Single Use Stomach Feeding Tube,Medical Disposable Nasogastric Tubing,Medical Disposable Pu Nasogastric,Disposable Medical Stomach Feeding Tube Shaoxing Jenston Medical Products Co., Ltd. , https://www.sxjcmed.com
1 Way and function 1.1 Cleaning and sterilizing drying method (1) Drum rotary spray and gap type air flow and water flow exchange impact mode are mixed and cleaned, and the machine is slowly flipped.
(2) Hot pressing steam sterilization.
(3) Hot air drying or hot air vacuum vapor drying.
(4) Washing medium: water for injection; sterilization medium: pure steam; hot air filtration accuracy: 100 grades.
1.2 Functional requirements (1) Including the functions of rough washing, fine rinsing, silicidation, sterilization and drying, the whole process is in closed condition.
(2) It has the functions of spray roughing and air-blending mixing and rinsing, hot-press steam sterilization, hot air drying or hot air vacuum vapor drying.
(3) It can automatically suck and discharge, without manual contact pollution.
(4) It can be cleaned, sterilized and dried by natural rubber plug and butyl rubber plug which can adapt to the national standard.
(5) Cleaning and sterilizing the rubber plug to ensure the clarity (insoluble particles) meets the requirements of the Chinese Pharmacopoeia.
(6) Moisture control meets the requirements.
(7) Cleaning and sterilizing the dried rubber plug to ensure sterility and pyrogen-free after sterilization.
2 Structure and manufacture 2.1 Material (1) All parts of direct injection of clean water and gas, such as water for injection, gas system piping, pipe fittings, cleaning drum, cleaning chamber, pump, etc., are at least low-carbon austenitic stainless steel, of which injection The water pipe is made of 316L stainless steel polished pipe.
(2) All sealing materials are made of sanitary grade silicone rubber.
(3) Other materials should be corrosion-resistant, rust-free and free of particulate precipitation.
(4) Stainless steel materials should have a report on the corresponding material protection and solution treatment.
(5) Considering that parts that need to be sterilized frequently should be suitable for high temperature without deformation and corrosion.
2.2 Water and gas system (1) There is a water circulation system (two-stage filtration). Before the injection water circulation filtration, coarse filtration should be carried out. The coarse filtration is 0.45 μm, and the injection water fine filtration is 0.22 μm. Among them, the upper and lower parts of the water filter should be provided with exhaust, discharge (or sampling).
(2) Steam filtration and air filtration were provided, and the filtration was 0.22 μm; at the same time, compressed air filtration was provided, and the filtration was 0.22 μm.
(3) Water pressure ≥ 0.2MPa, air pressure ≥ 0.2MPa; water for injection water temperature ~ 60 ° C.
(4) The water and gas inlets are provided with terminal filters, and there is pressure display before the inlet or the use point (the water inlet has temperature display).
2.3 Piping system (1) The pipe needs to be polished, the pipe is welded by automatic argon arc welding, and the outer wall is polished after welding.
(2) The pipe connection uses a quick-opening sanitary joint that is easy to clean.
(3) There should be no dead ends in the pipeline to ensure that the remaining water can be drained when parking.
(4) The valves and pressure gauges of the pipelines shall be made of medicinal special valves or diaphragm valves, and the control valves shall also be able to drain water.
(5) Pipes with a surface temperature higher than 60 °C shall be insulated and insulated, the insulation material shall not contain chloride ions, and the outer layer shall be covered with a stainless steel protective cover.
(6) After the injection water pipeline assembly, it should be pickled and passivated.
(7) All piping shall indicate the flow of material in the piping.
2.4 Cleaning the drum and the cavity part (1) The cleaning drum is argon-arc welded, and the inner surface is polished after polishing. The surface roughness Ra≤0.4μm, each hole of the drum needs to be polished by the concave surface to ensure the polishing. Do not wear the rubber stopper when rotating the drum. At the same time, the inner rotation angle of the drum should be a transition of the arc, and there is no dead zone.
(2) The overflow trough plate on the cavity body should be designed to float easily, and there is no dead space in the trough plate. The inner weld surface needs to be polished, and the circumferential angle should be a circular arc transition.
(3) There is an easy-to-discharge clean water pipeline below the cavity cylinder, and the pipeline should be tilted to the low position of zui.
(4) The design and manufacture of the cavity shall be undertaken in accordance with the requirements of “capacity regulations†and corresponding qualified units. The water pressure test is required after the system.
(5) After the inner surface of the cavity cylinder is made, it needs to be polished, and the outer surface is covered with thermal insulation material.
2.5 In and out of the rubber plug device and the discharge door system (1) The rubber plug nozzle and the rubber plug door cannot be opened at the same time, and should be designed as interlocking structure.
(2) The automatic rubber plug door needs to have two parts: a safety protection door and a discharge safety door. The unloading safety door should be able to have a special mechanical self-locking structure. The door should have a sealing structure and strictly prevent leakage. The safety protection door should be able to be electrically controlled and interlocked. In addition to the electric control, it should be returned to the manual control.
