National new standard | Xiaocao Intelligent Expert System for Clean Environment -- Leader in Online Monitoring of Clean Environment (I)-latest technology-hugecore-smart agriculture

National new standard | Xiaocao Intelligent Expert System for Clean Environment -- Leader in Online Monitoring of Clean Environment (I)

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Application Area

In recent years, Xiaocao Group has actively built an intelligent expert system for Xiaocao clean environment, and implemented an all-round, digital and information supervision of the whole process of environmental monitoring. The system is developed according to the latest standard GB25915-2022 of "Clean room and related controlled Environment" issued by the National Standards Committee. It relies on cloud big data for decision analysis, uses artificial intelligence algorithm and expert system idea as the core for the overall design, and uses ARM architecture in hardware to provide quantitative analysis for various management roles such as "edible mushroom environmental monitoring". It fills the vacancy of current intelligent environmental monitoring.

Parts List

Technical Details

Recently, the National Standards Committee issued GB/T 2915.1-2021 "Clean Rooms and Related Controlled Environments-1: Air Cleanliness Levels", which is modified to adopt IOS 14644-1:2015 "Clean Rooms and Related Controlled Environments Part 1: Classification of Air Cleanliness Levels by Particle Concentration", which will replace GB/T 25915.1-2010 "Cleanrooms and Related Controlled Environments Part 1: Air Cleanliness", which will be implemented on March 1, 2022.

The main parameter requirements of the new GMP cleanliness level A, B, C, D

As shown in the table below:

Class A clean area
Air temperature	20℃~24℃
Relative humidity of the air	45％~60％
wind velocity	The horizontal wind speed ≥ 0.54m/s, and the vertical wind speed ≥ 0.36m/s
High-efficiency filter leak detection	＞99.97％
illuminance	＞300lx - 600lx
noises	≤75dB (dynamic test)

Class B clean area
Air temperature	20℃~24℃
Relative humidity of the air	45％~60％
Number of room ventilations	≥ 25 times/h
Differential pressure	The B-level area is ≥ 10Pa relative to the outdoors, and different areas of the same level should be consistent according to the airflow direction
High-efficiency filter leak detection	＞99.97％
illuminance	＞300lx - 600lx
noises	≤75dB (dynamic test)

Class C clean area
Air temperature	20℃~24℃
Relative humidity of the air	45％~60％
Number of room ventilations	≥ 25 times/h
Differential pressure	The C-level area is ≥ 10Pa relative to the outdoors, and different areas of the same level should be consistent according to the airflow direction
High-efficiency filter leak detection	＞99.97％
illuminance	＞300lx - 600lx
noises	≤75dB (dynamic test)

Class D clean area
Air temperature	18℃~26℃
Relative humidity of the air	45％~60％
Number of room ventilations	≥ 15 times/h
Differential pressure	The 100.000-class area is ≥ 10Pa relative to the outdoors
High-efficiency filter leak detection	＞99.97％
illuminance	＞300lx - 600lx
noises	≤75dB (dynamic test)

The standard provisions for each level of airborne particulates in the clean area are:

Cleanliness level	Maximum allowable number of suspended particles/m³				Approximate correspondence Traditional specifications
	Static		dynamic
	≥0.5μm	≥5μm	≥0.5μm	≥5μm
Grade A	3520	20	3520	20	Level 100
Class B	3520	29	352000	2900	Level 100
Class C	352000	2900	3520000	29000	10000 levels
Class D	3520000	29000	No prescripts	No prescripts	100,000 levels

Air Cleanliness Standard (GMP-97) for Pharmaceutical Production Cleanrooms (Zones) in China:

Cleanliness level Clean class	Maximum allowable number of dust / ≥ number of dust particles of 0.5 μm	≥ 5 μm dust particles	Maximum allowable number of microorganisms Plankton/cubic meter	Sedimentation bacteria/dish
Level 100	3500	0	5	1
10000 levels	350000	2000	100	3
100,000 levels	3500000	20000	500	10
300,000 levels	10500000	61800	1000	15

Chinese National Standard GB50073-2001 (equivalent to international standard ISO14644-1)

Air Cleanliness Class (N)	Greater than or equal to the maximum concentration limit of particle size in the table (pc/m3)
Air Cleanliness Class (N)	0.1μm	0.2μm	0.3μm	0.5μm	1.0μm	5.0μm
ISO Class 1	10	2
ISO Class 2	100	24	10	4
ISO Class 3	1000	237	102	35	8
ISO Class 4	10000	2370	1020	352	83
ISO Class 5	100000	23700	10200	3520	832	29
ISO Class 6	1000000	237000	102000	35200	8320	293
ISO Class 7				352000	83200	2930
ISO Class 8				3520000	832000	29300
ISO Class 9				35200000	8320000	293000

