Some standard content:
ICS11.120.30
C92
JB
Pharmaceutical Machinery Industry Standard of the People's Republic of China JB20003.5—2004
Production line for eyedrops - Labelling machine2004-02-05 issued
2004-06-01 implementation
National Development and Reform Commission issued
Foreword
Scope
Normative reference documents
2
3Model and mark
4Requirements
5Test method
6Inspection rules
7
Marking, instruction manual, packaging and storage directory
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JB20003.5—2004
This standard is proposed by China Pharmaceutical Equipment Industry Association. Foreword
This standard is under the jurisdiction of the Pharmaceutical Equipment Industry Standardization Technical Committee. The drafting unit of this standard: Beijing Aerospace Wanda High-Tech Development Center. The main drafters of this standard: Wang Jinyan, Feng Ruixin, Yuan Jingzhou, 42
1 Scope
Eye drop linkage line
Labeling machine
JB20003.52004
This standard specifies the marking, requirements, test methods, inspection rules and signs, instructions for use, packaging and storage of eye drop labeling machines.
This standard applies to eye drop plastic bottle labeling machines (hereinafter referred to as labeling machines). 2 Normative references
The clauses in the following documents become clauses of this standard through reference in this standard. For any dated referenced document, all subsequent amendments (excluding errata) or revisions are not applicable 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 any undated referenced document, the latest version applies to this standard. GB/T191 Pictorial markings for packaging, storage and transportation
GB/T5226.1-2002 Safety of machinery - Mechanical electrical equipment - Part 1: General technical conditions GB/T6388 Shipping and receiving markings for transport packaging
GB/T9969.1 General principles for instructions for use of industrial products GB/T10111
Methods for random sampling using random numbers GB/T13306 Labels
Technical conditions for packaging of electromechanical products||tt| |GB/T13384
GB/T16769
Method for measuring sound pressure level of noise from metal cutting machine tools YY/T0216-1995 Method for compiling product models of pharmaceutical machinery Good Manufacturing Practice for Pharmaceuticals (1998 Revised Edition) State Food and Drug Administration Pharmacopoeia of the People's Republic of China (2000 Edition) National Pharmacopoeia Committee 3 Model and marking
3.1 Model
The model of the labeling machine shall comply with the provisions of YY/T0216. DL·TO/O
Main parameters (applicable bottle diameter, mm)Main parameters (production capacity, pcs/min)Product type and characteristic code (L-linkage T-labeling)Product function code (D eye drop machine)
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JB20003.5—2004
3.2 Model marking example
4 Requirements
4.1 General
DLT120 /22
Bottle diameter 22mm
Production capacity 120 pcs/min
Eye drop linkage line·labeling machine
The design, manufacture, installation, use, repair, maintenance and verification of the labeling machine shall comply with the relevant principle instructions of the "Good Manufacturing Practice for Pharmaceuticals" (1998 revised edition).
4.2 Working conditions
4.2.1 Ambient temperature: The ambient air temperature for normal operation is 18℃~28℃. 4.2.2 Humidity: Relative humidity is 50%~60%4.3 Material requirements
4.3.1 The material of the labeling machine should be non-toxic, abrasion-resistant or rust-proof, and free of particle precipitation. 4.3.2 The print head is durable.
4.3.3 The material of the printing plate is not easy to age or deform. 4.4 Appearance requirements
4.4.1 The outer surface of the labeling machine should be flat and smooth, without protrusions, depressions, cracks and dead corners, and easy to clean and disinfect. 4.4.2 The edges of the exposed joint surfaces of parts 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, complete and durable. 4.5 Structural requirements
4.5.1 The entire labeling machine should have a height adjustment device. 4.5.2 The labeling parts should have a height adjustment device. 4.5.3 The labeling machine should have a printing device, and the position of the printing device should be adjustable. 4.5.4 Replacing the printing head, ribbon, and label paper should be quick and convenient. 4.6 Functional requirements
4.6.1 Production speed requirements:
The labeling machine should be able to meet the production speed requirements, be adjustable within the specified range, and be able to display the production speed and output. 4.6.2 Labeling function:
Can detect the label length to meet the labeling requirements of bottles of different diameters. 4.6.3 Interlocking function:
It has the function of not labeling if the bottle is missing.
