GMP requires dust particles for air cleanliness grade standards,
Number of floating bacteria, sedimentation number test
Guide: GMP tests the number of dust particles, the number of floating bacteria, and the number of sedimentation bacteria for the air cleanliness level standard. GMP Appendix Aseptic Drugs Chapter III, Article 11 provides for the dynamic detection of microorganisms in order to evaluate the status of aseptically produced microorganisms. The monitoring method includes sedimentation and bacteriostatic methods. Microorganisms should be dynamically monitored to assess the status of aseptically produced microorganisms. . Monitoring methods include sedimentation method, quantitative airborne bacteria sampling method and surface sampling method (such as cotton swab wiping method and contact dish method). Dynamic sampling should avoid adverse effects on the clean area. The review of the finished batch record should include the results of environmental monitoring. Monitoring of surfaces and operators should be performed after critical operations are completed. In addition to normal production operation monitoring, microbiological monitoring can be added after system verification, cleaning or disinfection is completed.
The standard regulations for dust particles and airborne particles are as follows:
Cleanliness level
Maximum allowable number of suspended particles / cubic meter
Static
Dynamic (3)
≥0.5μm
≥5.0μm (2)
≥0.5μm
≥5.0μm
Class A (1)
3520
20
3520
20
Class B
3520
29
352000
2900
Class C
352000
2900
3520000
29000
Class D
3520000
29000
Not regulated
Not regulated
Note: (1) In order to confirm the level of Class A clean area, the sampling amount of each sampling point shall not be less than 1 cubic meter. The level of airborne particles in the Class A clean zone is ISO 4.8, with a limit of ≥ 5.0 μm suspended particles. Class B clean areas (static) have airborne particles of the class ISO 5 and include suspended particles of two particle sizes in the table. For Class C clean areas (static and dynamic), the levels of airborne particles are ISO 7 and ISO 8. For class D clean zone (static) airborne particles are rated ISO 8 . The test method can be referred to ISO 14644-1.
(2) When confirming the level, a portable dust particle counter with a short sampling tube should be used to avoid the sedimentation of ≥5.0 μm suspended particles in the long sampling tube of the remote sampling system. In a unidirectional flow system, an isokinetic sampling head should be employed.
(3) The dynamic test can be carried out in the normal operation and medium simulation filling process, which proves that the dynamic cleanliness level is reached, but the medium simulation filling test requires dynamic test under the “worst conditionâ€.
The use of dust particle counters is the sampling and detection of clean room particles, confirming the number of indoor particles and cleanliness.
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The dynamic criteria (1) of microbial monitoring in the clean area of ​​the number of floating bacteria and sedimentation bacteria are as follows:
Cleanliness level
Floating bacteria
Cfu/m3
Settling bacteria (f90mm)
Cfu / 4 hours (2)
Surface microorganism
Contact (f55mm)
Cfu / dish
5 finger gloves
Cfu / gloves
Class A
<1
<1
<1
<1
Class B
10
5
5
5
Class C
100
50
25
-
Class D
200
100
50
-
Note: (1) The values ​​in the table are average values.
(2) The exposure time of a single sedimentation dish can be less than 4 hours, and multiple sedimentation discs can be continuously monitored and accumulated in the same position.
Airborne bacteria detection of sedimentation bacteria (passive method) quantitative airborne bacteria sampler method (active method) 2, environmental surface monitoring surface sampling method (such as cotton swab wiping method and contact dish method 3, personnel monitoring surface sampling method (contact dish method) )
Airborne bacteria sampling method--active method
Should meet the standard
GMP pharmaceutical food production quality management practices
ISO 14698-1/2 Biological pollution control in clean rooms and related control environments
GB/T 16293-2010 Test method for floating bacteria in clean room (area) of the pharmaceutical industry
The airborne microbial sampler is designed based on the principle of particle impact and isokinetic sampling theory. The sampled air with microorganisms is sprayed at a high speed by a suction pump and impinged on a culture dish containing the culture medium, and colonies are formed after being cultured to count.
A certain volume of air should be taken (the sampling volume should be representative)
The instrument should be verified.
Floating bacteria sampler manufacturers - Suzhou Changliu Purification Technology Co., Ltd., JYQ-II (50L) planktonic bacteria sampler, FKC-1 (100L) AC and DC handheld floating bacteria sampler in line with GMP standards.
★ Settling bacteria method - passive method
Settling dish exposure time in air <4 hours
Monitor the entire filling process
Can only give qualitative and semi-quantitative data
The results of the sedimentation disc should be evaluated in conjunction with the data of airborne bacteria.
Settling bacteria method: referred to as sedimentation bacteria concentration. The number of colonies (CFU) obtained by culturing in a 90 mm culture dish in the air for 30 min and covering the culture dish represents the number of bacteria that can be settled in the air.
★ Surface contact method: Contact disc sampling is better than cotton swab sampling. And easy to touch the disc
Our company provides 55mm contact plates for petri dishes: for the determination of surface microorganisms such as equipment, workshops, personnel, packaging materials. Instead of cotton swabs, the sampling step is reduced to ensure the accuracy and safety of the sampling. The surface area is 25cm2, meeting the sampling requirements specified in the new standard.
Environmental surface monitoring: surface sampling
Regular monitoring of contact with product surfaces, equipment, floors, walls, etc.
★Contact butterfly method: suitable for flat surface
Sampling area 25cm2
The medium is slightly raised, higher than the edge of the dish for easy sampling
Neutralizer/protective agent should be included in the medium
★ Cotton swab wiping method: suitable for irregular surfaces
Sampling area ~25cm2
Qualitative or quantitative
★ personnel monitoring
Surface sampling method (contact dish method), the sampling time is generally:
At the end of the work, take a sample before leaving the clean area
After handling abnormal conditions (re-dressing or changing gloves after sampling)
Monitoring at any time during the production process
pay attention:
Do not sample immediately after disinfection
Environmental Monitoring Microbiological Testing It is recommended to use the quantitative airborne bacteria sampling method (using the floating bacteria sampler). The airborne microbial sampler is designed according to the particle impact principle and the isokinetic sampling theory. The sampled air with microorganisms is sprayed at a high speed by a suction pump and impinged on a culture dish containing the culture medium, and colonies are formed after being cultured to count.
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