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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.

Application of W-Re thermocouples for in situ ultrahigh vacuum use over a wide temperature range Rev. Sci. Instrum. 76, 016104 (2005); 10.1063/1.1832171Three-dimensional flow analysis of spiral-grooved turbo booster pump in slip and continuum flow Compact ultrahigh vacuum sample exchange device with wide temperature range Rev. Sci.An intelligent molecular flow sensor [see Note (1) on next page] enables direct gas flow measurements in the transitional and molecular flow regimes, as well as in the slip and continuum flow regimes, thereby enabling flow measurements at pressures ranging from vacuum through atmospheric. The properties of this sensor are investigated, along with the sensor's transitional operating ranges. The IMFS operates as a mass flow sensor (directly measures the mass flow) in the transitional and molecular flow regimes, and it operates as a volumetric flow sensor in the continuum and slip flow regimes. Understanding of these properties and ranges of operation are critical for demanding leak testing, sealed closure integrity testing and vacuum test applications.

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