JB 20007.4-2004 Oral liquid bottle filling linkage line capping machine
Some standard content:
JB | Linkage line
Antibiotic glass bottle powder dispensing linkage line
Linear plunger filling machine
Released on 2004-02-05
Implemented on 2004-06-01| |tt||National Development and Reform Commission released
ICS11.120.30
C92
JB
Pharmaceutical Machinery Industry Standard of the People’s Republic of China JB20007.42004
Replace YY0217.4—1995
Oral liquid bottle filling linkage line
Capping machine
Production line for filling oral liquid Capping machine2004-02-05 released
2004 -06-01 Implementation
Released by the National Development and Reform Commission
Foreword...
Scope
1
2 Normative Reference Documents
3 Classification and marking
4 Requirements
5 Test methods
6 Inspection rules
7 Marks, instructions for use, packaging and storage items
Times|| tt||JB20007.4—2004
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JB 20007.4—2004
Foreword
This standard is based on the "Quality Management Practice for Pharmaceutical Production" and GB/T1.1 - 2000, GB/T1.2-2002 standardization work guide requirements, revision of YY0217.4-1995 "Oral Liquid Bottle Filling and Capping Machine". This standard replaces YY0217.4-1995 from the date of implementation. Compared with YY0217.4-1995, the main technical content changes of this standard are as follows: a) The main chapters and clauses of YY0217.4-1995 are deleted: 3.2, 3.3;
4.1.2, 4.3.2, 4.3 .3, 4.5.7, 4.6;—5.2, 5.7;
6.2.2.2;
7.3;
Additional notes.
Revised the main chapters and articles of YY0217.4-1995: b)
Chapter 1;
Chapter 2;
3.1;
4.1, 4.2, 4.3, 4.4, 4.5;
5.1.5.3.5.4.5.5.5.6.5.9.5.13.5.14;6.2.1.1.6.2.2.1b.6.2.2.3;
7.1 .2, 7.2, 7.4.
c) Mainly added chapters and clauses in this standard:
- See 4.1.6, 4.1.7, 4.5.4.7.4~4.7.8; see 5.1.5.3.1~5.3. 6;
—See 6.2.2.3;
See 7.2.
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: Shua Jingzhou, Xin Yi, Wang Zhaoli. 34
1 scope
Oral liquid bottle filling linkage
Cap machine
JB20007.4—2004
This standard specifies oral liquid bottles Classification and marking, requirements, test methods, inspection rules and signs, instructions for use, packaging and storage of filling and capping machines.
This standard applies to oral liquid bottle overfilling and capping machines (hereinafter referred to as filling and capping machines). 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 that reach an agreement based on this standard are encouraged to study whether to use the latest versions of these documents. For undated referenced documents, the latest edition applies to this standard. GB/T191 Packaging, storage and transportation pictorial marks
CB5226.1-2002 Mechanical safety mechanical and electrical equipment Part 1: General technical conditions CB/T6388 Transportation, 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/T 13306
GB/T13384
GB/T 16769
General technical conditions for packaging of mechanical and electrical products
Measurement method for noise and sound pressure level of metal cutting machine tools JG/T19 laminar flow clean workbench inspection standard YY0056
Regulated oral liquid bottles
YY0131 Oral liquid bottle tearing Pulled aluminum cover
YY/T0216 Pharmaceutical Machinery Product Model Preparation Good Manufacturing Practice (1998 Revised Edition) State Food and Drug Administration Pharmacopoeia of the People's Republic of China (2000 Edition) National Pharmacopoeia Commission 3 Classification and Labeling||tt ||3.1 The model of the filling and rolling machine should comply with the regulations of YY/T0216. 3.2 Model mark
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YL
GZ
3.3 Marking example
Main parameters: Production capacity ( Bottle/h)/Production control Oral liquid bottle specifications (mL) Product type and feature code: G - filling: Z - capping L - linkage line
Product function code: Indicates oral liquid machinery YIGZ15000/10 Type: Indicates a filling and capping machine suitable for 10mL controlled oral liquid bottles with a production capacity of 15,000 bottles/h. 4 Requirements
