Unveiling Confidence® in Extractables and Leachables Testing

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. Biotech Verde, 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

Biotech Verde 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 Biotech Verde 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 Biotech Verde 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

Biotech Verde applies key Extractables protocols to consumables, meeting regulatory requirements and individual preferences:

Biotech Verde 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: Biotech Verde 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.