Medical Injection Molding

Inox Cast- Your Premier Medical Injection Molding Solution Provider

Inox Cast is a professional service provider and leading supplier of components using medical injection molding. This effective process is also the most practical solution for your ideal medical production needs. In the factory, we have comprehensive machines which reach the qualities of consistency and safety. For that reason, you can fully count on Inox Cast!

Our medical injection molding uses durable equipment to create different medical components with quality finished. In the entire medical industry, this process is more preferred by most manufacturers.

However, we designed our medical injection molding with superior capabilities. It has the power to skyrocket your brand and products. In developing medical injection molding, we used medical-grade materials. Plus, we double-check the quality of machines and products before delivering them to you.

In the processing, our medical injection molding offers key advantages to be able to meet your precise requirements. This process commonly used in producing

• Orthopedics,
• Surgical equipment and parts,
• Implantable elements,
• Test tubes, beakers, etc
• Drug delivery apparatus & components, and
• Casings and housings medical equipment.

All these finished parts are sterilization-friendly and highly durable. In preferring our medical injection molding, you can get lots of benefits including cost-efficiency, exceptional accuracy, contaminant resistance, and durability in your production projects.

Inox Cast is highly capable of providing medical injection molding for your business, wherever you are located. Since we are well-knowledgeable in this industry, we understand each of your needs. And even help you hit the top of your market.

Inox Cast provides custom-made and standard medical injection molding. All are available at reasonable costs. So if you need our help, you can discuss it with us. Contact now!

Medical Injection Molding: The Ultimate Guide

If you want to skyrocket your medical injection molding business, then all information you need is right here.

This guide explores all the vital aspects of medical injection molding.

Take a look:

1.  What Is Medical Injection Molding?

It is the manufacturing of medical devices and components using medical-grade plastic materials that meet FDA regulations.

This process cost-effectively produces durable and reliable products.

It also guarantees accuracy, exacting quality and cleanliness standards, which are pretty critical in medical device production process.

medical injection molding

Medical injection molding is most suitable for high volume production runs and applications, requiring tight tolerances and consistency.

Hence, it is also used in medical device prototype development approval process for FDA and other uses in laboratory testing.

2.  Benefits Of Medical Injection Molding

Ordinarily, medical injection molding offers more advantages than similar production processes in the industry.

It is a smooth and seamless operation; medical sector suppliers and manufacturers gain access to numerous benefits inherent to the process, such as the following;

Cost Efficiency

The design of injection molding makes it a more economical manufacturing process, mainly when producing high volumes.

Thus, when you need medical components in bulk, medical injection molding will always guarantee cost-efficiency.

Industrial Standards and Regulation Compliance

All materials used in medical injection molding operations must comply with FDA guidelines.

It is imperative since the part designs are created to enhance patients’ safety as a major priority.

Moreover, the medical plastic parts need less finishing work and often maintain an easy-to-clean surface.

Various Material Choices

This plastic injection molding operation for medical devices provides the widest range of options for selecting materials.

Of course, this is imperative since it implies you can get the medical device made out of exact material of preference suitable for a specific application.

Incredible Accuracy

In medical device manufacturing, tight tolerance production is quite critical since millimetres and microns can make a significant difference.

Therefore, medical injection molding in skilled injection molding facilities can produce high quantities of devices with unmatched accuracy from piece to piece.

Longevity

Typically, plastics used in injection molding are known to be ruggedly durable.

They offer dogged strength and excellent resistance to a wide range of adverse environmental elements and usage.

Hence, the products derived from this particular operation can endure vibration, excess heat, and mechanical force without cracking or shattering.

Additionally, such products hardly cave to heat when undergoing sterilization in autoclaves.

Contaminant Resistance

Most plastic materials used in injection molding for medical devices are designed to resist a wide range of contaminants.

They are also easy to sterilize, and the process itself easily meets the FDA guidelines and related requirements.

Traceability

You can easily monitor the various manufacturing process steps from the start to the end.

Ideally, this is advantageous since it makes it easy to make necessary adjustments where applicable to ensure you attain a high-quality final product.

3.  Types of Materials For Medical Injection Molding

Plastics are used in medical injection molding since they offer various benefits over other materials and processes.

The design flexibility, production speed and overall cost of plastics make them ideal for making different medical devices.

