Releasing Potential Leachable Impurities From Your Biomanufacturing Process
As the utilization of single-use systems increases, the significance of extractable and leachable (E&L) testing has grown, becoming a regulatory requirement. Green Biotec, a leader in the field since 1996, offers Confidence® Extractables and Leachables Testing, ensuring patient safety by demonstrating that leachable impurities do not interfere with the active pharmaceutical ingredient.
Key Strengths of Confidence® E&L Testing
More than 25 Years of Expertise
Green Biotec brings profound understanding and expertise in extractables and leachables since 1996.
Flexible Scaling of Extract enables
Comprehensive extractable profiles with optimized turnaround and reduced validation costs.
Extractables Simulator (ExSim)
A qualified software platform predicts total extractable based on your process, replacing physical testing.
- Scaling algorithms for short and long contact times.
- Thousands of combinations and assemblies are possible.
Fast retrieval of legacy and calculation data.
[Evaluate Your Extractables Risk]How Green Biotec Ensures Your Success
Our Confidence® experts conduct an E&L risk assessment, evaluating the applicability of extractable profile data (EU GMP Annex 1) and guiding you through the entire validation process. The approach considers:
- Proximity of a process step to the patient.
- Consumables used.
- Product and process parameters.
- Drug development phase.
Confidence® E&L Portfolio
Extractables Guides
In-house studies for all Green Biotec products, identifying over 95% of extracted compounds.
Qualify design and installation and determine leachable testing needs.
[Request Extractables Guide]Extractables Assessments
Evaluate substances found in standard extractable analyses for individual customer processes.
The Extractables Simulator, the comprehensive first step of your validation, informs you.
Extractables Studies
Identify and avoid potential leachables when selecting packaging materials or processing equipment.
Customized extractable data creation based on individual requirements.
Leachables Testing
Complete leachable analyses, including screening and target analyses, for compounds present in the actual medical product.
Specific methods to detect leachables in complex pharmaceutical solutions.
Safety Evaluations
Correlate assessed extractable or leachable results to patient situations.
Calculate daily intake against exposure limits for safety assessment.
[Download Case Study – Reducing Validation Effort at Horizon Therapeutics]Comparison of Extractables Protocols
Green Biotec applies key Extractables protocols to consumables, meeting regulatory requirements and individual preferences:
- Green Biotec Standardized Extractables Approach
- USP <665> Draft
- BPOG
Featured Resources
Webinar: Confidence® Extractables Assessments powered by Exim
Learn how these assessments ensure patient safety and product quality.
[Watch Webinar]Blog Article: Mastering Extractables Scaling for Complex Assemblies with One Click
Explore how the Extractables Simulator transforms E&L validation.
[Read Blog Article]White Paper: Green Biotec Extractables Simulator: Simplifying E&L Through In-Silico Modeling
Dive into the in-silico modeling approach for E&L validation.
[Download PDF]Article: Development of a Standardized Extractables Approach for Single-Use Components
Gain insights into the development of a standardized approach for single-use components.
[Download PDF]Related Products
- Sterile Filtration
- Filter Transfer Sets
- Liquid Storage & Shipping
Embark on your journey to releasing potential leachable impurities with Confidence® Extractables and Leachables Testing by Green Biotec.