The reading requirements of the B+A clean area B+A in the new GMP are explained as follows: Class A (high-risk operation area) must reach static level 100, dynamic level 100, and the background area of ​​the area is grade B. That is, the background area is required to reach static level 100 and dynamic level.
Key words : B+A clean area Cleanliness detector 2.83L 28.3L dust particle counter plankton sampler
B+A level explanation:
1. Class A (high-risk operating areas, such as filling areas, areas where plastic stoppers are placed and open packaging containers in direct contact with sterile preparations, and areas for aseptic assembly or joining operations) are to achieve a cleanliness level of : Static 100, dynamic 100.
2, B + A cleanliness requirements are explained as: A level (high-risk operating area) to achieve static 100, dynamic hundred, and the background area of ​​the area is B, that is, the background area is required to reach static 100 , dynamic million.
3. It is not correct to understand B+A as dynamic to reach 10,000 levels and static to reach level 100.
The reference materials are as follows:
Traditional air cleanliness grading standards: GB/T16292-1996 (Chinese standard)
Particle size, numerical cleanliness level | Dust zui large allowable / cubic meter | Microbial Zui large allowable number | ||
≥0.5um | ≥5um | Floating bacteria / cubic meters | Settling bacteria/dish | |
Level 100 | 3,500 | 0 | 5 | 1 |
10,000 levels | 350,000 | 2,000 | 100 | 3 |
100,000 level | 3,500,000 | 20,000 | 500 | 10 |
300,000 | 10,500,000 | 60,000 | - | 15 |
Air cleanliness grading standard: ISO14644-1 (international standard)
Air cleanliness level (N) | Large concentration limit of particles greater than or equal to the particle size of the target particle size (units per cubic meter of air particles) | |||||
0.1 um | 0.2 um | 0.3 um | 0.5um | 1um | 5 um | |
ISO Class 1 | 10 | 2 | Â | Â | Â | Â |
ISO Class 2 | 100 | twenty four | 10 | 4 | ||
ISO Class 3 | 1 000 | 237 | 102 | 35 | 8 | |
ISO Class 4 | 10 000 | 2 370 | 1 020 | 352 | 83 | |
ISO Class 5 | 100 000 | 23 700 | 10 200 | 3 520 | 832 | 29 |
ISO Class 6 | 1 000 000 | 237 000 | 102 000 | 35 200 | 8 320 | 293 |
ISO Class 7 | Â | 352 000 | 83 200 | 2 930 | ||
ISO Class 8 | Â | 3 520 000 | 832 000 | 29 300 | ||
ISO Class 9 | Â | 35 200 000 | 8 320 000 | 293 000 | ||
Note: Due to the uncertainty involved in the measurement process, it is required to use no more than three valid concentration numbers to determine the level. | ||||||
Sterile drug appendix:
The standards for air suspension particles of the above various levels are as follows:
Cleanliness level | Suspended particles zui large allowable / cubic meter | |||
 | Static | dynamic | ||
 | ≥0.5μm | ≥5.0μm | ≥0.5μm | ≥5.0μm |
Class A | 3520 | 20 | 3520 | 20 |
Class B | 3520 | 29 | 352000 | 2900 |
Class C | 352000 Â | 2900 | 3520000 | 29000 |
Class D | 3520000 | 29000 | Not regulated | Not regulated |
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Compare and learn:
Cleanliness level | Suspended particles zui large allowable / cubic meter | |||
 | Static | dynamic | ||
 | ≥0.5μm | ≥5.0μm | ≥0.5μm | ≥5.0μm |
Class A | The traditional 100 grade, considering the particle size ≥ 5.0μm as ISO 4.8 | The traditional 100 grade, considering the particle size ≥ 5.0μm as ISO4.8 | ||
Class B | Traditional 100, ISO 5 | Traditional million, ISO 7 | ||
Class C | Traditional million, ISO 7 | Traditional 100,000, ISO 8 | ||
Class D | Traditional 100,000, ISO 8 | Not regulated | ||
Class B: Refers to the background area where high-risk operations such as aseptic preparation and filling are in Class A clean areas.
Clean room cleanliness testing experts and dust particles planktonic bacteria sampler factory in Suzhou long stay Purification Technology Co. reminder: select the new GMP particle counter in B + A 2010 class clean area the new GMP requirements for airborne particle counters: To confirm Class A The level of clean area, the sampling amount of each sampling point shall not be less than 1 cubic meter (28.3L/min), and the level of airborne particles in Class A clean area shall be ISO 4.8, with the suspended particles of ≥5.0μm as the limit standard. The cleanliness of other clean rooms should be counters of not less than 2.83 L/min.
Planktonic bacteria sampler pharmaceutical plant cleanliness level and monitoring should be dynamic monitoring microorganisms, microbial assessment aseptic conditions. The airborne microbial sampler is based on the particle impact principle and the isokinetic sampling theory. The sampled air with microorganisms is sprayed by a pump at a high speed and impinged on a culture dish containing the medium, and colonies are formed after being cultured to count.
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