Purpose and Importance

Pre-filled syringes (PFS) have become the preferred choice for parenteral drug delivery due to their convenience, accuracy, and reduced contamination risk. However, their complexity demands thorough testing to ensure product integrity, sterility, and functionality throughout the product lifecycle.

Testing in compliance with ISO 11040 and pharmacopeial standards (USP, EP, JP) ensures that both container and drug product perform as intended without compromising patient safety. Proper validation minimizes risks of leakage, particulate matter, and drug-device incompatibility.

Our Testing Capabilities

Accuprec Research Labs offers complete testing solutions for pre-filled syringes under ISO and regulatory guidelines. Our analytical, mechanical, and microbiological evaluations cover the entire performance spectrum.

• Dimensional & Visual Inspection: Verification of barrel, plunger, and stopper dimensions, as per ISO 11040-6 and 11040-8.
• Functional Testing: Break-loose, glide force, and plunger seal integrity assessments.
• Extractable & Leachable Studies: Evaluation of materials and potential leachables from syringe components.
• Container Closure Integrity Testing (CCIT): Helium leak and dye ingress methods to ensure airtight sealing.
• Particulate Matter & Sub-Visible Particle Testing: Light obscuration and microscopy-based methods per USP <788>.
• Sterility & Endotoxin Testing: Microbial safety assessments following pharmacopeial standards.

Our Approach

Our team integrates analytical and engineering expertise to validate both the device and the drug product. We follow structured protocols aligned with ISO 11040, USP <1207>, and PDA TR77 for device integrity and usability testing. Our validated equipment and environmental controls ensure precise, reproducible results for regulatory submissions.

Why Choose Accuprec

• ISO & GMP-Compliant Testing: Ensures global acceptance of results.
• Integrated Analytical & Microbiological Labs: Covering all physical and biological testing needs.
• Expertise in Device-Drug Interactions: Evaluating compatibility and stability for biologics and injectables.
• Fast Turnaround & Comprehensive Reporting: Supporting regulatory filings and technology transfers.

Outcome

Our PFS Testing services provide a holistic evaluation of the pre-filled syringe system, ensuring compliance, reliability, and patient safety. From initial design validation to final product release, Accuprec delivers quality data you can trust for regulatory confidence and global market access.