Some standard content:
ICS11.120.30
C92
JB
Pharmaceutical Machinery Industry Standard of the People's Republic of China JB20003.3--2004
Eye Drops Linkage Line
Tunnel Drying Drying machine
Production line for eyedropsDryingtunnel2004-02-05 release
2004-06-01 implementation
National Development and Reform Commission release
Foreword
1 Scope
2 Normative reference documents
3 Models and markings
4 Requirements
5 Test methods
Inspection rules
6||tt ||Logo, instructions for use, packaging and storage 7
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JB20003.3—2004
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JB20003.3—2004
Foreword
This standard is proposed by China Pharmaceutical Equipment Industry Association. This standard is under the jurisdiction of the Pharmaceutical Equipment Industry Standardization Technical Committee. This standard was drafted by: Beijing Aerospace Wanda High-Tech Development Center. The main drafters of this standard: Xin Yi, Feng Ruixin, Wang Jinyan. 22
1 Scope
Eye drops linkage line tunnel dryer
JB20003.3—2004
This standard specifies the marking of eye drops tunnel dryer , requirements, test methods, inspection rules and signs, instructions for use, packaging and storage.
This standard applies to eye drop plastic bottle tunnel dryers (hereinafter referred to as dryers). 2 Normative reference documents
The provisions in the following documents become provisions of this standard by being cited in this standard. For referenced documents with a reference period, all subsequent amendments (excluding corrigenda) or revisions do not apply to this standard. However, parties that reach 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 Pictorial marks for packaging, storage and transportation
GB5226.1-2002 Mechanical safety mechanical and electrical equipment Part 1: General technical conditions GB/T6388 Transport, packaging, receipt and delivery marks
GB/T9969.1 General instructions for use of industrial products GB/T10111
Method of random sampling using random numbers GB/T13306 Labeling
General technical conditions for packaging of mechanical and electrical products
GB/T13384||tt| |GB/T16769 Metal cutting machine tool noise sound pressure level measurement method JG/T19 laminar flow clean workbench inspection standard YY/T0216-1995 Pharmaceutical machinery product model preparation method Pharmaceutical Good Manufacturing Practice (1998 revised edition) National Medical Products Administration China Pharmacopoeia of the People's Republic of China (2000 Edition) National Pharmacopoeia Commission 3 Model and Marking
3.1 Model
The model of the dryer should comply with the regulations of YY/T0216. DL·H/O
Main parameters (heating power, kW)
Main parameters (belt width, mm)
Product type and feature code (L-linkage: H- Baked in) product function code ((D eye drops machinery) 23
JB20003.3—2004
3.2 Marking examples
4 requirements
4.1 General provisions||tt ||DL·H
420/15
Heating power 15kW
Mesh belt width 420mm
Eye drops linkage line·dryer
Drying The design, manufacture, installation, use, repair, maintenance and verification of the dryer should comply with the relevant principle instructions of the "Good Manufacturing Practice for Pharmaceuticals" (1998 revised edition)
4.2 Working conditions
Clean environment. Degree: The dryer should be placed in a class 100,000 clean area, and the cooling section points to the class 10,000 control area of ??the clean factory building. 4.3 Material requirements
4.3.1 The box of the dryer should be corrosion-resistant and non-toxic. , made of stainless steel with stable performance. 4.3.2 The conveyor mesh belt should be made of stainless steel braided belt that is resistant to moisture, high temperature and wear. 4.4 Appearance requirements
4.4.1 The outer surface of the drying machine should be smooth and smooth. Smooth, without bulges, dents, cracks and dead corners. 4.4.2 The edges of the exposed joint surfaces of the components should be neat and uniform, and there should be no obvious misalignment. 4.4.3 The installed nameplates, warning signs, function identification marks and grounding symbols should be clear and clear. Complete and durable. 4.5 Structural requirements
4.5.1 The dryer should be divided into three sections: preheating area, heating area and cooling area. 4.5.2 The air inlet above each working area of ??the dryer should be installed in accordance with " The purification filter required by the relevant regulations of the Pharmacopoeia of the People's Republic of China (2000 Edition)
4.5.3 The dryer should have a conveyor belt relaxation and tension adjustment device. 4.5.4 The dryer should have a temperature display. and record printing device. 4.5.5 The dryer has a height adjustment device. 4.5.6 The dryer should have an air pressure meter that displays the air pressure in each working area. 4.6 Functional requirements
4.6.1 Control function. :
4.6.1.1 The running speed of the conveyor belt is adjustable, and there should be two operating modes: manual and automatic. 4.6.1.2 The temperature of the heating zone is adjustable.
