Understanding Clean Room Standards: ISO, FS209, and EU GMP Explained

Clean Room Standards (ISO, FS209, EU GMP)

Clean room standards define the levels of airborne particles and other environmental factors permitted within a controlled space. These standards ensure a clean environment for industries such as pharmaceuticals, biotechnology, and electronics manufacturing. The most widely recognized standards are ISO 14644-1, the older US Federal Standard 209E (FS209), and the EU GMP Annex 1 standards.

 ISO Cleanroom Standards (ISO 14644-1)

The ISO 14644-1 standard classifies cleanrooms based on the concentration of airborne particles. It includes a range from ISO Class 1 (the cleanest) to ISO Class 9 (least stringent). The classification is based on the number of particles of specific sizes per cubic meter of air.

 ISO Cleanroom Classes

| ISO Class | Maximum Particles per Cubic Meter (Particles ≥ 0.1 µm) | Maximum Particles per Cubic Meter (Particles ≥ 0.5 µm) |

- ISO Class 1-4: Used for highly sensitive applications, such as semiconductor manufacturing and nanotechnology.

- ISO Class 5: Frequently used in pharmaceuticals and biotechnology industries for sterile drug manufacturing.

- ISO Class 7-8: Found in medical device production and general laboratory environments.

 US Federal Standard 209E (FS209)

 Although FS209E has been officially replaced by ISO 14644-1, it is still widely used in certain industries, particularly in the United States. FS209 classifies cleanrooms based on the number of particles of size 0.5 microns or larger per cubic foot of air.

 FS209E Cleanroom Classes

| Class   | Maximum Particles ≥ 0.5 µm per Cubic Foot |

- Class 100 (FS209E) is roughly equivalent to ISO Class 5, which is used in the production of sterile pharmaceuticals.

- Class 10,000 and Class 100,000 are comparable to ISO Class 7 and ISO Class 8, commonly found in medical device manufacturing and laboratories.

EU GMP (Good Manufacturing Practice) Annex 1 – Cleanroom Standards

 The EU GMP Annex 1 specifically regulates cleanrooms for sterile medicinal product manufacturing in the European Union. The classification is similar to ISO, but it also mandates limits for airborne particles during both "at rest" and "in operation" conditions. Annex 1 focuses on pharmaceutical cleanroom standards for microbial and particulate contamination.

 EU GMP Cleanroom Classes

| EU GMP Grade | Maximum Particles per Cubic Meter (At Rest) | Maximum Particles per Cubic Meter (In Operation) | Typical ISO Equivalent |

- Grade A: The highest cleanliness standard, typically used for aseptic filling and critical pharmaceutical operations (comparable to ISO Class 5).

- Grade B: The background environment for operations requiring Grade A, comparable to ISO Class 5 when "at rest" and ISO Class 7 "in operation".

- Grade C and D: Less stringent areas, suitable for preparation but not direct manufacturing of sterile products (similar to ISO Class 7-8). 

Key Differences between ISO, FS209, and EU GMP Standards

- Particle Size and Measurement Units:

   - ISO 14644-1 uses particles per cubic meter of air, while FS209E uses particles per cubic foot.

   - EU GMP focuses on both particle size and microbiological contamination, particularly for "at rest" and "in operation" states. 

- "At Rest" vs. "In Operation":

   - EU GMP Annex 1 emphasizes the difference between cleanroom conditions when the facility is not operating ("at rest") and during active production ("in operation"). This distinction is critical for pharmaceutical manufacturing.

Air Changes Per Hour (ACH) Requirements

Cleanrooms must maintain a specific number of air changes per hour, depending on their classification:

- ISO Class 5 / EU Grade A: 240-360 ACH

- ISO Class 7 / EU Grade C: 60-90 ACH

- ISO Class 8 / EU Grade D: 05-40 ACH

These high rates of air exchange ensure that particulate contamination is kept within acceptable limits.

 Applications of Different Cleanroom Standards

- ISO Class 1-4: Semiconductor manufacturing, nanotechnology.

- ISO Class 5 / EU Grade A / FS209 Class 100: Pharmaceutical sterile production, biotech manufacturing.

- ISO Class 7-8 / EU Grade C-D / FS209 Class 10,000-100,000: Medical device manufacturing, general laboratories.

                                                                      END OF THE DOCUMENT

You may like to read these links: 

1. Key Considerations in Cleanroom HVAC Design: Ensuring Optimal Air Quality and Contamination Control

2. Understanding Puff Panels: Types, Uses, Benefits, and Requirements for Clean Rooms and Laboratory Buildings

3. Key Considerations for HVAC Systems in Small Animal Laboratories with Room-Specific Air Change and Pressure Requirements

4. Optimizing HVAC System Design for Small Animal Facilities in India's Diverse Climate

SHARE

Owner

Hi. I’m Writer of Researchsop.com. ’ ’ Please share these SOPs to all concern pharma people for their development. I like to fullfill the need of curious people. These things inspire me to make things looks better.

• 
• 
• 
• 
•