Testing a Pre-Filled Syringe

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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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Our testing services for releasing and post surveillance of a Pre-filled Syringe

Analytical Chemistry

Extractables & Leachables Testing: Identifying and quantifying potential contaminants that could migrate from syringe materials into the drug product.

Cleaning Validation and Verification:
Verifying that all syringe manufacturing and filling processes are free from cross-contamination risks, ensuring compliance with strict regulatory standards for parenteral products.

Nanoparticle Sizing for Injectable Formulations:
Precise measurement of nanoparticle size in pre-filled syringe formulations, ensuring uniformity and stability critical to the efficacy of biopharmaceuticals and other complex formulations.

Particle / Powder Properties & Characterisation:
Comprehensive analysis of any particulate matter in pre-filled syringe solutions, assessing size, shape, and composition to ensure product quality and adherence to regulatory standards.

Formulation Development for Pre-filled Syringes:
Optimising drug formulations specifically for delivery via pre-filled syringes, addressing challenges such as viscosity, syringeability, and stability for smooth administration.

Physicochemical Testing of Pre-filled Syringe Solutions:
Evaluating the physical and chemical properties of drugs and excipients in pre-filled syringes, ensuring that the formulation remains stable and effective throughout its shelf life.

Solid State Analysis for Injectable Products:
Analysing the solid-state properties of formulations that may be lyophilised or solid in suspension within pre-filled syringes, optimising stability and reconstitution behaviour.

X-Ray Powder Diffraction Services:
Providing detailed analysis of the crystalline structure of solid forms used in pre-filled syringes, helping to ensure optimal delivery and consistency in performance across batches.

Microbiology & Sterility Testing

Sterility Testing: Using membrane filtration and direct inoculation methods in ISO class 7 (Grade D) compliant cleanrooms.

Endotoxin Testing: Conducting Limulus Amebocyte Lysate (LAL) testing using gel clot, kinetic chromogenic, and kinetic turbidimetric methods.

Bioburden Testing: Determining the number of viable microorganisms before sterilisation.

Microbial Identification: If you have bacteria present in your product, we can identify it allowing you to determine the potential source

Microbial Quality Testing: Testing for total aerobic microbial count (TAMC), total combined yeasts and moulds count (TYMC), and absence of specified microorganisms.

Environmental Monitoring: Incubation and enumeration of agar plates to monitor and detect contamination in our clients manufacturing and controlled environments. Providing onsite visits to consult upon cleanroom qualifications, risks assessments and environmental monitoring protocols.

Preservative Efficacy Testing: Evaluation of the efficacy of preservative systems through inoculation and subsequent neutralization.

Biological Indicator Population Verification: Confirm the manufacturer’s labelled population of spores on the Biological Indicators using extraction, heat shock and plate count method.

Integrity testing: Does your pre-filled syringe hold up against microbial ingress? We can help you determine this.

Biocompatibility

BEP and BER: The Biological Evaluation Plan (BEP) and Report (BER) together ensure a systematic assessment of syringe materials’ biocompatibility, verifying their compliance with ISO 10993 standards for safety.

Cytotoxicity Testing: Assessing the potential of syringe materials to cause cell damage (ISO 10993-5 / USP 87).

Sensitisation Testing: Evaluating the likelihood of materials to cause allergic reactions. (ISO 10993-10)

Irritation Testing: Determining the potential of materials to cause irritation upon contact with skin or mucous membranes. (ISO 10993-23)

Pyrogenicity Testing: Determining the potential febrile response mediated by the medical device components or contamination.(ISO 10993-11)

Hemocompatibility: This test investigates activation of platelets, formation of a thrombus, or injury to blood cells. (ISO 10993-4)

Performance Design Validation and Verification

Dose Accuracy Testing: Ensuring that the syringe delivers the correct dosage consistently without causing harm to the patient.

Functional Testing: Assessing parameters like cap removal force, break loose and glide force, needle penetration force (staked needles only), and air transport simulation (plunger movement).

Usability Testing: Evaluating the ease of use and safety features of the syringe, including tamper evidence and safety shield activation.

Leak Test under Compression: Ensuring no leakage occurs when the syringe is under pressure.

Container Closure Integrity: Evaluates whether the container system maintains a sterile barrier.

Air Transit: Evaluates the movement the stopper when subjected to sub-atmospheric pressures, as seen in air transport, too much movement can compromise the sterility.

Small Bore Connectors: If the pre-filled syringe has a luer fitting it is important to check the connection between the PFS and cannula/needle is secure. (ISO 80369)

Ageing, Transit, and Package Testing

Accelerated Ageing Studies: Simulating long-term storage conditions to predict product shelf life (ASTM F1980).

Transportation and Distribution Testing: Ensuring the syringe maintains integrity during shipping and handling, including vibration and impact resistance (ASTM D4169).

Package Integrity Testing: Verifying the seal integrity and overall durability of packaging materials (ISO 11607).

Real-time Ageing: Assessing product stability and integrity under actual storage conditions over time.

Stability Studies: Assessing the functionality of the device over predefined timepoints of storage and varying temperatures and humidity.

Understanding the components of a pre-filled syringe

Pre-filled Syringe Design and Transport Standards:

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 10993: Biological Evaluation

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

ISO 11607 – Seal Integrity, Accelerated Ageing, Transportation & Distribution Testing, Compatibility Testing, Environmental Conditioning.

ASTM D4169 – Final Manual Handling, Concentrated Impact, Low Pressure, Loose-Load Vibration, Vehicle Vibration, Stacked Vibration, Vehicle Stacking, Warehouse Stacking, Manual Handling, Conditioning.

USP 1207 – Dye Tightness, Trace Gas Detection, UV-Vis Detection of Methylene Blue Dye