4.6.2 Temperature display and printing record. Function: 4.6.2.1 The dryer can display the temperature of each work area in real time. 4.6.2.2 The printer in the dryer can print the temperature of each work area regularly. 4.6.3 Interlock function:
24||tt| |4.6.3.1 When bottles accumulate at the outlet of the dryer, the conveyor belt should automatically stop running. 4.6.3.2 When any fan stops, the dryer should automatically stop heating. 4.6.3.3 The temperature in the heating zone is higher than the set temperature. Within a limited time, the dryer should automatically stop heating. 4.7 Performance requirements
4.7.1 The air cleanliness inside the dryer should reach level 100. 4.7.2 The temperature range of the dryer heating zone is 80℃~95℃, and the control accuracy is ±2℃. 4.7.3 The temperature of the bottle at the outlet of the dryer should not be higher than room temperature by 10°C. 4.7.4 The surface temperature of the dryer box should not be higher than room temperature 15℃. 4.7.5 The bottles that come out of the box after drying should be dry and have no water marks, and should not become soft or deformed. 4.7.6 The conveyor belt of the dryer is stable, does not deviate or crawl during operation. 4.7.7 The sound pressure level of the dryer's load operation noise shall not exceed 80dB(A). 4.8 Safety requirements for electrical systems
JB20003.3—2004
4.8.1 The continuity of the protective grounding circuit of the electrical system should comply with the provisions of 19.2 in GB5226.1-2002. 4.8.2 The insulation resistance of the electrical system should comply with the provisions of 19.3 in GB5226.1-2002. 4.8.3 The voltage resistance of the electrical system shall comply with the provisions of 19.4 in GB5226.1-2002. 4.8.4 The protective grounding circuit of the electrical system should comply with the provisions of 8.2 in GB5226.1-2002. 4.8.5 Electrical system buttons shall comply with the provisions of 10.2 in GB5226.1-2002. 4.8.6 The electrical system indicators and displays should comply with the provisions of 10.3 in GB5226.1-2002. 4.8.7 The electrical system wiring shall comply with the provisions of Chapter 14 of GB5226.1-2002. 4.8.8 Electrical system markings, warning signs and project codes should comply with the provisions of Chapter 17 of GB5226.1-2002, 5 Test Methods
5.1 Technical Document Inspection
Check the drying by sensory method The machine's instruction manual, product certificate, material certificate and main instrument calibration certificate. 5.2 Material, appearance and structure inspection
Visually inspect the material certification information of the materials used, the appearance and structure of the machine. 5.3 Function test
5.3.1 Control function test:
Use the sensory method to test the mesh belt speed and temperature adjustment functions. 5.3.2 Temperature display and printing recording function test: Use sensory method to test the operation display and printing function. 5.3.3 Chain function inspection:
5.3.3.1 Stack bottles at the outlet of the dryer and observe the control of the mesh belt. 5.3.3.2 Run the dryer without load, disconnect the power supply of any fan, and observe whether the heating circuit can be cut off. 5.3.3.3 Run the dryer with no-load heating, set the actual operating temperature higher than the set temperature, and observe whether the heating circuit can be cut off. 5.4 Performance inspection
5.4.1. Air cleanliness test inside the dryer: 25 | 5.4.2 Heating zone temperature and temperature control accuracy test: When the operating temperature in the dryer tunnel reaches 80°C, a group (6 pieces) of calibrated standard platinum resistance probes are evenly distributed on the same plane in the tunnel. It is transported into the tunnel with the mesh belt, and the temperature value is randomly measured and compared with the set temperature value. 5.4.3 Exit bottle temperature rise test:
Within 30 seconds after the bottle exits the tunnel mouth, use a semiconductor point thermometer to measure the surface temperature of the bottle. 5.4.4 Box surface temperature rise test:
After the dryer has been running for 2 hours, use a semiconductor point thermometer to measure the box surface temperature. 5.4.5 Medicine bottle drying quality test:
Test by sensory method.
