Objective measurement of H₂O₂ uptake or residual concentrations in materials and the product environment
Realistic risk assessment
Evaluation of potential effects of H₂O₂ on product quality, stability, or microbiological testing
Solid basis for decision-making
Support for material selection, packaging design, or process adjustments
Early problem identification
Detection of critical H₂O₂ residues as early as the development or qualification phase
Greater process reliability
Reduction of the risk of false-negative or distorted sterility test results
Support in case of deviations
Targeted analysis of possible causes for abnormal microbiological test results
Regulatory-grade data
Documented results to support risk analyses and communication with regulatory authorities
Broad applicability
Suitable for various materials, packaging systems, and pharmaceutical products
Application
For manufacturers with the highest demands for quality
For aseptic production
Assessment of potential H₂O₂ uptake in materials, primary packaging, or products following decontamination. The results support risk assessment regarding product quality, stability, and potential residuals, particularly in the case of material or process changes as well as for oxidation-sensitive products.
For sterility testing in isolators
Residual H₂O₂ can kill microorganisms in sterility tests and lead to false-negative results. We check the robustness of your sterility testing under realistic conditions.
Process
Here’s how the H₂O₂ residue test works
1
Requirements analysis
We analyze your specific question (i.e., ingress or sterility test) and develop a tailored test protocol reflecting your real conditions, which is then approved by you.
2
Exposure and extraction
Materials are exposed under realistic conditions (at SKAN or on-site). Afterwards, absorbed H₂O₂ residues are extracted for quantitative laboratory analysis.
3
Quantification and simulation
We quantify the extracted H₂O₂ traces. For sterility test studies, we additionally incubate defined H₂O₂ concentrations with microorganisms and evaluate microbial growth by membrane filtration or direct inoculation.
4
Reporting and consultation
Results are documented in a study report and discussed with you. We provide clear recommendations for next steps, e.g., adjusting aeration times or process parameters.
Service highlights
Why SKAN is your partner for H₂O₂ risk assessment
Comprehensive safety perspective
We examine both the ingress of H₂O₂ into materials and its effect on microbiological tests for a complete risk assessment of your processes.
Reliable decision basis
Our studies deliver solid data for releases, stability studies, and microbiological test validations, including worst-case scenarios.
Expertise in isolators and analytics
Our experience in isolator technology, H₂O₂ decontamination, and microbiological analytics under BSL-2 conditions ensures precise, realistic results.
Investigation of H₂O₂ uptake in materials or packaging systems
Sterility tests
Evaluation of the influence of H₂O₂ residues on microbiological sterility tests
Study
Planning and execution of the study, including sample exposure, analytical and microbiological testing, and data evaluation
Documentation
Documentation of results for use in development, risk analysis, or qualification dossiers
Chemical analysis
Quantitative determination of H₂O₂ traces following material exposure
Microbiological testing
Evaluation of microbial growth under the influence of defined H₂O₂ concentrations using established sterility test methods
FAQs
We analyze whether and how much H₂O₂ can migrate into products during decontamination or filling, and whether residual amounts could compromise microbiological tests. This safeguards both product quality and test results.
Materials must be compatible with the extraction and analysis method. Products with antibacterial effects can mask the impact of H₂O₂, so multiple test rounds may be required.
We do not offer direct process solutions, but provide clear recommendations based on the study results, e.g., regarding aeration times, decontamination parameters, or alternative test approaches.
Suitable for all isolator-based systems using H₂O₂ decontamination, regardless of the manufacturer. Studies are carried out on SKAN isolators but are transferable to other systems.
