Injection molding is a popular production method in the medical business, with several benefits for a broad range of applications. Medical-grade plastic injection molding is utilized in various applications, including medical devices, components, laboratory and facility equipment, etc.
The flexibility of the injection molding process to match the medical business’s stringent criteria and regulatory demands is one of its primary benefits, which we’ll go over in more depth below.
Some Advantages of Injection Molding
Plastic injection molding medical parts, components, and devices have shown to be one of the most cost-effective and efficient solutions for achieving the quality and standards that medical suppliers demand. As a result, plastic injection molding is utilized in the medical device industry for a variety of purposes, including:
- Implantable components
- Containers such as beakers, test tubes, and other containers
- Medical and laboratory equipment housings and casings
- Surgical instruments and parts
- Components and equipment for drug distribution
- Orthopedics
These are just a handful of the applications for medical device plastic injection molding. Medical components designed by a plastic injection molding supplier may be used in almost any situation where robust, sterilization-friendly parts are needed in large quantities and with high precision.
Medical sector suppliers and manufacturers benefit from various advantages inherent in the technique and materials available when using injection mold. These advantages include:
Cost-efficiency
Injection molding is one of the most cost-effective manufacturing techniques available, mainly when producing large quantities. Plastic injection molding is virtually usually the most cost-effective solution when medical parts, components, and devices are needed in large quantities.
Exceptional accuracy
Tight-tolerance production is critical in the medical device sector, where millimeters or microns may make or break a component’s operation. Plastic injection molding factories with advanced technology can create many components and devices with excellent precision and slight variation from piece to piece.
Material selection
Plastic injection molding has one of the most diverse material libraries of any production method. While medical-grade criteria limit the number of materials that fulfill these essential parameters, the number of materials that do is still significant.
Durability
Many injection-molded plastics are robust and durable, withstanding severe conditions, vibration, and blunt force without cracking, fracturing, or shattering. Many injection molding plastics are also heat resistant, which can repeatedly be disinfected using an autoclave or other methods.
Contaminant resistance
Injection molding polymers for medical devices are designed to be contaminant-resistant and sterilizable. Furthermore, the injection two shot mold technique is simple to comply with FDA and other regulations.
Considerations for Medical Device Plastic Injection Molding
Plastic injection molding for medical equipment is a delicate procedure with a significant risk of failure. As a result, various factors must be considered throughout the design, planning, and production phases. These are some of them:
FDA regulations
As previously stated, FDA cleanliness and sterility rules are significant factors for medical components, both the parts themselves and the manufacturing process.
ISO certification and compliance
ISO standards oversee processes and outputs in various businesses, including the medical field. For example, a facility manufacturing medical components must fulfill ISO 13485:2003 requirements at a minimum, with Class I, II, or III compliance necessary depending on the items being made.
In addition to other application- or product-specific requirements, biocompatibility standards such as ISO 10993 may be necessary. Ensure that you or your manufacturing partner understand the requirements that apply to your application and that the facility can fulfill and maintain compliance via audit.
Material properties
The material selected for medical components and devices must have precise physical attributes to be acceptable for various uses. These are some of them:
Ability to be sterilized
This is necessary for any medical component, whether it is part of a device that interacts directly with the human body or is housed in a facility. In addition, to avoid damage to individuals with whom they contact, materials must be contaminant-resistant and sterilizable.
Durability
Easy-to-break materials aren’t practicable in the medical field, where they’re a safety hazard as well as a nuisance. Make sure the material you choose has the shatter and breaking resistance required in the medical profession.
Material Selection for Injection Molding of Medical Devices
We’ll look at some of the materials that fit the bill now that you know the advantages of plastic injection molding for medical components and devices, as well as the precise specifications these components must fulfill. Plastics, in general, outperform other materials and techniques in terms of design flexibility, overall cost-effectiveness, and manufacturing speed.
Silicone
Silicone is often used for components and parts that need a high level of flexibility. It has excellent durability and biocompatibility, as well as being highly cost-effective in large-scale manufacturing runs.
Polycarbonate
With exceptional impact and vibration resistance, this is one of the most robust materials available. In addition, because it can be nearly entirely transparent, polycarbonate is perfect for components where visibility is an advantage. It’s also resistant to heat and ultraviolet radiation.
Polyethylene
Polyethylene is ideally suited for the surfaces of prostheses and wearable devices due to its look, durability, and relative smoothness, owing to its high molecular weight. It’s strong and inexpensive, but it can’t be sanitized in an autoclave.
Polypropylene
This material is perfect for components that must be autoclave sterilized frequently because of its excellent heat resistance.
Conclusion
Plastic injection molding for medical devices is a sensitive process that has a high risk of failure. Therefore, several elements must be taken into account throughout the design, planning, and manufacturing stages.
The use of plastics in the medical field has grown exponentially over the past few years. Medical professionals use plastic to create safer, more comfortable, and more effective treatments for their patients.
Plastic can be molded into many shapes that make it easier to reach difficult areas or cover up sensitive ones; they can also act as a barrier between two parts of an organ which is essential when doing surgeries on internal organs like the heart. It’s hard to imagine where we would be without this material!
