Medical and pharmaceutical products play a vital role in the health and safety of patients. As such, ensuring the quality of each product and its individual components throughout the manufacturing process—from design to final inspection—is essential. For this reason, it is vital to partner with an experienced medical/pharmaceutical component manufacturer that emphasizes quality and offers complete part traceability from start to finish.
At Sterling Healthcare Manufacturing, we specialize in full-service, turnkey plastic component injection molding solutions. Our comprehensive part manufacturing capabilities allow customers to maintain oversight over the production of their parts, resulting in greater transparency and accountability. Additionally, we maintain ISO 9001:2015, our new ISO 13485 and employ the use of FDA/medical-grade materials to ensure our injection molded components fully meet the strict specifications and standards of the medical and pharmaceutical industries.
Plastic injection molding is an efficient and cost-effective method of producing medical and pharmaceutical parts to high levels of precision, accuracy, and quality. It is used to create components from medical devices and equipment to laboratory tools and testing instruments. The following page provides an overview of the plastic injection molding process and its essential role in the medical and pharmaceutical industries.FDA-Registered Nasal and Throat Testing Swabs
The Importance of Plastic Injection Molding in the Medical & Pharmaceutical Industries
Advancements in material manufacturing techniques and technologies have led to the widespread use of plastics in modern manufacturing operations. In the medical and pharmaceutical industries, plastics are often used alongside the injection molding process to produce prototypes and full-production units of medical device and equipment components. As newer plastic materials and component designs are developed, injection molded plastics have increasingly contributed to lower infectious disease rates, better pain management, and lower medical costs.
Advantages of Plastic Injection Molding for Medical Applications
Compared to other plastic manufacturing processes, plastic injection molding offers a number of clear advantages, especially when working with a knowledgeable and skilled injection molding partner. These benefits encompass the following:
- Compliance with industry standards/regulations: Engineering-grade plastics can be used in plastic injection molding operations to create parts that enhance patient safety and comply with FDA guidelines. Additionally, these medical plastics parts require less finishing work than metal ones, resist contamination, and maintain an easy-to-clean surface.
- Traceability: In the medical and pharmaceutical industries, traceability is essential. At Sterling Healthcare Manufacturing, our complete part traceability capabilities provide customers with the peace of mind that comes with knowing we are actively and carefully monitoring every step of the manufacturing process.
- Mechanical properties: Injection molded parts made from engineering-grade plastic resins exhibit exceptional mechanical properties, including tensile strength, high-temperature resistance, and tolerances comparable to those of metal parts.
- Material waste: While injection molding operations generate some material waste, we have a system in place to recycle our excess plastic to increase our overall sustainability and decrease our environmental footprint.
- Flexibility: By working with uncolored virgin material, we can customize each part color to meet the exact needs of the customer.
- High volume repeatability: In medical device manufacturing, a few millimeters or microns can differentiate between a functional component and a failed component. Sterling Healthcare Manufacturing—must have the skills to produce high-precision, high-accuracy components in both small and large quantities.
- Cost savings: Injection molding is a cost-effective manufacturing method, especially for high production volumes. By employing automation technology and energy-efficient equipment, we further reduce our labor and utility costs. These savings can then be passed on to our customers.
Injection Molding Applications in the Medical & Pharmaceutical Industries
As indicated above, injection molding is one of the most efficient and cost-effective ways of manufacturing parts that meet the strict specifications and standards of the medical and pharmaceutical industries. For example, the process is often used to manufacture the small, high-precision components found in diagnostic testing kits, such as the lateral flow in-vitro diagnostic test cartridge produced in large quantities by our team.
Examples of other plastic injection molded parts for the medical and pharmaceutical industries include:
- Laboratory supplies, such as beakers, test tubes, and other containers
- Enclosures for medical and laboratory equipment, such as housings and casings
- Surgical and surgical prep equipment and supplies
- Dental X-ray equipment components
Medical-Grade Plastic Options
The injection molding process accommodates a wide range of plastic materials, making it well-suited to produce medical and pharmaceutical parts from whatever medical-grade plastic is required for the project. There are numerous plastics suitable for medical injection molding operations, each of which offers unique properties and performance characteristics. Common plastic material options for medical injection molding include:
- Polyethylene: Polyethylene is a widely used thermoplastics found in many industrial and commercial products. 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: Polypropylene is one of the most commonly used plastics. It is characterized by its ruggedness, durability, and elasticity, as well as its resistance to chemicals and electricity.
- Polystyrene: Polystyrene is a hard plastic with little to no flexibility. It exhibits excellent machinability, good impact resistance, and decent dimensional stability. It is often used for its aesthetic quality and easy-to-customize surface.
- Polycarbonate: Polycarbonate is a strong engineering-grade thermoplastic that offers dimensional stability and flame retardant properties. It is also resistant to damage stemming from impact, high heat, and UV radiation.
- PEEK: Polyetheretherketone (PEEK) is a high-performance thermoplastic known for its extraordinary mechanical properties, including resistance to thermal degradation, wear, tracking, and radiation.
Given the broad selection of suitable material options available, the first step in choosing a material for a project is narrowing down the list to the material family that fulfills the most part requirements (e.g., tensile strength, temperature load rate, etc.). From there, it is much easier to select the grade that best suits the project. Online databases—such as UL Prospector, MAT Web, and The British Plastics Federation—can provide information about materials that can further facilitate the selection process.
Selection Considerations for Medical Grade Plastics
As mentioned above, there are many types of plastics available for medical injection molding operations. Each plastic possesses distinct qualities that influence how it performs in specific applications. Some of the key factors to consider when choosing between the material options include:
- Strength: The selected material should provide the level of strength needed to support the application.
- Industry standards: It should fully comply with FDA and medical industry standards relevant to the final component.
- Operating conditions: The material should accommodate all of the requirements of the application environment. For example, if the finished component part will be subjected to chemical or high heat (e.g., in sterilization operations), the material should offer adequate chemical and temperature resistance.
- General use: The material should be chosen with regard to who will use and how it will be used. For example, surgical instruments should be lightweight, functional, and ergonomic. At the same time single-use drug delivery products (e.g., tubing, bags, needles, and connectors) should be flexible, durable, transparent, sterile, and, most importantly, cost-effective.
Medical and Pharmaceutical Solutions from Sterling Healthcare Manufacturing
At The Sterling Healthcare Manufacturing, we understand the importance of quality in component manufacturing. By leveraging our extensive knowledge of the medical and pharmaceutical industries, we provide full-service, turnkey plastic injection molding solutions that fully comply with industry specifications and standards. For additional information about our plastic injection molding capabilities and how we serve the medical and pharmaceutical industries, contact us today.
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To see an example of our work in the medical industry, check out this case study documenting how we optimized the mold design for a polystyrene diagnostic kit. You’ll also learn about how our custom capabilities — such as machine vision inspection — guarantee quality, cost efficiency, and 100% reliability for every order we complete.