Testing a Pre-Filled Syringe

Comprehensive Testing for Pre-filled Syringes

Pre-filled syringes streamline drug delivery by combining the container and delivery system, reducing contamination risks and the risk of medication errors as well as being easier to use, have less drug overfill and are less time consuming to use compared to a multi-dose vial. 

At Cormica, we provide comprehensive testing services to ensure these products meet stringent safety and efficacy standards. Our labs conduct a wide range of tests, including dose accuracy, sterility, and functional performance, adhering to GMP, GLP, ISO and ASTM standards.

Complete Solutions for Pre-filled Syringe Testing

From design verification to regulatory submission, Cormica offers a full suite of testing services for pre-filled syringes. Our expertise covers method development, method validation, accelerated ageing and stability studies, and post-market surveillance. We also provide microbiological QC testing and other critical assessments to ensure your products are safe, effective, and compliant with all regulatory requirements. Partner with us for reliable, end-to-end testing solutions.

GMP, GLP and ISO 17025

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Services we offer to help you launch, release and post surveillance of Pre-filled Syringes

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Pre-Filled Syringe Device Testing Requirements Diagram

Pre-filled syringe compliance standards testing cormica

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Understanding Pre-filled Syringes Compliance

ISO 11608 – Dose Accuracy, Visual inspection 

ISO 80369 – Air Leakage/Positive Pressure Liquid Leakage, Separation Force, Unscrewing Force, Resistance to Overriding, Stress Cracking, Ease of Assembly.

ISO 11040 – Break Loose, Glide Force, Flange Breakage, Luer Cone Breakage, Burst resistance, Luer Lock Collar Adaptor Pull-Off Force or Torque Resistance, Lue Lock Rigid Cap Removal, Needle Penetration Force, Needle Pull Out Force, Residual Volume.

ISO 7886 – Liquid Leakage at Syringe Plunger Stopper

ISO 23908 – Safety Shield Activation Force

ISO 8537: Barrel Dimensions, Piston Design, Air Leakage During Aspiration, Liquid Leakage During Compression, Plunger Movement, Plunger/Stopper Pull-Out Forces, 2nd Packaging

ASTM D6653 – Air Transport – Plunger Movement

Pre-filled syringe compliance
Glass Pre filled syringe
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Pre-Filled Syringe Manufacturing Process

  1. Syringe Barrel Forming
  2. Washing
  3. Siliconisation
  4. Sterilisation
  5. Fill Finish
  6. Stoppering
  7. Assembly

Types of Pre-Filled Syringes

  • Dose set (Single Chamber) Pre-filled syringes
  • Multi-Dose set (Dual Chamber) Pre-filled syringes
  • Pre-loaded Syringes for Auto Injectors
  • Reusable Pre-filled syringes
  • Plastic Pre-filled syringes
  • Glass Pre-filled syringes
  • Staked Needle Pre-filled syringes
  • Needle Free Pre-filled syringes
  • Tamper evident Pre-filled syringes
  • Pre-filled syringes with Safety Shield
Glass pre filled syringe pen testing
Cormica Pre-filled Syringe timeline

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