Simplifying the Approach to Specify and Measure Product Seal Integrity and Leak Tightness

Sterile products must maintain their sterility over their entire shelf life. Container closure systems such as those found in syringes and vials provide a seal between rubber and glass containers. This seal must be ensured to maintain product sterility. A mass extraction system has been developed to check container closure integrity for a variety of container closure systems such as vials, syringes, and cartridges. In order to demonstrate the method's capability, various types of defects (e.g., glass micropipette, laser drill, wire) were created in syringes and vials and were tested. This study demonstrated that a mass extraction system was able to distinguish between intact samples and samples with 2 μm defects reliably when the defect was exposed to air, water, placebo, or drug product (3 mg/mL concentration) solution. Also, it was verified that the method showed consistent results, and was able to determine the acceptance limit using 3σ for syringes and 6σ for vials.

show abstract

Simplifying the Approach to Specify and Measure Product Seal Integrity and Leak Tightness

Cited by 3 publications

References 3 publications

Leakage Dynamics of Glass Bottles on Container Closure Integrity Testing: Influence of Different Laser-Drilled Microhole Geometries

Leakage Dynamics of Glass Bottles on Container Closure Integrity Testing: Influence of Different Laser-Drilled Microhole Geometries

Development of Leak Tightness Specifications for Automotive Fuel System Components as Required to meet Hydrocarbon Emission Regulations using the Equivalent Channel Concept and its Implementation Method for Production Leak Testing

Mass Extraction Container Closure Integrity Physical Testing Method Development for Parenteral Container Closure Systems

Contact Info

Product

Resources

About