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General specifications for industrial clean room

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Recently, the Ministry of Housing and Urban-Rural Development issued a mandatory national norm \"Industrial Clean Room General Norm (Draft for Comment)\", including design, construction, acceptance and performance of industrial clean room, including pharmaceutical industry, medical equipment, electronics industry And maintenance has made mandatory requirements, for example:


Unrelated pipelines with clean rooms should not be made in cleanlocks.


The empty noise level of the unidirectional stream and the mixed stream cleaning chamber should not be greater than 65dB (a), and the empty noise level of the non-single stream cleaning chamber should not be greater than 60 dB (a). When the end of the air conditioner system is purified, the empty noise level of the unidirectional stream and the mixed stream should not be greater than 70 dB (a), and the niimate noise level of the non-single stream cleaning chamber should not be greater than 65dB (a .


Table 2.2.6 Differential differences in clean room and surrounding space


1222-2

Note: 1 is not subject to this value when the upper technology sandwich or lower technique of different grade clean room is connected.


The clean room should set an anti-static environment according to the production process, and anti-static standards should meet the requirements of Table 2.2.7.


Table 2.2.7 Indoor control electrostatic potential absolute value



grade

Electrostatic potential absolute value limit

Indoor control electrostatic potential absolute value

≤100V


≤200V


≤1000V


The amount of new wind in the clean room should ensure that the indoor personnel are not less than 40m3 per hour.


The clean room of the air cleanliness is strict than 8 levels (such as A, a Class B clean room) must not use a heat sink.


The setting of cleanlocks should meet the following provisions:


1. Clean level is a level A, B-class medical clean room and other clean rooms that are strict than 6 levels should not be set;


2. The remaining clean indoor settings are dedicated to a clean room.


The arrangement of the production wastewater drainage pipeline in the clean room should meet the following requirements:


1. Process equipment connected to gravity flow wastewater collecting pipelines, should be provided with water seal below its discharge port, and the water seal height shall not be less than 50mm;


2. Gravity flow waste water pipe should be set;


3. Clean indoor delivery contains toxic and harmful hazardous characteristics and after leakage, the production wastewater pipeline that forms contaminated with groundwater, soil should not be laid directly.


Clean indoor lighting should be used in clean room special lamps.


The rigorous nature of the air-conditioning system in the pharmaceutical industry A, B and other industries, 1 to 5, and in line with the provisions of the high-pressure wind tube, and should be leak detection; the pharmaceutical industry C, D level and other industries 6 ~ The medium and low-pressure purification air conditioning system of the 9-level clean room should be less than 1 system for leak detection.


The purification air conditioning system unit is in pressure at 1000 Pa, and the leakage rate should not be greater than 1%.


Clean room test project


Serial number

project

Require

1

Indoor work area (or specified height) section wind speed

One-way flow

2

Air supply

Non-unioneering flow

3

Airflow flow

There is an industry request

4

Static pressure difference

Inspection

5

New air volume

Inspection

6

High efficiency and ultra efficient filter leakage

Level 5 or severely 5-level clean room and clean room with industry requirements

7

Drainage high efficiency filter leak

Inspection

8

Cleanliness

Inspection

9

temperature

There is a constant temperature and humidity environment

10

Relative humidity

There is a constant temperature and humidity environment

11

noise

Inspection

12

Floating bacteria or concentrating bacteria

Clean room required for microbial limit parameters

13

Illumination

There is an industry request

14

Static electricity

There is an industry request

15

Anti-microscopy

There is an industry request

16

Gas-loaded molecular contaminant concentration

There is an industry request

17

Warming structure

Detection as needed


Before the cleansing room test, the environment should be thoroughly cleaned. The test item first should measure the wind speed, air volume, airflow, static pressure difference, and then perform filter leakage, and then measure the clean level.


For biological clean rooms, the microbial limit should be detected after the improvement items such as cleanliness, and the microbial limit should be detected, and the microbial limit shall not be disinfected.


Content and requirements of performance parameters monitoring


1222-3


Note: The air cleanliness level is generally detected in dynamic, but it can also be carried out in static.


The Clean Room A Clean Area in the Pharmaceutical Industry is monitoring, and the other levels are detected in static.


Full text See PDF file03. General Specification for Industrial Cleansing Room 2021.12.21.pdf



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