5.4.6 Conveyor belt operation test:
Use sensory method to test.
5.4.7 Noise test:
The dryer is tested in accordance with the regulations of GB/T16769 with a sound level meter under the highest production speed and load operation condition. 5.5 Electrical system testing
5.5.1 The continuity, insulation resistance and withstand voltage tests of the protective grounding circuit of the electrical system shall be tested in accordance with the provisions of 19.2, 19.3 and 19.4 in GB5226.1-2002 respectively.
5.5.2 The protective grounding circuit, buttons, indicators and displays, wiring, markings, warning signs and project codes of the electrical system shall be in accordance with GB5226.1-2002 8.2, 10.2, 10.3, Chapter 14 and Check the provisions of Chapter 17. 6 Inspection Rules
6.1 Inspection Categories
The inspection of drying machines is divided into factory inspection and type inspection. 6.2 Factory inspection
6.2.1 Each dryer should pass the inspection by the inspection department of the manufacturing unit before it can leave the factory. It should be accompanied by a product certificate when leaving the factory. 6.2.2 Factory inspection shall be carried out one by one according to the provisions in Table 1. Table 1 Full sealing machine factory inspection items
Project categorybzxz.net
General items
Main items
Inspection items
4.2,4.3, 4.4, 4.5.1 , 4.5.2, 4.5.3, 4.5.54.5.4, 4.5.6.4.6. 4.7,4.8
6.2.3 If the dryer is found to be unqualified during the factory inspection, it will be returned for repair, such as If the product is still unqualified after repair, it will be judged as a substandard product and will not be allowed to leave the factory.
6.3 Type inspection
6.3.1 Type inspection shall be carried out when one of the following situations occurs: a) When the product is trial-formulated or transferred to a factory for production; b) The structure, material, and process of the product have significant differences. When there is a major change; 26
e) When the product resumes production after 2 years of suspension; d) When the national quality supervision agency proposes a request for type inspection; e) When the pharmaceutical manufacturer conducts equipment certification. 6.3.2 Type inspection items:
Type inspection shall conduct a comprehensive quality assessment and review of all technical requirements of this standard. 6.3.3 Sampling rules:
JB20003.32004
The prototypes for type inspection shall be selected from 10% of the products that have passed the factory inspection, and one unit shall be tested. The sampling method shall be carried out in accordance with the provisions of GB/T10111.
6.3.4 Judgment rules:
The type inspection is deemed to be qualified when all inspection results in the type inspection meet the requirements of this standard. During the inspection, if any of the electrical safety performance of protective grounding circuit continuity, insulation resistance, and withstand voltage fails, the product will be deemed to have failed the type inspection. If other performance is found to be unqualified, double sampling is allowed to test the unqualified items. If the inspection results still do not meet the requirements of this standard, the type inspection will be judged to be unqualified.
7 Logo, Instructions for Use, Packaging and Storage 7.1 Logo
7.1.1 Each dryer should have a product label fixed in a location that is not easily damaged and is obvious. The size and technical requirements of the sign shall comply with the provisions of CB/T13306.
7.1.2 The dryer label should include the following: #) Product model and name:
b) Main parameters:
e)
Product number and manufacturing Date;
d) Manufacturer’s name and trademark;
e) Product standard number.
7.1.3
Packaging, storage and transportation markings shall comply with the provisions of GB/T191. 7.1.4 Transportation packaging, receipt and delivery markings shall be carried out in accordance with GB/T6388. 7.2 Instructions for use
The product instructions for use shall comply with the provisions of GB/T9969.1, and the instructions for the electrical part shall comply with the provisions of 18.2 in GB5226.1-2002.
7.3 Packaging
7.3.1 The packaging of the dryer should be carried out in accordance with the regulations of GB/T13384. 7.3.2 The following documents should be included in the packaging box:
a) Product instruction manual, foundation installation drawing: b) Product certificate of conformity;
Packing list;
c)|| tt||d) Material certificates, instrument and sensor calibration certificates specified in this standard. 7.4 Storage
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JB20003.3—2004
The storage validity period of dryer packaging is 6 months from the date of shipment. 7.4.1
The dryer should be stored in a dry room or under a shed, and should not be tilted or pressed heavily. 7.4.2
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32004
The prototypes for type inspection should be selected from 10% of the products that have passed the factory inspection, and one unit should be tested. The sampling method shall be carried out in accordance with the provisions of GB/T10111.
