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Purpose
Ensure that all environmental indicators in the cleanroom meet the specified requirements, ensure product quality, and provide a basis for environmental monitoring.
Scope
Applicable to cleanroom Environmental monitoring, microbiological laboratory environmental monitoring, and clean sampling environmental monitoring.
Responsibilities
Quality Assurance Department: Responsible for formulating environmental monitoring standards for clean rooms (areas) and conducting daily supervision and inspection.
Quality Control Department: Responsible for regular monitoring of the cleanliness of clean rooms (areas), recording monitoring data, and issuing monitoring reports.
Production Workshop: Responsible for daily monitoring of the temperature, Relative humidity, and air pressure of clean rooms (areas) and recording data.
Engineering Equipment Department: Control and adjust the temperature, relative humidity, air pressure, and illumination of negative cleanrooms (areas), monitor the number of ventilation times of negative cleanrooms (areas), and record monitoring data.
Detailed description of content
1.Environmental monitoring standard basis
GBIT16292-2010 Floating particle measurement method for clean rooms (areas) in pharmaceutical industry
GBIT16294-2010 Detection method for sedimentation bacteria in clean rooms (areas) in pharmaceutical industry
2.Temperature and relative humidity
Standard:
When the production process has no special requirements for the temperature and relative humidity of the clean workshop, the temperature should be controlled at 18℃~26℃, and the relative humidity should be controlled at 30%~65%. When the production process has special requirements for the temperature and relative humidity of the clean workshop, it should be determined according to the process requirements.
Measurement method:
The clean workshop is monitored by a temperature and humidity meter, and the data is recorded
Measurement frequency: 2 times/day (once in the morning and once in the afternoon)
Measurement location: the main operation room of each clean area
3.Pressure difference
Standard:
The static pressure difference between the clean room (area) and the outdoor atmosphere should be greater than 12 Pa, the static pressure difference between the clean room (area) and the non-clean room (area) should be greater than 10 Pa, the dust-producing room (such as: batching room, crushing room, granulation room, mixing room, tableting room, coating room, etc.) and the clean corridor should maintain a relative negative pressure, and the static pressure difference between adjacent clean rooms (areas) with different clean levels should be greater than 5 Pa.
Measurement method:
Micro differential pressure meter for monitoring and recording
Measurement frequency: 2 times/day (once in the morning and once in the afternoon).
Measurement location: corresponding position indoors.
4.Clean room ventilation times
The ventilation times for clean level 10,000 are not less than 20 times/h; the ventilation times for clean level 100,000 are not less than 15 times/h; the ventilation times for clean level 300,000 are not less than 10 times/h.
Measurement method: First use an Air volume meter to measure the air volume of each air outlet and calculate the ventilation times.
Measurement frequency: 1 time/season; measurement location: indoor air inlets.
| Cleanliness level | Maximum allowable number of dust particles: pieces/m3 (static) | Maximum allowable number of microorganisms cfu (static) | ||
| ≥0.5um | ≥5μm | Sedimentation bacteria/90 blood 0.5h | Planktonic bacteria (m3) | |
| 10000level | 350000 | 2000 | 1.5 | 50 |
| 100000level | 3500000 | 20000 | 3 | 150 |
| 300000level | 10500000 | 50000 | 5 | 200 |
Air cleanliness standard,Measurement method, frequency and measurement location: The measurement method is in accordance with the provisions of the national standard "GB/T16292-2010 Test method for suspended particles in clean rooms (areas) of pharmaceutical industry" and "GB/T 16294-2010 Test method for sedimentation bacteria in clean rooms (areas) of pharmaceutical industry". Specific implementation of environmental monitoring and inspection procedures. The measurement requirements for clean room (area) air cleanliness are static tests. Dynamic measurements are carried out during annual verification. At least one of the two measurement indicators listed in microorganisms is required to be measured. Our company uses sedimentation bacteria. In empty or static testing, the number and arrangement of suspended particle sampling points should be as uniform as possible and shall not be less than the minimum number of sampling points. In dynamic testing, the number and arrangement of suspended particle sampling points should be set according to the production and key process operation areas of the product.
5.Test method for dust particles in clean rooms (areas)
This test method adopts the counting concentration method, that is, by measuring the number of suspended particles with a particle size greater than or equal to 0.5um and 5um in a unit volume of air in a clean environment, the suspended particle cleanliness level of the clean room is evaluated.
