Single-use technologies have transformed biopharmaceutical manufacturing. They enable faster changeovers, greater manufacturing flexibility, and reduced cleaning requirements, but they also introduce a critical materials-related challenge: extractables and leachables (E&L).
Polymeric and plastic materials are not completely inert. Under real-world manufacturing conditions, including varying chemical environments, temperatures, and contact times, organic and inorganic compounds can leach from plastic equipment directly into the drug substance or final product. If uncharacterized, these leachables can alter drug stability, degrade efficacy, or present toxicological risks.
Regulatory authorities increasingly expect manufacturers to demonstrate that materials and components used in pharmaceutical and biopharmaceutical manufacturing are suitable for their intended use and that potential extractables and leachables risks have been appropriately assessed. With the official implementation of USP <665> on May 1, 2026, expectations around material qualification, documentation, and risk management have become significantly more structured. Compliance requires a continuous, risk-based approach integrated directly into bioprocessing operations.
Navigating E&L risk assessment and operational capacity
Aligning single-use portfolios with evolving regulatory expectations presents practical challenges for biopharmaceutical organizations:
- Regulatory filings and inspections: Health authorities require robust E&L characterization data within regulatory dossiers and site inspections. Incomplete material characterization or inadequate risk assessment can create quality and supply-chain challenges, particularly where critical single-use components are used in commercial manufacturing.
- Internal resource constraints: Gathering missing vendor data, reconciling incomplete supplier dossiers, and managing specialized testing places a heavy burden on internal MS&T, QA, and QC teams, taking focus away from core manufacturing priorities.
- Supply-chain continuity: Unqualified single-use components introduce operational vulnerabilities. Resolving material characterization gaps proactively ensures uninterrupted material release and supports long-term supply continuity.
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Proven field execution: USP <665> remediation at scale
Avertim helps Life Sciences leaders turn regulatory expectations into structured, execution-ready processes. A recent engagement with a global vaccines manufacturer highlights how technical rigor and pragmatic execution safeguard site operations:
- Quantifiable impact: Achieved a 15% reduction in the total number of components requiring individual lab testing while maintaining 100% uninterrupted active vaccine supply across all commercial lines.
- Scope: Assessed E&L properties for 150 single-use systems across 6 commercial vaccine lines at a major production site.
- Risk-based clustering: Applied risk-based component clustering to group materials with shared chemical and contact profiles, eliminating redundant testing and streamlining the overall assessment approach.
- Targeted remediation: Identified 59 quality gaps, managed 60 external laboratory studies, and performed 31 toxicological safety assessments (evaluating maximum daily dose exposure models to ensure patient safety thresholds were met).
- Enterprise data integration: Built a site-wide material attribute registry encompassing 15,000 line items integrated across SAP and Veeva Vault
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The Avertim advantage: Hands-on execution alongside strategic advisory
Meeting USP <665> expectations requires dedicated technical capacity that internal teams cannot easily absorb alongside routine commercial output. The Avertim Quality, Risk, and Compliance team integrates directly with your site staff to manage the workload end-to-end.
How we support your site:
- Portfolio gap audits: Rapid baseline mapping to pinpoint missing data across all fluid-contact components.
- Vendor and testing management: Sourcing technical dossiers from suppliers and managing third-party laboratory studies.
- Toxicological safety assessments: Developing defensible patient safety and exposure models based on worst-case daily dose calculations.
- Enterprise alignment: Registering qualified material data into SAP, Veeva, and QMS platforms to guarantee permanent audit readiness.
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Secure your manufacturing continuity
With USP <665> now in effect, proactively reviewing single-use portfolios allows organizations to address potential data gaps systematically without interrupting daily commercial output.
By combining deep technical expertise with hands-on execution, Avertim enables life sciences companies to resolve single-use compliance gaps cleanly, efficiently, and with full operational alignment.
Reach out to us to review your USP <665> readiness and strengthen your single-use supply chain today.
