Our state of the art facility is equipped with 15,000 square feet of cleanroom space that range from class 1,000 to class 100,000 and one "white room." Each room is designed to meet the needs of a variety of medical device manufacturing requirements well into the future. Our combined equipment resources include RF hole punching, RF sealing and tipping, UV/solvent bonding, die cutting, packaging, and custom-form, fill and sealing equipment. Automated assembly allows us to better control our processes and, as a result, maintain cost efficiency.

Our operating, manufacturing and quality assurance systems, as well as our trained staff are flexible and easily adapted to a broad spectrum of contract assembly operations. The contract assembly activities may be as simple as a single assembly or labeling operation of a subassembly or component to a total assembly, packaging, contract sterilization and distribution of a finished device.

The melting and molding of smooth, consistently uniform tips onto the ends of plastic tubing through heat generated by combining radio frequency (RF) with custom fixtures and tooling.

RF Hole Punching: the process of producing holes with highly polished edges in plastic tubing. Our state-of-the-art equipment, which punches or melts the holes by heating our dies with radio frequency energy combined with our unique technology, is easily adjusted to produce multiple holes in a variety of tubes and materials during a single cycle. Cold Punching: our most cost-effective procedure, we use a mechanical press to cleanly cut precise holes in the side of plastic tubing. Side Hole Drilling: when a radiused edge is not required, we adapt our unique technology to our drill presses to cleanly cut precise holes in the side of plastic tubing. Skiving: a process perfected for precision side cuts on tubing by customizing our fixtures and blades in a mechanical press. APPLICATIONS • Urinary Catheters • IV Catheters • Cannulae • Gastrology Tubing • Oxygen Tubing • Suction Catheters

the sealing or fusing of vinyl materials and components, including Clam-shell blister packages. Our dual cycle operation, which uses radio frequency heating technology, can deliver two different sealing applications simultaneously. In a single press closure, our innovative process can seal such components as tubing and valves between two sheets of vinyl and, at the same time, fuse sheets of material to form a bag. APPLICATIONS • Drainage Bags • Fluid Bags • IV Bags • Ostomy Pouches • Wound Care Bags • Oxygen Bags • Pressure cuffs • Waste Bags • 360 Degree Tube Seals • Seal Clam-shell Type Blister Packages

the dispensing of a variety of adhesives and solvents of varying viscosities to cylindrical and flat surfaces. To ensure smooth and accurate distribution of adhesives, we rely on our precise dispense valve systems with invaluable programmable dispense times and reservoir tanks. The way we cure UV adhesives depends on our customers and the type of bond and product configuration they give us. We use what best meets the need: either Spot Weld UV curing devices, UV lamps in a stationary curing chamber or variable speed conveyors.

the high-speed, efficient cutting of materials where precision and edging specifications are required. We get the job done by combining the power of our hydraulic press with Swing-Out Head with our custom cutting dies and fixtures.

the application of foil or heat transfers such as graduation markings, product identification and customer logos to flat or slightly crowned surfaces. Our high tech Hot Stamping Equipment is outfitted with must-have digital-controlled processing functions. The invaluable slide table attachment helps us meet customers' imprinting needs by holding a wide variety of sizes, materials and product configurations. Hot Stamping may be utilized to imprint information such as • Graduation Marks • Product Identification • Customer Logos

the complex process of encasing customer products in air, vacuum and modified-atmosphere packs. Our time-proven method is to thermoform a roll of film into a custom die, forming a pocket to hold the customer's product. This package is then heat-sealed with one of a variety of top films: poly, nylon, paper or Tyvek. An automatic high-speed operation, this sophisticated system not only creates a reliable sterile barrier for medical devices, it is also superbly adaptable to a variety of forming and sealing configurations simply by changing the die and cutting equipment. And we're happy to customize your package. We can In-Line Emboss lot numbers and In-Line Print elaborate package artwork, including bar coding.

VALIDATION As a full service contract manufacturer, Apogee Medical Inc., not only performs validations for Apogee owned equipment and processes, we will also validate customer-supplied equipment. Each validation package includes comprehensive protocols and reports for: • Installation Qualification of the applicable equipment • Operational Qualifications for the equipment utilizing tooling and materials unique to each application or product • Process Qualification of the entire manufacturing process from start to finish In addition, Apogee Medical, Inc. performs process validation for contract services such as EtO and Gamma Sterilization. CE MARKING Our comprehensive ISO 9000-2000 compliant Quality System and experienced staff allow us to validate and qualify products and processes, as well as, prepare detailed Technical Files required for "CE Marking" your product for introduction into the European Community. PRE-MARKET NOTIFICATION -510(K) PREPARATION If your product is being modified or being introduced into the market for the first time, Apogee Medical, Inc., will perform necessary research, testing and analysis to demonstrate the device is substantially equivalent to a device already cleared by the Food and Drug Administration for distribution. Apogee will prepare and support a comprehensive Pre-market Notification -510(k) for the submission to the U.S. Food and Drug Administration.

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