6.3.4 Judgment rules:
The type inspection is judged to be qualified when all inspection results in the type inspection meet the requirements of this standard. During the inspection, if any of the electrical safety performance of protective grounding circuit continuity, insulation resistance, and withstand voltage fails, the product will be deemed to have failed the type inspection. If other performance is found to be unqualified, double sampling is allowed to test the unqualified items. If the inspection results still do not meet the requirements of this standard, the type inspection will be judged to be unqualified.
7 Logo, Instructions for Use, Packaging and Storage 7.1 Logo
7.1.1 Each dryer should have a product label fixed in a location that is not easily damaged and is obvious. The size and technical requirements of the sign shall comply with the provisions of CB/T13306.
7.1.2 The dryer label should include the following: #) Product model and name:
b) Main parameters:
e)
Product number and manufacturing Date;
d) Manufacturer’s name and trademark;
e) Product standard number.
7.1.3
Packaging, storage and transportation markings shall comply with the provisions of GB/T191. 7.1.4 Transportation packaging, receipt and delivery markings shall be carried out in accordance with GB/T6388. 7.2 Instructions for use
The product instructions for use shall comply with the provisions of GB/T9969.1, and the instructions for the electrical part shall comply with the provisions of 18.2 in GB5226.1-2002.
7.3 Packaging
7.3.1 The packaging of the dryer should be carried out in accordance with the regulations of GB/T13384. 7.3.2 The following documents should be included in the packaging box:
a) Product instruction manual, foundation installation drawing: b) Product certificate of conformity;
Packing list;
c)|| tt||d) Material certificates, instrument and sensor calibration certificates specified in this standard. 7.4 Storage
27
JB20003.3—2004
The storage validity period of dryer packaging is 6 months from the date of shipment. 7.4.1
The dryer should be stored in a dry room or under a shed, and should not be tilted or pressed heavily. 7.4.2
28
32004
The prototypes for type inspection should be selected from 10% of the products that have passed the factory inspection, and one unit should be tested. The sampling method shall be carried out in accordance with the provisions of GB/T10111.
6.3.4 Judgment rules:
The type inspection is deemed to be qualified when all inspection results in the type inspection meet the requirements of this standard. During the inspection, if any of the electrical safety performance of protective grounding circuit continuity, insulation resistance, and withstand voltage fails, the product will be deemed to have failed the type inspection. If other performance is found to be unqualified, double sampling is allowed to test the unqualified items. If the inspection results still do not meet the requirements of this standard, the type inspection will be judged to be unqualified.
7 Logo, Instructions for Use, Packaging and Storage 7.1 Logo
7.1.1 Each dryer should have a product label fixed in a location that is not easily damaged and is obvious. The size and technical requirements of the sign shall comply with the provisions of CB/T13306.
7.1.2 The dryer label should include the following: #) Product model and name:
b) Main parameters:
e)
Product number and manufacturing Date;
d) Manufacturer’s name and trademark;
e) Product standard number.
7.1.3
Packaging, storage and transportation markings shall comply with the provisions of GB/T191. 7.1.4 Transportation packaging, receipt and delivery markings shall be carried out in accordance with GB/T6388. 7.2 Instructions for use
The product instructions for use shall comply with the provisions of GB/T9969.1, and the instructions for the electrical part shall comply with the provisions of 18.2 in GB5226.1-2002.
7.3 Packaging
7.3.1 The packaging of the dryer should be carried out in accordance with the regulations of GB/T13384. 7.3.2 The following documents should be included in the packaging box:
a) Product instruction manual, foundation installation drawing: b) Product certificate of conformity;
Packing list;
c)|| tt||d) Material certificates, instrument and sensor calibration certificates specified in this standard. 7.4 Storage
27
JB20003.3—2004
The storage validity period of dryer packaging is 6 months from the date of shipment. 7.4.1
The dryer should be stored in a dry room or under a shed, and should not be tilted or pressed heavily. 7.4.2
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