About SJ Group
SJ Group is a group company integrating with part research, manufacturing, After Sales Service and technical support.
Why Choose Us
High Precision Equipment
SJ Group is a group company integrating with part research, manufacturing, After Sales Service and technical support.
High Quality Products
Automotive molds, Medical molds, Packaging molds, Liquid Silicone Rubber molds, Precision Injection molding.
High-Efficiency Communication
Efficient feedback is a commitment and attitude to our customers.
Good service
Providing technical support, troubleshooting, and maintenance services.
-
![Cleaning Room Molding]()
Add to Inquiry -
![Medical Products Moulding]()
Add to Inquiry
Clean Room Injection Molding is a specialized form of injection molding that takes place in a controlled environment designed to minimize airborne contaminants. It is used to manufacture medical devices and other high-precision products requiring a sterile environment.
Clean Room Injection Molding: Maintaining a Quality-Producing Environment
In medical manufacturing, the ability to minimize component exposure to foreign contaminants is critical. Clean room molding has emerged as an effective and vital process for producing high-quality plastic parts that are safe for use in a variety of medical applications, including surgical instruments, implantable devices, prosthetics, and drug delivery systems.
With specialized equipment, highly trained staff, and additional certification criteria, clean room injection molding provides the environment and capabilities to meet the most stringent demands and regulations faced by the medical industry.
What Constitutes Clean Room Manufacturing?
Clean room manufacturing is a specialized process that is used to produce medical components and other sensitive parts in a controlled environment. The primary objective of clean room molding is to minimize exposure to foreign particulates such as mold, dust, bacteria, or other airborne contaminants, which can compromise the integrity of the medical components being produced.
There are several types of clean rooms ranging from Class 1 to Class 9. Class 1 carries the strictest regulations and is usually reserved for incredibly sensitive components, such as those used in life sciences or in electronics manufacturing processes that involve nanoparticles.
Most medical device manufacturing takes place in Class 7 or 8 clean rooms, the latter of which provides air cleanliness levels of 100,000 particles per cubic foot and requires a HEPA filtration system and a minimum of 20 air exchanges per hour.
How Clean Room Molding Differs from Traditional Injection Molding
Clean room injection molding is distinguishable from traditional injection molding in two primary ways:
Facility Environment – Clean room manufacturing requires a dedicated clean room facility with controlled temperature, humidity, and air quality. This minimizes the presence of contaminants and ensures the integrity of the manufactured medical components.
Operator Attire and Procedures – Clean room manufacturing also requires operators to wear specialized attire such as gowns, gloves, masks, and shoe covers to prevent contamination due to human contact. Operators must also be trained to follow strict protocols regarding hand hygiene and frequent gown changes to maintain as much cleanliness as possible.
Limitations of Clean Room Injection Molding
Due to the additional precautions of clean room injection molding, investing in this process can be costly. Constructing an environment that can drastically reduce contamination comes with related expenses including specialized equipment, air filtration systems, and strict monitoring protocols.
Clean room molding is also sometimes limited in the size and complexity of components it can produce. Due to the need for constant cleanliness, the size and complexity of parts must be manageable within the confines of both the clean room environment and the parameters of the clean room molding process itself.
Advantages
Clean room manufacturing comes with a variety of advantages, the most obvious of which is contamination control. By minimizing contamination, the risk of end-use product failure or compromised patient safety is dramatically reduced.
Clean room molding also enhances the quality of the medical components, as consistent production standards are essential to maintaining a clean environment. Stringent monitoring and quality control ensure virtually no defects, which improves overall reliability and performance, and optimizes the manufacturing process for maximum cost-efficiency and part quality.
Clean room manufacturing also ensures medical components are manufactured in compliance with the strict regulations imposed by organizations such as the FDA, thereby enhancing a producer's ability to consistently supply medical devices to meet demand without major delays due to violations.
Injection Mold Growth in a Clean Room Environment
Injection moulding in a clean room setting is a manufacturing method that involves creating precise plastic components devoid of dust or particles that might contaminate the result. This method is frequently employed in the medical, pharmaceutical, and microelectronics sectors, where the product's quality and purity are crucial. Certain measures and standards must be followed to ensure injection moulding is carried out in a clean room. These incorporate:
Clean room design
The clean room should be created to minimize the entry of outside pollutants. To stop airborne particles from entering the workstation, the room must maintain a regulated airflow and positive pressure.
Clean room garments
Coveralls, hair nets, face masks and gloves are just a few examples of the clean room attire employees must wear when working in the area. These clothing items assist in reducing product contamination caused by staff.
Equipment for clean rooms
All equipment used in a clean room must be specially made and approved for use there. To avoid contamination, the equipment must also be constantly maintained and cleaned.
Procedures for clean rooms
Each step must be designed to reduce the danger of contamination. This covers the frequent cleaning of surfaces, separating various tasks, and using cleanroom cleaning products.
Substance control
Every substance used in a clean room must be expressly certified for it. Avoid using materials that could produce particles or other types of contamination.
