Cleaning strategy as the foundation for optimal decontamination performance
Cleanability expertise
Scientific expertise and study design according to international standards
Interdisciplinary team
Holistic approach with experience in engineering, microbiology, and process design
Individual studies
Simulation of different cleaning conditions, surrogate testing, and definition of worst-case scenarios
Risk management
Identification of critical points, recommendations for actions, and support in the cleaning strategy
Precise data analysis
Recovery factors for materials, evaluation of airborne particles, and quantitative assessment of cleaning performance
Design validation
Analysis of hygienic design aspects; material resistance, cleanability, and decontamination capability
Flexible test location
Depending on the test, possible at your location
GMP-compliant
Addressing cross-contamination according to GMP guidelines
Application
Achieving success with a customized cleaning study
Strategy development for new isolators and equipment
Through targeted testing, optimal chemistries, contact times, and methods, as well as residual contamination, are evaluated to validate the cleaning strategy under real-world conditions.
Cleaning assessment for existing systems
To evaluate existing cleaning processes, quantitative and qualitative analyses are performed. Various conditions are simulated, residual contamination is assessed, and airborne particles are analyzed during operations or product changeovers.
For equipment manufacturers and operators
SKAN evaluates material resistance against cleaning supplies, assesses hygienic design, and investigates spore inactivation. Materials that are not suitable or locations that are difficult to access are identified.
Process
Five steps to a comprehensive cleaning strategy
1
Requirements analysis
Analyze needs, product properties, expected contamination levels, and acceptance criteria to define the study scope.
2
Create protocol
Development of a detailed test protocol for your approval, ensuring the study design covers all relevant aspects, including material compatibility and mapping.
3
Cleanability tests
Simulate target contamination using surrogates, test different cleaning conditions, measure residual contamination, and mapping of the contamination spread.
4
Documentation and results
Prepare and release the study report; communicate data analysis and interpretation by SKAN experts.
5
Risk assessment and recommendation
Discussion of the results, risk assessment, decision support, and recommendations for optimizing the cleaning strategy.
Service highlights
Cleaning strategy based on scientific testing
Early identification of critical areas
Through targeted contamination testing and mapping, difficult-to-access or cleaning-critical areas are identified, allowing design, cleaning parameters, or process workflows to be adjusted at an early stage.
Support for regulatory requirements
Documented tests, traceable methods, and clear data analyses support companies in systematically addressing requirements from EU-GMP, in particular regarding cross-contamination and risk assessment.
Improved operational safety
Through a better understanding of cleaning performance under realistic conditions, production processes can be operated more reliably and safely.
Assessment of the chemical resistance of materials to cleaning supplies or disinfectants used
Cleanability testing with surrogate contamination
Targeted application of a defined model contamination (surrogate) to different materials; simulation of various cleaning conditions, and determination of residue concentrations or recovery rates
Contamination mapping with fluorescent tracer
Simulation of production or cleaning processes using a fluorescent tracer to identify worst-case locations and to evaluate the spread of contamination and the cleanability of critical areas
FAQs
No, validation remains your responsibility. SKAN provides studies, tests, and recommended actions as a basis for internal validation.
Yes. Formulation, materials, and contamination limits are required to obtain meaningful results.
No. The study applies to all isolators and equipment types, including non-SKAN devices.
The mapping visualizes critical contamination points, defines worst-case positions, and enables a well-founded risk assessment.
