GMP Requirements and Equipment Selection for Clean Areas in Biopharmaceutical Workshops
2024.08.24
GMP Requirements and Equipment Selection for Clean Areas in Biopharmaceutical Workshops
In the biopharmaceutical industry, the entire production process must comply with GMP standards to ensure product quality. But what exactly is GMP?
GMP, or Good Manufacturing Practice, is a set of mandatory standards applied in industries such as pharmaceuticals and food. These standards are designed to ensure that products, including food, drugs, and medical devices, meet quality specifications to ensure consumer safety.
GMP covers various aspects of production, including raw material selection, production processes, equipment and facilities, and product quality control. It requires manufacturing companies to have excellent production equipment, rational production processes, comprehensive quality management, and stringent testing systems to ensure that the final product meets regulatory requirements.
Cleanroom Classification under International GMP Standards
GMP Cleanroom Grade | Typical Applications | Cleanliness Level | Airborne Particulate Limits (particles per m³) | Microbial Limits (CFU/m³) |
Grade A | Critical zones where high-risk operations are performed, such as the aseptic filling and compounding of sterile products (e.g., injectables, eye drops). | Highest cleanliness | At rest: ≤ 3,520 particles ≥ 0.5 µm In operation: ≤ 3,520 particles ≥ 0.5 µm | At rest: ≤ 1 CFU/m³ In operation: ≤ 1 CFU/m³ |
Grade B | Background environment for Grade A zones, commonly used in sterile product preparation areas like biopharmaceutical production (e.g., antibodies, vaccines). | High cleanliness | At rest: ≤ 352,000 particles ≥ 0.5 µm In operation: ≤ 3,520 particles ≥ 0.5 µm | At rest: ≤ 10 CFU/m³ In operation: ≤ 5 CFU/m³ |
Grade C | Areas where less critical sterile activities occur, such as preparation and filling of less risky products (e.g., cell culture operations, buffer preparation). | Moderate cleanliness | At rest: ≤ 3,520,000 particles ≥ 0.5 µm In operation: ≤ 352,000 particles ≥ 0.5 µm | At rest: ≤ 100 CFU/m³ In operation: ≤ 50 CFU/m³ |
Grade D | Clean areas for initial stages of production or handling less hazardous substances (e.g., preparation of starting materials, equipment cleaning areas). | Basic cleanliness | At rest: Not defined In operation: ≤ 3,520,000 particles ≥ 0.5 µm | At rest: ≤ 200 CFU/m³ In operation: ≤ 100 CFU/m³ |
Additional Notes:
- Airborne Particulate Limits
: The numbers represent the maximum permissible concentration of particles of size 0.5 µm or larger in a cubic meter of air. These limits are crucial for maintaining a contamination-free environment during both "at rest" (no personnel or operations) and "in operation" (with personnel and operations ongoing) conditions.
- Microbial Limits
: These limits represent the maximum permissible levels of viable microorganisms (measured in Colony Forming Units or CFU) per cubic meter of air. The stricter the cleanliness grade, the lower the acceptable CFU count.
- Grade A
environments require the most stringent controls, often necessitating unidirectional airflow systems (laminar flow) and the use of isolators or barrier technologies to prevent contamination.
- Grade B
areas support Grade A operations and maintain high cleanliness to protect sterile processes.
- Grade C
and Grade D environments are progressively less stringent, suitable for supporting operations where sterility is critical but does not demand the highest level of cleanliness.
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