ISO 13485:2016 Certified - FDA Registered

Injection Molding

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At Medbio, we assume the responsibility of providing our customers the highest quality products, on time. ISO 13485:2016 certified and FDA registered, Medbio satisfies the expectations of the most demanding medical device manufacturers. Whether its problematic transfer tooling or complex new product builds, Medbio will deliver the quality you expect.

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Medbio is an ISO 13485:2016 certified full service contract manufacturer.
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We have 45 molding presses ranging in size from 17 ton to 350 ton, contained in an ISO Class 8 certified clean room and a micro-molding press contained in a modular, ISO Class 7 certified clean room. Medbio uses modern hydraulic and hybrid-hydraulic/electric injection molding machines that utilize innovative, hydraulic technology to achieve dynamic accuracy that is usually only obtained using high-end electric molding machines. Through much testing, Medbio staff has determined our hydraulic molding machines are a cleaner alternative to lubricated, ball-screw-driven, electric machines when molding in a controlled environment area (CEA). Multiple, air-cooled, electric motors create non-laminar air movement that further discourages the use of electric machines. The relationship between the screw/barrel and the molding process is optimized by using modular injection units. Shot capacity and screw design are critical when preparing pelletized polymers for injection into complex injection molds.
Scientific molding techniques are employed using Kistler-brand cavity pressure transducers. Molding processes are developed using a series of tests that define the capabilities of each unique mold, material and machine combination. Cavity pressure integrals are controlled and monitored throughout the mold’s life-cycle. Slight variations in the molding process can lead to major variations inside of the mold’s cavity. With flush-mount and behind-the-pin cavity- pressure sensors, these amplified changes can be observed and trigger alarms to notify personnel so that root-cause analysis can begin. Without the use of cavity-pressure technology, these fluctuations within the mold can go unnoticed.

Medbio knows that over 80% of the injection molding process is dedicated to cooling molten plastic. The cooling process, that begins as plastic first enters the mold, needs to be controlled in order to properly bring the amorphous plastic back to its solid state. Precision temperature-control units coupled with cavity pressure profiles that cater to the plastic’s unique morphology are key to producing the high quality plastic injection molded components that are required in today’s medical devices.

Due to the challenges of maintaining a clean room molding facility, Medbio uses pressurized water in place of particulate-matter-generating, oil-based, heat-transfer fluid systems. Other benefits of this strategy include: More efficient transfer of heat from the mold when compared to higher-viscosity, heat-transfer fluids, as well as avoiding the unnecessary disposal of spent fluids.

Material is pre-dried in a modular Motan-brand desiccant drier. Arburg- brand driers are used press-side to dry and convey resin to the molding machines. Resin is bathed in desiccated air as it resides in the receiver on the feed throat of the molding machine. We do not use a central material handling system. By using the press-side drying concept, we are able to control cross contamination that is inherent in central material handling systems.

Medbio is well-versed in the molding of resins used in the medical and biotechnology industries. Some of the resins that our staff have experience with are the following:













This list is not all inclusive.

Due to the low to mid-volume nature of many medical, surgical applications, we have had to adapt. Medbio uses modular tooling whenever possible and change-over times have thus been minimized. Historically, we average approximately 1 change-over per day, per machine.

The medical device molding processes that are developed at Medbio are “data driven”. Each production-intent mold undergoes a series of studies in order to determine optimal processing conditions. Our technical staff is well versed in “Scientific” molding principles. Our molds are built to accommodate “Scientific” processes that can accommodate variation and are repeatable over time.

When Medbio is awarded the opportunity to develop tooling for a customer, tooling is designed by people who live and breathe injection molding. Starting from the point of injection, runners, gates and vents are designed with care to insure that molded parts can be produced that are free of defects, both visible and functional. Again, cooling is at the forefront of the tooling development process. We are constantly pursuing technological advancements that help us to fulfill our mission to provide high-quality injection molding services and on time delivery to our customers.
Innovative.  Trustworthy.  Knowledgeable.  Passionate.
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