Single-Use and Filter Validation Services
Streamline your path to market with our validation services – Optimize, accelerate, and simplify your process
- Validation Services replicate your process conditions through lab-based testing to support safe drug production. We deliver tests, certificates, and expert guidance to ensure confidence at every stage.
- Backed by decades of filtration and biopharmaceutical experience, our ISO-certified labs in key regions provide tailored services aligned with global standards, delivering reliable results for diverse formulations—from biologics to complex injectables.
- Access a full range of validation services—from physical and microbial testing to extractables and leachables—designed to support patient safety and address your specific needs, enabling a streamlined regulatory readiness process.
Discover our main services
Confirms sterilizing-grade filters produce sterile effluent under process-specific conditions, supporting safe drug manufacturing.
Verifies chemical compatibility and filter integrity of your filtration system to ensure safe drug production.
Ensure patient safety with risk-based E&L testing, assessing plastic material impact on biopharmaceutical processes for safe drug production.
Delivers solutions for unique filtration, single-use assembly and bioprocessing materials challenges.
Tailored validation services to facilitate regulatory compliance
With decades of experience and a global team of specialists, our comprehensive validation services facilitate regulatory compliance and reduce process risks. We tailor solutions to support your specific needs, helping you select, test, and validate filters and single-use systems.
Upstream to the compounding tank/mixing bag
- Chemical compatibility
- Extractables/patient safety
Final storage single-use assembly
- Chemical compatibility
- Extractables/patient safety/leachables
- Non-permeation test
Final sterilizing filters and/or single-use assembly
- Bacterial retention validation
- Bubble point/diffusion determination
- Chemical compatibility
- Extractables/patient safety/leachables
- Binding study
- Particle shedding study
- Vmax™ confirmation i.e. filter fouling evaluation
Bioburden Reduction Filter
- Chemical compatibility
- Extractables/patient safety
- Bubble point/diffusion determination
Sampling System
- Chemical compatibility
- Functionality test
- Non-permeation test
Our predefined service levels help you determine the right level of support. Whichever you choose, our validation experts will be with you every step of the way. Refer to the table below for more information.
Classic or advanced service level comparison chart
| Service Level Comparison Chart | Classic | Advanced |
|---|---|---|
| Satisfies Applicable Global Regulatory Expectations | ✓ | ✓ |
| Regulatory Query/Inquiry Assistance | ✓ | ✓ |
| Online Support | ✓ | ✓ |
| Call-in Support from Project Management Team | ✓ | ✓ |
| Test Customization1 | - | ✓ |
| Bacterial Retention and Compatibility Study Conditions | Process duration 48 h Max Room temperature range2 | Maximum process duration
Maximum process temperature |
| Extractables Study Conditions | Model solvent(s) selected based on risk level Extraction temp 40 °C and duration 24h, 7d or 21d | Customizable |
| Integrity Testing | 1 product lot | Up to 3 product lots |
| Documentation | Templated | Customizable |
| Documentation Revision | 1
On specific fields3 | Up to 3
on full document |
Related resources
- Brochure: Validation Services Extractables and Leachables Testing Brochure
This brochure provides details on our validation services for extractables and leachables.
- Brochure: Validation Services Global Brochure
Regulatory guidance documents provide a framework to manufacturers for the production of drugs that are safe for administration to patients.
- App note: When Do You Need to Consider Revalidating the Performance of Your Sterilizing-grade Filter?
Any product or process change that could potentially affect the cGMP compliance of a validated process or system should be evaluated and a risk assessment should be performed to evaluate the impact.
- Technical note: Aseptic Validation Master Plan
Our experienced Validation Services team has summarized best practices for validating performance of critical filtration systems used in aseptic processing. If you need help, they can provide support on the various tests to meet global regulatory requirements.
- Datasheet: Comprehensive Validation Services
Test parameters by service level
Related webinars
This webinar will provide recommendations for addressing risks associated with Single-Use Systems raised in EU GMP Annex 1.
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