Some standard content:
JB | |tt||Water chestnut type coating machine
Swing granulator
Released on 2004-02-05
Implemented on 2004-06-01
National Development and Reform Commission Release
ICS11.120.30
C92
JB
Pharmaceutical Machinery Industry Standard of the People's Republic of China JB20016—2004
replaces YY0253—1997
High efficiency coating machine
Highefficiencycoatingmachine2004-02-05 release
2004-06-01 implementation
National Development and Reform Commission release
Foreword
Scope| |tt||1
2 Normative reference documents
3 Classification and labeling
4 Requirements
5 Test methods
6 Inspection rules||tt ||7
Logo, instruction manual, packaging and storage items
times
JB20016—2004
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JB20016—2004
Foreword| |tt||This standard is based on the requirements of the "Good Manufacturing Practice for Pharmaceutical Products" and the GB/T1.1-2000, GB/T1.2-2002 Standardization Work Guidelines, and is based on YY0253-1997 "High Efficiency Coating Machine" Revision. This standard replaces YY0253-1997 from the date of implementation. Compared with YY0253-1997, the contents of this standard have changed as follows: a) Some chapters and articles in YY0253-1997 have been deleted: Definitions (Chapter 3);
-High-efficiency coating machine design and production documents (5.1 ,5.2): Working environment conditions of high-efficiency coating machine (5.3.5.4); Explosion-proof requirements for high-efficiency coating machine workshop (5.5): radial runout and axial movement requirements of coating drum (5.12.3); control system requirements (5.18).
b) Revised some chapters and articles in YY0253-1997: 1 Preface:
Reference standards (Chapter 2);
Product classification (Chapter 4); || tt||Requirements (Chapter 5);
Test methods (Chapter 6);
Inspection rules (Chapter 7);
Marking, packaging, storage (Chapter 8 ).
c) Some new chapters and clauses added to this standard: requirements (see 4.2, 4.3, 4.9.3);
Instructions for use (see 7.2);
Electrical and safety performance requirements (see 4.14). This standard is proposed by China Pharmaceutical Equipment Industry Association. This standard is under the jurisdiction of the Pharmaceutical Equipment Industry Standardization Technical Committee. The unit responsible for drafting this standard: Beijing Aviation Manufacturing Engineering Research Institute of Aviation Industry Corporation of China. The main drafters of this standard: Yang Wenxue, Xu Zhiyuan, and Wang Liwen. 28
1Scope
High-efficiency coating machine
JB20016—2004
This standard specifies the classification and marking, requirements, test methods, and inspection rules of high-efficiency coating machines and marking, packaging and storage. This standard is applicable to high-efficiency coating machines for coating solid pharmaceutical preparations, tablets, and pills. 2 Normative reference documents
The provisions in the following documents become provisions of this standard through reference in this standard. For dated reference documents, all subsequent amendments (excluding corrigenda) or revisions do not apply to this standard. However, parties to an agreement based on this standard are encouraged to study whether the latest versions of these documents can be used. . For undated referenced documents, the latest edition applies to this standard. GB/T191 Packaging, storage and transportation pictorial mark
Surface degree parameters and their numerical values
CB/T1031
GB/T3280 stainless steel cold-rolled steel plate
GB5226.1 2002 Mechanical Safety Machinery and Electrical Equipment Part 1: General Technical Conditions GB/T6388 Transport Packaging Receipt and Delivery Marks
CB/T9969.1 General Instructions for Use of Industrial Products Method of random sampling using random numbers CB/ T10111:
GB/T13306 label
General technical conditions for mechanical and electrical product packaging
GB/T13384
GB/T16769
Noise pressure level of metal cutting machine tools Measurement method YY/T0216 Pharmaceutical machinery product model compilation method Pharmacopoeia of the People's Republic of China (2000 edition) National Pharmacopoeia Commission Good Manufacturing Practice (1998 revised edition) State Food and Drug Administration 3 classification and labeling
3.1 classification|| tt||3.1.1 The high-efficiency coating machine is a closed drum, automatic spray coating machine. According to the drum structure type, it is divided into two types: porous and non-porous. 3.1.2 The high-efficiency coating machine consists of the following main parts: a) coating host;
b) hot air supply device:
c) exhaust device;
d) spray Drop device;
e) Electrical system.
