When creating components for medical and pharmaceutical devices, manufacturers must meet extremely high standards of quality. Since medical equipment and devices directly affect the health and safety of users, parts are subject to stringent regulatory standards for material quality, precision, and traceability.
The Rodon Group is proud to offer superior-quality plastic injection molding services for a variety of customers in the medical and pharmaceutical industries. Our full-service turnkey capabilities include full-component traceability and adherence to even the most rigid industry standards. An experienced medical equipment parts manufacturer, we have the industry knowledge necessary to ensure that your medical and pharmaceutical components are manufactured to exact specifications within tight tolerances.
Restrictions on Specifications
To ensure compliance with health and safety regulations in the medical and pharmaceutical industries, parts manufacturers must conduct quality assurance checks and monitor every step of the way. The Rodon Group takes quality assurance seriously, which is why we have developed a comprehensive ISO 9001:2015-certified quality management system to ensure our products meet or exceed industry standards and regulations for all components. We use medical-grade and engineering-grade resins that meet strict FDA standards, and all our components can be custom-engineered for enhanced chemical-resistance, durability, thermal-resistance, and antimicrobial properties. Our intensive understanding of the medical and pharmaceutical industries allows us to produce top-quality parts for imaging, diagnostic, testing, and surgical equipment.
Designing for Your Material
Every plastic resin has different characteristics that make it useful. For sensitive medical device components, for example, it is especially important to consider the application when choosing your material. Rodon’s seasoned injection molding experts have an in-depth understanding of resin properties and medical industry requirements to make certain that you have the best material for the application. As an experienced medical part manufacturer, we will help ensure that your resins are effective while meeting FDA, RoHS, REACH, and NSF regulations.
Whether you need high-strength plastic material to withstand pressure or a temperature-resistant plastic that can withstand frequent sterilization processes, Rodon has the right injection-molding material for your application.
Common materials used for injection-molded medical components include:
Polyethylene is light, flexible, tough, and biologically inert, but it cannot withstand high sterilization temperatures. It is often used for medical supplies such as dispensing bottles, IV tubes, and medical implants. It is available in several variations—e.g., LDPE, HDPE, and UHMW—with varying levels of rigidity and durability. UHMW is often integrated into prosthetics for the hip, knee, or other joints.
Polypropylene is highly durable and can withstand the extreme temperatures of autoclave and radiation sterilization processes. This makes it ideal for reusable medical devices such as syringes, test tubes, beakers, and pipettes.
Polystyrene is notable for its hardness, chemical- and temperature-stability, and biocompatibility. It is transparent, less flexible than other medical grade plastics, and often used in test tubes, Petri dishes, and diagnostic equipment.
Polycarbonate is transparent, tough, and highly resistant to impacts, UV radiation, and heat, all of which make it highly valuable for manufacturing dialysis equipment, IV connectors, and even surgical implements.
When you use plastic instead of metal for medical components, you reduce the potential for adverse effects due to corrosion, contamination, and patient sensitivities. The physical and chemical properties of molded plastics are better suited to meet the rigorous standards of the medical industry while maintaining patient health and safety.
Considering Part Quantity
When creating your medical component design, production quantity is an important consideration. Injection-molded parts can be produced in high quantities with multi-cavity molds, thereby increasing the overall production efficiency. Injection molding is ideal for producing complex parts that are common in the medical industry. With advance planning, molds can be created to quickly and efficiently produce detailed components that meet or exceed industry standards.
Keeping Design Cost Low
Injection molding is a cost-effective way to create complex parts that would otherwise be expensive to manufacture. Plastic is less expensive to produce and form than metal, and injection molding produces less material waste. The ease with which plastic can be molded and formed makes injection molding faster, easier, and more cost-effective than other tooling methods.
To ensure the best service at the lowest price, select a manufacturer with a wide range of manufacturing and tooling capabilities and press sizes. Ideally, your products should be completed through one provider to reduce overhead and streamline the process.
Choose The Rodon Group for Your Injection Molding Needs
At The Rodon Group, we are dedicated to providing reliable, medical-grade parts and components that meet and exceed stringent standards in the medical and pharmaceutical sectors. Although we do not manufacture body-invasive parts, we provide full-service, turnkey plastic injection molding solutions that fully comply with industry specifications and standards. To learn more about Rodon's injection molding services for medical and pharmaceutical applications, visit our medical & pharmaceutical industry page or request a quote today.