Cleanroom injection molding is a manufacturing process used to create medical devices, implantables, and other products. It’s a specialized technique that requires specific equipment and supplies to ensure that the cleanliness of your product isn’t compromised. This article will explain what cleanrooms are and how they can help maintain sterility during manufacturing processes.
What Is Cleanroom Injection Molding?
Cleanroom injection molding is a manufacturing process used to create plastic parts. It is typically used in the medical industry to make medical devices, implants, and other tools for the body. Cleanroom injection molding can also be used for fluid delivery systems.
In fact, the number of applications is so many that the Straits Research firm predicts that global plastic injection molding will become a $15 billion economy by 2030, at a CAGR of 4% from 2021 to 2030. This process has many benefits over other manufacturing methods because it’s faster and requires less energy than traditional plastic production methods.
Cleanroom injection molding is an ideal solution when you need the following:
- A quick turnaround time with high-quality results
- A high degree of precision in your finished product
- An affordable price point
A Cleanroom Requires a Sterile Environment to Work In
Injection molding requires a sterile environment to prevent contamination. Any item injected into the mold could contaminate the product, making it ineffective or unsafe. This can lead to product liability lawsuits. The new 2020 Product Liability Litigation Report from Lex Machina shows that product-error lawsuits are increasing in the USA.
Injection molding also requires a clean room because of the delicate process. Anything on your tools and equipment, such as dust or dirt, could get into your injection-molded product and cause costly issues.
Hence, you need to design the cleanroom correctly for best-molded products. If you have the expertise to build the cleanroom, that’s well and good. But if you don’t have profound knowledge in this area, it is best to seek professional help.
You can search for cleanroom manufacturing and installation service providers on the internet and get a list of options. You can pick anyone based on your preferences and likes. Getting professional help will ensure no errors in the cleanroom setup, mitigating the chances of potential errors.
ISO 7 and ISO 8 Cleanrooms
The ISO 7 and ISO 8 standard addresses the cleanliness of the air in a cleanroom. Minimum cleanness is required for working with medical devices and other sensitive equipment. In addition to being cleaned and sanitized, ISO 7 rooms require a laminar flow air filter, HEPA filter, and air pressure control. ISO 7 standard cleanrooms allow 352,000 or less > 0.5 microns per cubic meter particles.
On the other hand, ISO 8 cleanroom classifications have specific requirements regarding temperature, humidity, and an air exchange rate that must be met to be considered ISO 8 compliant. ISO 8 cleanrooms allow 3,520,000 or less > 0.5 microns per cubic meter of particles.
Post-Molding Operations in a Cleanroom
After the mold has been injected with material, it must be removed from the machine. This process is called demolding and is typically done by hand. The molds are then cleaned of residual materials to be used again in another injection cycle.
A cleanroom environment allows for more control over these processes than other spaces, which may not have the air filtration or monitoring capabilities necessary to ensure quality results during each manufacturing stage.
Demolding of molded products can be challenging. The parts may get damaged during demolding. For instance, if you apply excessive pressure while demolding, the product’s shape might get damaged. A study published in the Springer journal states that you can use reverse compensation as a demolding method to prevent post-molding distortion.
Cleanroom Injection Molding Requires Specialized Machines and Equipment
The cleanroom environment is designed to be germ-free. This means that all equipment must be designed specifically for this environment, including the machines and tools used to inject plastic into molds. In addition, all surfaces and parts of the injection molding machine need to be easy to clean and disinfect so as not to contaminate the product being manufactured.
Cleanroom injection molding equipment features:
- Plastics are stored in a separate clean room from where they are processed
- The transfer system is designed for minimal cross-contamination between plastic batches
- Plastic containers are fed into the machine by hand instead of using automated hoppers or conveyors
- Some machines have special doors that open only when they’re closed
According to Straits Research firm, the global injection molding machines market is currently standing at $10.724 billion in 2021 and is expected to reach $16.964 billion by 2030, at a CAGR of 5.9%.
Applications of Cleanroom Injection Molding
Cleanroom injection molding can be beneficial across industries. Everyone can benefit from cleanroom injection molding, from the pharmaceutical industry to the food sector.
Create Medical Tools, Parts, and Materials
Cleanroom injection molding creates medical tools, parts, and materials. These include:
- Medical implants: Cleanroom injection molding can create devices like hearing aids or pacemakers surgically implanted into the body.
- Medical tools: Cleanroom injection molding can be used to create surgical instruments such as forceps and scalpels. This process also allows for the creation of plastic handles for metal blades or needles. These are then sterilized before surgery so they don’t transmit bacteria from one patient to another during surgery.
- Fluid delivery devices: Cleanroom injection molding can create syringes and other disposable products that deliver fluids like medicine or saline solution into patients’ bodies during procedures such as dialysis or chemotherapy treatments. This is a common use case due to the health industry’s stringent quality control standards regarding what goes inside people’s bodies.
Create Fluid Delivery Devices
Cleanroom injection molding can be used to create fluid delivery devices. These devices are used in various medical, aerospace, and energy industries. In fact, some of the world’s most complex products rely on these specialized tools. For example:
- Heart stents are tiny tubes that prop open arteries after angioplasty or heart surgery.
- Shunt valves help regulate blood flow through the heart by redirecting fluid around clogged vessels.
- Heart pumps like ventricular assist devices (VADs) supplement failing hearts with mechanical pumps that can improve the quality of life for patients whose natural organs aren’t functioning correctly and may even extend their lives long enough for transplants to become viable options down the road.
Create Implantables
An implant is a medical device to repair or replace damaged or diseased tissue. Implants are used in dentistry, orthopedics, and other areas of medicine. The most commonly used implants include:
- dental implants to replace missing teeth
- bone grafts that can be attached to the jawbone to rebuild bone loss due to trauma or disease
- silicone rubber discs placed over roots that have been extracted during a tooth extraction procedure
Conclusion
Injection molding is a process that can be used to create a wide range of products. Knowing your options when choosing the suitable injection molding machine for your project is essential.
Cleanroom injection molding is explicitly designed for medical applications and requires special equipment and procedures to maintain its sterile environment throughout production.