• MEDICAL AND HEALTH CARE MOLDS

MEDICAL AND HEALTH CARE MOLDS

Medical injection molding is an economically effective method for producing medical parts with strict tolerances.

Medical injection molding is a manufacturing process for producing plastic medical instruments and components. It involves melting plastic resin pellets and injecting the molten material into molds to form specific shapes. This process allows precise control of the size and shape of the product while adhering to strict quality and regulatory standards.

The process is capable of producing durable and reliable medical devices approved by the FDA. This type of molding can also be used for prototyping to send for urgent FDA approval. Medical injection molding can be conducted in clean rooms, and the parts can be safely sterilized. Let’s take a closer look at injection molding.

Injection molding is a very common method for forming plastic parts and components. Depending on the material, the parts’ tolerances may be very strict and easy to process. Injection molding is one of the most common types of molding plastics. It can be used in various industries, not just medical injection molding. In fact, there might be various injection-molded parts around you that you aren’t even aware of. Your basic pen, keyboard, or even your smartphone contains injection-molded components.

Advantages of Using Injection Molding in the Medical Industry:

Cost-Effectiveness:
While manufacturing molds requires a significant upfront investment in time and money, injection molding is highly cost-effective when producing in large quantities. Batch injection molding spreads the mold cost across thousands of parts, reducing the overall cost per part.

High Precision:
Injection molding is renowned for its accuracy and repeatability, making it ideal for the medical industry. In the medical field, even the slightest error can lead to part or equipment failure. Injection molding enables companies to manufacture hundreds or thousands of identical parts quickly, providing excellent precision and compliance with strict tolerances.

Compatibility with Various Materials:
Compared to all other manufacturing processes, injection molding is one of the most versatile in terms of material selection. While some materials may not be suitable for use in the medical industry, many materials can meet various requirements and regulations.

Excellent Strength, Durability, and Mechanical Properties:
Injection-molded parts are robust and durable. They can resist vibration, impact, and harsh environments. Some have heat resistance, meaning they can be easily sterilized through high-pressure sterilizers without any damage.

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Common Medical-Grade Injection Molding Materials:

Polyethylene (PE):
This thermoplastic material with high molecular weight is suitable for wearable medical devices. However, PE cannot be sterilized using high-pressure sterilizers due to its poor heat resistance.

Polypropylene (PP):
PP has high heat resistance, making it ideal for producing parts that require regular sterilization with high-pressure sterilizers. PP is also tough, lightweight, cost-effective, and resistant to radiation, chemicals, electricity, and organic solvents.

Polystyrene (PS):
PS offers good impact resistance and dimensional stability. It is non-toxic, affordable, tasteless, FDA-compliant, and lightweight, making it suitable for petri dishes and test tubes.

Polyetheretherketone (PEEK):
PEEK has strong chemical resistance, radiation resistance, and wear resistance. Due to its incredible heat resistance, PEEK is suitable for sterilization and injection molding. It is commonly used in orthopedic instruments, dental implants, healing caps, and spinal fusion devices.

Polycarbonate (PC):
This robust and flexible engineering thermoplastic has high vibration resistance, heat resistance, impact resistance, and UV resistance. PC has good dimensional stability and is commonly used in medical instruments.

Choosing the Right Material for Medical-Grade Products:

Choosing materials for medical injection molding involves considering not only use cases and specific material properties but also:

Durability and Strength:
In the medical industry, using fragile materials is not practical. It’s crucial to select materials resistant to breakage and fracture, providing the required durability and strength for the intended applications.

Operating Conditions:
Before deciding on a material, the application environment must be considered. For example, if parts need frequent sterilization and exposure to high temperatures, heat-resistant materials like polypropylene should be used. On the other hand, if parts need to be flexible and durable, robust materials like polycarbonate should be chosen.

Ease of Use:
Consider who will be using the part and how it will be used. Cumbersome, ergonomically impractical surgical instruments can hinder surgeons’ work. Lightweight, ergonomic, fully functional, and easy-to-sterilize surgical instruments can play a crucial role.

Compliance: Complying with FDA Regulations and ISO Standards:

When manufacturing plastic parts and products for the medical industry, whether through injection molding or other manufacturing processes, strict compliance with FDA regulations and obtaining ISO certification is essential. Medical industries are subject to strict regulations, and any parts or products manufactured must comply with FDA regulations, pass audits, and meet relevant standards.

WIT MOLD’s Medical and Pharmaceutical Solutions:

At WIT MOLD, we understand the importance of quality in component manufacturing. Leveraging our rich knowledge in the medical and pharmaceutical industries, we offer comprehensive services, turnkey plastic injection molding solutions that fully comply with industry specifications and standards. For more information on our plastic injection molding capabilities and how we serve the medical and pharmaceutical industries, please contact us immediately.

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