Clean room manufacturing in injection molding is a critical service for industries where product purity, regulatory compliance, and long-term performance are a major concern. Clean room manufacturing is a major part of preventing contamination in plastic components, enabling businesses to adhere to regulatory standards, particularly those in the medical, pharmaceutical, biotech, semiconductor, and electronics industries. By utilizing clean room manufactured plastic components, OEMs can shore up the performance of their end-use products and gain a competitive advantage over their competitors. But exactly what is a clean room in manufacturing and what advantages does it bring to the process? Let’s find out.
The Different Classifications of Manufacturing Clean Rooms
In the case of injection molding, there are nine different classes of clean rooms that might be available: ISO Class 1-9. ISO Class 1 clean rooms are the most controlled environments, allowing a maximum of 10 particles per cubic meter. These types of facilities are usually reserved for manufacturing ultra-sensitive components, such as some found in semiconductor fabrication and nanotechnology.
On the other end of the spectrum, ISO Class 9 clean rooms are the least stringent. They allow for 35,200,000 particles up to 0.5 microns in size and are primarily used in less critical areas where some control over contamination is still necessary, such as certain industrial applications.
At Westec, our clean rooms range from ISO Class 6-8:
ISO Class 6 clean rooms allow for a maximum of 35,200 particles up to 0.5 microns per cubic meter and are ideal for manufacturing parts used in pharmaceutical and food processing applications, as well as certain medical device applications.
ISO Class 7 clean rooms allow for up to 352,000 particles up to 0.5 microns per cubic meter of air. They are a good option for less critical pharmaceutical parts manufacturing and some electronics assembly.
ISO Class 8 clean rooms Class 8 clean rooms allow for up to 3,520,000 particles up to 0.5 microns per cubic meter of air and are also good for some components in pharmaceutical and biotech applications.
We also offer soft wall and hard wall clean room manufacturing.
Soft Wall vs Hard Wall Clean Rooms
As one might expect, the difference between soft and hard wall clean rooms lies in their constructions. While hard wall clean rooms are often fixed structures within a facility, soft wall clean rooms can be modularized and set up in various different areas to allow for maximum flexibility during the manufacturing process.
At Westec, we leverage our soft and hard wall clean room manufacturing capabilities to offer custom injection molding solutions that meet the precise needs of each of our customers. We can also utilize them for secondary operations such as assembly when contamination control is required.
The Advantages of Clean Room Manufacturing
To answer the question “what is a clean room in manufacturing”, we would be remiss not to go into the specific advantages of this particular manufacturing process. Clean room manufacturing brings a range of advantages, including:
- Contamination control—Clean rooms are designed to minimize contamination from microorganisms, particles, and other impurities. This helps ensure the production of high-purity, defect-free components essential for sensitive applications
- Flexible manufacturing solutions—Clean rooms can be configured to accommodate various manufacturing needs, from small batch production to large-scale production.
- Improved product quality—Stringent environmental controls help maintain consistent temperatures and humidity levels, leading to higher precision and reliability in manufactured parts.
- Reduced risk of product failures—Thanks to the mitigation of contaminants getting into the manufactured parts, defects related to contamination can be significantly reduced.
- Facilitates advanced manufacturing processes—Clean rooms are essential for manufacturing sensitive components, and these environments can enhance the use of advanced technologies and techniques to produce highly complex parts.
Westec Offers Clean Room Injection Molding Solutions for Critical Components
At Westec, we are a single-source provider for injection-molded plastic parts for critical applications. Whether you need medical components produced in a clean room environment, robust parts for consumer products, or any other specialized items, we offer turnkey solutions from design to assembly.
Searching for a reliable injection molding partner in California? Contact us today to discuss your needs and find out how we can assist you.
