Medical Injection Molding Services
PRECISION. PASSION. PEOPLE.
Medical, Diagnostic, and Pharmaceutical Product & Device Manufacturing Industries
Your solution partner for innovative product development and manufacturer of Medical, Diagnostic, and Pharmaceutical products. MOS Plastics is ISO 13485 certified and FDA registered regional contract manufacturer offering 3 facilities in California and Mexico.
Quality Plastic Injection Molding Services for Medical Devices
In the healthcare industry, MOS Plastics is a world leader when it comes to diagnostic device and medical injection molding. We are a top-tier, preferred supplier for well-respected medical device and technology leaders such as Abbott, Agilent, Allergan, and Cepheid.
Turnkey Injection Molding Solutions
At MOS Plastics, we are heavily invested in new technology, equipment, and processes as a commitment to our customers. If you are looking for complete turn-key manufacturing/assembly, MOS Plastics is your solution for class ll and class lll finished medical device projects. Our medical injection molding operations provide class 7 cleanrooms with horizontal and vertical medical injection molding machines to support cost-effect, tight tolerance parts to market in a timely manner.
The Medical Injection Molding Process at KS Plastics
1. Clamping: Securing the Mold
In the first step, the mold is securely closed using high pressure. This ensures that the mold can withstand the injection force during the subsequent steps. Proper clamping is critical to preventing mold misalignment, which could result in product defects.
2. Injection: Introducing Molten Plastic
Molten medical-grade plastic is injected into the mold cavity under high pressure. The material fills the mold completely, taking on the precise shape of the part. This step is key to ensuring accuracy and consistency in the final product.
3. Cooling: Shaping the Plastic
Once injected, the molten plastic cools and solidifies within the mold. Cooling time is controlled to ensure the plastic retains the desired properties and shape. The cooling phase is essential for ensuring part strength and dimensional accuracy.
4. Ejection: Finalizing the Product
Once the plastic has cooled and hardened, the finished part is ejected from the mold. The ejection process must be done carefully to avoid damage to the part and to ensure it maintains its integrity during removal.
Why is Medical Injection Molding Important?
Medical injection molding plays a vital role in the healthcare industry due to its ability to support the high-volume production of parts while maintaining precision and complexity. The process enables the creation of intricate designs and ensures that tight tolerances are met, which is essential for the performance and safety of medical devices. From simple items like syringes to more complex components such as implants, injection molding is integral to the manufacture of a wide variety of medical products. Its ability to deliver consistent quality, day in and day out, makes it an indispensable tool in the medical field.
Examples of Products Manufactured Through MIM
Injection molding is used to produce a broad spectrum of medical products. These include essential items such as syringes and catheters, which require high precision and sterility, as well as more complex devices like implants and surgical instruments. Other medical products made through injection molding include diagnostic test kits, fluidic components, and connectors for electronic medical devices.
1. Surgical Instruments
Medical injection molding is used to create high-precision surgical instruments such as forceps, clamps, and scissors. These tools must meet rigorous standards for strength, durability, and sterility. The injection molding process ensures consistent quality across large batches of instruments, which is critical for their performance during procedures.
2. Implants
Injection molding is used to manufacture medical implants, such as joint replacements, dental implants, and bone screws. These products require precise molding to ensure they fit properly and function effectively within the human body. The molding process allows for complex shapes, which are essential for the implant’s functionality.
3. Diagnostic Devices
Medical injection molding is key in the production of components for diagnostic devices, including test kits, sample tubes, and fluidic components. These products need to meet strict standards for accuracy and cleanliness, which the molding process supports by maintaining tight tolerances and quality.
4. Catheters
Catheters, used for medical procedures such as heart surgeries or urinary tract management, are another product manufactured using injection molding. These devices are typically made from flexible medical-grade plastics that need to be precisely molded to ensure ease of insertion and durability.
5. Syringes
Syringes are a staple in medical care, used for administering medication, vaccines, and fluids. Injection molding ensures that syringes are made with precise dimensions, ensuring safety and effectiveness. The high-volume production capacity of injection molding makes it ideal for producing the large quantities of syringes required globally.
6. Fluidic Components
Fluidic components, such as valves, pumps, and connectors used in medical devices, are often manufactured using medical injection molding. These parts require exacting tolerances to ensure proper fluid flow, as even minor deviations can impact the performance of medical equipment.
7. Connectors and Housings
Injection molding is commonly used to manufacture connectors and housings for electronic medical devices. These components need to provide both mechanical protection and reliable connectivity, and the precision of injection molding ensures they meet these requirements.
The versatility of injection molding allows it to be used for both simple and highly specialized medical devices, ensuring that a wide range of needs in the healthcare industry can be met.
