Injection molding is used throughout the pharmaceutical sector, harnessing medical-grade plastics to create a vast range of components, equipment, and devices.
The production of parts for medical use demands exceptionally high precision levels and vital compliance with regulatory standards.
These rigid standards make the production method a key factor in product development.
This article will explore the benefits of plastic injection molding in the manufacture of products for the medical industry and the typical applications of injection molding for medical devices.
Choosing Infallible Production Techniques For Medical Components
Parts failure in the medical industry can be catastrophic, so there is no room for error or deviation from component specifications.
Some of the many considerations when designing and planning manufacturing processes include:
- FDA Regulations: These cover sterility in both the parts and the production method itself. Manufacturers must be able to pass audits and achieve regulatory approval for medical-grade plastic injection molding.
- ISO Certifications: Facilities producing medical parts must comply with ISO standard 13485:2003 along with Class I, II, or III depending on the components in question.
- Biocompatibility Standards: Additional compliance can be required to ISO 10993, where there are product-specific requirements to meet.
- Material Selections: Raw materials used to produce medical components will need to comply with baseline property standards, such as sterilization, durability, and the ability to operate seamlessly in extreme environments.
These factors carry substantial importance and can be met through precision injection molding techniques, making it one of few suitable manufacturing methods for medical devices.
Applications Of Injection Molding For Medical Devices
Plastic injection molding is one of the most effective ways to achieve the specifications and quality control standards in medical device manufacture. In addition, it is efficient and cost-effective.
Manufacturers use injection molding across a range of applications, including the production of:
- Surgical instruments and parts
- Casings for laboratory equipment
- Implantable parts and devices
- Drug delivery systems
The plastic injection molding process is suitable in almost any scenario where parts must be sterilization friendly, are needed in considerable volumes, must be made of remarkably durable materials, and meet precise specifications.
Benefits Of Plastic Injection Molding For Medical Equipment
Suppliers and manufacturers to the medical industry often opt for injection molding due to several compelling benefits.
Injection molding is a cost-effective manufacturing method that is optimum for high production volumes. The bulk production of medical parts and components is almost always more economical with this technique.
Tolerances in medical equipment production are minimal, so accuracy to millimeters or microns is fundamental. Professional plastic injection molding manufacturers can create large numbers of components to incredibly precise standards, with negligible tolerance variances.
Flexible Material Compatibility
Injection molding affords access to a wide range of materials. Each material must meet medical-grade requirements.
Plastics used in injection molding are exceptionally strong and durable, resistant to harsh temperatures, force, and vibrations. Heat resistance and the ability to be repeatedly sterilized without cracking or shattering is essential.
Resistance to Contaminants
Contaminants in medical settings are a severe risk, so plastics used in medical injection molding are designed to be resistant and easily sterilized for regular use.
Selecting Plastic Injection Molding Materials For Medical Sector Parts Production
Plastics, in general, are versatile and offer design flexibility, cost-efficiencies, and fast production times.
Selecting the appropriate materials for medical injection molding is crucial and will depend on the intended application of the part being manufactured.
Some of the most commonly used materials are:
- Silicone – used for flexibility, durability, and cost-effectiveness in significant production volumes.
- Polycarbonate – an especially strong material, resistant to vibrations and substantial impacts. Manufactured polycarbonate can also be very transparent, heat resistant, and UV light-resistant.
- Polyethylene – a material with a high molecular weight, suited for prosthetics and wearable medical devices. This material is smooth, durable, and robust but is not suitable for autoclave sterilization.
- Polypropylene – used for component parts requiring regular sterilization, it has tremendous heat resistant properties and radiation resistance.
Thousands of alternative plastic resins are widely available for commercial manufacturing and offer properties that make them ideal for plastic injection molding for medical applications.
Injection molding provides the opportunity to manufacture from this broad range of materials with reliable standards and high volume production, producing parts from medical plastics that are incredibly cost-effective, healthcare solutions.