Summary:
The clean room commissioning stage belongs to the completion commissioning; our implementation is carried out in the air state and static state, and services are provided: air volume (air change times) measurement, temperature and humidity test, cleanliness test, pressure difference adjustment, illuminance test, noise test, airflow flow pattern analysis, high-efficiency filter leak detection, etc.
◆ according to specifications:
Test method for suspended particles in clean room (area) of pharmaceutical industry (GB / T 16292-2010)
Technical code for construction of clean operation Department of hospital (gb50333-2013)
Code for design of clean room gb50073-2013 code for construction and acceptance of clean room GB 50591-2010
Code for design of clean workshop in electronic industry (GB 50472-2008)
Experimental animal environment and facilities (GB 14925-2010)
Clean rooms and related controlled environments - Part 3: Test methods (GB / T 25915.3-2010 / ISO 14644-3:2005)
Drug production quality management specification (revised in 2010)
Test method for clean room (area) of pharmaceutical packaging material production plant ybb0042004-2015
Test method for planktonic bacteria in clean rooms (areas) of pharmaceutical industry (GB / T 16293-2010)
Test method for settling bacteria in clean room (area) of pharmaceutical industry (GB / T 16294-2010)
Technical code for construction of laboratory animal facilities (GB 50447-2008)
Experimental animal environment and facilities (GB 14925-2001)
Guidelines for drug production and validation (2003 Edition)
◆ the importance of system debugging in clean room is shown in the following aspects:
I. find and solve problems in equipment, facilities, control, technology and other aspects to put the clean room into normal operation; find problems and correct design and installation defects.
2. Achieve the system design objectives, that is, the internal environmental parameters of the clean room meet the design requirements; the most important guarantee to ensure the design quality.
III. on the premise of meeting the design requirements of various control parameters, reduce the operation cost as much as possible, and ensure the system to operate in the state of low consumption and energy saving.
◆ equipment performance measurement and adjustment
1. Be familiar with relevant technical documents and drawings of air conditioning system, indoor and outdoor air calculation parameters, air volume load, temperature and humidity control accuracy requirements and other processes;
2. The commissioning personnel, together with the design, construction and construction units, shall go to the site to find out the places where the installation quality of the air conditioning system is unqualified, and the places where the construction does not conform to the design, which shall be recorded in the defect list and corrected within a time limit;
3. Prepare the instruments, meters, necessary tools and relevant records required for commissioning;
4. After the commissioning of each sub project is completed, the comprehensive performance of air conditioning system shall be measured to determine whether the comprehensive index of system linkage operation meets the design requirements. If not, further adjustment shall be made in the measurement;

5. Test the cleanliness, temperature, humidity and static pressure of the clean room. If it fails to meet the requirements, further adjustment is required.

◆ implementation of commissioning content
1. Measurement of air supply volume at each air supply outlet of the room, conversion of total air supply volume of the room, total air supply volume of the system and air change frequency of the room:
Use the air volume tester to adjust and test the air volume of each air supply outlet, and then add the air volume of all air supply outlets in each room to get the air volume of each room, and then add the air volume of each room to get the total air volume of the system.
Divide the air supply volume of each room by the volume of the room to get the air change times of the room.
After testing, the air supply volume of each air supply outlet, the total air volume of the room, the total air supply volume of the system and the air change frequency of the room shall meet the design requirements.
Standard: total air volume: 0-20%; air volume at each air outlet: ± 15%; fresh air volume: ± 10%.
2. Detection of static pressure difference:
The measurement of static pressure difference shall be carried out after the whole connected clean room system is opened and running stably. All doors shall be closed tightly. The surrounding of the pressure pipe shall be sealed as much as possible, and the pipe shall be extended from the soft pad under the door as much as possible. If the door joint is opened, the pressure difference will drop. The measurement sequence shall be from the highest pressure room designed to the low pressure room in turn, from the cleanliness level Said, should start from the highest level clean room gradually to the lower level of measurement.
Considering that the pressure difference between different levels of clean rooms is actually small, the accuracy of the micro pressure difference meter has higher requirements. Not less than 2.0pa.
Standard: no less than 5pa (New GMP no less than 10Pa) for different levels and between indoor clean area and non clean area; no less than 10Pa for clean room and outdoor area.
3. Detection of indoor cleanliness:
The minimum number of sampling points for the determination of cleanliness shall be determined in accordance with schedule 1.1. The sampling times of each point shall not be less than 3, and the sampling times of each point can be different. Conditions: after the air volume and positive pressure are adjusted, the room shall be cleaned as required, and the biological clean room shall be disinfected as required, with sufficient pre cleaning (air blowing) time. At most two people wear clean clothes to enter, and try to be in the downwind direction.
Table of minimum sampling points: 1.1
Area (M2)
Cleanliness
Level 100
Level 1000
Level 10000
Level 100000
< 10
2-3
Two
Two
Two
Ten
Four
Three
Two
Two
Twenty
Eight
Six
Two
Two
Forty
Sixteen
Thirteen
Four
Two
One hundred
Forty
Thirty-two
Ten
Three
Two hundred
Eighty
Sixty-three
Twenty
Six
Four hundred
One hundred and sixty
One hundred and twenty-six
Forty
Thirteen
One thousand
Four hundred
Three hundred and sixteen
One hundred
Thirty-two
Two thousand
Eight hundred
Six hundred and thirty-three
Two hundred
Sixty-three
Note: the meaning of area in the table is: for unidirectional flow (laminar flow) clean room, it refers to the area of air supply and sealing surface; for turbulent flow room, it refers to the area of room
When the number of sampling points is less than 9, 95% UCL value is calculated, and the number of sampling data is more than 10. Standards: refer to specifications and design.
4. Detection of indoor floating bacteria and settling bacteria:
The indoor floating bacteria test point and cleanliness test point can be the same; sampling must be carried out according to the steps described in the instructions of the instrument used, and special attention shall be paid to the disinfection and sterilization of the instrument before testing.
For the determination of settling bacteria, the Petri dishes shall be arranged in representative places and places with little air flow disturbance. The number of Petri dishes can be the same as the number of sampling points determined according to schedule 1.1, but the minimum number of Petri dishes shall meet the requirements of schedule 1.2.
Table 1.2 minimum number of dishes
Cleanliness level
Number of required φ 90 Petri dishes (calculated by sedimentation of 0.5h)
Level 100
Fourteen
Level 1000
Five
Level 10000
Two
Level 100000
Two
5. Leakage detection of high-efficiency air filter after installation: for the high-efficiency filter installed at the end of air supply and exhaust, the scanning method shall be applied to the filter installation frame and full section leakage detection. When the sampling port is placed 2cm ~ 3cm away from the surface of the filter to be inspected, it shall move at the speed of 5mm / S ~ 20mm / s to scan the whole section of the filter to be inspected, the head glue and the installation frame. Standard: when the specified reading is greater than 0.01% of the concentration of upstream aerosol, there is leakage.