soil, etc). Contact the Sales Department at sales@nelsonlabs.com for a specific quote on your product cleaning or disinfection validation.