Medical

A few special resin require high temperature injection and widely use for medical plastic parts, such as PEI, PSU and PEEK etc.

Characteristics and applications of PEI materials

PEI is an amorphous high-performance polymer with excellent heat resistance, good chemical resistance, inherent flame retardancy and excellent dimensional stability.

Based on the characteristics of PEI, the material is often used in the medical, aircraft, automobile, tableware/public catering industry, telecommunications, molded interconnect device (MID), electrical and lighting industries. The following focuses on the application process and mold analysis of PEI materials in the propulsion rack parts of the stapler.

High temperature molding PEI medical device analysisHigh temperature injection mold characteristics

Since the material is a high-temperature material, all corresponding mold features must also be processed according to the manufacturing method of high-temperature molds. The corresponding manufacturing methods of high-temperature molds have the following precautions:

It takes time to consider the insulation design when designing the mold;

The mold needs to consider the thermal expansion coefficient of the mold base, mold core and other sliding parts;

The selection of mold steel and the selection of materials for various parts need to be of high temperature resistant type;

When designing the mold, each sliding movable part shall be marked with reasonable tolerance and matching clearance;

Pay attention to the design of runners and entry points;

The waterway layout should be reasonable to maintain the consistency of the mold temperature.

High temperature mold injection process characteristics

This material is a high temperature material, and some of it contains glass fiber, and its viscosity is high, and the fluidity is slightly poor. The corresponding molding process characteristics need to pay attention to the following matters:

A special high-temperature mold special machine equipped with a special screw is required;

Mold temperature controllers, water pipes, machine heat insulation boards, etc. need to use special types;

The moisture content of the material has a great influence on the appearance, so it is necessary to ensure the adequacy of drying;

Control the heat in the hot runner and control the crystallinity of the molding material;

Combine mold flow analysis and scientific mold testing to determine a reasonable injection speed (speed affects viscosity and shear heat.

A case of PEI material mold opening on stapler propulsion rack parts

The push rack part is a part in the ultrasonic knife of the medical stapler. The part has certain requirements on the strength of the product, and the product is long and not easy to fill. The deformation and straightness of the product are required.

SEASKY TOOLING adopts the production method of high temperature mold, adding heat preservation measures during mold design, combining mold flow analysis and the physical property of the material, using two plate mold and gate on the end of medical plastic part.

Guide column guide sleeve, middle toss, counter and other parts, all adopt high-temperature mold special models. When designing the mold, reasonable tolerances and matching gaps are set for the sliding parts based on the consideration of thermal expansion coefficient to ensure the high volume production of the mold. The mold production adopts special double alloy screw injection molding machine, and the best production process is obtained through the combination of scientific mold test method and mold flow analysis.

Problems that are easy to occur when PEI advances rack production

Material viscosity is high, the screw of injection molding machine should be cleaned reasonably before each production, otherwise the product is easy to produce black spots.

After production, synchronization needs a timely and reasonable way to clean the screw;

The product is prone to discoloration in the production process, so it is necessary to control the mold temperature, material temperature and injection speed in the process;

During production, the thickness of meat is easy to produce shrinkage marks. It is necessary to confirm the stable molding process through scientific mold trial method in the early stage, and monitor the molding process for each batch.

Clear plastic molding lens

Plastic clean room molding

SEASKYTOOLING is Shenzhen China medical injection molder. We have class 100000 ISO 8 clean room medical lab plastics molding plant. We specilized in medical disposables plastic parts molding and clear plastic molding in clean room injection molding factory.

Till to Nov. 2019,  we offer 1 gram to 600 gram plastic molding production in our clean room. We have 90ton to 250 ton (Haitian and FAUNC) injection molding machine in clean room. Always we invest our injection molding plant to meet our new customers’ needs. We are contract medical plastic manfuactuer for North Americal, Europe, Oceania and China.

Clean room injection molding plant ChinaWe customize our injection machine to be reliable production for PC, PCTG, PP and PS etc. transparent plastic molding.  Our customized injection machine is 30% more stable and faster than standard injection machine. Please kindly review below to understand our capacity of medical plastic molding and clear plastic molding.

Medical plastic molding in Clean room

We make following OEM medical plastic molding parts in clean room.

  • Medical kit,
  • biometrics plastic parts manufacture,
  • Medical disposables plastic parts,
  • One time used plastic labware etc.

Except for medical plastic molding, we also offer prototype manufacturing for medical plastic device. We can produce  your medical plastic parts based on your drawing. Also we can optimize your plastic product for production by using DFM and mold flow simulation. Most of engineers or designers in SEASKYTOOLING have more than 15 years experience.

 

Clear plastic molding in Clean Room.

Our customized Haitian injection machine and FAUNC machine is specilized in clear plastic molding with PC, PCTG, PS, SAN and PMMA etc. resin. This will assure our optic plastic lenses with high quality.

Clear plastic molding glassClear plastic molding lens

In house mold manufacturing to support injection molding in Clean Room.

SEASKYTOOLING have in house mold manufacturing. We have 19+ years for plastic injection mold manufacture experience for north America and Europe. Our strong mold making team support us to have high quality and reliable injection mold for injection molding in clean room. Also it is quick to repair mold to prevent cessation of production. You can watch below video to understand more for our injection mold manufacture.