4.6.4 Printing function:
4.6.4.1 Can print different specifications and sizes. 4.6.4.2 Can print three rows of characters, and the printing length is adjustable. 44
4.6.4.3 Can replace ribbons of different widths and specifications. 4.7 Performance requirements
4.7.1 No-load performance:
No-load operation is flexible, stable and unobstructed, and there is no abnormality in the electrical control system. 4.7.2 Load performance:
When the load is running, the conveyor should ensure that the bottles are in place and the labeling is timely and accurate. 4.7.3 Labeling quality:
The labels affixed by the labeling machine should be flat and wrinkle-free. 4.7.4 Printing quality:
The printed words are clear, the ink color is consistent, and the position is accurate. 4.7.5 The horizontal error of labeling is less than or equal to ±0.6mm, and the height error of labeling is less than or equal to ±0.6mm. 4.7.6 Labeling pass rate:
The labeling pass rate should be greater than or equal to 98%.
4.7.7 Noise:
The sound pressure level of the noise during load operation is not greater than 70dB(A). 4.8 Safety requirements for electrical systems
JB20003.5—2004
4.8.1 The continuity of the protective earthing circuit of the electrical system shall comply with the provisions of 19.2 of GB5226.1-2002. 4.8.2 The insulation resistance of the electrical system shall comply with the provisions of 19.3 of GB5226.1-2002. 4.8.3 The withstand voltage of the electrical system shall comply with the provisions of 19.4 of GB5226.1-2002. 4.8.4 The protective earthing circuit of the electrical system shall comply with the provisions of 8.2 of CB5226.12002. 4.8.5 The buttons of the electrical system shall comply with the provisions of 10.2 of GB5226.1-2002. 4.8.6 The indicator lights and displays of the electrical system shall comply with the provisions of 10.3 of GB5226.1-2002. 4.8.7 The wiring of the electrical system shall comply with the provisions of Chapter 14 of GB5226.1-2002. 4.8.8 The marking, warning signs and project codes of the electrical system shall comply with the provisions of Chapter 17 of GB5226.1-2002. 5 Test methods
5.1 Technical document inspection
Use the sensory method to check the instruction manual, product certificate, material certificate, and calibration certificate of the main instruments and meters of the labeling machine. 5.2 Working condition inspection
5.2.1 Temperature and humidity detection:
Use a thermometer and a hygrometer to measure the temperature and humidity of the working environment of the labeling machine. 5.3 Material, appearance and structure inspection
Visually inspect the material certification data of the materials used, the appearance and structure of the machine. 5.4 Functional test
5.4.1 Production speed and output test:
Adjust the labeling machine speed to the designed maximum speed, input bottles, run under load for 30 minutes, reset the output data on the display screen to zero, and use a tachometer or stopwatch to count for 5 minutes. Adjust the operating speed within the specified range, and test the speed adjustment effect by testing the production speed. 45
JB20003.5—2004
5.4.2 Labeling function, interlocking function, and printing function test: Use visual inspection when under load.
5.5 Performance test
5.5.1 No-load test:
Start the labeling machine without load, run it from low to high speed for 2 hours, and trace the operation and control functions. 5.5.2 Load test:
After the labeling machine passes the no-load test, carry out a load test, input bottles, simulate the normal production process and run for 30 minutes to confirm the synchronization and coordination performance.
5.5.3 Labeling quality test:
Inspect by sensory method.
5.5.4 Labeling level error and labeling height error test: The labeling machine simulates the normal production process for the test, randomly selects 10 labeled bottles, and measures them respectively with a vernier caliper. The labeling level error measurement method is shown in Figure 1, and the labeling level error value is calculated according to formula (1); the labeling height error measurement method is shown in Figure 2, and the labeling height error value is calculated according to formula (2).
Figure 1
Figure 2
Labeling level error = HH,
Labeling height error = H?-H≤
Where:
Hactual——Actual size of labeling height;
Hnominal——Nominal size of labeling height;
H1, H2——Actual height of both ends of the label from the bottom of the bottle. 5.5.5Printing quality test:
Visual inspection.
5.5.6Labeling pass rate test:
(1)
(2)
Labeling machine simulates normal production procedures for testing. The machine continuously extracts 600 bottles, inspects product quality and calculates product pass rate according to formula (3).