Regulatory Standards & Compliance
At MOS Plastics, we understand the importance of regulatory compliance in medical device manufacturing. Our operations are ISO 13485 certified, which means we meet the stringent requirements for quality management systems specific to medical devices. We are also FDA registered, ensuring our products meet all necessary regulatory standards for safety and efficacy. To further ensure product sterility and safety, our facilities operate with Class 7 cleanrooms, maintaining an environment that is free of contaminants, which is crucial for producing medical-grade components. In addition, our use of cleanroom environments helps us comply with the strict standards required for medical device manufacturing.
Sterilization Methods
Sterilization is a key part of the medical injection molding process. At MOS Plastics, we utilize several sterilization methods to ensure that our products are safe for medical use. Autoclaving, which uses high-pressure steam, is commonly used for sterilization, as well as gamma radiation, which ensures microbial safety. Ethylene oxide is also used for devices that cannot withstand heat. These sterilization methods are essential to ensuring that the medical components we produce are safe for patient use and comply with healthcare industry regulations.
The Role of Cleanrooms in Medical Injection Molding
At KS Plastics, our medical injection molding process takes place in state-of-the-art cleanroom environments to ensure the highest standards of cleanliness and safety are met. Cleanrooms are specialized, controlled environments designed to reduce the presence of airborne particles, microbes, and other contaminants that could affect the quality and safety of medical components.
Cleanrooms are essential for manufacturing medical devices because even the smallest particle contamination can result in defects or compromise the sterility of medical products. For example, contamination during the molding process could affect the biocompatibility of the plastic used in devices like syringes, implants, or catheters, making them unsafe for patient use. Therefore, manufacturing in a cleanroom environment ensures that only parts that meet the highest cleanliness standards are produced.
At KS Plastics, we operate Class 7 cleanrooms, which are rigorously controlled to limit dust, airborne bacteria, and chemical vapors. These cleanrooms are equipped with HEPA filters that trap particles as small as 0.5 microns, and the air within is constantly monitored for cleanliness. Our cleanroom protocols also include strict gowning procedures for operators to prevent contamination from clothing or skin, further ensuring that the medical components produced are safe and sterile.
In addition to maintaining cleanliness, cleanrooms provide the necessary environmental control for temperature and humidity, which are crucial for the precise molding of medical components. These conditions help maintain the consistency and quality of the products, ensuring that they meet the tight tolerances required for medical devices.
Ultimately, the use of cleanrooms at KS Plastics ensures that every part produced is free from contamination, meets all regulatory standards, and is safe for use in healthcare applications.
Types of Plastics Used in Medical Injection Molding
In medical injection molding, the materials used are crucial to the functionality and safety of the end product. At MOS Plastics, we specialize in using medical-grade thermoplastics that offer both biocompatibility and durability. These materials are selected not only for their ability to withstand the rigors of medical applications but also for their compatibility with the human body, ensuring there are no adverse reactions. The thermoplastics used are also able to endure sterilization methods like autoclaving and gamma radiation, making them ideal for medical device manufacturing.
Why Choose MOS Plastics?
MOS Plastics is committed to providing turnkey medical injection molding solutions that meet the highest standards of quality and precision. Our state-of-the-art facilities in California and Mexico include Class 7 cleanrooms and over 60 molding machines, allowing us to produce medical components at scale while maintaining strict quality control.
We have a proven track record as the preferred supplier for leading companies in the healthcare industry, including Abbott, Agilent, and Allergan. With our deep expertise in medical device manufacturing, we are able to deliver cost-effective, tight tolerance parts that meet your specifications and timelines.
Contact Us
Ready to get started with your medical device project? Contact MOS Plastics today to learn more about our precision injection molding services and how we can help you manufacture high-quality medical components that meet the industry’s stringent standards.
Frequently Asked Questions (FAQ)
- What types of medical devices can be made with injection molding?
Medical injection molding can be used to create a broad range of products, from syringes and surgical instruments to more complex devices like implants, diagnostic kits, and fluidic components. The versatility of the process makes it suitable for many applications in the medical field. - What are the key benefits of medical injection molding?
Medical injection molding provides high-volume production of parts with precise tolerances and the ability to create complex designs. This ensures that the products are reliable, safe, and consistent, making it essential for producing medical devices. - What materials are used in medical injection molding?
We use biocompatible thermoplastics, which are durable, safe for use in the human body, and able to withstand sterilization processes like autoclaving and gamma radiation. - How do you ensure the quality of your medical products?
We maintain strict quality control measures, ensuring that all products are tested for biocompatibility, strength, and sterility. Our ISO 13485 certification and FDA registration ensure that our manufacturing processes meet the highest standards for medical devices. - What is the difference between cleanroom molding and standard injection molding?
Cleanroom molding is performed in a controlled environment designed to limit contamination, making it essential for manufacturing medical components. In contrast, standard injection molding does not involve these stringent cleanliness controls, which is why cleanroom molding is vital for medical device production. - What sterilization methods do you use?
We use autoclaving, gamma radiation, and ethylene oxide to sterilize our products, ensuring that they are safe and meet all regulatory requirements for use in healthcare.