Cleanroom Injection Molding

Our ISO 8 Cleanroom

SeaskyMedical’s cleanroom has gained ISO 13485:2016 certification. Through the construction of clean rooms, we lower the content of pollutants such as particles, harmful air, and bacteria in the air. Also, indoor temperature, humidity, pressure, air velocity and distribution, noise, vibration, lighting and static electricity are controlled within a certain range of requirements.

  • Fewer air pollutants
  • Proper humidity and pressure
  • Static-free
  • Easy-to-clean latex floors

Our Class 8 Medical Device Clean Room

Cleanroom injection mold

Specialized in clean room injection molding and with more than 3600 square meters production environment, Seskymedical has 10 advanced plastic injection molding machines. Our medical device cleanroom is ISO 13485-2016 and CMA certified, considered “World class” by our demanding partners because the actual test results of our class 100,000 cleanroom exceed ISO 8 and are equal to ISO 7 cleanroom. 

The temperature, humidity, and air filtration are all regularly monitored to identify and eliminate sources of contamination so as for part traceability and compliance. The strict controls surrounding the validation of equipment and procedures guarantee that our customer’s project is executed with extreme precision and reproducibility. 

When manufacturing medical devices, medical injection molding company must maintain a sterile environment. As any bacteria or microorganisms can bring a safety concern for patients and animals. 

As a medical device component manufacturer, our investments in Class 7 &8 Clean room have resulted in greater efficiency and a better environment which brings superior medical products at a more competitive price.


When you need a unique and cost-effective medical plastics solution, look to us for the following: 

Why We Use Clean Room to Make
Sterile Injection Molding

In order to prevent medical devices and disposables free from contaminants, Seaskymedical carries out sterile injection molding and assembly in clean room to ensure bacteria and pollutants do not impact the safety and function of medical moled products.

Keep Hygiene

To avoid affecting product quality and reliability, cleanroom settings reduce daily pollutants and dust particles. This is critical for firms who want to build trust in medical products by ensuring that their standards meet all health and safety requirements.

Prevent Contamination

Our sterile injection molding in clean room prevents contamination by means of the positive pressure as it avoids non-filtered air from flowing back again to the cleanroom via the exhaust terminals, which ensures that air pollutants don’t gather on small components, impacting their ability to function.

Increase the Likelihood of Injection Machine

Airborne contamination is a significant issue in the medical injection industry. The cleanroom system solves this by carefully managing air flow rates and direction, as well as compression, temperature, and humidity levels, hence increasing the machine life span and performance.

High Performance of Clean Room

Seaskymedical Clean room has a high performance for medical injection mold due to its advantages of static control、humidity and air pressure control as well as Latex floor. It gives good cleaning performance and it does not absorb dust easily. Our clean room is designed in such a way that they can be very cost-effective to operate.

Our Medical Clean Room Injection Molding Capabilities

ISO Class 8 Cleanroom Injection

Our Clean room for medical devices typically meets the class 8 criteria. We have high-precision injection molding machines and imported precision finishing technology. Every few years, we modernize our machinery to maintain product quality and timely delivery.

IQ/OQ/PQ Validation

Thanks to clean room injection molding, medical device parts and disposables could pass IQ/OQ/PQ certification. There are some rigorous inspection procedures for medical molded products. You don’t need to worry about their quality and sterilization.

Product Part Validation

With the help of mirror spark machines, high-speed CNC, and three-dimensional precision manufacturing and measuring equipment, dimensions of medical parts from concept to machining to material selection and manufacturing are monitored and validated all the time.

High-Quality Micro Injection Machine

Advanced injection molding machines from Germany and Japan are working in our clean room, ensuring great production efficiency and large-volume repeatability for medical equipment and consumables. No matter how small the medical parts, our micro injection molding is a great option.

Manufacture Class I/Class II/ Class III Medical Devices

Class I and Class II medical devices are frequently manufactured in our cleanrooms. Clean room injection guarantees the hygiene standard for medical devices. Class III devices require more regulatory oversight, thus they are manufactured under the most strict standards.

Rigorous Quality Control & Inspection

Our medical injection moulding cleanroom adheres to the ISO 13485:2016 quality assurance standard. All plastic materials have biocompatibility reports, their color also has medical certification. Finished products go through a rigorous inspection before delivery.

Medical Clean room Packaging

As a competent clean room injection manufacturer, we provide full services and support to our clients. Like other medical device injection molding factory, apart from clean room molding, efficient and secure cleanroom packaging service is also provided to secure the sterilization.

Medical Clean Room Assembly

As a full-service contract manufacturer of clean room injection, our clean room is well-suited to assembling particle-sensitive medical device components due to our strict control of clean room, which could save our customers time and expense.

Our Clean Room Injection Molding Process

The intricacies of cleanroom injection molding have become more complex as the necessity for cleanliness has grown. The regulation of cleanliness levels continues to be a growing concern. Due to the impact of environmental pollution, which contributes to medical component contamination, clean room molding requires a consistent level of management.

medical products design

Plastic medical products design

We provide both medical product development and design services. You can simply provide us with a 3D or a 2D drawing of desired products no matter if it's for human or animal, with the tolerance requirements, and our team will design them by using various software like SolidWorks, AutoCad, Mold Flow MPI and enhance it for manufacturability.

