Evaluation of material suitability for aseptic environments
Service area
Contamination & cleaning strategy
Lifecycle
Design & QualificationValidationOperation
Material compatibility tests at a glance
Reliable testing of materials in aseptic production environments
Regulatory compliance
Fulfillment of Annex 1 (chapters 4.5 and 4.7) and international standards
Universal applicability
Can be used for devices, materials, and components, irrespective of the manufacturer
Individual setup
Dedicated test systems with customizable test setups
Chemical and biological resistance
Proof of resistance to cleaning chemicals and microorganisms
Practical tests
Analysis of decontamination with spores as well as H₂O₂ sorption and permeation
High data quality
Careful analysis and sound interpretation of the results
Robust decision-making basis
Helps select, integrate, or replace materials
SKAN expertise
Long-standing experience in isolator technology, test design, and data analysis
Application
For pharma, biotech, and material suppliers
For pharma and biotech companies
Assessment of the suitability of materials and devices in isolators or aseptic environments. Tests show whether new or existing components can be decontaminated reliably.
For manufacturers and pharma suppliers
Manufacturers of devices, consumables, or primary packing material receive proof of the resistance of their products to H₂O₂ decontamination.
When changing materials
Those looking to replace materials in isolators or aseptic areas, e.g., for cost or sustainability reasons, can ensure their suitability.
Process
Structured workflow from initial requirements to a reliable test report
1
Requirement analysis
Joint clarification of the requirements and relevant materials.
2
Create test report
Detailed planning of the test design and approval by you.
3
Test performance
Material testing for chemical and biological resistance, decontamination, and sorption/permeation behavior, depending on the requirements.
4
Analysis and documentation
Analysis of the results, creation of the study report.
5
Communication and discussion
Presentation of results, addressing open questions, and clarification of potential follow-up investigations.
Service highlights
Informed material decisions for safe aseptic processes
Clear material evaluation
The tests provide reliable data on chemical and biological resistance as well as the sorption and diffusion behavior of materials. This enables informed decisions regarding their selection or replacement.
Regulatory compliance
The studies support regulatory verification of material suitability. The documented results can be used in validation dossiers, GMP documentation, and inspection preparations.
Risk reduction in operation
Early identification of critical materials helps prevent decontamination issues, prolonged outgassing times, or microbiological risks.
Assessment of whether materials can withstand cleaning chemicals and H₂O₂ decontamination cycles over the long term
Surface decontamination testing
Demonstration of decontamination efficacy on spore-challenged materials and surfaces in isolators
Biological resistance testing
Investigation of whether materials allow or promote microbiological growth under defined conditions
Sorption/diffusion analysis (H₂O₂)
Analysis of how materials absorb, re-release, or permeate H₂O₂ through flexible packaging
Chemical resistance testing
Immersion of samples in specific chemicals or exposure to a defined number of decontamination cycles; subsequent macro- and microscopic analysis as well as weight measurement
Surface decontamination testing
Decontamination of spore-inoculated material carriers in a reference isolator; removal of carriers at defined time intervals and evaluation of microbial growth after incubation in comparison to reference BIs
Biological resistance testing
Incubation of inoculated material carriers under defined conditions; subsequent microscopic analysis of bacterial growth
Sorption/diffusion analysis (H₂O₂)
Exposure of a material sample to H₂O₂; subsequent measurement of desorbed or permeated H₂O₂ to determine the decay time (k-value) or permeation rate
FAQs
Yes. The reports are documented so that they can be used for GMP documentation, validation dossiers, and approval documentation.
Materials that absorb or diffuse H₂O₂ can impair decontamination and cause extended off-gassing times.
Ideally in the early project phase to prevent material replacement later in the scale-up or in routine production.
Above all, polymers, elastomers, or complex assemblies that encounter H₂O₂. Our tests show early on whether a material is suitable.
Standard studies are based on established methods. Individual studies, however, consider different process conditions, material types, or the customer’s regulatory requirements.
Yes. When introducing more sustainable or more cost-effective alternative materials, the tests prove their suitability for aseptic processes and facilitate the approval process.