4.1 Working conditions
4.1.1 Ambient temperature: 18%~28℃.
4.1.2 Ambient air purity: 100,000 levels. 4.1.3 The use of oral liquid bottles should comply with the regulations of YY0056. 4.1.4 The use of aluminum caps for oral liquid bottles should comply with the regulations of YY0131. 4.1.5 The gas source used should be free of oil, water and impurities, filtered by 20um level, and the pressure should be 0.35MPa~0.5MPa. 4.1.6 A high-level liquid storage tank and a nitrogen storage tank should be equipped. 4.1.7 Online cleaning and disinfection devices should be configured. 4.2 Material requirements
The parts in contact with the chemical liquid in the rolling mill should be made of stainless, non-toxic, corrosion-resistant and chemically stable materials, and have corresponding material certificates.
4.3 Appearance requirements
4.3.1 The outer surface of the filling mill should be flat and smooth, without defects such as unevenness, burrs and obvious scratches. 4.3.2 The nameplates, warning signs, function identification marks and grounding symbols installed on the filling and rolling machine should be complete and effective, durable and clear and easy to remember.
4.4 Structural requirements
The filling and rolling machine should have a bottle feeding mechanism, a filling mechanism, a cap feeding mechanism, a capping mechanism, a laminar flow mechanism and an electrical monitoring system (including no bottle no spraying device).
4.5 Functional Requirements
4.5.1 The liquid channel of the Zi rolling mill should be able to achieve online cleaning and disinfection. 4.5.2 The filling mill should meet the production speed requirements, and the speed is adjustable within the specified range. 4.5.3 Control function: control the incoming bottle count, control the outgoing bottle accumulation, control the filling volume and filling error, and control the production speed. 4.5.4 Display function: display production speed and total output. 4.5.5 Chain function: No spraying without bottles.
4.5.6 Protection function: When the protective cover is opened, it should automatically stop. 4.6 Performance requirements
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4.6.1 The loading error should not be greater than ±2% of the standard error. 4.6.2 There is no dripping from the filling needle of the filling and rolling machine. 4.6.3 The damage rate should not be greater than 1%.
4.6.4 The pass rate of capping should not be less than 98%. 4.6.5 The appearance of the wrong cover is not scratched and the cover is not loose. 4.6.6 The noise pressure of the filling mill during load operation shall not exceed 80dB(A). 4.6.7 The laminar air flow purification workbench of the filling and rolling mill has a cleanliness level of 10,000. 4.6.8 No-load performance:
4.6.8.1 There should be no oil leakage from the reduction box after the filling mill is operated without load. 4.6.8.2 After no-load operation, the surface temperature rise of the reduction gearbox should not exceed 35°C. 4.6.9 Negative cut performance:
When the filling and rolling mill is operating under load, the movements of each process are sensitive and reliable; there must be no gas or liquid leakage at the joints of each pipeline. 4.7 Electrical system safety requirements
JB20007.4-2004
4.7.1 The continuity of the protective grounding circuit of the electrical system shall comply with the provisions of 19.2 in CB5226.1-2002. 4.7.2 The insulation resistance of the electrical system should comply with the provisions of 19.3 in GB5226.1-2002. 4.7.3 The withstand voltage of the electrical system shall comply with the provisions of 19.4 in GB5226.1-2002. 4.7.4 The protective grounding circuit of the electrical system should comply with the provisions of 8.2 in GB5226.1-2002. 4.7.5 The buttons of the electrical system should comply with the provisions of 10.2 in GB5226.12002. 4.7.6 The indicators and displays of the electrical system should comply with the provisions of 10.3 in GB5226.1-2002. 4.7.7 The wiring of the electrical system should comply with the provisions of Chapter 14 of GB5226.1-2002. 4.7.8 The markings, warning signs and project codes of the electrical system shall comply with the provisions of Chapter 17 of CB5226.12002. 5 Test methods
