SHENZHEN PHARMPAL COMPANY
Address
1405#, Chiwan Petroleum Building, Shenzhen,518052,China
Work Hours
Monday to Friday: 9AM - 6PM
In pharmaceutical cleanroom classification, different classes denote varying levels of cleanliness. The lower the class number, the stricter the standards and the cleaner the environment. For example, an ISO Class 1 cleanroom has a more stringent particle count requirement than an ISO Class 5 cleanroom. Each class aligns with specific industry standards, ensuring consistency and reliability in pharmaceutical manufacturing.
The Federal Standard 209E and ISO 14644-1 are two different sets of standards that define cleanroom classifications. While the Federal Standard 209E was widely used in the United States, the ISO 14644-1 has become the more globally accepted standard. Here’s a comparison of the cleanroom classes between the two standards:
Cleanroom Class | ISO 14644-1 (Maximum Allowable Particles/m³) | Federal Standard 209E (Maximum Allowable Particles/ft³) |
ISO 1 | 10 | Class 1: 35 |
ISO 2 | 100 | Class 10: 350 |
ISO 3 | 1,000 | Class 100: 3,500 |
ISO 4 | 10,000 | Class 1,000: 35,000 |
ISO 5 | 100,000 | Class 10,000: 350,000 |
ISO 6 | 1,000,000 | Class 100,000: 3,500,000 |
ISO 7 | Not specified | N/A (Note: ISO 7 and 8 were not explicitly defined in 209E) |
ISO 8 | Not specified | N/A (Note: ISO 7 and 8 were not explicitly defined in 209E) |