Cleanroom testing items

serial number	project	request
1	Wind speed of the cross-section of the indoor work area (or specified height).	One-way flow must be inspected
2	Supply air volume	Non-one-way flow must be checked
3	Airflow pattern	It must be inspected when required by the industry
4	Differential static pressure	Must be checked
5	Fresh air volume	Must be checked
6	Leak detection of high-efficiency and ultra-high-efficiency filters	Class 5 or stricter than Class 5 cleanrooms and cleanrooms with industry requirements must be inspected
7	Exhaust air high-efficiency filter leak detection	Must be checked
8	Cleanliness level	Must be checked
9	temperature	It must be inspected when there is a requirement for a constant temperature and humidity environment
10	relative humidity	It must be inspected when there is a requirement for a constant temperature and humidity environment
11	noise	Must be checked
12	Planktonic or sedimentary bacteria	Cleanrooms with microbial limit parameters must be inspected
13	illuminance	It must be inspected when required by the industry
14	electrostatics	It must be inspected when required by the industry
15	Anti-micro-vibration	It must be inspected when required by the industry
16	Concentration of airborne molecular pollutants	It must be inspected when required by the industry
17	Tightness of the envelope structure	Detect as needed

Before the cleanroom test, the tested environment should be thoroughly cleaned. The test items should first measure the wind speed, air volume, air flow pattern, and static pressure difference, and then the filter leak detection, and then measure the cleanliness level.

For biological clean rooms, the microbial limit should be detected after the completion of the required inspection items such as cleanliness level and surface disinfection, and air disinfection should not be carried out before the microbial limit is detected.

The content and requirements of performance parameter monitoring in clean rooms

Monitoring projects			Maximum time interval
Air cleanliness standards	Pharmaceutical industry	A	Continuous online monitoring
		B	3 months
		C、D	6 months
	Other industries	≤3	Contact Online Monitoring
		3< cleanliness ≤ 5	6 months
		＞5	12 months
Environmental Microbiological Standards	Pharmaceutical industry	A、B	per batch
		C	weekly
		D	6 months
Wind speed and volume			12 months
Differential static pressure			1 month

Note: The air cleanliness level is generally tested under dynamic conditions, and the current Xiaocao clean environment intelligent expert system can evaluate the clean environment according to the three perspectives of static environment, dynamic environment and sterilization environment.

In recent years, Xiaocao Group has actively built an intelligent expert system for Xiaocao's clean environment, and implemented all-round and whole-process digital and information-based supervision of environmental monitoring. The system is developed according to the latest standard of "Clean Room and Related Controlled Environment" GB25915-2022 issued by the National Standards Committee, relying on cloud big data for decision-making analysis, with artificial intelligence algorithms and expert system ideas as the core for overall design, and using ARM architecture in hardware to provide quantitative analysis for various management roles such as "environmental monitoring of edible fungi", filling the gap of current environmental intelligent monitoring.

Grass clean environment intelligence experts evaluate cleanliness standards

(1) Six kinds of particles can be evaluated according to international standards (ISO), pharmaceutical production standards, and Chinese national standards;

(2) Through different warning light colors to show what level the current purification level belongs to;

(3) Evaluate the clean environment from the three perspectives of static environment, dynamic environment and sterilization environment;

(4) Conduct independent assessment of the microbial environment of aseptic production, predict the risk of infection in advance, and avoid adverse effects caused by unclean environment.

At present, the system standardizes the number of sampling points, area, particle sampling time, sampling volume and sampling sensor in the clean room, and the environmental parameters that can be sampled are: national standard PM1.0, national standard PM2.5, national standard PM10, American standard PM1.0, American standard PM2.5, American standard PM10, total suspended particulate matter (TSP) μm0.3, total suspended particulate matter (TSP) μm0.5, total suspended particulate matter (TSP) μm1.0, Total suspended particulate matter (TSP) μm2.5, total suspended particulate matter (TSP) μm5, total suspended particulate matter (TSP) μm10, fresh air outlet, air supply outlet, return air outlet, exhaust air outlet, wind speed, air volume, laminar flow Reynolds number Re=pvd/g, static pressure difference between clean area and non-clean area, pressure difference between clean area and clean area, ozone concentration, ultraviolet intensity and other data. Through the establishment of mathematical models in different production and processing environments to carry out the comprehensive scheduling and intelligent control of sterilization equipment, in the actual control process of continuous effect evaluation, through the convolutional neural network algorithm (CNN) and reinforcement learning (RL) algorithm to continuously optimize the control model, to achieve the purpose of accurate, economical and efficient purification and sterilization environment control.

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