5.1 Working condition test
5.1.1 Visual inspection of the quality of bottles and aluminum caps.
5.1.2 Use a 2.5-level pressure gauge to check the air source pressure. 5.2 Material, appearance and structure inspection
Visually inspect the material certification information, machine appearance and structure of the materials used in the breast filling machine. 5.3 Functional test
5.3.1 Structural requirements and filling principles ensure that there are no dead corners and mechanical friction in the liquid channel, and online cleaning and disinfection should be possible. 5.3.2 Production speed test:
After the filling mill is running under load, use a stopwatch to count for 5 minutes at the rated speed to detect the production speed. Then adjust the transmission device and check the speed adjustment effect in the same way as testing the production speed. 5.3.3 Control function test:
Before the filling mill leaves the factory, purified water is used instead of the chemical solution to simulate the normal production process for control function testing. 5.3.4 Display function test:
Visually inspect the display function during the operation test.
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5.3.5 Chain function test:
Remove the bottle at the bottle dialing star wheel and observe whether the corresponding filling needle should No medication. 5.3.6 Protection function test:
When the filling and rolling machine is operating normally, it should automatically stop when the protective cover is opened. 5.4 Performance test
5.4.1 Loading error test
Sampling, use a balance to check the loading error by mass method. 5.4.2 Inspection of no dripping from the liquid needle: visual inspection.
5.4.3 Determination of breakage rate
When the filling and rolling mill is running at normal load and rated speed, count the total number of bottles in and the total number of bottles out in 30 minutes, and use formula (1) to calculate: breakage rate (%) Total number of incoming bottles - total number of outgoing bottles
Total number of incoming bottles
5.4.4 Determination of capping pass rate:
X100
(1)
fill When the rolling mill is running at normal load and rated speed, count for 30 minutes, and use equation (2) to calculate the ratio of the number of capping qualifications to the total number of bottles discharged: capping qualification rate (%):
5.4.5 Capping quality Inspection:
Qualified number of capping
Visually inspect the appearance of the rolled cap. 5.4.6 Noise test:
When the filling mill is running with positive load, use a sound level meter to measure according to the regulations of GB/T16769. 5.4.7 No-load performance test:
After 1 hour of no-load operation, the reduction box should be visually inspected without oil dripping: Use a secondary industrial thermometer to check the surface temperature rise of the reduction box and motor. 5.4.8 Load performance test of filling and capping machine:
.(2)
The load performance test should be carried out after passing the no-load inspection. During the inspection, it should be gradually adjusted from low-speed operation to high-speed operation. Then it should be stably operated at the rated speed. The continuous operation time should be no less than 30 minutes for confirmation. 5.4.9 Laminar flow purification device cleanliness test: After the laminar flow purification device works for 1 hour, measure according to the regulations in JG/T19. 5.5 Electrical system quality test
5.5.1 The continuity, insulation resistance and withstand voltage inspection 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 8.2, 10.2, 10.3, Chapter 14 and Chapter 14 of CB5226.1-2002 respectively. Check the provisions of Chapter 17. 6 Inspection Rules
6.1 Each filling and rolling machine must pass the quality inspection and be accompanied by a product certificate before it can leave the factory. 6.2 Inspection Classification
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The inspection of filling and rolling mill is divided into factory inspection and type inspection. 6.2.1 Factory inspection
JB20007.4—2004
6.2.1.1 Factory inspection shall be carried out one by one in accordance with the requirements in Table 1. Only qualified products shall be allowed to leave the factory and shall be accompanied by a product certificate. Table 1 Factory inspection items
Project categories
Second general items
Main items
Inspection items
4.2,4.3,4.4,4.5.1,4.5 .3 | , then submit it for inspection after trimming. If it still fails, it will be judged as a non-conforming product.
