The mandatory national standard 'General Specification for Industrial Cleanrooms' is here! _Industry News_News_sz-pharma

Recently, the Ministry of Housing and Urban-Rural Development issued a mandatory national specification 'General Specifications for Industrial Cleanrooms (Draft for Comment)', which covers the design, construction, acceptance and performance of industrial cleanrooms including the pharmaceutical industry, medical pharma machinery, and electronics industries. Mandatory requirements for maintenance and maintenance, for example: pipes not related to clean room should not be clearly set in clean room. The empty state noise level of unidirectional flow and mixed flow cleanrooms should not be greater than 65dB(A), and the empty state noise level of non-unidirectional flow cleanrooms should not be greater than 60dB(A). When a fan filter unit is used at the end of the purification air-conditioning system, the air-state noise level of the one-way flow and mixed-flow clean room should not be greater than 70dB(A), and the air-state noise level of the non-one-way flow clean room should not be greater than 65dB(A) ). Table 2.2.6 Pressure difference between clean room and surrounding space Note: 1 When the upper technical interlayer or the lower technical interlayer of different grades of clean room are connected, it is not limited by this value. The clean room should set up an anti-static environment according to the production process requirements, and the anti-static standard should meet the requirements in Table 2.2.7. Table 2.2.7 Absolute value of indoor control electrostatic potential The fresh air volume in the clean room should ensure that each person in the room is not less than 40m3 per hour. The clean room with air cleanliness level stricter than Class 8 (such as Class A and Class B clean rooms) shall not use radiators for heating. The setting of the floor drain in the clean room should meet the following requirements: 1. The medical clean room with cleanliness class A and B and other clean rooms stricter than class 6 should not have floor drains; 2. The floor drains set in the rest of the clean rooms should be clean Room dedicated floor drain. The layout of the production wastewater drainage pipes in the clean room shall comply with the following requirements: 1. The process pharma machinery connected to the gravity flow wastewater collection pipe shall be provided with a water seal below the discharge outlet, and the height of the water seal shall not be less than 50mm; 2. The gravity flow wastewater pipe shall be Set up ventilation pipes; 3. The production wastewater pipelines that contain toxic and harmful dangerous characteristics and cause pollution to groundwater and soil after leakage shall not be directly buried in the clean room. Clean room lighting should use special lamps for clean room. The tightness of the air ducts of the purification air-conditioning system in the clean rooms of Class A, B and other industries in the pharmaceutical industry and Class 1 to 5 in other industries should meet the requirements of high-pressure air ducts, and all air leakage detection should be carried out; The medium and low pressure purification air conditioning system of the 9-level clean room should conduct air leakage detection for 30% of the air ducts and not less than one system. Under the static pressure of 1000Pa, the air leakage rate of the purification air conditioning system unit should not be greater than 1%. Clean room testing items Before clean room testing, the environment to be tested should be thoroughly cleaned. The test items should first measure the wind speed, air volume, airflow pattern, static pressure difference, and then perform filter leak detection, and then measure the cleanliness level. For the biological clean room, the microbial limit should be detected after the required inspection items such as cleanliness level are completed and the surface is disinfected, and air disinfection should not be performed before the microbial limit is detected. Contents and requirements of performance parameter monitoring of clean room Note: Air cleanliness level is generally tested under dynamic conditions, but it can also be performed under static conditions. The A-level area of ​​the clean room in the pharmaceutical industry is monitored under dynamic conditions, and other levels are detected under static conditions.

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