Ready for USP <665> and USP <1665> by May 1, 2026
Compliance with USP <665> (« Plastic Components and Systems Used to Manufacture Pharmaceutical Drug Products ») and USP <1665 (« Characterization and Qualification of Plastic Components for Manufacturing of Pharmaceutical and Biopharmaceutical Drug Substances and Products ») becomes mandatory starting May 1, 2026. Preparing now is essential to:
- Mitigate E&L Risks: Prevent contamination early.
- Ensure Approval Readiness: Avoid costly delays.
- Protect Process Integrity: Guarantee safe, reliable manufacturing.
Start today to secure compliance and safeguard your future success. Avisulting provides the expertise to guide you there with confidence.

Key Applications of USP Standards for SUS
Application | What It Means for You | Your Benefits |
Filling Tubes | ✔ Ensure chemical compatibility and minimize contamination risks during aseptic manufacturing. | ✅ Safer drug production with compliant materials. |
Storage Bags & Bioreactors | ✔ Validate material safety for storage and bioprocessing of drug substances, ensuring process integrity. | ✅ Reliable performance in critical bioprocessing steps. |
Mixing & Transfer Systems | ✔ Evaluate the impact of SUS on drug product quality during mixing, transfer, or scale-up activities. | ✅ Improved quality and consistency during manufacturing scale-up. |
Primary Packaging | ✔ Assess E&L risks for materials used in vials, prefilled syringes, or pouches, safeguarding patient safety. | ✅ Reduced contamination risks and compliance with safety standards. |
Tubing Systems | ✔ Analyze potential chemical interactions during fluid transfer to meet USP <665> compliance. | ✅ Ensure smooth and compliant fluid transfers in critical operations. |
Filters & Connectors | ✔ Examine components facilitating sterile filtration or system interconnection to mitigate risks. | ✅ Enhanced sterility and operational integrity in connected systems. |
Sampling Devices | ✔ Evaluate sampling systems for compatibility with drugs, ensuring contamination-free results. | ✅ Accurate and reliable drug sampling aligned with quality protocols. |
Disposable Sensors & Probes | ✔ Confirm compliance for real-time monitoring devices integrated within SUS. | ✅ Advanced monitoring capabilities to maintain compliance and process efficiency. |

How Avisulting Supports You
Service Area | How Avisulting Supports You | Your Benefits |
Comprehensive E&L Assessments | ✔ Advanced simulation tools to identify risks across SUS applications. | ✅ Proactive risk mitigation for extractables and leachables (E&L). |
Regulatory Documentation | ✔ Detailed compliance documents and risk management plans tailored for SUS. | ✅ Ready-to-submit files aligned with global regulatory expectations. |
Tailored Risk Management Plans | ✔ Customized strategies for storage bags, mixing systems, and final drug packaging. | ✅ Flexible solutions for unique project needs. |
Lifecycle Management | ✔ Continuous compliance monitoring for SUS systems. | ✅ Long-term adherence to evolving regulatory standards. |
Global Network of Experts | ✔ Collaborations with toxicology and analytics specialists to support custom projects. | ✅ Access to cutting-edge insights and proven expertise. |
✔ Expertise across disciplines, from chemical characterization to regulatory strategy. | ✅ Comprehensive support from start to finish. |
Why Choose Avisulting?
🤝 Trusted Expertise: Years of experience in E&L risk assessment and regulatory compliance.
🔍 Focused Solutions: Tailored guidance for biotech, pharma, and CMOs/CDMOs.
📊 Comprehensive Support: From initial risk assessment to lifecycle management.
Contact Us
Achieving compliance with USP <665> and USP <1665> is critical for regulatory success and product safety. Let Avisulting guide you through every step of the process.
📧 Email: francois.bianchi@avisulting.com
🌐 Website: www.avisulting.com
📍 Address: Rue des Cèdres 9, 1920 Martigny, Switzerland