How Clean is Clean? ISO Knows, On A Scale of 1-9

In the realm of plastic injection molding, especially in the production of plastic medical devices, cleanliness is of utmost importance. Maintaining a clean environment during the manufacturing process helps ensure that the final products meet stringent quality and safety standards. To achieve this, facilities often use clean rooms that adhere to various levels of ISO classification. In this blog post, we will explore the different ISO classification levels for clean rooms and their importance in plastic injection molding facilities that manufacture plastic medical devices.

What Is an ISO Clean Room? An ISO clean room is a controlled environment where the concentration of airborne particles is regulated and maintained within specific levels. The International Organization for Standardization (ISO) has established a set of standards for clean rooms, known as ISO 14644. These standards define different cleanliness levels based on the number of particles present in a given volume of air. The ISO classification system ranges from ISO 1 (the cleanest) to ISO 9 (the least clean).

ISO Classification Levels

1. ISO Class 1: This is the highest standard of cleanliness, allowing only 10 particles per cubic meter of air that are 0.1 microns in size or larger. This level is rarely used in plastic injection molding for medical devices due to the extreme level of cleanliness required.
2. ISO Class 2: Slightly less stringent than ISO Class 1, this level allows up to 100 particles per cubic meter of air of 0.1 microns or larger. Again, this level is typically more than what is necessary for most medical device manufacturing.
3. ISO Class 3: This classification permits up to 1,000 particles per cubic meter of air of 0.1 microns or larger. While still very clean, it’s more achievable and relevant to certain specialized medical device manufacturing.
4. ISO Class 4: Clean rooms of this level allow up to 10,000 particles per cubic meter of air at the 0.1-micron size range. It is commonly used in the production of certain medical devices.
5. ISO Class 5: Perhaps the most common level for plastic medical device manufacturing, ISO Class 5 clean rooms allow up to 100,000 particles per cubic meter of air at the 0.1-micron size. This level is suitable for many injection molding processes for medical devices.
6. ISO Class 6: This classification is less stringent than ISO Class 5, permitting up to 1,000,000 particles per cubic meter of air at the 0.1-micron size. This level may still be acceptable for some medical device manufacturing.
7. ISO Class 7: Allowing up to 10,000,000 particles per cubic meter of air at the 0.1-micron size, ISO Class 7 is sometimes used in less critical areas of medical device production.
8. ISO Class 8: This level permits up to 100,000,000 particles per cubic meter of air at 0.1 microns. While less clean than previous levels, it may be used for supporting areas rather than critical production spaces.
9. ISO Class 9: The least strict classification, ISO Class 9 is often used for non-critical areas of medical device manufacturing.

Why Clean Rooms Are Important

Clean rooms play a critical role in the plastic injection molding of medical devices. These rooms ensure the safety, quality, and reliability of the final products by minimizing contamination risks during the manufacturing process. Particles in the air can lead to defects in products, compromising their performance and safety.

Additionally, maintaining a clean environment can help facilities comply with regulatory standards and improve the overall efficiency of the manufacturing process. Proper ISO classification ensures that the clean room’s cleanliness level matches the requirements of the specific medical device being manufactured.

Bottomline

ISO classification levels for clean rooms are essential in plastic injection molding facilities that produce plastic medical devices. By adhering to these standards, manufacturers can ensure the quality and safety of their products while meeting regulatory requirements. The proper selection and maintenance of the appropriate ISO classification level play a vital role in successful medical device manufacturing.