6.2.2 Type inspection
6.2.2.1 Type inspection shall be carried out when one of the following situations occurs: 8) When the product is trial-made or transferred to a factory for production: b) The structure, materials, When there are major changes in the process; c) When the product resumes production after 2 years of suspension: d) When the national quality supervision agency proposes a requirement for type inspection. 6.2.2.2 Sampling:
The prototypes for type inspection shall be selected from 10% of the products that have passed the factory inspection according to the method specified in GB/T10111, and one unit shall be tested. 6.2.2.3 Judgment rules:
During the type inspection, if one of the electrical safety performance of protective grounding circuit continuity, insulation resistance, and withstand voltage fails, the product will be judged to have failed the type inspection. If one of the other items is unqualified, the unqualified item should be retested twice. If it is still unqualified, the product will be judged to have failed the type inspection.
7 Marks, Instructions for Use, Packaging and Storage 7.1 Marks
7.1.1 Each filling and rolling machine has a product label fixed at the position specified on the drawing, and the label should comply with the regulations of GB/T13306. 7.1.2 The label of the filling mill should include the following: a) product name and model;
b) manufacturer name;
e) product number and manufacturing date;
d) Main parameters;
e) product standard number.
7.1.3 Storage and transportation markings should comply with the regulations of GB/T191. 7.2 Instructions for use
Product instructions for use shall comply with the provisions of GB/T9969.1. 7.3 Packaging
7.3.1 Product packaging should comply with the regulations of GB/T13384. 39
2 Material, appearance and structure inspection
Visually inspect the material certification data, machine appearance and structure of the materials used in the breast filling machine. 5.3 Functional test
5.3.1 Structural requirements and filling principles ensure that there are no dead corners and mechanical friction in the liquid channel, and online cleaning and disinfection should be possible. 5.3.2 Production speed test:
After the filling mill is running under load, use a stopwatch to count for 5 minutes at the rated speed to detect the production speed. Then adjust the transmission device and check the speed adjustment effect in the same way as testing the production speed. 5.3.3 Control function test:
Before the filling mill leaves the factory, purified water is used instead of the chemical solution to simulate the normal production process for control function testing. 5.3.4 Display function test:
Visually inspect the display function during the operation test.
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5.3.5 Chain function test:
Remove the bottle at the bottle dialing star wheel and observe whether the corresponding filling needle should No medication. 5.3.6 Protection function test:
When the filling and rolling machine is operating normally, it should automatically stop when the protective cover is opened. 5.4 Performance test
5.4.1 Loading error test
Sampling, use a balance to check the loading error by mass method. 5.4.2 Inspection of no dripping from Zili liquid needle: visual inspection.
5.4.3 Determination of breakage rate
When the filling and rolling mill is running at normal load and rated speed, count the total number of bottles in and the total number of bottles out in 30 minutes, and use formula (1) to calculate: breakage rate (%) Total number of incoming bottles - total number of outgoing bottles
Total number of incoming bottles
5.4.4 Determination of capping pass rate:
X100
(1)
fill When the rolling mill is running at normal load and rated speed, count for 30 minutes, and use equation (2) to calculate the ratio of the number of capping qualifications to the total number of bottles discharged: capping qualification rate (%):
5.4.5 Capping quality Inspection:
Qualified number of capping
Visually inspect the appearance of the rolled cap. 5.4.6 Noise test:
When the filling mill is running with positive load, use a sound level meter to measure according to the regulations of GB/T16769. 5.4.7 No-load performance test:
After 1 hour of no-load operation, the reduction box should be visually inspected without dripping oil: use a secondary industrial thermometer to check the surface temperature rise of the reduction box and motor. 5.4.8 Load performance test of filling and capping machine:
.(2)
The load performance test should be carried out after passing the no-load inspection. During the inspection, it should be gradually adjusted from low-speed operation to high-speed operation. Then it should be stably operated at the rated speed. The continuous operation time should be no less than 30 minutes for confirmation. 5.4.9 Laminar flow purification device cleanliness test: After the laminar flow purification device works for 1 hour, measure according to the regulations in JG/T19. 5.5 Electrical system quality test
5.5.1 The continuity, insulation resistance and withstand voltage inspection 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 8.2, 10.2, 10.3, Chapter 14 and Chapter 14 of CB5226.1-2002 respectively. Check the provisions of Chapter 17. 6 Inspection Rules
6.1 Each filling and rolling machine must pass the quality inspection and be accompanied by a product certificate before it can leave the factory. 6.2 Inspection Classification
38
The inspection of filling and rolling mill is divided into factory inspection and type inspection. 6.2.1 Factory inspection
JB20007.4—2004
6.2.1.1 Factory inspection shall be carried out one by one in accordance with the requirements in Table 1. Only qualified products shall be allowed to leave the factory and shall be accompanied by a product certificate. Table 1 Factory inspection items
Project category
Second general items
Main items
Inspection items
4.2,4.3,4.4,4.5.1,4.5 .3 | , then submit it for inspection after trimming. If it still fails, it will be judged as a non-conforming product.