However, these plastics come in various variants; thus, it would be essential to ensure you pick the right one.

Here are the commonly used plastic materials in medical injection molding;

Polycarbonate

It is among the strongest plastic variants that exhibit high mechanical and vibration resistance.

This material is suitable for parts and components where clear visibility is a concern since you can get it to a completely transparent option.

Polycarbonate also exhibits incredible resistance to heat and UV.

Polyethene

It features an exceptional chemical resistance at a reasonable cost and a wide variety of material properties that suit medical applications.

This plastic material is inert, can endure heat levels when sterilized in an autoclave and has high impact strength.

It is used for making several medical devices used for invasive and non-invasive applications.

Silicone

Silicone is an ideal plastic material for medical devices where flexibility is the greatest concern.

It guarantees excellent biocompatibility and durability, and it is quite cost-effective, especially at high volume production runs.

Polypropylene

It is highly resistant to impact under any form of cracking under stress.

Polypropylene is also resistant to heat and exhibits immense radiation resistance; hence can easily be sterilized via autoclave without losing its properties.

You can also use it in making devices for applications that need hinges.

PVC

This is a low-cost plastic material often used in medical applications such as tubing, artificial limb and blood bag materials.

PES

It is popular for its sturdiness and stability at high temperatures.

PES is flame-retardant and hardly suffers any compromise to its strength regardless of extreme high temperatures and flame applications.

Moreover, it exhibits lower resistance to a few solvents and some weathering conditions like UV.

It is an ideal choice for making medical devices that require autoclave and steam sterilization.

PPSU

This material offers ultra-high-strength, biocompatibility, good chemical resistance, and thermal stability.

It is used in a wide range of medical appliances, dental and surgical instruments, as well as healthcare applications.

4.  Factors To Consider When Choosing Material For Medical Injection Molding

Ordinarily, plastic materials for medical injection molding are in numerous alternatives.

However, different materials are suited for different medical applications.

It is the reason it is imperative to look into some critical factors to ensure you obtain the best choice possible.

Some notable considerations to have in mind during material selection include the following;

Flexibility

In this case, it refers to a material’s ability to bend to extreme levels without degrading, breaking or deforming.

It is different from strength since the material can possess a high degree of hardness but still maintain flexibility.

Hardness

This aspect describes the material’s ability to resist deformation, whether through indentation, abrasion or penetration etc.

Usually, some applications would need materials at a higher end of hardness scale, whereas others only require softer materials.

Chemical Resistance

If you are making medical devices for handling, mixing and testing different chemical substances, ensure the material is inert and non-reactive to such compounds.

The essence here is to enhance safety and integrity of the process, ultimately.

Biocompatibility

In a typical medical industry, organic compatibility is relatively a critical aspect in various applications.

This is particular for devices used in invasive procedures like implantable devices and other operations such as joint replacement.

Radiation Resistance

In circumstances where the material is likely to interact with radiation, whether for sterilization or otherwise, it must be able to retain its physical properties.

The essence here is to ensure that the operation is not compromised at any level.

Heat Handling

Most plastic medical devices are often subjected to sterilization in an autoclave through steaming.

Of course, the temperatures in such appliances are usually high.

Therefore, it becomes important to ensure the material you are choosing can withstand such conditions when exposed to high heat.

Cost

Ordinarily, the correct physical properties are fundamental considerations in most medical applications.

However, cost also remains a core factor, significantly where materials varied price points can fulfil a similar need.

Operation Conditions

It would be prudent if the material you select accommodates all the demands of the application environment.

For instance, if the finished component part is exposed to high heat or chemicals, the material should provide adequate temperature and chemical resistance.

5.  Medical Injection Molding Techniques

Several techniques are used in plastic injection molding for medical devices.

However, five major types are often used, and they include the following;

Thin-wall Molding

It is a popular technique for producing a wide range of tools or effects involving the function and comfort of a patient.

As the term suggests, the process involves creating walls of a medical device that make them thin relative to the entire piece.

thin wall molding

Even so, practically, this process tends to mean walls thinner than 1mm.

Thin wall molding requires frequent injection molding equipment.

However, for the thin walls to retain their structural integrity, the base material used must be plastics.

The specific material used in this process is dependent on the particular medical device you are producing.

