Medical injection molding encompasses the healthcare sector by adopting economical material options and compliance with stringent FDA and ISO standards. These products enhance reliability and contribute to the overall safety of patient care.
Injection molding is renowned for its precision and accuracy, when it comes to the production of these parts. Moreover, it is a widely applicable, and acceptable technique for revolutionizing healthcare industry products. Plastics in this context are significantly important due to their distinct features in terms of flexibility, diversity, reliability, and resilience.
However, it’s imperative that these products must comply with strict FDA or ISO standards. FDA has classified three categories for medical components such as Class I, II, and III. Among these, class I dictates low risk components and is often subjected to the least regulatory compliance. Class II, medical products are considered moderate risk, and similarly, Class III grades are tremendously high risk components and require the highest level of scrutiny to meet these regulatory standards.
This blog entails the important considerations for producing medical components and their significance in the healthcare industry. Moreover, it highlights the plastic types and medical products that are ideal for injection molding.
Medical Injection Molding: An Overview
Medical injection molding is an additive manufacturing technique to fabricate durable and highly precise medical components. The cost effectiveness and strength are unique qualities of this technique.
In addition to disposable syringes, surgical components, and medical implants, injection molding produces efficient, economical, and sterilized medical accessories.
Furthermore, the production of these parts takes place in a highly risk free or disinfective environment to meet rigorous regulatory standards.
Injection molding uses medical grade thermoplastics. These plastics are not only durable but also come with compatibility parallel to patient safety requirements. However, not all plastics are compatible with the molding process. In this way, certain key determinants should be followed. For instance, workability, price, stress tolerance levels, and dimensional stability of material. Moreover, it offers economical pros when exploited for large-volume production.
Most Commonly Used Plastics For Medical Injection Molding:
Injection molding accommodates various medical grade resins widely adopted for shaping intricate featured medical parts. Let’s take an overview of plastics used in medical components for injection molding.
1. Polycarbonate (PC):
PC is an engineered grade medical thermoplastic, known for its high optical clarity, dimensional stability, and impact resistance. Moreover, PC is resistant to ultraviolet radiation (UV). Due to these peculiar properties, polycarbonate is broadly used in sterilized and non-toxic medical components such as; oxygenators, blood reservoirs, filters, goggles, disposable syringes, etc.
2. Polypropylene (PP):
PP comes in semi crystalline form and notably cost efficient for large volumes. Polypropylene is considerably vital for its flexibility and ease of moldability. For that reason, design manufacturers use PP for hygienic medical components including beakers, non-absorbable sutures, test tubes, connectors, puppets, medical implants, and hernia repairs.
3. Polyethylene:
Polyethylene is known as a biomaterial for medical implants. It benefits healthcare professionals for its high durability, rigidity, mobility, and low cost. Moreover, polyethylene comes in three forms; HDPE, LDPE, and UHMW, each offering distinct features and applications. Among these, UHMW possesses sound dampening characteristics and is ideal for the production of facial and cranial reconstruction components.
4. Acrylonitrile Butadiene Styrene (ABS):
ABS offers high durability, conformity, aesthetics, and ease of coloration in medical devices. Its lightweight feature adjacent to high strength and machineability makes it an ideal choice among healthcare professionals. Alongside this, it has gained significant attention due to its strong resistive ability to gamma rays during the molding process. It is widely used in applications including; prosthetics and drug delivery systems.
5. Polyetheretherketone (PEEK):
PEEK is a high performance polymer that lends its use in medical implant applications. It is considered an optimal option for dental, spinal, cardiovascular, bone modules, and trauma fixation implants. Moreover, it gains attraction in orthopedics uses. Medical professionals prefer PEEK due to its resilient nature and superior resistance to temperature, chemicals, cracks, and radiation.
Medical Products Ideal For Injection Molding:
Injection molding is a rapid production method for fabricating diverse medical use components. The strict quality control mechanism and automation have been on the rise for this technique.
Let’s discuss some daily use medical products that come from this affordable process to the market.
1. Orthopedics:
Orthopedics are go to choice for medical professionals for fixing deformations of a patient’s bones. Mostly, these components need intricate features, repeatability, and precision, and here injection molding ideally steps in. Some of the key examples include; inserts, liners, and support orthopedics braces intended for patient needs.
Injection molding techniques such as; overmolding, and insert molding are commonly employed to form these smart medical orthopedics.
2. Implantable Components
When it comes to forming implantable medical prototypes, injection molding is considered a prime option due to its consistent reliability and longevity.
These are made through hypoallergenic or biocompatible materials such as; medical grade silicon plastics and bioabsorbable polymers. Some common types made through custom injection molding include;
- Femoral stems
- Tibial trays
- Encapsulating housings
- Cardiovascular and, neuro implantable components.
These implants help to prolong patient lives, so need to be perfect.
3. Lab Tools and Equipements
Injection moldings play a vital role in shaping low cost medical tools and equipment. Medical research frequently needs precise and reliable laboratory instruments for testing and research purposes. These include ergonomic surgical instruments, catheter locks, disposable syringes, IV tubes, and personal protective equipment.
4. Housings and Enclosures for Medical Devices
Enclosures and housing offer clean and sterilized solutions to medicare machines, hardware, tools, surveillance, and diagnostic equipment. Moreover, these casings are helpful to protect them from any environmental impact by maintaining their integrity.
Unlike conventional techniques such as; CNC machining, 3D printing, or vacuum casting, injection molding brings more economical advantages in terms of fidelity, and long term viability for these components.
5. Disposables
There is a great demand for disposable or single use medical components across healthcare sectors. In some cases, it’s prohibited to use the same component twice. So, these are used on single patients at once due to hygiene, and health concerns.
When it comes to the production of these disposables, injection molding is a well-suited option. It enables design manufacturers to produce demanding equipment with high precision in a short turnaround. Some examples include; syringes, blood bags, surgical gloves, and bandages.
Summing Up:
Injection molding stands as the central process for fabricating medical products. It offers dozens of benefits when employed for intricate or complex medical prototypes.
Moreover, it has gained significant attention due to its reliability, and quickness that makes it sound for various healthcare use components. However, there are some major concerns related to meeting strict compliance regulatory standards. Despite these, injection molding is widely adopted for the production of single use prosthetics to stringent quality medical implants.
Furthermore, it facilitates healthcare professionals to choose biocompatible materials from a wide range. Although, it’s critical to make a sound choice of material, consulting with experts helps you this way intended for your specified applications.
FAQs:
Q1. What is Injection molding?
Injection molding injects the molten material (thermoplastic) into a mold die or cavity. Then high pressure is applied that shapes the molten material into the desired configuration upon cooling and solidification.
Q1. How to choose the right plastic for medical product manufacturing?
To choose suitable plastics, certain determinants should be kept in mind; for instance,
- Flexibility
- Biocompatibility
- Durability
- Design complexity
Q2. Any alternative to injection molding for medical product formation?
There are other options too for creating metal components, like 3D printing, and CNC machining. These techniques are widely used but come with higher initial costs. Injection molding is preferred due to its economical benefits for large volume production.
Q3. Types of injection molding used in medical devices?
Here are the most common types of injection molding used for shaping medical products;
- Thin wall molding
- Gas assisted injection molding
- Liquid silicon injection molding
Q4. Which medical products does injection molding serve?
Injection molding helps to form various medical products, including; syringes, housing enclosures, equipment for Dental X-rays, and lab tools.
Resources:
- Injection Molding and its applications to drug delivery: Retrieved From: Science Direct
- Morphology Development during micro injection molding of thermoplastics: Retrieved From: Science Direct