Drug delivery device selection and evaluation

Container critical dimensions (detection limit down to 5 microns or less)

ZebraSci has the measurement system capabilities to quantify critical container dimensions to ensure they meet intended specifications and function properly when assembled together (tolerance stack-up analysis)

• Primary container dimensions
• Plunger stopper dimensions
• Needle inner diameter dimension

Pre-filled syringe testing

• Rigid needle shield removal force – measures the force required to pull off the needle shield to expose the needle for injection use
• Needle Safety Device (NSD) Activation Force – measures the force required to activate the needle-stick safety feature of the NSD
• NSD separation force – measures the force required to remove NSD components, such as the NSD body and the finger flange
• Break-Loose and Glide Force (BLGF) – Measures the force required to initiate stopper movement (Break-Loose force) and the force required to sustain stopper movement to the end of injection (glide force)
• Deliverable volume – measures the volume of the delivered dose to ensure that the required amount of drug product is delivered
• Syringe flange/tip breakage resistance – measures the force required to break the syringe flange or tip and the resistance to breakage
• Leakage at stopper – pressurizes a filled and stoppered syringe to confirm that liquid does not ingress into the stopper ribs and confirms the system’s resistance to unintended overpressurization by pressurizing
• Syringe fitment with sharps container/carton/refrigerator – confirms that syringe dimensions fits with sharps disposal containers on the market, primary packaging, and refrigeration needs

Pen injector testing

• Needle attachment/detachment torque – measures the torque required to attach and remove a needle from pen injector
• Dose accuracy (including last dose accuracy) – measures the delivered dose from a pen injector to ensure that it delivers its intended dose. Testing is performed following requirements listed in ISO 11608-1
• Total deliverable volume – measures the total volume of drug in the cartridge
• Pen disassembly – method to disassemble pen injector to non-destructively remove cartridge for additional testing
• Resealability – measures cartridge septum resealability per ISO 11608-3
• Coring – measures cartridge septum coring per ISO 11608-3
• Cartridge Break-Loose and glide force – measures the force required to initiate & sustain plunger movement per ISO 11608-3
• Cartridge CCI – high voltage leak detection and helium leak detection are preferred methods for cartridge CCI testing
• Leakage after pressurization – cartridge will be pressurized and then observed for signs of leakage at the stopper and crimp per ISO 11608-3, by observing the pressurized cartridge

Autoinjector (AI) testing

• Injection time – measure the time to complete a full injection from the device
• Deliverable volume – measures the volume of the delivered dose to ensure that the required amount of drug product is delivered
• Needle injection depth – measures needle penetration depth of AI during intended use
• Cap removal force – measures the force required to remove the AI cap prior to injection
• AI activation force – measures the force required to initiate an injection during normal use
• AI lock-out override force – measures the force required to override the lock-out mechanism for AI devices
• AI fitment with sharps container/carton/refrigerator – confirms that AI dimensions fits with sharps disposal containers on the market, primary packaging, and refrigeration needs

On-body/wearable device testing

• Deliverable volume/dose accuracy: the main objective of this test is to measure and verify the actual volume of a drug product delivered by an on-body injector. This is a critical evaluation conducted to assess the ability to accurately deliver the intended dose
• Injection time: this test evaluates the duration it takes for the on-body injector to deliver the drug product into the patient’s body. This test is crucial to assess the time required for the device to deliver the target dose
• Needle injection depth – measures needle penetration depth of on-body injector during intended use
• Needle shield/cap removal force – measures the force required to remove the on-body cap prior to injection
• Button push force – measures the force required to initiate an injection during normal use
• ZebraSci offers a variety of methods to assess container closure integrity. We recommend a combination of Helium and High Voltage Leak Detection for on-body injectors. CCI testing is essential to verify that the container closure system effectively prevents any leakage or contamination of the drug product

Additional tests (device indicators):

• Break-Loose Glide Force: this test can be done to assess the required forces needed to initiate the gliding of injections. This test assesses the ease of activation for the device
• Unintended volume release: this test evaluates the unintended release of drug product from the injector before or after the intended purpose
• End of dose completion: this test is performed to verify that on-body injectors successfully administer the entire dose without any potential interruptions
• Any other test applicable to cartridge assessment (e.g. silicone distribution analysis) will apply to on-body injectors
• Adhesive peel testing: this test measures the force required to remove peels or layers so the patient can easily access the adhesive pad to attach to the body

Other testing

• IV Bags and flexible packaging
• Pumps
• If a you are interested in a test method that is not found on our offerings list, we also have capabilities to create new methods to meet your needs