Validation
To ensure the product satisfies the relevant quality standards, it is vital to routinely validate the clean room setting and the injection moulding procedure.
An injection moulding cleanroom must be kept in good condition to guarantee product quality and avoid contamination. The following actions may be taken to keep an injection moulding cleanroom tidy:
Create standard operating procedures (SOPs) for handling raw materials, running injection moulding equipment, and cleaning the cleanroom to establish cleanroom protocols. Teach these procedures to all staff.
Stop the spread of germs, dust, and other contaminants. To reduce the number of pollutants entering the cleanroom, install air filtration systems, HEPA filters, and airlocks.
Establish a regular cleaning programme for the cleanroom and its associated equipment. When cleaning the injection moulding equipment, use the proper cleaning products according to the manufacturer's recommendations.
Require staff to dress appropriately by providing cleanroom gowns, gloves, and shoe coverings. Allow staff to change into cleanroom clothing in a gowning area before entering the cleanroom.
Continually check the cleanroom's temperature, humidity, and airborne particle levels. Verify the quality and purity of the items made in the cleanroom.
Keep a record of everything, including cleaning procedures, equipment upkeep, and test findings. Keep track of everyone who enters and exits the cleanroom.
Schedule routine maintenance for the air filtering systems, cleanroom equipment, and injection moulding machines. Observe the maintenance guidelines provided by the manufacturer.
When it comes to industries with sensitive applications - the medical, biotech, pharmaceutical, electronics, and aerospace industries come to mind - few capabilities are more important than clean room manufacturing. When you're looking for an injection molding partner, it's important to understand the difference between the cleanroom classifications in manufacturing so you can be sure your supplier has the capabilities you need. So, what are cleanroom classifications and how do they relate to your products? Let's find out.
What are Cleanroom Classifications in Plastic Manufacturing?
In general, there are a total of 9 cleanroom classifications: ISO Class 1-9. When it comes to injection molding, Class 8 is the most common, but let's take a closer look at each category and how they are distinct from one another.
ISO Class 1
Of the nine classes, the ISO Class 1 Clean Room is the cleanest. With maximum particles per cubic feet at ≤ 10 particles, the regulations for this class are extremely strict and injection molders must implement stringent controls to maintain low levels of airborne particles.
ISO Class 1 Clean Room manufacturing is most commonly used in extremely sensitive environments, such as those required for semiconductor manufacturing, pharmaceuticals, nanotechnology, and critical optics where even minute particles can significantly impact part quality.
ISO Class 2
The next cleanest is the Class ISO 2 Clean Room. It allows for slightly higher levels of particulate contamination at ≤ 100 particles maximum particles per cubic meter. These clean rooms still require high levels of control to maintain cleanliness.
ISO Class 2 Clean Rooms are best for applications that require very high levels of cleanliness, such as, once again, pharmaceuticals and bioelectronics.
ISO Class 3
With maximum particles per cubic meter at ≤ 1,000 particles, ISO Class 3 Clean Rooms are a little less stringently controlled than ISO Classes 1 and 2. ISO Class 3 Clean Rooms are best for applications where cleanliness is critical for product performance, such as those in microelectronics, optics, and precision engineering industries.
ISO Class 4
An ISO Class 4 Clean Room allows for ≤ 10,000 maximum particles per cubic meter. This class of clean rooms is ideal for applications where cleanliness is still important but not as critical as those that require Class 1-3 clean rooms. Industries like medical device manufacturing, aerospace, and automotive assembly benefit from ISO Class 4 Clean Rooms.
ISO Class 5
With an allowable maximum particles per cubic meter at ≤ 100,000 particles, ISO Class 5 Clean Rooms are easier to maintain than Classes 1-4, though strict controls are still in place to maintain consistently low levels of airborne particles.
ISO Class 5 Clean Rooms are suitable for industries like pharmaceutical compounding, biotechnology research, and food processing.
Clean Room Molding: Custom Contamination-Free and Precise Parts
Clean room molding is a precision manufacturing process that takes place in a highly sterile environment. This expertise is critical for the complex and sensitive components required by the medical, pharmaceutical and biotechnology industries. The purpose of the clean room is to keep the product free of contamination, maintain low levels of air particles, temperature and humidity, ensuring optimal conditions for the injection molding process. Plastic parts are manufactured in clean rooms, which reduces the risk of contamination from dust and other particles. Clean room molding ensures the highest product quality, meets strict industry standards, and provides reliable, contamination-free plastic components for precision industries.
Points to Consider in a Clean Room Molding Environment
Several crucial points must be considered when operating within a clean room molding to ensure a contamination-free and high-quality production environment:
Air Quality Control
Air quality control is critical during clean room molding processes. Maintain strict control over air quality by regularly monitoring and filtering air to meet cleanliness standards, often classified under ISO classifications like ISO 7 or ISO 8, depending on the specific application.
