Crile Clamps for the Validation of Washer- Disinfectors

The guideline compiled by the DGKH, DGSV and AKI for the validation and routine monitoring of automated cleaning and disinfection processes for medical devices includes the testing of washer-disinfectors with well- defined test devices (Crile clamps).

Since 2005, SMP manufactures test devices in accordance with the guideline for validation. The production process is done in a laboratory area accredited to ISO 17025.

We provide crile clamps which have been contaminated with coagulable sheep blood for the validation of cleaning processes of washer-disinfectors. The production process strictly follows a quality- assured process which includes:

  • Incoming components inspection
  • Cleaning and disinfection (incl. monitoring)
  • Maintenance
  • Sterilization (incl. monitoring)
  • Contamination with quality-assured, coagulable sheep blood
  • Drying
  • Vacuum packaging
  • Production-lot-based documentation

Our quality-assurance system is accredited to ISO 17025, which guarantees the high quality standard of these products and their analysis.

Protein analysis
In addition to the production of the test devices, we can provide third-party, quality-assured analysis of the residual amount of protein left on the clamps after reprocessing. Investigations are done in triplicate using a modified OPA assay for spectrophotometric determination.

In the case of elevated readings, a BCA assay and hemoglobin test are performed to exclude interferences, e.g. caused by residues of cleaning chemistry.