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Updated: May 1, 2026
Failure of Cleaning Verification in Pharmaceutical Industry Due to Uncleanliness of Stainless Steel Surface
Published on: August 11, 2017
Use of synthetic single-stranded oligonucleotides as artificial test soiling for validation of surgical instrument
Nadja Wilhelm1, Nadja Perle1, Robert Simmoteit2
1Department of Thoracic, Cardiac, and Vascular Surgery, University Hospital Tuebingen, Calwerstraße 7/1, 72076 Tuebingen, Germany.
Abstract:
Surgical instruments are often strongly contaminated with patients' blood and tissues, possibly containing pathogens. The reuse of contaminated instruments without adequate cleaning and sterilization can cause postoperative inflammation and the transmission of infectious diseases from one patient to another. Thus, based on the stringent sterility requirements, the development of highly efficient, validated cleaning processes is necessary. Here, we use for the first time synthetic single-stranded DNA (ssDNA_ODN), which does not appear in nature, as a test soiling to evaluate the cleaning efficiency of routine washing processes. Stainless steel test objects were coated with a certain amount of ssDNA_ODN. After cleaning, the amount of residual ssDNA_ODN on the test objects was determined using quantitative real-time PCR. The established method is highly specific and sensitive, with a detection limit of 20 fg, and enables the determination of the cleaning efficiency of medical cleaning processes under different conditions to obtain optimal settings for the effective cleaning and sterilization of instruments. The use of this highly sensitive method for the validation of cleaning processes can prevent, to a significant extent, the insufficient cleaning of surgical instruments and thus the transmission of pathogens to patients.
Insights
New synthetic DNA (ssDNA_ODN) effectively measures surgical instrument cleaning. This sensitive method validates cleaning processes, preventing pathogen transmission and improving patient safety.
Area of Science:
- Biomedical Engineering
- Infectious Disease Control
- Analytical Chemistry
Background:
- Surgical instruments contaminated with biological material pose infection risks.
- Inadequate cleaning and sterilization can lead to postoperative inflammation and disease transmission.
- Validated cleaning processes are critical for ensuring surgical instrument safety.
Purpose of the Study:
- To introduce a novel method for evaluating surgical instrument cleaning efficiency.
- To utilize synthetic single-stranded DNA (ssDNA_ODN) as a reliable test contaminant.
- To establish a sensitive and specific assay for cleaning process validation.
Main Methods:
- Coating stainless steel test objects with synthetic ssDNA_ODN.
- Implementing routine washing processes for contaminated test objects.
- Quantifying residual ssDNA_ODN using quantitative real-time PCR (qPCR).
Main Results:
- Developed a highly specific and sensitive assay with a detection limit of 20 fg.
- Demonstrated the utility of ssDNA_ODN as a test soiling for cleaning validation.
- Enabled determination of cleaning efficiency under various conditions.
Conclusions:
- Synthetic ssDNA_ODN provides a robust tool for validating medical cleaning processes.
- This sensitive qPCR-based method significantly enhances the detection of residual contaminants.
- Effective validation of cleaning protocols can substantially reduce the risk of surgical site infections.
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