Temperature and Humidity Control
Clean room molding temperature and humidity levels are strictly monitored to ensure stable material properties and molding conditions and prevent problems such as warpage or product defects.
Optimized Airflow
Utilize positive airflow systems in ISO 7 and ISO 8 cleanrooms to uphold air purity and restrict particle concentrations within defined limits.
Material Handling
Safely store and manage raw materials and components inside the clean room to thwart external contamination, including the proper storage and handling of resin pellets.
Material Compatibility
Confirm that all materials used in the clean room molding are compatible with the cleanroom environment and will not release contaminants during processing.
Use of Electric Machinery
Prefer electric machinery over hydraulic systems in most cleanroom settings to minimize the generation of airborne particles.
Equipment Maintenance
Regularly maintain and clean injection molding machines, molds, and auxiliary equipment to prevent the generation of contaminants during operation.
Packaging Compliance
Use materials such as cardboard or coated plastic for packaging in clean room molding and avoid packaging materials such as certain types of corrugated cardboard that can create excessive particles.
Contamination Control
Use measures such as air curtains, partitions, and positive pressure systems to minimize the entry of particles from outside the clean room.
Personnel Adherence
Enforce stringent gowning protocols for personnel, encompassing the use of cleanroom attire, gloves, masks, and hairnets to minimize the introduction of contaminants. In ISO 8 environments, coverage requirements may be even more stringent.
By meticulously addressing these considerations, a clean room molding environment can maintain the highest standards of cleanliness and produce components that meet stringent quality requirements.
Applications of Clean Room Molding
Clean room molding finds a wide range of applications, particularly in the production of various medical devices. An ISO 7 cleanroom is adept at providing packaging services and facilitating contract assembly. The process involves the creation of customized fixtures and the utilization of automation to ensure efficient assembly, whether for straightforward or intricate operations. In an efficient ISO 7 cleanroom environment, the following products can be manufactured:
Implantable Medical Devices
Syringes
Infusion Equipment and Respirator Components
Medicine Bottles
Infusion Bags
Biological Sensor
Lab Equipment
The principle of clean room operation is that factors that reduce cleanliness must be thoroughly eliminated from the clean room.
However, in the case of plastic molding for medical use, production in a clean room is inevitable, so it is necessary to install injection molding machines and its auxiliary equipment in the clean room.
Therefore, it is necessary to take measures against equipment that impairs cleanliness in the clean room.
Plastic injection molding machine
Cleanliness is reduced by the gas generated from the hot resin. In plastic injection molding, it is necessary to purge before starting molding to discharge the resin that has accumulated in the cylinder of the molding machine. However, this operation significantly reduces the cleanliness in the clean room. As a countermeasure, it is necessary to install a device at the portion for the purge to discharge generated gas outside the clean room.
Maintenance of mold
In plastic injection molding, daily mold maintenance is required to maintain product quality, mold durability and mold life.
However, some of the cleaners, lubricants, rust inhibitors, mold release agents, etc. used for mold maintenance reduce the cleanliness in the clean room.
As a countermeasure, when performing mold maintenance, move the mold outside the clean room and perform mold maintenance. When performing mold maintenance in a clean room, wipe the mold with alcohol instead of spray-type lubricant or cleaner.
Exhaust from plastic injection molding machines
Plastic injection molding machines are equipped with a number of fans to remove the heat generated by themselves. If dust or dirt accumulates in the plastic injection molding machine, the fans will blow up the air and spread the dust or dirt in the clean room. It is important to clean the inside of the molding machine every day, especially for fans where dust and dirt easily accumulate.
Plastic materials
When bringing plastic raw materials into the clean room and supplying to plastic injection molding machines, the cleanliness reduces. There are the following two factors.
● Bags for plastic raw material and plastic raw material itself
Most bags for plastic raw material are paper bags, and paper causes a reduction in cleanliness. In addition, the plastic raw material itself has fine powder attached, and there is a risk of lowering the cleanliness level at the time of use.
As a countermeasure, the material tank is installed outside the clean room and is supplied to the hopper of the injection molding machine using the material supply device.
● Material supply device
The plastic material is supplied from the material tank to the hopper of the plastic injection molding machine by the material supply device. The exhaust of this material supply device reduces the cleanliness in the clean room. A HEPA filter is used for the filter of the material supply device to prevent a decrease in cleanliness.
Our Factory
SJ Group was established in 1987, Hongkong. SJ Group starts from precision automotive mold building, and step into packaging mold building, medical mold building, liquid silicone rubber mold building, precision part injection. After 30 years of development, now we have 6 subsidiaries, several overseas after-sale offices. SJ Group is a group company integrating with part research, manufacturing, After Sales Service, and technical support. The major business of SJ Group: precision injection molds for automotive, packaging, medical and liquid silicone rubber.
FAQ
We're professional clean room injection molding manufacturers and suppliers in China, specialized in providing high quality customized products. We warmly welcome you to buy high-grade clean room injection molding made in China here from our factory.
