Injection Molded Parts for the Medical & Pharmaceutical Industry
At Elimold, we provide services for both small and large medical plastic injection molding companies. We are ISO 13485:2016 registered at all medical locations including FDA site registrations. Our quality system is rooted in the CFR 21 820 guidelines and we take great pride in making quality components while containing risk. All projects go through stringent design reviews including complete DFMEA and PFMEA is analysis to ensure quality designed into the part and not inspected for after manufacturing. We employ automated inspection and real time process monitoring to ensure defects are contained and zero escapes result.
Development partner for pioneering medical injection molding solutions
Working closely with medical technology pioneers, we turn new ideas into solutions that support advanced medical treatments.
Together with our partners, we develop high precision medical injection molded products and assemblies competently, flexibly and to the highest quality standards. We ensure smooth industrialisation through professional project management.
Our robust product development and quality assurance programmes ensure that the medical products perform with the highest reliability as part of the application, superior quality and compliance with the demanding industry standards.
FDA Requirements
The Federal Food and Drug Administration (FDA) has different requirements for plastic materials based on the amount of contact the device or part will have with the human body. These requirements are divided into three broad categories.
- The most regulated plastic in medical devices are those that will be implanted in the human body. These medical devices have a long list of requirements and must be made of certified non-toxic materials and materials proven not to break down over the lifetime of the implant. These parts must also be manufactured in a certified clean room.
- The next category of medical devices are rated for prolonged, external skin contact with the human body. These medical devices have more relaxed FDA requirements and can be manufactured by most injection molding companies.
- The last category of medical devices will have limited contact with the human body. An example would be a cardiac monitor. Human interaction is limited to interacting with the plastic outer shell or the plastic buttons of the monitor. This category of medical devices has the fewest FDA regulations when compared to the other medical device categories.
Cleanroom Assembly & Packaging
To provide our customers a single source solution, we offer ISO Class 7 (10K) cleanroom assembly and packaging services to complete your medical device injection molded project while adhering to the critical medical quality standards required when plastic injection molding medical parts. We offer complete quality control and inspection including IQ, OQ, and PQ validations, and lot traceability. Using automated work cells to provide increased throughput and speed-to-market.
Process Validation
In many cases, our medical device customers look to process validation to ensure quality parts. After all, patients lives depend on PTI to deliver high quality parts each and every time.
Process Validation as defined by the FDA is “The collection and evaluation of data, from the process design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality products.”
Process validation is the best way to ensure the production of safe parts, to reduce rejection rates, to prevent part failures in the field and to ensure the part meets with application, specification and regulatory obligations.
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.
Injection Molding Technologies For Demanding Medical Applications
With our comprehensive portfolio of Medical Grade MT materials, we offer a very high variety of materials in injection molding in medical technology and thus excellent choices for individual applications.
In addition, we offer extensive injection molding materials expertise for an application-specific material development with in-house compounding.
Overmolding, insert molding, multi-component injection molding, injection molding MuCell®-technology can offer flexible solutions for the integration of functions as well as the production of medical assemblies. Through various printing and marking technologies (e.g. laser marking), surface treatments, deburring technologies (e.g. blasting), custom requirements regarding haptics, optics and traceability are met.
Custom Medical Injection Molding With Elimold
Our precision injection molding options include scientific molding, R&D molding, high-cavitation molding, micro molding, over molding, and insert molding.
As the industry leader for medical plastic injection molding companies, our mold maintenance plan ensures each mold undergoes regular cleaning and review at predefined intervals based upon the number of setups and cycles. Mold inspections, general mold maintenance, major mold maintenance, and preventative maintenance are standard operating procedures.
Elimold offers in-depth conceptual design support. Our engineers use DFM and DFA to address risks before production.
Our secondary operations include ultrasonic cleaning, cnc machining, liquid filling and sealing, and shrinkwrapping.
Our product finishing capabilities include hot stamping, banding, pad printing, silk screening, flaw coating, conductive painting, cosmetic painting, metalizing, and plating.
Our assembly and joining capabilities include product filling, foil/heat sealing, ultrasonic welding, heat staking, mechanical assembly, pinning & UV/hot melt gluing, custom packaging/kitting, and pouching.
Keys to Successful Injection Molding for Medical Devices
You can expect that Elimold will provide all needed injection molded components utilizing our in-house expertise in part DFM, tool design, tool build, and part processing with scientific molding technologies.
At Elimold we understand the quality of a product is only as good as the quality of tooling produced. Elimold focuses on offering high quality tooling solutions featuring robust processes and reduced speed-to-market timing. More about Tooling capabilities.
All components molded at Elimold are for healthcare applications, and our molding processes are validated using IQ/OQ/PQ protocols. We specialize in components that rely upon complex geometry and challenging quality requirements. Using scientific molding practices we assure premium components with each press cycle. More about Thermoplastics capabilities.
At Elimold we understand that precision matters when it comes to micro molded medical parts. We manufacture even the smallest parts while still holding precise tolerances. Our in-house tooling department is equipped to provide custom micro-prototyping and production molds. More about Micro/Mini capabilities.
At Elimold, we have proven that complex silicone parts can be produced repeatedly in nearly half the lead-time as traditional silicone molding options. With capabilities that range from up-front product development through the introduction of finished devices, we can bring your silicone program to market in the shortest time with the most predictable outcome. More about Silicone capabilities.
History, experience and precision injected into every medical mold
Husky Medical Molds Powered by Elimold
Elimold molds have been renowned in the medical mold industry for their precision, speed, and excellent repeatability. Because of their compact cluster design, consistent wall thickness, and high-volume capacity, Elimold medical molds have been the pre-eminent choice for use in medical and laboratory settings. Elimold mold technology is exclusive to Husky medical injection molding systems and solutions. Husky Technologies customers enjoy an enhanced level of technical expertise in the production of the highest-quality parts, additional capacity to increase speed-to-market, and improved responsiveness delivered by the industry’s largest global service and support network.
Medical Injection Molding Samples & Applications
- Implantables
- Imaging Components
- Ear, Nose & Throat
- Orthopedics
- Regenerative Medical Devices
- Device Housings
- In-Vitro Diagnostics
- Gastroenterology
- Home Healthcare Devices
- Prenatal Care
- Cardiovascular
- Surgical Devices & Instruments
- Pharmaceutical
- Labware
- Dental Products
- Emergency Care
Turnkey solutions for your medical device development
Elimold uses plastic injection molding in the fabrication of medical components for the many advantages it affords. We rely on MIM for the following reasons:
- It offers a versatile method for mass production
- It allows for the production of prototypes at nearly any scale
- Injection molding affords detailed features and complex geometries
- Injection molding easily create physical prototypes for newly designed equipment in order to facilitate necessary testing and monitoring
- Plastic injection molding allows for great detail within the cast
Elimold uses injection molding as a very cost-effective way to produce high-grade plastic devices. The use of extreme-pressure mold injection vastly reduces the amount of time required for production. This allows rapid turnaround at high volumes, as well as reduced labor costs compared to other production methods.
We offer start-to-finish manufacturing services, including:
- Assistance with new product design
- Engineer services using CAD software
- Complete in-house mold shop utilizing CAM software
- Affordable short production/prototype runs
- Full-scale production runs 24/7
- Product assembly & fulfillment with custom packaging
Medical and Pharmaceutical Solutions from Elimold
At The Elimold, 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.