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Nuoze Fluid Technology (Shanghai) Co., Ltd

E-mail
fengjunjie@noozle.com.cn
Phone
13918684639
Address
Building 4, 3255 Shengang Road, Songjiang District, Shanghai

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Airflow crusher isolator

NegotiableUpdate on 01/05

Model

Nature of the Manufacturer: Producers

Product Category

Place of Origin

Online Consult

Overview

According to the different needs of customers in project implementation, we provide corresponding airflow crusher isolation systems for them. For the preparation of ultrafine powders of flammable, explosive, or toxic products, they cannot be directly exposed to the air, which may cause explosions or personal safety accidents. In order to meet various crushing needs, specialized isolators for ultrafine powder airflow crushers have been widely used.

Product Details

　　Airflow crusher isolator

　　Self control system:

Automatic control system including airflow pulverization, online cleaning, air filtration, and closed operation equipment

Verification service:

Nuoze Fluid has a professional verification service team responsible for the verification of pharmaceutical water equipment, liquid preparation process systems, clean pipeline systems, and high-pressure gases.

Verification service:

The verification lifecycle starts from the development of the URS, goes through design confirmation, construction phase, installation confirmation, operation confirmation, and finally confirms the completion of the URS through performance confirmation. Verification is the establishment of written evidence to ensure compliance with the customer's predetermined quality characteristics.

DQ (Design Confirmation): refers to the confirmation of the design and selection of a project or system, including the standards and supporting documents adopted for design and selection, as well as the confirmation of supplier information.

Note: Standard equipment can be selected and confirmed based on user needs without design confirmation, while non-standard equipment must undergo design confirmation. Design confirmation must confirm that the design documents have met the user's requirements. Design documents, drawings, and technical specifications should meet the requirements of the technical terms of the equipment purchase contract.

IQ (Installation Confirmation):

　　Installation confirmation mainly includes but is not limited to the following contents:1. Open box inspection: Confirm whether the packing list matches the packing list;

Appearance inspection: Confirm whether the equipment is damaged or corroded;

Identification inspection: Various labels on the equipment (name, model, manufacturer, serial number, equipment tag number, etc.) meet the design requirements; Are the documents required to be provided by the manufacturer/supplier complete;

2. Confirmation of installation environment conditions

Confirm whether the equipment is suitable for the installed environment and meets the requirements of drug production. GMP specifies the cleanliness level, temperature and relative humidity requirements, ventilation and dust removal requirements for different types of equipment in the factory building.

Public system inspection, such as connections and parameters of water, electricity, compressed air, steam, process vacuum, and vacuum dust removal.

3. Installation confirmation

Inspection of instrument list, parameters, installation location, and calibration records.

Computer/program control system installation confirmation, control system adjustment initial parameter check.

Inspection of motor and pump parameters (model, factory serial number, operating direction, etc.).

Pipeline pressure test, acid pickling and passivation test, and test report.

The installation status of auxiliary equipment and movable devices related to the equipment, such as support platforms, storage tanks, buffer tanks, and weighing instruments, as shown in the completion drawing. OQ (Operational Qualification): The main content of Operational Qualification is:

1. Applicability of SOP draft;

2. Reliability of external working conditions;

3. Accuracy of instrument display;

4. The fluctuation of equipment operating parameters;

5. Stability and safety of equipment operation;

Note: After completing the equipment installation confirmation, sufficient no-load tests should be conducted on each part and the whole of the equipment according to the drafted standard operating procedures (SOP). Through the tests, the applicability of the SOP draft, the fluctuation of equipment operating parameters, the reliability of instruments, and the stability of equipment operation should be examined to ensure that the equipment can operate accurately within the required range and achieve the specified technical indicators. During this process, it may be necessary to supplement and modify the sOP appropriately, as well as make certain adjustments to the equipment (all of this information will be summarized and analyzed by the validation team, and opinions will be provided and submitted for relevant review and approval).

PQ (Performance Qualification): Performance qualification is a trial production conducted by simulating actual production conditions. It is usually tested with blank materials first to preliminarily determine the applicability of the equipment. The validation batch can be determined based on the characteristics of the product and equipment. If it can be confirmed that the equipment can operate stably and meet the needs of the production process, the verification team will summarize the relevant information and submit it for review and approval. After that, the equipment can operate continuously.

　　Airflow crushing closed isolation system

　　Airflow crusher isolatorFeatures:

All parts in direct contact with the material are made of 316L stainless steel, and the surface is polished to RA ≤ 0.25um

The other metal parts are made of 316 stainless steel and polished to RA ≤ 0.8um on the surface

The part in contact with the visible glass is made of borosilicate

The gasket in contact with the product is made of PEEK or polytetrafluoroethylene

The gasket in contact with the product is made of EPDM rubber or PTFE

Environmental temperature: 0-40 ° C

Working temperature: 0-50 ° C

The company has several service engineers with over ten years of industry experience, who can provide customers with relevant technical services and training at any time. Since its establishment, it has had customers in various fields such as biology, medicine, food, electronics, petroleum, and chemical engineering. Whether it is the preparation and production of nanomaterials, testing and quality control, or the engineering design of advanced production lines, we can provide customers with complete solutions.