Ensuring Safe & Compliant Injections with PFS Testing

Introduction

Pre-filled syringes (PFS) have revolutionized drug delivery by providing convenience, accuracy, and reduced contamination risks. However, their complex design requires meticulous testing to ensure safety, sterility, and performance compliance. Accuprec Research Labs offers ISO 11040-compliant PFS testing to guarantee that every injectable product meets global regulatory and quality benchmarks.

Why PFS Testing is Critical

• Ensures patient safety by validating sterility and material compatibility
• Confirms mechanical integrity and performance of syringe systems
• Prevents contamination from extractables, leachables, or silicone residues
• Meets ISO 11040 and pharmacopoeial standards for pre-filled devices

Accuprec’s Capabilities

Our specialized PFS testing facility conducts detailed evaluations across multiple parameters, including:

• Dimensional and mechanical testing – Plunger glide force, break-loose force, seal integrity
• Extractable & leachable studies – Chemical safety of syringe components
• Particulate and silicone oil analysis – Ensuring particulate control
• Container closure integrity (CCI) – Sterility and leak-proof assurance
• Functional testing – Dose accuracy, dead-space volume, needle penetration

Regulatory Alignment

All studies are conducted following:

• ISO 11040-4 & 11040-6 standards
• USP <1207> for container closure integrity
• Pharmacopoeial requirements (EU, US, JP)

Meet Us at CPHI Frankfurt 2025

Join us at Stall D96 | Hall 6.1 at Messe Frankfurt, Germany, and explore our end-to-end PFS testing solutions that ensure global regulatory compliance and patient confidence.