Proactive Planning for USP <382> Elastomeric Plunger Functional Suitability Testing
To help the pharmaceutical industry meet upcoming regulatory requirements, we have successfully completed tooling for pre-filled syringes and are advancing to the next phase of testing preparation and service deployment.
With USP <382> set to be implemented in December 1 2025, regulating the functional suitability of elastomeric components (such as plungers) in parenteral packaging and delivery systems. Testing services will be available shortly to support your compliance and quality assurance needs.
USP <382> establishes standardized testing methods to evaluate the functional suitability of elastomeric plungers in syringe and cartridge systems. Key testing aspects include:
• Plunger Break-loose Force
• Plunger Extrusion Force
• Plunger Seal Integrity Test
As critical components in direct contact with drug products, plungers significantly impact the product’s seal integrity, safety, and user experience. USP <382> offers a clear framework to help pharmaceutical manufacturers and packaging suppliers ensure product quality and regulatory compliance, ultimately protecting patient safety.
Our Key Testing Services
1. Plunger Break-loose Force Test: Measures the initial force required to start plunger movement in a liquid-filled system, ensuring the force is neither too high (causing difficulty) nor too low (risking leakage).
2. Plunger Extrusion Force Test: Evaluates the sustained force needed to expel contents smoothly and consistently, preventing injection difficulties or plunger instability.
3. Plunger Seal Integrity Test: Assesses the plunger’s ability to maintain a fluid-tight seal under pressure, preventing microbial ingress and preserving product sterility and safety.
Why Choose Us?
• Comprehensive Pre-filled Syringe Tooling Support to accelerate your product development and manufacturing transition.
• Precision Testing Equipment fully compliant with USP <382> standards, delivering reliable and reproducible results.
• Regulatory-Compliant Testing Protocols with detailed reports suitable for submission and audit purposes.
• Experienced Technical Support from sample preparation, test planning, to data analysis by our expert team.
• Flexible Collaboration Models ranging from one-time testing to long-term technical service partnerships tailored to your needs.
With USP <382> coming into effect soon, the pharmaceutical industry is entering a new era of regulatory rigor for elastomeric component performance. By completing our pre-filled syringe tooling and acquiring specialized testing equipment, we are fully prepared to help our clients conduct the required evaluations efficiently and in compliance with the latest standards.