INNOVATIVE PLASTIC CONTAINERS Capitol Vial, Inc. is a vertically integrated ISO 9001-certified manufacturer of one-piece plastic containers. Patented molding technology enables Capitol Vial, Inc. to produce containers that are airtight, leak-proof, and sterile by process. All of Capitol Vial's molds are designed and built in-house to meet exacting specifications. Utilizing the latest Wire and RAM EDM technology, molds are built within.0005" tolerance. In addition to tooling capabilities, Capitol Vial can apply engineering expertise to integrate its container technology into both customers' and in-house high speed packaging lines. This integration provides customers with turnkey solutions to their unique packaging applications. Taking advantage of strengths in the areas of tool design, mold building, manufacturing, and packaging, Capitol Vial, Inc. has become a leading provider for the pharmaceutical, medical device, diagnostic testing, drug testing, water testing, health care, food, dairy, and confectionery industries. Capitol Vial Three Seal Design Figure #1 illustrates the critical aspects of the three seal design. The figure also depicts the position of the lid as it approaches the container during closing. The hinged design positions the lid at the appropriate angle to ensure proper closure. Figure #1 The first seal is formed by the union of the lid valve (Figure #2) with the inside surface of the container wall. The integrity of this seal is obtained by forcing the top of the container into a small space between the valve and the wall of the lid. The structural interference encountered during closing and the shrinkage that occurs during the curing stage create the airtight seal. Figure #2
The second seal is formed by the union of the top edge of the container wall (Figure #3) and the inside wall of the lid. Similar to the first seal, it is a combination of structural interference and shrinkage that guarantees the integrity of the seal. This feature's primary function is to provide a leak proof seal that prevents fluids from entering or exiting the container. The third seal is formed by the union of the outer wall of the container (Figure #4) and the undercut around the inside wall of the lid. This seal provides the another layer of protection against fluid ingress and egress and also determines the amount of internal air pressure the container will withstand. The level of internal air pressure is controlled by the ratio of surface contact to undercut. Figure #3 Figure #4 Molding and Curing The critical aspect of Capitol Vial s injection molding technology is its ability to close the container before the material is fully set. By closing the container while the part is still hot, Capitol Vial, Inc. uses the natural curing properties of the plastic to help form the seals inherent in the container design. The process for closing the container in the mold is shown in the figures below. The mold consists of two sides, the cavity and the core. The container can be closed in the mold because the cavity that forms the lid is located in a movable piece of the mold called the flipper. Plastic is injected into the mold from the bottom of the body cavity and forms around the cores. The hinge of the container provides the pathway for the plastic to flow from the body to the lid cavity. As depicted in Step 1, the container remains in the cavity after the cores have retracted. This differs from many injection molding processes where the part is usually removed from the cavity by the retracting core. Step 1
With the core side retracted, the flipper is free to rotate upwards. Step 2 illustrates the flipper moving the lid towards the body of the container. The flipper rotates 180º until the lid is closed onto the body of the container. Since the container is still hot, the plastic flexes and allows the seal to form without distortion. Step 2 As the flipper returns to its home position in Step 3, the lid is secured to the body of the container and the normal shrinkage process continues. Along with the airtight seals, shrinkage also creates the living hinge of the container. The hinge is molded in the open position and as a result acquires memory for this orientation. The hinge also obtains memory in the closed position. This dual memory creates a robust living hinge which maintains its integrity indefinitely. Step 3 Once the flipper is fully retracted, the container is ejected from the mold in Step # 4 with the use of a mechanical pin and air pressure. The container continues to cool until it reaches ambient temperature. Figure #5 shows the distortion that occurs when the lid is closed after the material has cooled and has fully set. Since shrinkage has occurred, the plastic is less flexible and the first and third seal areas are distorted upon closure. This distortion damages the integrity of the seals and prevents the container from being airtight or leak-proof. Capitol Vial's unique closing processes prevent the plastic from cooling excessively before closure and ensure a perfect seal. Step 4 Figure #5
Features and Benefits One-piece design Eliminates tolerance mismatches between bottles and caps Removes any cross contamination issues Improves productivity through ease of opening and closing Reduces number of inventory items Cost effective The container can be easily opened or closed with one hand. Container and lid are made of the same material Container and lid have the same coefficients of shrinkage and expansion and will maintain the integrity of their seal despite large variations in temperature Sterile by process / FDA /CFR 21 standards Eliminates need to perform secondary means of sterilization Prior to Opening Tamper evident by process (Pictures at right) Only manufacturer that can ensure tamper evidency as container exits mold The tamper evident arrow is molded to the body of the container and is inserted into the arrow box when the container is closed in
the mold. The arrow separates from the body of the container and is ejected from the arrow box upon the initial opening. Eliminates need to provide secondary means of tamper evidence After Opening Customizable Able to make any size, shape, color, or clarity Easy to emboss, engrave, label, and silk-screen Child-proof closures Chain of custody closures Additional snap seal or locking tab closures can be added to eliminate accidental opening Compatible with Activ-Pak family of products Create uniform environment inside of container (e.g. RH) Environmentally friendly 100 % recyclable Leak proof / airtight (approximately 100 micrograms a day depending on size and style of container - see graph) Improves safety by eliminating potentially hazardous substances leaking from container Maintains product integrity and prolongs shelf-life Allows container to maintain sterility throughout life cycle Operational Practices 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. PROCEDURE: Leak Detection Testing 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. 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. Moisture Vapor Transfer Rate Testing (MVTR) PURPOSE: Validates seals in the container. Serves as a diagnostic tool by indicating imperfections in the seal area before product is non-conforming. Measures the force required to open the container. Ensures container can be easily opened by anyone. Measure the volatile odors inside the container. Ensures containers conform to baseline odor parameters. Determines MVTR through the seal and sidewall of the container. 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.
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. Microbiological Testing Determines the impact strength of the container at different temperatures. Ensures containers can withstand impact across a range of environmental conditions. Determines the sterility of the container. Swab inside wall of containers and transfer to growth agar for enumeration. 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. 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. Quantifies internal air pressure required to break container seal. Validates the efficacy of airtight seal Ensures container meets minimum requirements to withstand air transport. Detects and rejects any container which does not meet the airtight specification. For more information contact: Capitol Vial, Inc. 2039 McMillan Street Auburn, Alabama 36832 Telephone: (334) 887-8311 Fax: (334) 887-8328 E-mail: sales@capitolvial.com