5.5.7Noise test:
Product pass rate. Number of bottles qualified in the test
Total number of bottles tested
100%
The labeling machine is tested with a sound level meter in accordance with the provisions of CB/T16769 at the highest production speed and under load. 46
(3)
5.6 Electrical system inspection
JB20003.5—2004
5.6.1 The continuity, insulation resistance and withstand voltage tests of the protective grounding circuit of the electrical system shall be inspected in accordance with the provisions of 19.2, 19.3 and 19.4 of GB5226.1-2002.
5.6.2 The protective grounding circuit, buttons, indicator lights and displays, wiring, markings, warning signs and project codes of the electrical system shall be inspected in accordance with the provisions of 8.2, 10.2, 10.3, Chapter 14 and Chapter 17 of CB5226.1-2002. 6 Inspection rules
6.1 Inspection classification
The inspection of labeling machines is divided into factory inspection and type inspection. 6.2 Factory inspection
6.2.1 Each labeling machine shall be inspected and qualified by the inspection department of the manufacturing unit before it can be shipped. The product certificate shall be attached when it is shipped. 6.2.2 Factory inspection shall be checked one by one according to the terms in Table 1. Table 1 Factory inspection items of labeling machines
Item category
General items
Main items
Inspection items
4.2,4.3,4.4,4.5.1,4.5.2, 4.5.3,4.5.54.5.4,4.6, 4.7,4.8
6.2.3 If a labeling machine is found to be unqualified during the factory inspection, it shall be returned for repair. If it is still unqualified after repair, it shall be judged as a unqualified product and shall not be allowed to ship out of the factory.
6.3 Type inspection
6.3.1 Type inspection shall be conducted in any of the following circumstances: a) When the product is trial-formed or transferred to another factory for production; b) When the product structure, material, or process has undergone significant changes; c) When the product resumes production after being discontinued for 2 years; d) When the national quality supervision agency proposes a requirement for type inspection; e) When a 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:
The sample for type inspection shall be selected from the products that have passed the factory inspection. When the batch is greater than 10 units, 10% shall be selected and one unit shall be tested. When the batch is less than 10 units, one unit shall be randomly tested. The sampling method shall be carried out in accordance with the provisions of CB/T10111. 6.3.4 Judgment rules:
When all the test results in the type inspection meet the requirements of this standard, the type inspection shall be judged to be qualified. If any one of the electrical safety performance of the protection grounding circuit continuity, insulation resistance, and withstand voltage is unqualified during the inspection, the product type inspection is judged to be unqualified. If other performances are 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 is judged to be unqualified.
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7 Marking, instruction manual, packaging and storage 7.1 Marking
7.1.1 Each labeling machine should fix the product label in a position that is not easily damaged and obvious. The label size and technical requirements should comply with the provisions of CB/T13306.
7.1.2 The labeling machine label shall include the following contents: a)
Product model and name;
b)
e)
Main parameters:
Product number and manufacturing date;
d)
Manufacturer name and trademark;
e)
7.1.3
Product standard number.
The packaging, storage and transportation marks shall comply with the provisions of GB/T191. 7.1.4 The transportation packaging, receiving and shipping marks shall comply with the provisions of GB/T6388. 7.2 Instruction manual
The product instruction manual shall comply with the provisions of CB/T9969.1, and the instruction manual of the electrical part shall comply with the provisions of 18.2 of GB5226.1-2002.
7.3 Packaging
7.3.1 The packaging of the labeling machine shall be carried out in accordance with the provisions of GB/T13384. The following documents shall be attached to the packaging box:
7.3.21
a)
Product instruction manual, foundation installation drawing; product certificate of conformity;bZxz.net
b)
c) Packing list;
d) Material certificate specified in this standard, calibration certificate of instruments, meters, sensors, etc. 7.4 Storage
7.4.1 The storage validity period of the labeling machine packaging is 6 months from the date of leaving the factory. 7.4.2 The labeling machine should be stored in a dry room or under a shed, and shall not be tilted or pressed heavily. 48
1. Each labeling machine should be inspected by the inspection department of the manufacturing unit before it can leave the factory. The product certificate should be attached when leaving the factory. 6.2.2 The factory inspection shall be carried out one by one according to the terms in Table 1. Table 1 Labeling machine factory inspection items
Project category
General items
Main items
Inspection items
4.2,4.3,4.4,4.5.1 ,4.5.2, 4.5.3,4.5.54.5.4,4.6, 4.7,4.8
6.2.3 If the labeling machine is found to be unqualified during the factory inspection, it will be returned for repair. 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; c) 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:
Samples for type inspection shall be selected from products that have passed factory inspection. When the batch size is greater than 10 units, 10% will be taken and one unit will be tested. When the batch quantity is less than 10 units, one unit will be randomly tested. The sampling method shall be carried out in accordance with the provisions of CB/T10111. 6.3.4 Judgment rules:
When all inspection results in the type inspection meet the requirements of this standard, the type inspection is judged to be qualified. 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.
