Fully automatic tubular multi effect distilled water machine

　　Multi effect tubular distilled water machineIt is the main equipment for producing injection water in the pharmaceutical industry, which has greatly improved through years of GMP renovation projects. With the upcoming release of the new version of GMP in China and people's awareness of EU GMP, pharmaceutical companies' requirements for distilled water machines are also increasing. This article will provide a new cognitive explanation of the basic requirements for distilled water machines.

　　Multi effect tubular distilled water machineBasic requirements for equipment

1.1 Material/Surface

(1) Surface that does not come into contact with products and cleaning media: The surface is smooth, easy to clean, and does not react with cleaning agents and disinfectants. The material should be at least 304.

(2) Surface in contact with products and clean media: Surface roughness (Ra0.4 μ m), electro polishing, provide roughness measurement report, material 316L, provide material certification.

1.2 Welding

All welding (pipeline and equipment in contact with the product) operations must comply with the following specifications: (1) Welder Confirmation Test (ISO9606); (2) Welding and similar processes (ISO6520-1)

Welding must use automatic track welding technology. In some areas, automatic rail welding equipment cannot be used for pipelines before manual welding can be used.

1.3 Sealing

Sealing of parts in contact with products and clean media: suitable for use and installation (operation and sterilization), resistance to temperature and materials, provide specified material certificates.

1.4 Aseptic emptying filter

The pore size is 0.22 μ m, hydrophobic, and can be tested for online integrity. The material of the filter housing should be 316L or equivalent. The inner surface of the filter housing should have no cracks, and the surface polishing degree should reach Ra0.4 μ m or higher. Additionally, an electric heating device is required.

1.5 Sampling valve

The water sample should be cooled to 50 ℃. The sample cooler should be a tubular heat exchanger designed with double tube plates, with a rated pressure of 1.0 MPa, and the refrigerant used is chilled water. The sampling point is easily accessible and leaves sufficient sampling space.

1.6 Evaporator

(1) Each evaporator should be designed with a double tube plate, and the rated pressure of the heat exchanger shell and pipeline should be 10 barg. The equipment includes a feedwater preheater and a separator.

(2) The initial evaporator should be a sanitary vertical pipeline, fixed tube plate, and natural circulation. The vertical pipeline is self-supporting, and each section of the pipeline is detachable. The shell matches the detachable dome and bottom.

(3) The evaporator shell should provide internal monitoring operation mirrors.

1.7 Condenser

(1) The condenser is designed with double tube plates. The "U-tube" shell and tube heat exchanger use feedwater as the coolant, and the tube bundle is detachable. The injection water is condensed and collected in the condenser shell. The rated pressure of the heat exchanger shell and pipeline is 10 barg. Suppliers should provide connections for pressure testing pipelines.

(2) The condenser should be vented to the atmosphere through an air filter, with a 316L stainless steel casing and an internal electropolished Ra0.4 μ m. The filter element is connected by clamps and valves, and should meet the requirements of on-site integrity testing.

1.8 Heat exchanger

(1) All heat exchangers in contact with injection water should be double tube plate and tube heat exchangers. Insulation between tube plates, injection water flows through the tube side.

(2) The operating pressure on one side of the heating fluid is lower than that of the injection water. When a leak occurs, it flows towards non product flow. The heat exchange fluid should flow counter current through the heat exchanger.

(3) The heat exchanger needs to be insulated with 30mm asbestos (chlorine free), wrapped in 304 stainless steel, and polished with a Ra0.8 μ m. All heat exchangers need to undergo fluid (pressure holding) testing to ensure the integrity of the test run, which is part of the system pressure holding test. Meanwhile, the manufacturing and installation of the heat exchanger must ensure its complete emptying.

1.9 Preheater

The preheater is of sanitary type. The initial effect preheater should be designed with double tube plates, and the "U-shaped tube" tube heat exchanger uses feedwater as the cooling liquid for the pipeline, and the tube bundle can be disassembled. The rated pressure of the heat exchanger shell and pipeline is 10 barg. Suppliers should provide connections for pressure testing pipelines.

1.10 Distilled liquid cooler

The distilled liquid cooler should be designed as a sanitary double tube plate tube system, using seamless piping. In order to conduct leakage testing, there should be grooves or drainage holes between the inner and outer pipes.

1.11注射用水储罐

(1) The injection water tank should include a level switch, temperature, level transmitter, conductivity display, electrically heated filter, 0.22 μ m air filter, and spray ball.

(2) The injection water storage tank and accessories in contact with the product and clean medium should be made of 316L or equivalent material, with no cracks on the inner surface and a polishing degree of Ra0.4 μ m or higher. The design of the tank allows for easy and thorough cleaning, with all edges rounded.

(3) The storage tank should be designed for insulation, with a jacket for automatic (steam) heating insulation, and the temperature inside the tank should not be lower than 80 ℃.

(4) The tank should be completely emptied without any condensation or water residue.

(5) The storage tank requires a manhole (DN500).