White Room Vs. Clean Room Injection Molding
For manufacturing contamination-sensitive medical, electronic, or aerospace products, maintaining a controlled environment is crucial for ensuring the quality and safety of the products. White rooms and clean rooms are controlled environments that offer unique advantages. Manufacturers must understand their differences to ensure product quality and safety standards are met. This blog post will discuss the importance of white room and clean room injection molding, focusing on Class 7 and 8 clean rooms and how these controlled environments benefit customers by delivering superior quality products.
White Room vs. Clean Room Injection Molding: Key Difference
The primary difference between white room and clean room injection molding is the level of cleanliness and how that cleanliness is maintained. Clean rooms, particularly Class 7 and 8, adhere to more stringent standards for air quality, particle counts, and contamination control than white rooms. This makes clean room injection molding a more suitable choice for products requiring a higher level of cleanliness and contamination control. Below we cover both in greater detail.
What is White Room Injection Molding?
White room injection molding is a process where the manufacturing area is designed to minimize contamination by controlling the environment, including temperature, humidity, and airflow. They rely on a robust HVAC system to filter contaminants out of the air. While white rooms don’t require controls as stringent as clean rooms, white rooms provide a controlled atmosphere for manufacturing products that require a higher level of cleanliness than standard manufacturing settings.
Features of a white room are dependent on the manufacturer; some features you may encounter include the following:
Controlled access: Typically, only those trained and with reason to be in the white room will have access to reduce the risk of contamination.
Air filtration: White rooms use air filtration systems to remove particulates and maintain a clean environment. While not as comprehensive as the HEPA filters used in clean rooms, these systems still provide significant air purity.
Employee PPE and Attire: Personnel working in a white room must wear appropriate PPE as in any manufacturing setting. However, to prevent contamination, they must also wear attire, such as lab coats, hair nets, and beard coverings. Often a separate robing area is used so that particles on clothing are not transferred into the manufacturing space.
Regular cleaning: White rooms are cleaned regularly to maintain a clean environment and minimize the risk of contamination.
What is Clean Room Injection Molding?
Clean room injection molding has stricter environmental controls that must adhere to specific airborne particles and contamination standards. Clean rooms are classified according to the number of particles permitted per cubic meter of air. The requirements for cleanroom classification are set by International Organization for Standardization (ISO) in its standard ISO 14644-1 Cleanrooms and Associated Controlled Environments. The lower the class number, the fewer particles and a cleaner environment. This post will focus on Class 7 and 8 clean rooms.
The International Organization for Standardization (ISO) sets the standard for clean rooms, ensuring consistency and reliability across the industry. Class 7 clean rooms permit a maximum of 352,000 particles (0.5 microns or larger) per cubic meter of air and 60 air changes per hour, while Class 8 clean rooms allow up to 3,520,000 particles (0.5 microns or larger) per cubic meter and have 20 air changes per hour. However, adding additional equipment or workers into the room can increase the number of particulates and change the class level, so the manufacturer must maintain the proper cleanliness level.
Some key features of Class 7 and 8 clean rooms include the following:
HEPA filtration: High-Efficiency Particulate Air (HEPA) filters pleated mechanical air filters that can theoretically remove 99.97% of airborne particles with a size of 0.3 microns (µm), according to the EPA.
Positive air pressure: Clean rooms maintain positive air pressure. This means the air pressure is higher inside the clean room than outside, which prevents outside air from entering the controlled environment and minimizes the risk of contamination.
Employee PPE and Attire: In addition to normally required PPE, employees follow strict gowning procedures before entering the room, including wearing specialized clothing such as coveralls, booties, and head covers, to minimize the introduction of contaminants.
Regular cleaning and monitoring: Clean rooms are cleaned and monitored frequently to ensure they meet the established ISO standards.
How Customers Benefit from White Room or Clean Room Injection Molding
When products must be protected against contamination and particulates, white rooms and clean rooms are necessary. By choosing an injection molder with white room or clean room molding capabilities, customers can enjoy several significant benefits:
High-quality products: The stringent cleanliness standards of white rooms and clean rooms help to ensure that the final products are free from contaminants and that product specifications can be met.
Regulatory compliance: White rooms and clean rooms allow you to meet regulatory compliance for the cleanliness of products like medical devices and components.
Reduced risk of product recalls or failure: having a medical device recalled or having an electronic product fail in use can be costly and damaging. By minimizing the risk of contamination, white room, and clean room injection molding can reduce the likelihood of product recalls or product failure, saving customers time, money, and potential reputation damage.
A Reliable Molding Partner
At Intertech, we have extensive experience providing precision parts for a number of industries, including the highly regulated medical industry. We have the technology and environment required to deliver high-quality products that meet your requirements and any regulatory requirements. With our white room or class 7 and 8 clean room molding and assembly capabilities, customers can trust their products are manufactured with the utmost care, leading to better outcomes for their end-users and a competitive edge in the marketplace.
Get in touch with our team today to learn more.