Instrument: A dust particle counter is used.
| aera | Cleanliness level | ||
| (m2) | 10000 | 100000 | 300000 |
| 10 | 2 | 2 | 2 |
| ≥10~<20 | 2 | 2 | 2 |
| ≥20~<40 | 2 | 2 | 2 |
| ≥40~<100 | 4 | 2 | 2 |
| ≥100~200 | 10 | 3 | 3 |
| Note: For non-unidirectional clean rooms (areas) above Class 10,000, the area refers to the room area. | |||
The location of the sampling points should meet the following requirements:
The sampling points are generally evenly arranged at a horizontal position at a height of 0.8m from the ground. When there are more than 5 sampling points, they can also be arranged in layers in an area at a height of 0.8~1.5m from the ground, but each layer must have no less than 5 points. Limitation of the number of sampling times For any small clean room (area) or local air purification area, the number of sampling points shall not be less than 2, and the total number of sampling times shall not be less than 5 times. The sampling times of each sampling point can be more than 1, and the sampling times of different sampling points can be different.
Sampling volume The minimum sampling volume of each time for different cleanliness levels is shown in the table
Test data processing and result judgment
After the test is completed using the GL1-01D dust particle counter, the 95% confidence UCL value of 0.5mm and 5um will be automatically printed out, and the purification level will be judged.
| Minimum sampling volume L/time | Cleanliness level 10000 100000 300000 | ||
| ≥0.5μm | 2.83 | 2.83 | 2.83 |
| ≥5um | 8.5 | 8.5 | 8.5 |
6.Sedimentation bacteria test method
By the principle of natural sedimentation, the biological particles in the air are collected in the culture medium plate. After a period of time, under suitable conditions, they are allowed to multiply to visible colonies for counting. The number of colonies in the flat culture plate is used to determine the number of live microorganisms in the clean environment, and the cleanliness of the clean room (area) is evaluated based on this. During static testing, no more than 2 testers are allowed to work in the room.
The number of sampling points and their layout are the same as the suspended particle determination method:
Prepare soybean casein agar culture medium culture plate with aseptic operation
Strictly disinfect the surface of the culture plate before testing.
Place the prepared culture dishes one by one according to the sampling point layout diagram, and then open the culture dish lids from the inside to the outside one by one to expose the culture medium to the air.
| Settling bacteria | Dust particle count | ||
| 10,000 100,000 300,000 | 10,000 100,000 300,000 | ||
| Measurement frequency | 1 time/month 1 time/quarter 1 time/half year | 1 time/month 1 time/quarter 1 time/half year | |
| Measurement location | Clean room | Clean room | |
| Monitoring Tools | 9cm diameter nutrient agar dish | Particle Counter | |
In static testing, the exposure time of the culture dish is 30 minutes; in dynamic testing, the exposure time of the culture dish is no more than 4 hours.
After all sampling is completed, the culture dish is inverted in a constant temperature incubator and cultured in an incubator at 30℃~35℃ for 3 days. For each batch of culture medium, 3 culture dishes are selected as control cultures.
N=(C+C, +.--+C)/n4.2.6.7. Colony count calculation method: Calculation of the average colony count of the settling bacteria at each measuring point. That is,, Wu Zhong: N is the average colony count, that is, the reported colony count of the test result of the measuring point, C is the colony count on the plate, and n is the number of plates (culture dishes).
7.Illumination
Standard: The clean room (area) should provide sufficient lighting according to production requirements. The illumination of the main studio should be 150 lux; local lighting can be set up in the production area with special requirements for illumination.
Measurement method
Use a light type illuminance meter for measurement
Measurement frequency: 1 time/year
Measurement location: main functional operation room
8.Noise
The noise of the clean room (area) should not be higher than 60 decibels, of which the local 100-level room should not be higher than 63 decibels, and the local 100-level area and the whole room 100-level room should not be higher than 65 decibels.
Use a noise meter for measurement
Measurement frequency: 1 time/year
Measurement location: main functional operation room
Reference documents
GB/T 16292-2010 Test method for suspended particles in clean rooms (areas) of pharmaceutical industry
GB/T 16294-2010 Test method for sedimentation bacteria in clean rooms (areas) of pharmaceutical industry
