Overview of Biofilm and Surrogate Devices
T.E.S.T Ltd provides a comprehensive range of ISO 15883-4 compliant surrogate devices and specialist biofilm testing services to support validation of endoscopy washer disinfectors (EWDs) and drying cabinets.
These services are designed to support compliance with HTM 01-06 requirements and demonstrating effective decontamination performance.
Our team of microbiologists, Authorising Persons (AP(D)), and Authorising Engineers (AE(D)) can guide you in selecting the most appropriate validation approach is selected for your endoscopy equipment.
For advice on HTM 01-06 endoscopy validation, please get in touch.
ISO 15883-4 Compliant
HTM 01-06 Validation Support
End-to-End Validation Solution
Controlled In-House Preparation
Biofilm Monitoring and Risk Control
Biofilm formation within endoscope washer disinfectors and associated pipework presents a significant risk to effective decontamination.
Biofilms develop when microorganisms adhere to internal surfaces and produce a protective matrix, allowing bacteria to persist within
- Channels
- Connector
- Water pathways
Once established, they can:
- Reduce the effectiveness of disinfection
- Act as a continuous source of contamination
Organisms such as Pseudomonas aeruginosa can survive within biofilms and show increased resistance to routine cleaning and chemical treatment.
How we help
Routine validation using surrogate devices:
- Identifies inadequate cleaning performance
- Verifies effective processing of complex endoscope channels
When combined with microbiological monitoring, this provides assurance that decontamination systems are operating in line with HTM 01-06.
Washer Disinfector (EWD) Surrogate Devices
Our surrogate devices offer a practical solution towards the HTM 01-06 validation of endoscopy washer disinfectors.
Manufactured and tested in our in-house laboratory, they are designed to deliver consistent and reliable performance.
Key features
- Modular design tailored to your requirements
- Adjustable channel size and number
- Compatible connector types
- Option to include multiple bacterial species
This flexibility ensure accurate simulation of real-world conditions during validation.
Drying Cabinet Surrogate Devices
We also supply EN ISO 15883-4:2018 compliant surrogate devices for drying cabinets, supporting full validation of endoscopy equipment in line with HTM 01-06.
Our service includes:
- Installation and removal by experienced engineers
- Supply of contact and settle plates
- Supprot across all stages of validation
This provides a complete solution for endoscopy va;idation, from testing through to verification.
Frequently Asked Questions
Surrogate devices are used during validation of endoscopy washer disinfectors and drying cabinets to simulate internal channels and assess cleaning, disinfection and drying performance. They provide a controlled and reproducible method of verifying that equipment is operating in accordance with recognised validation requirements.
Yes. Our surrogate devices are constructed in accordance with EN ISO 15883-4:2018 and aligned with national guidance for washer disinfector validation. Devices are manufactured and enumerated within our validated in-house laboratory to ensure consistency and reliability.
Biofilm testing assesses the ability of washer disinfectors to remove or reduce biofilm-associated microorganisms under controlled laboratory conditions. Biofilms can develop within channels and internal surfaces, increasing resistance to disinfection. Testing provides additional assurance of cleaning and disinfection effectiveness and can be completed during validation activities.
Yes. We provide technical support throughout the validation process to ensure clarity, compliance and confidence in your results.
Our team can assist with validation planning, protocol design, sample requirements and interpretation of findings. We work closely with you to ensure testing aligns with relevant standards and guidance, including HTM 01-06 and other applicable regulatory frameworks.
Following testing, we are available to discuss results, answer technical queries and provide supporting documentation where required. Our aim is to ensure the validation process is clear, robust and fully supported from start to finish.
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