(3) The screw plug conveying mechanism generally recommends spiral discharge. When the spiral is discharged, it is necessary to ensure that the argon arc weld of the spiral surface is smooth and smooth and polished with the contact surface of the rubber plug, and there is no dead space. The setting of the helix angle should facilitate the discharge of the rubber plug.
2.6 Mechanical transmission (1) The sealing of the shaft and the cavity of the cavity should be mechanically sealed, and the main body of the seal is made of low-carbon austenitic stainless steel.
(2) The surface of the main shaft in contact with the seal is subjected to special surface hardening and surface refining treatment to achieve no leakage.
2.7 Sampling port: The sampling side of the water quality (clearness) after cleaning the rubber plug shall be provided on the back side of the machine (100,000 level). It may be equipped with a clean water or sanitary ball valve.
2.8 Others (1) A silicone oiling device shall be provided on the machine according to the process requirements.
(2) The whole machine is easy to clean and easy to repair.
(3) Safety device: mechanical overload protection device shall be provided; the safety valve on the container shall be prepared according to the requirements of “capacity regulationsâ€.
(4) The setting of the fresh air outlet should consider the actual situation of the clean factory.
3Electrical and control 3.1 Speed ​​control function: The cleaning drum rotation speed can be frequency-controlled, can be set according to the menu and displayed on the interface.
3.2 Control display (1) PLC control, man-machine interface. The graphical operation terminal has a friendly interface, and the help menu provides a number of process steps that can be selected first, and can also be set on the touch screen by itself. The cycle process dynamically displays the process status of the selected program and the change in process parameters in the process. During the cycle, you can flip through the pages to see historical trends. At the same time, process parameters can be printed for user archiving.
(2) There are online display and printing cylinder heating temperature and time parameters and curves.
(3) If an alarm occurs, immediately interrupt the operation, enter the safe state, and the main method of popping up the alarm information and troubleshooting on the touch screen.
(4) The air pressure and flow of the air pressure can be automatically adjusted and menu settings, and displayed on the interface.
3.3 Chain and control (1) When the machine is running, the safety gate of the rubber plug cannot be opened.
(2) When the circulation pump is not turned on, the machine does not operate.
(3) The machine can be started only when the vacuum pump is operating normally.
(4) Automatically stop and alarm when the following conditions occur:
a when the machine fails;
b When the temperature inside the cavity reaches 121 °C, the corresponding steam pressure is 0.125MPa. When the steam pressure is >0.14MPa, when the sterilization temperature does not match the set value (+1°C or -2°C), it should automatically alarm;
c hot air temperature >130 ° C;
d when compressed air ≤ 0.6MPa;
e When the vacuuming time is too long or the vacuum degree is ≤ -0.095MPa;
f when the water level is too low;
h The safety protection door of the rubber plug nozzle and the rubber plug is opened or not closed at the same time, or the safety protection door of the rubber plug nozzle and the rubber plug is not closed when working;
i When the control valve is faulty or the transmitter is over-ranged.
3.4 connectivity:
(1) The unit can be started only when the auxiliary equipment (such as a compressor) is operating normally.
(2) When the 100-level laminar flow at the rubber plug door is in normal operation, the finished rubber plug can be produced.
3.4 Installation environment requirements (1) 100,000 cleanliness space at the feed plug.
(2) The rubber plug should be in the 10,000-degree cleanliness space. The cleaned and dried rubber plug discharge should be filled into the aseptic tank under the protection of 100-level laminar flow.
3.5 Main control indicators (1) Container tightness test, sterilization chamber leakage rate under vacuum condition: within 5 minutes, the pressure change in the chamber should be <3.0 mbar/min;
(2) Monitoring of dust particles in the sterilization chamber, in line with the standard of 100 cleanliness.
(3) High-efficiency filter integrity test in the sterilization chamber, the aerosol penetration rate ≤0.01%;
(4) The test of the correct control state of the equipment automatic control system: the error between the corrected temperature indication, the sensor, the temperature recorder reading value and the standard thermocouple indication value shall be <±1.0 °C; b corrected time recorder and standard time The error between the indicating devices is ≤±1%; the error between the c-calibrated pressure gauge and the vacuum gauge and the standard is ≤±10%;
(5) The airborne heat distribution test in the sterilization chamber, the temperature of each point (including the cold spot) is ≤±1 °C in each sterilization procedure;
(6) The moisture control of the rubber plug after cleaning and drying in each step, using the dry weight loss weighing method, the water content: butyl rubber plug is ≤0.1%; the natural rubber plug is ≤0.05%;
(7) Check the degree of clarity of the rubber plug. For each batch of 40 samples of random sample, the method of clearness inspection is to take a 250ml drop bottle and add 100ml of distilled water without a hair point, and then put 40 rubber plugs under special inspection light. Check no more than 7 gross points.
Selection of rubber plug cleaning machine
This point is an example of a cleaning method in which an airflow and a water flow exchange impact, and other models can be referred to corresponding changes.