Genetic diagnostic reagent purification project-Zhijiang Bio

Zhijiang BioGMP cleanroomInstallation　　

Project Name：Shanghai Zhijiang Biotechnology Co.

　　Project content：10,000 class, 100,000 class purification project

　　Industry Category：Genetic Diagnostic Reagents

　　■Introduction of Zhijiang Bio

　Shanghai Zhijiang Biotechnology Co.Ltd. is a high-tech enterprise specializing in the development, production and sales of nucleic acid diagnostic reagents and instruments, and is one of the leading enterprises in the production of molecular diagnostic reagents in China.

　　Headquartered in Shanghai, the company is located in Shanghai Zhangjiang Hi-Tech Park and Pujiang Hi-Tech Park, with an R&D center and manufacturing facilities covering an area of more than 10,000 m2. As an expert in the field of molecular diagnostics, the company has developed more than 300 genetic diagnostic kits. They are mainly used in medical clinics, public health emergencies, entry-exit inspection and quarantine, food inspection, animal husbandry, aquaculture and other fields. The products developed cover almost all the legal infectious diseases in China. More than 30 products have been approved by the State Food and Drug Administration. At present, the product market has covered more than 30 provinces and cities in China, and exported to more than 70 countries in Europe and America.

　　The purification project constructed by Shanghai LJ has a grade of 10,000 and 100,000, temperature: 18-26℃, humidity 45-65%, the production base has 2800 square meters, the production process meets the requirements of GMP purification workshop certification.

　　■ Cleanroom clean room project completion acceptance of the commissioning of the preparatory work before

　　1, the clean room purification project commissioning organization preparation：

　　The commissioning team headed by the construction unit (owner) with the participation of design unit, construction unit and supervision unit personnel is established. The commissioning team leads the overall work of commissioning, the commissioning team coordinates the relationship between all parties, and the commissioning team provides various soft and hard conditions for the commissioning work.

　　2、Commissioning outline of clean room purification project preparation

　　Under the leadership and organization of the commissioning team, the commissioning outline is prepared. Commissioning outline is the guiding document of commissioning work. The content of the commissioning outline includes: organizational division of labor, material mobilization; commissioning project, commissioning method, commissioning instrument; commissioning procedure, commissioning progress, commissioning plan arrangement, etc. The preparation of the commissioning outline makes the commissioning personnel clear in mind, unified in understanding, consistent in pace and neat in action, so that the commissioning work is carried out smoothly.

　　3、The clean room construction site quality of the clean room will be inspected.

　　Under the leadership organization of the commissioning team, relevant leaders and technical personnel of construction unit, design unit, construction unit and supervision unit participated in the construction site and construction quality for a comprehensive meeting inspection. From the refrigeration station, heat exchange station, boiler room, substation and distribution station, air-conditioning machine room to the cooling, heating, power supply system, air-conditioning purification system and automatic control system. From the construction quality of equipment (freezers, boilers, pumps, cooling towers, air conditioners, etc.), fittings (valves, air outlets, mufflers, etc.), pipes and pipelines to insulation, equipment foundations, pipe supports and hangers, etc. will be fully inspected. To see whether the construction according to the map, check and design drawings do not match the place, to find the construction quality of unqualified items and check the reasons. And the construction, processing, installation and other quality issues one by one to fill out “ defect schedule ”, put forward rectification advice, the deadline (before the official commissioning) rectification completed.

　　4、Clean room purification project of the air conditioning equipment, air conditioning system cleaning：

　　① It is very necessary to carry out a comprehensive and thorough cleaning of the clean room before commissioning. The ground, wall, ceiling, doors and windows of the clean room should be carefully, comprehensively and thoroughly cleaned (it is better to ask professional cleaning company); the air conditioning equipment, air conditioning ducts (air supply duct, air return duct, new air duct), air conditioning accessories (cleaners, valves, air outlets, etc.) should be checked, leak detection and wipe test. Until the clean requirements are met.

　　②Install coarse and medium-effect filters for the first air blowing. On the basis of thorough cleaning, install the coarse and middle-effect filters in the air conditioner. Air-blowing of the whole purified air conditioning system, air-blowing time is 24~36 hours, so that the whole system can be initially purified.

　　③Installation of high efficiency filter. High efficiency filter can be installed after the system is air blown. Before the installation of high-efficiency filters, it is required to leak detection one by one, and plugging for those with leaks. Leak detection is carried out on the temporary leak detection table, and the dust source uses atmospheric dust. The high efficiency filters that are qualified can only be installed, and after installation, the installation seal of the high efficiency filters will be tested again for leaks (using dust particle counter scanning) to achieve qualified installation.

　　④High efficiency filter installation leak detection after passing the second air blowing on the purified air conditioning system. The air blowing time is 24 hours, and then the commissioning procedure can be carried out.

　　5, clean room purification project test instruments, meters, tools for the preparation

　　① The instrumentation used in the commissioning should be debugged and calibrated before the commissioning (over the use of time also need to be re-calibrated). The instruments used include instruments for measuring air speed, air volume, temperature, relative humidity, differential pressure, noise, vibration, rpm, time, atmospheric pressure and cleanliness, etc.

　　② debugging equipment and tools used in the preparation. Such as: electrician's tools, plumber's tools, metalworker's tools, pliers' tools and ladders for climbing up and down. And ask the construction unit to cooperate with electricians, plumbers, metalworkers and pliers.

　　③ Preparation of drawings and record forms used for commissioning and testing work.