Tip Cap and Needle Shield Functional Suitability Tests
Both tip caps and needle shields serve a vital role in maintaining the sterility of the contents within the container. The tests for these components are designed to quantify the forces needed to remove them prior to dose administration. A closure system is deemed satisfactory if it strikes a balance between ease of manual removal of the tip cap or needle shield and the prevention of accidental loss of these components during storage or transportation.
Gateway to Precision: Mastering Needle Shield Functionality
There are two procedures used for this evaluation: Procedure A examines the axial pull-off force required to remove needle shields and tip caps, while Procedure B measures the torque force required to remove a Luer-lock rigid tip cap. Tip caps and needle shields are designed to maintain the sterility of the container contents. The tests demonstrate the forces required to remove the tip cap or needle shield before administering a dose. A closure system is considered satisfactory if the force needed to remove the closure allows for the manual removal of the tip cap or needle shield with relative ease while preventing the accidental loss of these components during storage or transit.
The following terms and definitions apply to the tip cap and needle shield functional suitability tests:
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Needle Shield:
An elastomeric cover that fits over the needle fixed to a syringe. The needle shield is intended to physically protect the fixed (staked) needle of a syringe, to allow needle sterilization, and to maintain sterility of the syringe contents and of the needle up to the time of dosage form administration. Needle shields are removed by axial pull-off force. -
Tip Cap:
An elastomeric component that seals the nozzle end of a syringe barrel. The tip cap is intended to physically protect the nozzle or Luer end of the syringe, to permit sterilization of the nozzle, and to maintain sterility of the syringe contents and of the nozzle up to the time a needle is affixed and the dosage form is administered. Tip caps are removed by axial pull-off force. -
Luer Lock Rigid Tip Cap (LLR tip cap):
An elastomeric component designed with a plastic Luer lock adapter collar system that seals the nozzle end of a syringe barrel. The LLR tip cap is intended to physically protect the nozzle or Luer end of the syringe, to permit sterilization of the nozzle, and to maintain sterility of the syringe contents and of the nozzle up to the time a needle is affixed and the dosage form is administered. LLR tip caps are removed by torque force.
Early-Phase Development
Container Closure
Integrity Testing
Particulate
Analysis
Medical Device
Analysis
Extractables
& Leachables
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