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.Â
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
Extractables & Leachables Testing
Cleaning Validation and Verification
Particle / Powder Properties & Characterisation
Bioburden Testing
Microbial Identification
Quality Control & Batch Release
Preservative Efficacy Testing
Biological Indicator Testing
Microbial Integrity Testing
Biological Evaluation Plan (BEP)
Biological Evaluation Report (BER)
Biocompatibility Testing ISO 10993
- Cytotoxicity Testing
- Irritation
- Sensitization
- Material Mediated Pyrogenicity
- Acute Systemic Toxicity
- Subacute Toxicity
- Subchronic Toxicity
- Chronic Toxicity
- Genotoxicity
- Carcinogenicity
- Hemocompatibility
- Implantation
- Reproductive / Developmental Toxicity
Design Verification & Validation Testing
Physical Prefilled Syringe Testing – ISO 11040
Needle Injection Systems Testing
Parental Containers Testing
Pre-Filled Syringe Device Testing Requirements Diagram
Recent Cormica Device Testing Resources
Understanding Pre-filled Syringes Compliance
ISO 11608 – Dose Accuracy, Visual inspectionÂ
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 Manufacturing Process
- Syringe Barrel Forming
- Washing
- Siliconisation
- Sterilisation
- Fill Finish
- Stoppering
- 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
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