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Production of APIs: Introduction to the Process of Agitated Nutsche Filter Dryer

Time : 2023-02-09 Hits : 25

--------------------WUXI ZHANGHUA PHARMACEUTICAL EQUIPMENT CO. LTD

5.1

1、Product Overview

Multi-functional Agitated Nutsche Filter Dryer (“Three in One”) is to complete successively the process of filtration, washing, liquid-removal, drying, and discharging in a closed container. It can simplify the process flow, improve production efficiency, prevent material pollution, clean in place (CIP), and sanitize in place (SIP). Additionally, it is convenient for material in and out, and realizes mechanical-electrical integration.

5.2

2、Introduction to Structure

2.1. Structure of Agitated Nutsche Filter Dryer: As vertical equipment made of stainless steel, it consists of a lifting mechanism, a stirring device, a tank, a mechanical sealing device, a chassis unit, a discharge valve unit, a sampling device, a dust catcher, a hydraulic unit, and a cleaning and sterilizing device, control devices for automatic and manual operation, electric control cabinets, and other electrical accessories, realizing the integration of electromechanical instruments.

2.2. Nozzlesof Agitated Nutsche Filter Dryer: inlet, cleaning port, nitrogen inlet, thermometer port, pressure gauge port, sight glass port, vacuum port of the trap, sterilization port, outlet, sampling port, heating (cooling) nozzle, backflush port, vacuum port, balance port, lamp hole, filtrate port, etc.

3、Main Functions

The following process can be done in an Agitated Nutsche Filter Dryer:

3.1.  Pressing/Pumping

3.2.  Pressure filtration/Suction filtration

3.3.  Beating/Washing

3.4.  Smoothing filter cake

3.5.  Vacuum drying

3.6.  In-Place Sampling

3.7.  Powder scraping and discharging

3.8.  In-Place Cleaning

3.9.  In-Place Sterilization

3.10.  Parameter display

3.11.  Parameter record

4、Process Flow

4.1. Feeding: Press the material into the “Three-in-One” tank with compressed air or nitrogen or pump the material into the “Three-in-One” tank by vacuum conveying.

4.2. Filtration: Operation is under pressure or vacuum to achieve solid-liquid separation. During filtration, the filter cake is flat, and the solid and liquid is well separated.

4.3. Washing: A 360° rotatable spray ball is installed inside the tank, so that the cleaning liquid is evenly distributed in the container, which can realize the internal cleaning of the container and material washing. The filter cake and the washing liquid are mixed by stirring with the lifting paddle, which helps the slurry to crystallize and the filter cake to be fully washed.

4.4. Smoothing material: The stirring paddle is applied to smooth the cracks on the surface of the filter cake to improve the drying efficiency of suction filtration and shorten the time.

4.5. Drying: The filter cake is loosened layer by layer by the stirring paddle and heated evenly by the heating device. In a vacuum state, the heat transfer medium is passed into the tank jacket and the stirring paddle to heat the wet material, accelerate the solvent evaporation, and speed up the drying rate.

4.6. Sampling: After the filter cake is dried for an appropriate time, in-place sampling is performed to analyze the moisture content of the filter cake to meet the internal piloting quality requirements of the product, and then it can be cooled by refrigerant to prepare for discharging.

4.7. Discharging: The material is scraped, loosened, pushed through the stirring paddle and automatically discharged from outlet on the side of the tank wall.

4.8. CIP, SIP of the Tank: After the material is completely discharged, the tank will be cleaned in-place with WFI, then sterilized and dried for later use.

5.3

5、Applications

5.1. Applicable Industries

5.1.1.   Production of Sterile and Non-sterile APIs

5.1.2.   Biopharmaceuticals

5.2. Applicable Products

5.2.1.  Corrosive products

5.2.2.  Non-heat-sensitive product

5.2.3.  Toxic products

5.2.4.  Sterile products

5.2.5  Non-sterile products

6、Technical Parameters and Specifications

6.1. Technical Parameters

微信图片_20230209103101

 6.2. Specifications

微信图片_20230209103058

7、Technical Features and Advantages

7.1. When it is used in a clean plant, the motor and reducer are fixed, only the stirring shaft moves up and down in the container, so the air disturbance in the clean room is very small. In order to prevent dust, the power part of the driving unit is sealed with a stainless-steel cover to facilitate external cleaning.

7.2. The replacement of the filter plate in the chassis unit is very easy. The filter screen is also fixed while the body flange is fastened. Since there are no fastening bolts and bolt holes on the surface of the filter screen, it is clean and free of liquid accumulation, which meets the requirements of GMP and is suitable for occasions with high requirements for cleanliness.

7.3. It consists of a simple S-shaped curved paddle, which can complete all operations, such as material stirring, drying, and discharging. With simple shape, the paddle is easy to clean, and complies with GMP requirements.

7.4 The stem inside the discharge valve cavity is covered with metal bellows which is resistant to high pressure and temperature. The valve is sealed by double O-ring compression, which is hydraulically driven to lock. The valve body is a liquid-free structure, equipped with SIP system.

7.5. All-round heating and cooling of the cylinder, chassis, agitator, and dust catcher can be carried out, and the head is insulated to speed up drying or cooling to improve production efficiency. Heating method: The barrel part is heated by the overall jacket, and the other is heated by the flow channel.

7.6. The lubricating method of the lifting inner shaft in the stirring and lifting unit is changed from oil-fueled to oil-free (self-lubricating) connection, which not only simplifies the process, but also improves the sterility of the equipment.

7.7. The nozzles on the tank head are all flared, and the height of the exposed part is designed as low as possible, so that the nozzles are easier to clean.

7.8. The stirring shaft in the tank body is covered with pressure and temperature-resistant 316L metal bellows. The upper and lower ends of bellows are respectively connected with the mechanical seal and the stirring shaft seal, which can prevent the friction material, generated when the stirring shaft rotates or moves up and down, from falling into the tank and contaminating the material.

7.9. The cleaning, sterilization and drying of tanks and pipelines during or after the entire operation can be fully automatic, which can not only reduce human intervention, but also improve efficiency.

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