Nonetheless, the prototypes often go through extensive rounds of evaluation to guarantee their usability.

Some benefits of using thin wall molding for your plastic medical devices is that it is cost-effective, safe and guarantees clean parts.

Moreover, this process allows faster cycle times and thus comes in handy where high-volume production is a concern.

Liquid Silicone Injection Molding

Surface-borne infections are a significant concern in medical facilities, but some medical devices such as tubes and respiratory masks need to stay more hygienic than others.

Thus, this specific injection molding technique is ideal for such devices since it has a rubber-like substance that produces chemical resistance.

liquid sillicone injection molding

Besides, the environment ensures there is no ambient air, moisture or dust that settles on mold or mixture while it sets.

During the process, it produces a rubber-like substance, which is highly resistant to chemicals.

Of course, silicone hardly reacts with biological tissue hence an ideal choice for making invasive medical devices.

The primary raw material for silicone rubber is sand or silicon dioxide, often processed into pure silicone after reacting with methyl chloride.

Ideally, the main benefit of this process is that its products offer high resistance to water, ozone, extreme temperature and weather.

Moreover, this operation gives excellent resistance properties to finished medical parts.

Metal Injection Molding

Metal equipment is ideal when producing parts with high density, maneuverability and small size.

In this molding operation, a powder made from the desired combination of metals is formed using atomization technology.

Hence, the powder is formed into a pellet-like form known as a feedstock.

It includes a plastic binding compound to make the substance relatively easy to mold during injection process.

metal injection molding

After injection of the mixture, a binder is removed using a solvent, a catalytic process, thermal furnaces or a combination of these methods.

Hence, it leaves the metal only, leading to close to 100% density.

Metal injection molding is beneficial since it offers cost-effective options to manufacture high-volume complex parts.

It also reduces production time and net-shape manufacture with few material waste.

Gas-Assisted Injection Molding

This molding technique comes in handy in eliminating sink marks occurring on surface of finished plastic medical devices.

It solves the fault by running gas through channels built in the mold.

Ordinarily, the gas carves a hollow path through middle of the thicker sections creating required pressure to force resin tightly against mold walls.

Gas assisted injection molding

In essence, this creates a smooth part, which is structurally sound with zero sink marks.

Technically, this method is suitable for forming complex devices without visual blemishes.

Since pressure exerted by gas reduces if it fails to flow in a straight line, it is not recommended to make devices with a sharp corner in their design.

Of course, the main advantage of using this method is that it produces parts without sink marks, surface blemishes and warps.

Also, it makes stronger plastic medical devices that are more aesthetically appealing.

3D Printing

However, it is majorly used to create different prototypes to evaluate a design before going into production using injection molding.

You can use this method to print actual injection molds using plastics.

For particular medical devices, 3D printing is used for creating molds out of plastic.

Its main advantage is that it is significantly faster in producing prototypes.

Moreover, it offers flexibility, thus allowing for design and creation of complex shapes.

6.  Applications Of Medical Injection Molding

Unbelievably, injection molding medical parts are not necessarily used in hospitals and doctor’s offices as they seem to be.

Instead, you can find them in different locations, including laboratories, clinics, and learning and research institutions.

Ordinarily, medical-grade plastics injection molding makes various medical devices, laboratory components and facility equipment among others.

Moreover, the products are vital in dental and pharmaceutical industries to provide the following uses;

• Implantables
• Home healthcare devices
• Device housings
• Surgical devices and instruments
• Orthopedics
• Imaging components
• Regenerative medical devices
• Prenatal care
• Dental products
• Gastroenterology
• In-Vitro diagnostics
• Labware including test tubes, beakers etc.

7.  Importance Of Medical Injection Molding

Medical injection molding is vital in attaining the best results when making plastic devices.

Some notable importance of using this process include the following;

• Enhanced ergonomics
• Improved functionality
• Minimizes burden of sterilization
• Reduced weight
• Lower cost

8.  Considerations In Medical Injection Molding

Ideally, medical injection molding is a crucial operation where the stakes of failure tend to be somewhat high.

Thus, it would be ideal for taking various considerations into account when designing, planning and manufacturing processes.

The primary considerations include the following;

FDA Guidelines

Notably, FDA guidelines for cleanliness and sterility are basic considerations for medical devices, whether in part or manufacturing process.

