Cleanroom Injection Molding Made Simple
Updated: Oct 28, 2019
The demand for cleanroom injection molding has been on a steady incline as the medical, aerospace, and biotech industries continue to evolve and grow. New product designs require prototyping and full-scale product manufacturing in an isolated cleanroom environment.
In this article you will learn what to look for in a cleanroom molding environment and how to set one up for your business.
What is Cleanroom 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 their specialized parts to be created in a cleanroom environment for added safety and precaution.
It is most commonly used for medical injection molding and other medical parts.
Inside the cleanrooms, machines must be checked and cleaned regularly. Floors, walls, tools, and workstations are to remain sanitary and sterile on all occasions during production and cleaned properly afterwards. Cleanrooms are also to be properly ventilated with filtered air.
It is mandatory for cleanroom molding workers to wear special attire including hairnets, gowns, gloves, and shoe covers. Any special attire worn inside the cleanroom must not be worn outside the area. Typically a separate clean gowning area is provided.
Why Do You Need Cleanroom Molding?
As mentioned above, the reason to have a cleanroom is to adapt to certain industries. For example, injection molding is a widely utilized form of manufacturing in the medical sector because of its versatility, cost efficiency, and can easily adapt to cleanroom standards.
Medical injection molding offers companies the flexibility they need while sticking with the requirements of cleanliness and safety.
Companies are now beginning to exclusively seek out manufacturers with an operable cleanroom. And with the growing list of industries that now require a cleanroom, the need for more cleanroom injection molding manufacturing is in high demand.
Industries that require cleanroom capabilities:
What Are the Types of Cleanrooms?
There are nine different ISO cleanroom classifications which are measured by how clean the air is inside the room. This is determined by the number of particles in one cubic foot of air. The ISO classes go from ISO Class 1 to ISO Class 9 (Class 1 being the most clean and stringent).
Per the chart below, you can see the nine types of classes and the standards that go along for each class that meet the clean room injection molding requirements.
There are also cleanrooms that are Good Manufacturing Practice (GMP) compliant which ensures products are consistently being manufactured to quality standards.
Being GMP compliant relies on clean internal surfaces, airflow, and operations at all times of manufacturing.
How to Make a Clean Room Environment?
If you are thinking about building a clean room for your business, there are a few key factors to think about.
1. Map our your injection molding clean room design. You want to make your cleanroom only as big as you need it to be. Condense the size as much as possible because cleanrooms can get expensive fast.
Something to think about is do you want to be able to mold, assemble, and package the product inside your cleanroom. If so, you’ll need extra space.
2. Decide what ISO class you are going to strive for prior to building. This will help you decide on filtration, airflow, and blower needs as well (which can all affect space).
3. Once you have the size of your room, you need to calculate your airflow. A helpful formula to use is “Needed airflow = surface x minimum airspeed.”
4. Find a filtration system that can filter at least 99.95% of the particles from the room.
5. Finally, think about the material used to build the structure. Wood is commonly used for the frame, with either windows, plastic, or PVC foil for the walls. Everything must be sealed properly or the integrity of the filtration system will fail.
An Example of A Cleanroom Injection Molding?
At Aberdeen Technologies, we are proud to have an isolated area that meets the clean room injection molding requirements. We specialize in medical injection molding along with insert molding for consumer products, aerospace, and electronics. Since not all of the services we offer require cleanroom injection molding, we have two different spaces.
Our non-cleanroom space hosts our mold making and tooling workspace, along with three of our insert molding machines, while our cleanroom is completely separated from the rest of our shop for the critical care parts.
Our cleanroom space is GDP compliant and currently holds three vertical injection molding machines that solely produce medical, aerospace, and other critical care and high-tolerance parts. An example of these parts are shown below:
Our cleanroom does have space for a fourth injection molding machine, but we currently use that extra space to assemble and package the products to keep them sanitary and safe.
Let us know below what your cleanroom looks like or if you are in need of a cleanroom injection molding manufacturer to help with your next project.
Move your project forward with Aberdeen Technologies.
As your injection molding design guide, we can help you design and manufacture your molds, run productions, and provide parts for first article approval.