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3.2 mark
3.2.1 The model preparation of high-efficiency coating machine should comply with the regulations of YY/T0216. 3.2.2 Model preparation:
BGOOO
Improved investment design job serial number (A, B, C)
Specification code: Structural feature code expressed in terms of production capacity per pot (kg): W - non-hole rolling sheet; perforated sheet is not marked. Type code: high efficiency
Product function code: coating machine
3.2.3 Marking example:
a) BGW150 type: Indicates a high-efficiency coating machine with a production capacity of 150kg per pot and a non-porous drum. b) BG150A type: represents an efficient coating machine with perforated rollers and a production capacity of 150kg per pot after the first improved design. 3.3 Specification parameter series
The specifications and parameters of high-efficiency coating machine should comply with the provisions of Table 1. Table 1 Specificationswww.bzxz.net
Applicable occasions
Test and small batch production
Medium batch production
Mass production
4 requirements
Specifications Parameters (maximum total weight of tablets after coating per pot, kg) 2,5,10
50,75,100,150
250,300,350
4.1 The outer surface of the high-efficiency coating machine should be flat and smooth , no scratches, no rust, easy to clean. 4.2 The stainless steel used in the high-efficiency coating machine should be austenitic stainless steel that complies with CB/T3280. Its material does not chemically change with the drugs and does not absorb the drugs.
4.3 The high-efficiency coating machine should have devices that facilitate transportation and installation. 4.4 The motor used in the high-efficiency coating host should be an explosion-proof motor, and the fans used in the hot air supply device and exhaust device should be explosion-proof fans. 4.5 The pipe connections of the high-efficiency coating machine should be correct, and each working pressure pipe should be well sealed and leak-free. 4.6 Each moving part of the high-efficiency coating machine should move flexibly, without jamming, and the various movements should be coordinated. Each operating handle should be adjustable. 4.7 The surface of the parts in direct contact with the drug in the high-efficiency coating machine should be smooth and smooth. The coating liquid delivery pipeline should be corrosion-resistant, the structure should have no dead corners and blind tubes, and it should be easy to clean and disinfect. 4.8 The lubrication system of the high-efficiency coating machine should not cause contamination to the medicine or container. 4.9 Coating host requirements
4.9.1 The inner wall surface of the coating roller should be smooth and flat, without dead corners or pits, and there should be no burrs around the air holes. The surface roughness of the inner wall of the coating roller should comply with the regulations of GB/T1031, and its Ra value should not be greater than 1.6um. 4.9.2 The stirring device inside the coating roller should not have sharp corners or sharp edges. 4.9.3 The coating main machine should run smoothly and be able to adjust the speed steplessly. 30
4.9.4 The noise sound pressure level of the dry operation of the coating host shall not be greater than 75dB(A). 4.10 Requirements for hot air supply device
4.10.1 The hot air supply device can automatically control the temperature, and its temperature adjustment range is from room temperature to 80°C, with a tolerance of ±2°C. JB20016-2004
4.10.2 The hot air supply device should have air dust removal and purification filters that are easy to install. Its air purification should reach level 100,000. 4.10.3 The hot air supply device should be able to adjust the heating air volume, and the air inlet of the device should be able to connect to the air eliminator. 4.10.4. The hot air supply device should have noise reduction measures and be placed in a soundproof room. The background noise sound pressure level generated at the coating machine during operation shall not exceed 75dB(A).
4.11 Exhaust device requirements
4.11.1 The exhaust device should allow the coating exhaust gas to pass through the After filtering and dust removal, it is discharged outdoors. 4.11.2 The fan of the exhaust device should be installed reasonably and the air volume should be adjustable. 4.11.3 The exhaust frame should have noise reduction measures and be placed in a soundproof room. The background noise sound pressure level generated at the coating machine during operation shall not exceed 75dB(A).
4.12 Requirements for syrup dripping device
4.12.1 When the syrup wax pump is started frequently, the delay time between starting and stopping should not be greater than 1.5s. 4.12.2 The syrup pot should have a temperature adjustment device, and the adjustment temperature range is from room temperature to 90°C, with a tolerance of ±3°C. 4.13 Requirements for film spray and other devices
4.13.1 The film spray should be able to be started and stopped at any time. The spray should be in the shape of a cone and fan, with uniform atomization, and the nozzle of the spray gun should not be filled with water. 4.13.2 The flow rate of the film spray device should be adjustable. 4.13.3 The film spray device used in the coating machine where the medium solution is an organic solvent should be driven by an explosion-proof drive device. 4.14 Electrical and safety performance requirements
4.14.1 The connection and wiring of the electrical system and the identification of wires shall be in accordance with the provisions of 14.1 and 14.2 in GB5226.1-2002. 4.14.2 The buttons, indicator lights and displays of the electrical system should comply with the provisions of 10.2, 10.3 and 10.9 in GB5226.1-2002. 4.14.3 The operation panel of the electrical system should be protected by PELV (Security Extra Low Voltage) and should be in accordance with the provisions of 6.4 in CB5226.1-2002.
