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.

About Mark Xu

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