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Capitol Vial, Inc. is an ISO 9001-certified supplier that manufactures containers in class 100,000 and class 10,000 clean rooms. All air in the clean rooms passes through HEPA filters every 20 minutes to remove particles greater than .5 microns in size. Every room is environmentally controlled to help reduce machine variability and thus improve product quality.
The quality system is maintained through strict adherence to the ISO 9001 standard. Capitol utilizes Statistical Process Control (SPC) and Statistical Quality Control (SQC) to quantify variability in its manufacturing operations. Failure Mode and Effects Analyses (FMEA) are conducted to develop robust processes and facilitate continuous improvement. Quality testing consists of hourly in-process inspections and laboratory analysis. The laboratory analysis is both quantitative and qualitative. An interval based sampling plan determines the frequency of product testing and enables non-conforming product to be easily isolated. The following tests are conducted to ensure adherence to product specifications.
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Leak Detection Testing
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Opening Force Place container top-up into the holding vice and align the cap under the sensor arm. Activate the cylinder and read measure gauge at the end of the upward stroke. |
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Electronic Organoleptic Testing Punch ¼ inch hole in lid of container and insert flexible hose of an electronic nose (Aroma Scan) into the container. Remove the flexible hose when test is complete. |
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Moisture Vapor Transfer Rate Testing (MVTR) Open container and place a predetermined amount of desiccant into the container. Close the container and place into an environmental chamber (80% RH @ 72ºF). Weigh the containers at given intervals and record weight gain. |
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Impact Testing (Drop Testing) Fill containers with water and place at three different conditions: (a) room temperature (b) 36ºF (refrigerator temperature) and (c) 0ºF (freezer temperature). Drop containers bottom first and inverted from a 4-foot height. Inspect containers for damage and record data. |
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Microbiological Testing Swab inside wall of containers and transfer to growth agar for enumeration. |
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Internal Pressure Test Invert container (cap side down) under a water bath and insert a probe through the sidewall. Inject air through the probe into the container until the container shows signs of air leakage in the water bath. Measure the air pressure with a calibrated pressure gauge. |
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Continuous In-line Testing Place an inert gas (argon) into the container prior to closing. Measure the amount of escape through the seal area of the container by using a continuous in-line measurement system. |
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