4.14.4 The continuity of the protective grounding circuit of the electrical system shall be in accordance with the provisions of 8.2.3 in GB5226.1-2002. 4.14.5 The insulation resistance between all power circuit conductors and protective grounding circuits in the electrical system should be greater than 1 Me at 500V DC voltage
4.14.6 All circuit conductors in the electrical system and the protective grounding circuit should withstand at least A voltage impact of 1s time, 50Hz rate, and 1000V voltage without breakdown, except for circuits intended to work at or below the PV voltage. 4.14.7 The markings, warning signs and project codes of the electrical system should comply with CB5226.1-2002 The provisions of Chapter 17. 4.14.8 Protective covers should be installed on exposed rotating parts of high-efficiency coating machines, and clear, eye-catching, and durable safety warning signs should be placed on dangerous parts.
4.14.9 High-efficiency coating machines should have interlocking, emergency stop, and safety alarm functions, and can work reliably. 4.15 The appearance quality and uniformity of the tablets coated by the high-efficiency coating machine should comply with the provisions of the "Pharmacopoeia of the People's Republic of China" (2000 edition). 5 Test methods
5.1 Visually inspect the outer surface of the high-efficiency coating machine. The surface should be flat, smooth, without scratches or rust, making it easy to clean. 31 | | tt | | JB20016—2004 | 5.3 Visually inspect whether the high-efficiency coating machine is equipped with devices that facilitate transportation and installation. 5.4 Open the back door or side door of the coating host, hot air supply device, and exhaust device, and visually inspect the motor and fan types. 5.5 Visually inspect the connection status of each pipe of the commercial coating machine. Pass compressed air to each pressure pipe. Keep the pressure for 10 minutes under the design working pressure. Apply foaming agent (or soapy water) to the pipe connections and observe the pipe connections. Seal leakage. 5.6 Check whether each moving part moves flexibly, there should be no jamming, and the operating handle should be adjustable. 5.7 Visually inspect the surface and shape of the parts in direct contact with the drug in the high-efficiency coating machine and check the material certification information. 5.8 Visually inspect the sealing or isolation measures of each lubrication system of the high-efficiency coating machine. 5.9 Coating host test
5.9.1 Visual inspection The inner surface of the coating drum should be smooth, flat, without dead corners, and there should be no burrs around the air holes when touched by hand. 5.9.2 Visually check that the outer surface of the mixer installed in the coating drum should not have sharp corners or sharp edges. 5.9.3 Start the coating main machine and operate the speed adjustment button. The speed should be steplessly adjusted from low speed to high speed and the operation should be smooth. 5.9.4 Start the coating host and measure the operating noise with a sound level meter according to the method specified in GB/T16769 at the maximum speed without load. 5.10 Hot air supply device test
5.10.1 Set the temperature above room temperature and 80℃ on the thermostat to conduct two temperature control error tests. Start the hot air supply device respectively. When the outlet hot air temperature is low At the set temperature, the thermostat should turn on the heating source to heat the air: when the outlet hot air temperature is higher than the set temperature, the thermostat should turn off the heating source to cool it down and observe the temperature control error. 5.10.2 Start the hot air supply device and use a particle counter (dust analyzer) at the exit to check the air dust removal and purification status. The air purification should reach level 100,000.
5.10.3 Start the hot air supply device and adjust the hot air supply adjustment mechanism by hand. The air volume should be adjustable. 5.10.4 Visual inspection: The structure of the heating air supply device should have measures to reduce noise. Start the hot air supply device, and use a sound level meter to test the background noise 1m directly in front of the coating machine. 5.11 Exhaust device test
5.11.1 Open the cabinet door of the exhaust device and visually inspect the filter device. It should be a medium-efficiency filter device. 5.11.2 Start the exhaust device and adjust the exhaust adjustment mechanism by hand. The air volume should be adjustable. 5.11.3 Visual inspection of the exhaust device structure should take measures to reduce noise. Start the exhaust device and test the background noise with a sound level meter 1m directly in front of the coating machine.