Plastic Mold Design

Plastic Mold Design

Our injection mold designers have more than 10 years of experience in designing and manufacturing medical pieces and precise molds. materials, cooling systems, ejection mechanisms and other factors are considered when we put forward a perfect mold tool design. Wall thickness is modified to perfection as well.

medical plastics

Material Selection

Injection mold material selection has an influence on the tolerance, dimension, strength, and cost of medical injection molded items. Material color is also certificated. We collaborate with certified color masterbatch suppliers to ensure that you get the best medical-grade material at the best pricing.

CNC Machining

CNC machining

CNC plastic machining uses computer instructions to produce parts or molds. Our mirror spark machine, a high-speed CNC, and three-dimensional precision production technology enable us to manufacture molded products within a relatively short time.

injection mold in clean room

Medical Molding Method in Clean Room

The quality of the end product is strongly influenced by the molding method. Mold precision and quality depend on molding methods. No matter medical insert molding, medical overmolding, micro molding in a clean room, you need to determine which method to use when selecting plastic material.

secondary operation

Secondary Operation

In order to offer a completely comprehensive solution to our clients, we execute value-added secondary operations in our injection molding facility. These secondary operations include clean room medical device assembly, sterile packaging, ultrasonic bonding and pad printing.

How We Deal With Pollutants When
Clean Room Injection Molding

Medical Plastic Injection Molding

Our medical equipment is of suitable size, has absolute construction, and is in the proper location to facilitate cleaning, maintenance, and operations.

To avoid any mix-ups or contamination, we allocate enough room for the proper installation of parts and equipment.

Control cleanroom temperature and humidity.

Set up filtration units to prevent bigger airborne particles.

Staff wears gowns, hairnets, and overshoes.

Sterilize the injection machines regularly.

Why Choose Seaskymedical as Your Clean Room Injection Manufacturer?

With our 3600 square meters factory and more than 10 advanced injection machines, Seaskymedical, a professional clean room injection manufacturer, is able to produce totally sterile and safe medical plastic products for both human and animals.

Provide value-added services

We provide value-added services that include welding, printing, assembling, packaging, and sterilization in clean room. Our expertise with resins and medical-grade plastics ensures that we can manufacture products to meet exact specifications.

Specialize in injection molding in clean room

We have specialized in injection molding in a cleanroom for more than 10 years. Different clean room injection molding methods like micro injection、insert mold are available in Seaskymedical and could meet medical requirements.

Extreme precise, advanced injection molding machine

Seaskymedical introduced German and Japanese micro-injection machines, the minimum injection volume is 5g or 8g, the rate of fire is 250mm/s, the maximum temperature of the barrel is 450 degrees Celsius, and the machine is equipped with a long nozzle (saving glue), compared with ordinary trace amounts, the injection machine has higher control precision.

Experienced in injection molding

We are experienced in medical injection molding for more than 10 years. We have a broad understanding of materials and can handle a variety of medical-grade plastics. We can fulfill the demanding criteria and tight tolerances of the medical area with our knowledge and competence.

Rigorous product validation

We have a rigorous product validation that includes dimension testing, production environment disinfection, cleanliness, humidity, and pressure testing. This means you get an entirely assessed high quality, sturdy and enduring sterile medical product.

One-stop worry free service

We provide a one-stop worry-free service. From medical products design, mold design to cleanroom molding 、assembly and packaging. During the development of the product, we provide free technical support and services for medical products and injection molding for reducing our customers’ time and cost.

Quick delivery time

As a reliable clean room injection manufacturer, we ensure a quick lead time of medical molded products with the advanced injection machines. Our fastest lead time is delivery time 4 weeks, once you decide to work with us and place an order.

Our ISO 8 Cleanroom

SeaskyMedical’s cleanroom has gained ISO 13485:2016 certification. Through the construction of clean rooms, we lower the content of pollutants such as particles, harmful air, and bacteria in the air. Also, indoor temperature, humidity, pressure, air velocity and distribution, noise, vibration, lighting and static electricity are controlled within a certain range of requirements.

  • Fewer air pollutants
  • Proper humidity and pressure
  • Static-free
  • Easy-to-clean latex floors

How We Maintain Cleanroom Production Conditions

To reduce personnel contact and maintain cleanliness, we separate the feed from the injection and equip our production line with automated equipment such as robotic arms.

In addition, we disinfect the cleanroom every day, and conduct cleanliness tests twice a day and record the test data carefully.

Successful Cases

Check through our cases and see how we solve problems with robust injection molding capabilities.

Disposable anaesthetic laryngoscope plastic blade molding

Medical 96 deep well plate plastic molding

Medical plastic lure tapper manufacture

Thin wall micro medical plastic molding

Pipette tip plastic molding

Precision injection molded parts for medical instrument endoscope

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