Hence, it is advisable to ensure you choose a material that meets these standards, and the manufacturer should pass an audit or other regulatory requirements.

Durability

Easily breakable materials pose a threat and inconvenience in the medical industry.

Therefore, always make sure the specific choice you make guarantees shatter and breakage resistance.

Suitability To Extreme Conditions

Ordinarily, bio-implants should handle the challenging human body environment, including durability and reliable operation when subjected to different conditions.

Most plastics used in injection molding for medical devices often meet such requirements.

Sterilization Ability

It is a minimum requirement for any medical device, irrespective of whether it is used in a facility or part of a device interacting with human body.

Essentially, you must use contaminant-resistant materials that can be sterilized to prevent harm to those interacting with them.

ISO Certification And Compliance

Generally, ISO guidelines govern processes and outputs across various industries, including medical sector.

A facility producing medical devices at a minimum should meet ISO 13485:2003 standards with extra compliance to Class I, II or III.

9.  Regulation And Compliance Of Medical Injection Molding

Notably, medical injection molding needs a stringent process, and a careful choice of materials guarantees zero complications likely to cause failure.

It is the reason ISO regulations governing outputs and processes are used in different fields, including medical industry.

ISO 13485:2003 standard is a minimum requirement for any facility manufacturing medical devices.

It additionally requires Class I, II and III compliance based on the specific devices manufactured.

In certain instances, additional compliance is needed, like meeting ISO 10993 standards or biocompatibility.

Some medical device manufacturers can assist in case product or application-specific requirements are required.

They may provide you with all the relevant documentation to meet such requirements.

Furthermore, FDA guidelines regarding sterilization and cleanliness should be met when manufacturing medical components.

It also applies to both items manufactured and the specific environment where they are manufactured.

Material must also meet the required standards, and company manufacturing must pass the stipulated regulatory requirements like medical-grade approval audits.

10.  Post Molding Operations In Medical Injection

Several post molding operations and assemblies are available in medical injection molding operations.

However, the most suitable one depends on several factors but primarily the specific application of the medical device.

Nevertheless, here are the main secondary operations common in medical injection molding parts;

In-Mold Decoration

It is a process surrounding labeling or decorating a plastic object during injection molding process.

Ordinarily, the mold closes, and molten plastic resin is injected into the mold to conform to object’s shape.

Hot plastic encloses the decoration or label, making it an integral part of a molded object.

CNC Machining

The essence of this process is to attain finished dimensions that are difficult to attain through injection molding process.

Plastic part is held in position by a fixture, and machining is accomplished by using numerous cutting tools based on type of plastic.

It is done using CNC machining centers with multi-axis capability.

Painting

It is a post-processing operation that adds colored coatings to medical injection molding parts.

Most injection molders can utilize colored plastic materials though pigmented are somewhat more expensive.

Painting medical injection molding parts is available in three types, which include; powder coating, spray painting and silk screening.

These available options allow you to attain any color, whether in gloss or satin finish depending on industrial or individual preference.

Hot Stamping

It is a dry printing process that uses a controlled heat, pressure and accuracy timing to transfer color hue from foil to plastic materials.

It creates a permanent bond between custom medical injection molding part and the foil.

This process increases productivity, multiple colors in first step and offers several materials and finishes.

Pad Printing

It is a technique for printing different inks onto plastic parts to enhance the visual aesthetics at a low cost.

This process is a highly reliable process for producing parts to an excellent standard.

You can use it to print a wide range of graphics on surface of the injection molding device without difficulty.

Laser Marking

It is a fast, tool-less operation that eliminates need for surface preparation while conveying high-resolution effects to medical injection molding parts.

This process provides an option for in-mold painting and mold-in graphics, which all apply decorative elements during injection molding process.

Ultrasonic welding

It is a joining process that utilizes high-frequency ultrasonic acoustic vibrations to create a strong-state weld between two plastic pieces.

This operation uses an ultrasonic horn vibrating between 20,000 and 40,000 times per second while it maintains slight contact with plastic device.

The vibration causes friction, which in turn produces adequate heat to melt the plastic.

Clamping force is often applied for a particular hold time to ensure the parts don’t move during the process.

More Resources:

Metal Injection Molding

Clean Room Injection Molding

For all your medical injection molding needs, contact us now.