Design for manufacture for plastic molding parts in Clean Room.

Design for manufacture (we call it DFM) is a process to analyze plastic product design based on injection mold design experience. We will offer a easy understanding report to you to optimize plastic product design. It is picture with words, it is easy to understand even though you do not have experience for injection molding. You can also have us to optimize your plastic product design to offer 3D drawing back to you for approval.

Below video to show you a example for DFM report.

Mold flow simulation for injection molding medical parts.

Mold flow simulation is to use mold flow software to simulate plastic injection molding process for your medical plastic parts mold design. Generally the simuation is based defined gate location, water cooling line, clamping force and injection pressure etc. production process. It is easy to find out where we should optimize on product design and mold design. After this simulation, we will offer a reprot to you as well. It is picture with words, also it is quite easy to understand too. Please kindly watch below video to understand more.

Cleanroom injection molding

Clean room injection molding becomes simple

With the continuous development and growth of the medical, aerospace, and biotechnology industries, the demand for clean room injection molding has been steadily increasing.Medical plastic product manufacturing and biomedical plastic parts and the other electronic parts are requested in an isolated clean room environment.

In this article, you will learn what to look for in a clean room molding environment and how to set up products for your business.

Clean room injection molding

Clean room injection molding

What is clean room injection molding?

Cleanroom molding is the process of manufacturing plastic parts in an isolated room, designed to reduce the risk of particle contamination. Many industries require the creation of their dedicated parts in a clean room environment to increase safety and preventive measures.

It is most commonly used in medical injection molding and other medical equipment and medical consumable parts.

Inside the clean room, the machine must be inspected and cleaned regularly. Floors, walls, tools and workbenches should always be kept in a hygienic and sterile state during the production process, and should be properly cleaned afterwards. The clean room should also be properly ventilated with filtered air.

Clean room styling workers must wear special clothing, including hairnets, gowns, gloves and shoe covers. Any special clothing worn in the clean room shall not be worn outside the area. Usually, a separate clean dressing room is provided.

Why do you need clean room injection molding?

As mentioned above, the reason for having a clean room is to adapt to certain industries. For example, injection molding is a widely used manufacturing form in the medical field because of its versatility, cost efficiency, and can easily adapt to clean room standards.

Medical injection molding provides companies with the flexibility they need while adhering to clean and safe requirements.

As the list of industries requiring clean rooms continues to grow, the demand for more clean room injection molding manufacturing has become urgent.

Industries requiring clean room functions:

-Medical

-aerospace

-Biotechnology

-Pharmaceuticals-Military

-Optics

-Food and drink

What are the types of dust-free clean rooms?

There are 9 different ISO clean room classifications, which are measured by the cleanliness of the indoor air. It depends on the number of particles in one cubic foot of air. ISO grades range from ISO grade 1 to ISO grade 9 (level 1 is the cleanest and most stringent).

In the chart below, you can see the nine types of categories that meet the requirements of clean room injection molding and the standards that each category follows.

cleanroom grade iso

cleanroom grade iso

 

There are also clean rooms that comply with “Good Manufacturing Practices” (GMP) to ensure that products are consistently manufactured in accordance with quality standards.

Comply with GMP requirements and always maintain clean inner surfaces, airflow and operation during the manufacturing process.

How to create a clean room environment?

If you are considering building a clean room for your business, you need to consider some key factors.

1. Draw out your medical equipment injection molding clean room design. You just want to make the clean room reach the required size. Reduce the size as much as possible, because clean rooms can quickly become expensive.

One thing to consider is whether you want to be able to injection mold, assemble and package your products in a clean room. If so, you will need additional space.

2. Determine which ISO category to strive for before building. This will also help you determine the filtration, airflow and blower needs (all of which affect the space).

3. After determining the size of the room, you need to calculate the airflow. A useful formula used is “desired airflow = surface x minimum airspeed”.

4. Find a filtration system that can filter at least 99.95% of the particles in the room.

5. Finally, consider the materials used to build the structure. The frame is usually made of wood, and the wall is made of windows, plastic or PVC foil or color steel plate. All items must be properly sealed, otherwise the integrity of the filtration system will be ineffective.

An example of clean room injection molding?

At SEASKY TOOLING, we are proud to have an isolated area that meets the requirements of clean room injection molding. We specialize in medical injection molding and injection molding for consumer products, aerospace and electronic products. Since not all services we provide require clean room injection molding, we have two different spaces.

Our non-clean room space is our mold manufacturing and mold work area, as well as 6 injection molding machines, and our clean room is completely isolated from the rest of the workshop and is used to store critical care components.

Our clean room space meets GMP requirements and currently has 6 vertical injection molding machines, which only produce medical, aerospace and other intensive care, medical consumables and high-endurance parts. Examples of these parts are as follows:

We have a dedicated packaging area for medical injection molded parts that can also be used for the assembly of medical products.

Please tell us below what your clean room looks like, or if you need a clean room injection molding manufacturer to help you with your next project.

Require risk-free project evaluation.

Medical injection molding can be run in SEASKY TOOLING. We will conduct product manufacturability analysis and cost and production risk assessment. The evaluation report is provided with pictures and texts. SEASKY TOOLING is ISO13485-2016 certified medical plastic molding company, also we have ISO 8 certified cleanroom for plastic molding.