dzprc 负压隔离器 Negative pressure isolator suzhou dzprc tech Co., Ltd.

产品图 product map Weighing and loading Charging and loading Feeding cans Mobile isolation Stepping isolation Dryer isolation

产品标准 product standard

设备介绍1 product presentation1 HMI MANOMETER air exhaust FAN Air intake HEPA air exhaust HEPA materials and supplies pass box water pistol operation rim A drain Feeding rim

设备介绍 2 product presentation 2 air exhaust air intake lifter Electric valve IBC TANK Continuous bag charge point valve Shock feeding charge point valve IBC TANK

negative pressure airflow+HEPA 设备原理 principle Principle and application of equipment： 1、The equipment adopts a sealed operation mode, enclosed box, airtight door, negative pressure airflow and other ways to ensure the isolation effect of the internal and external equipment. isolation Closed box airtight door negative pressure airflow+HEPA

参数 parameter 箱体材料：316L 不锈钢 Box Material: 316L Stainless Steel Pressure holding differential: greater than - 80 pa 电压：380v 50-60Hz Voltage: 380V 50-60Hz 高效过滤器 H13 high efficiency particulate air (HEPA) filter H13 系统负压维持阶段工作噪声<65dB(A) Noise < 65dB(A) in the negative pressure maintenance stage of the system 舱体密闭性：符合ISO10648-2标准要求 Compliance with ISO 10648-2

配件说明 Accessories description 1、箱体 Box body 舱体材料：SUS316L不锈钢 Cabin Material: SUS316L Stainless Steel 3、门采用气囊密封Airbag seal 2：门采用钢化玻璃 Door: toughened glass

4、高效过滤器 HEPA 4.1采用康斐尔品牌 法国进口 Import from France with Comfil Brand， 4.2 过滤效率H13 Filtration efficiency H13 4.3保障工作区洁净度和排气洁净度 Ensure internal cleanliness and exhaust cleanliness 4.4作为耗材部分，采用更换简单的结构安装和拆卸 As consumables, install and disassemble with simple replacement structure 5、采用超细玻璃纤维纸作滤料 Using Ultrafine Glass Fiber Paper as Filter Material

5、手套 glove 采用美国皮尔康品牌 Pilcon, USA

6.清洗工具 6.Cleaning tool

7、物料传递方式 Material transfer mode 1、连续袋子传递物料和器具 Continuous Bag Transfer Materials and Tools

7、物料传递方式 Material transfer mode 2 αβ阀转运物料 Alpha Beta Valve Transfer Material

控制系统Control system

用户管理 user management

系统画面 System picture

Equipment service DQ confirmation is to verify the performance, material, structure, accessories, control and instrumentation of the equipment according to the customer's requirements and production process, and to verify the rationality and reliability of the product in the design process. FAT validation is to prove the reliability of the product quality of the equipment before it is packed and delivered through a series of experimental tests in the manufacturing plant, and to prove that the equipment can meet the basic requirements of design validation, product factory standard and national GMP requirements. IQ confirmation is to provide a series of test data through site installation, debugging and verification activities to prove that the installation documents, installation conditions and installation results of the products meet the design requirements, and that the data and documents meet the GMP management requirements. OQ confirmation: First, check the inspection report of the product provided by the verifier, check and test the technical parameters of the equipment, confirm that the performance of the product meets the design requirements and meets the relevant requirements of GMP. Purpose of PQ confirmation: On the basis of installation confirmation and operation confirmation, according to the specific production process of the manufacturer, the corresponding test products are added to carry out the test, confirming that the operation performance of the equipment meets the design requirements and the relevant requirements of the new version of GMP，FDA.

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