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JB 20003.5—2004
7 Logo, Instructions for Use, Packaging and Storage 7.1 Logo
7.1.1 Each labeling machine should be in a state that is not easily damaged and Fixed product signage in a conspicuous position. The size and technical requirements of the sign shall comply with the provisions of CB/T13306.
7.1.2 The labeling machine label should include the following: a)
product model and name;
b)
e)
main parameters :
Product number and manufacturing date;
d)
Manufacturer name, trademark;
e)
7.1.3
Product standards.
Packaging, storage and transportation markings shall comply with the provisions of GB/T191. 7.1.4 The transportation and packaging receipt and delivery markings shall be in accordance with the provisions of GB/T6388. 7.2 Instructions for use
The instructions for use of the product shall comply with the provisions of CB/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 labeling machine shall be carried out in accordance with the regulations of GB/T13384. The following documents should be enclosed in the packaging box:
7.3.21
a)
Product instruction manual, foundation installation drawing; product certificate of conformity;
b)||tt ||c) Packing list;
d) Material certificates and calibration certificates for instruments, sensors, etc. specified in this standard. 7.4 Storage
7.4.1 The storage validity period of labeling machine packaging is 6 months from the date of shipment. 7.4.2 The labeling machine should be stored in a dry room or under a shed, and should not be tilted or pressed heavily. 48
1. Each labeling machine should be inspected by the inspection department of the manufacturing unit before it can leave the factory. The product certificate should be attached when leaving the factory. 6.2.2 The factory inspection shall be carried out one by one according to the terms in Table 1. Table 1 Labeling machine factory inspection items
Project category
General items
Main items
Inspection items
4.2,4.3,4.4,4.5.1 ,4.5.2, 4.5.3,4.5.54.5.4,4.6, 4.7,4.8
6.2.3 If the labeling machine is found to be unqualified during the factory inspection, it will be returned for repair. 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; c) 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:
Samples for type inspection shall be selected from products that have passed factory inspection. When the batch size is greater than 10 units, 10% will be taken and one unit will be tested. When the batch quantity is less than 10 units, one unit will be randomly tested. The sampling method shall be carried out in accordance with the provisions of CB/T10111. 6.3.4 Judgment rules:
When all inspection results in the type inspection meet the requirements of this standard, the type inspection is judged to be qualified. 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.
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7 Logo, Instructions for Use, Packaging and Storage 7.1 Logo
7.1.1 Each labeling machine should be in a state that is not easily damaged and Fixed product signage in a conspicuous location. The size and technical requirements of the sign shall comply with the provisions of CB/T13306.
7.1.2 The labeling machine label should include the following: a)
product model and name;
b)
e)
main parameters :
Product number and manufacturing date;
d)
Manufacturer name, trademark;
e)
7.1.3
Product standards.
Packaging, storage and transportation markings shall comply with the provisions of GB/T191. 7.1.4 The transportation and packaging receipt and delivery markings shall be in accordance with the provisions of GB/T6388. 7.2 Instructions for use
The instructions for use of the product shall comply with the provisions of CB/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 labeling machine shall be carried out in accordance with the regulations of GB/T13384. The following documents should be enclosed in the packaging box:
7.3.21
a)
Product instruction manual, foundation installation drawing; product certificate of conformity;
b)||tt ||c) Packing list;
d) Material certificates and calibration certificates for instruments, sensors, etc. specified in this standard. 7.4 Storage
7.4.1 The storage validity period of labeling machine packaging is 6 months from the date of shipment. 7.4.2 The labeling machine should be stored in a dry room or under a shed, and should not be tilted or pressed heavily. 48
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