5.12 Syrup Dripping Device Test
5.12.1 After starting the syrup end-acting pump, then shut down the snail-acting pump, use a stopwatch to measure the delay time, and repeat the test twice. 5.12.2 Set the temperature above room temperature and 90°C on the thermostat to conduct two temperature control error tests. Fill the syrup insulation pot with an appropriate amount of water and start the thermostat. When the water is heated to the set temperature, the thermostat automatically turns off the heater. When the water temperature is lower than the set temperature, the thermostat should automatically turn on. The heater heats the water and observes its temperature control error. 5.13 Thin film spray device test
5.13.1 Connect the pipeline between the end drive system and the spray gun as required, and place the suction pipe in a container filled with water. Turn on the compressed air switch, connect the communication signal to open the needle valve of the spray gun, start the screw system, adjust the pump speed or flow regulator, and adjust the liquid flow; turn on the atomizing air, adjust the atomizing air pressure through the regulating valve and adjust the flow regulator Atomize air flow and observe the atomization effect. 5.13.2 Disassemble the outer cover of the film spray device and visually inspect the type of its drive device. 32
film spray and other devices used for coating medium solutions using organic solvents should be explosion-proof drive devices. 5.14 Electrical and safety performance Test
JB20016-2004
5.14.1 According to the provisions of 14.1 and 14.2 in GB5226.1-2002, visually inspect the connection and wiring of the electrical system and the marking of the wires. 5.14.2 According to the provisions of 10.2, 10.3, and 10.9 in CB5226.1-2002, visually inspect the buttons, indicators, and displays of the electrical system. 5.14.3 According to the provisions of 6.4 in CB5226.1-2002, the operation panel of the electrical system for visual inspection shall be protected by PELV (Security Extra Low Voltage).
5.14.4 Check the continuity of the protective grounding circuit of the electrical system according to the test method specified in 19.2 of CB5226.1-2002. 5.14.5 According to the test method specified in 19.3 of GB5226.1-2002, check the insulation resistance between all power circuit conductors and protective grounding circuits in the electrical system.
5.14.6 According to the test method specified in 19.4 of GB5226.1--2002, conduct a voltage withstand check on all circuits in the electrical system, except circuits intended to operate at or below the PELV voltage. 5.14.7 Visually inspect the markings, warning signs and project codes of the electrical system, which should comply with the provisions of Chapter 17 of GB5226.1-2002.
5.14.8 Visually inspect the exposed rotating parts and safety signs of dangerous parts of the high-efficiency coating machine. They should be clear, eye-catching, strong and durable.
5.14.9 Start the high-efficiency coating machine, set up faults, and visually inspect interlocks, emergency stops, and safety alarms. It should work reliably. 5.15 Start the high-efficiency coating machine and run it continuously for 2 hours without load (1 hour each at medium speed and high speed). There is no abnormal noise. The control system works normally and there is no shutdown accident.
5.16 Start the high-efficiency coating machine and use the blank tablets (or tablets) that have passed the press inspection to coat the period coating and film coating.The appearance quality and uniformity of the packaged tablets shall be tested according to the content uniformity test method in Appendix
6 Inspection Rules
6.1 Each high-efficiency coating machine must pass the inspection by the quality inspection department of the manufacturing unit and be accompanied by a product certificate before leaving the factory. 6.2 Factory inspection and type inspection:
6.2.1 Factory inspection
6.2.1.1 Factory inspection shall be carried out on a unit-by-unit basis according to the terms specified in Table 2. Table 2 Factory inspection items
Item category
General performance
Main performance
Inspection items
4.1.4.3.4.4.4.5,4.6.4.7, 4.8.4.9.1,4.9.2,4.9.3.4.9.4,4.10.3,4.11.1.4.11.2,4.13.2,4.13.3,4.14.1,4.14.2,4.14.3,4.14.7, 4.14.8, 4.14.9, 5.154.12.1, 4.13.1, 4.14.4, 4.14.5, 4.14.66.2.1.2 If unqualified products are found during the inspection process, they should be returned for repair and then submitted for inspection after repair. If it is still unqualified, it will be deemed as unqualified product.
6.2.2 Type inspection
6.2.2.1 Type inspection shall be carried out in one of the following situations: a) When the product is trial-made or transferred to a factory for production: 33
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