6.2.2 Type inspection
6.2.2.1 Type inspection shall be carried out when one of the following situations occurs: 8) When the product is trial-made or transferred to a factory for production: b) The structure, materials, When there are major changes in the process; c) When the product resumes production after 2 years of suspension: d) When the national quality supervision agency proposes a requirement for type inspection. 6.2.2.2 Sampling:
The prototypes for type inspection shall be selected from 10% of the products that have passed the factory inspection according to the method specified in GB/T10111, and one unit shall be tested. 6.2.2.3 Judgment rules:
If one of the electrical safety performance of protective grounding circuit continuity, insulation resistance, and withstand voltage fails during the type inspection, the product will be judged to have failed the type inspection. If one of the other items is unqualified, the unqualified item should be retested twice. If it is still unqualified, the product will be judged to have failed the type inspection.
7 Marks, Instructions for Use, Packaging and Storage 7.1 Marks
7.1.1 Each filling and rolling machine is fixed with a product label according to the position specified on the drawing, and the label shall comply with the regulations of GB/T13306. 7.1.2 The label of the filling mill should include the following: a) product name and model;
b) manufacturer name;
e) product number and manufacturing date;
d) Main parameters;
e) product standard number.
7.1.3 Storage and transportation markings should comply with the regulations of GB/T191. 7.2 Instructions for use
Product instructions for use shall comply with the provisions of GB/T9969.1. 7.3 Packaging
7.3.1 Product packaging should comply with the regulations of GB/T13384. 39
2 Material, appearance and structure inspection
Visually inspect the material certification information, machine appearance and structure of the materials used in the breast filling machine. 5.3 Functional test
5.3.1 Structural requirements and filling principles ensure that there are no dead corners and mechanical friction in the liquid channel, and online cleaning and disinfection should be possible. 5.3.2 Production speed test:
After the filling mill is running under load, use a stopwatch to count for 5 minutes at the rated speed to detect the production speed. Then adjust the transmission device and check the speed adjustment effect in the same way as testing the production speed. 5.3.3 Control function test:
Before the filling mill leaves the factory, purified water is used instead of the chemical solution to simulate the normal production process for control function testing. 5.3.4 Display function test:
Visually inspect the display function during the operation test.
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5.3.5 Chain function test:
Remove the bottle at the bottle dialing star wheel and observe whether the corresponding filling needle should No medication. 5.3.6 Protection function test:
When the filling and rolling machine is operating normally, it should automatically stop when the protective cover is opened. 5.4 Performance test
5.4.1 Loading error test
Sampling, use a balance to check the loading error by mass method. 5.4.2 Inspection of no dripping from the liquid needle: visual inspection.
5.4.3 Determination of breakage rate
When the filling and rolling mill is running at normal load and rated speed, count the total number of bottles in and the total number of bottles out in 30 minutes, and use formula (1) to calculate: breakage rate (%) Total number of incoming bottles - total number of outgoing bottles
Total number of incoming bottles
5.4.4 Determination of capping pass rate:
X100
(1)
fill When the rolling mill is running at normal load and rated speed, count for 30 minutes, and use formula (2) to calculate the ratio of the qualified number of capping and the total number of bottles discharged: capping pass rate (%):
5.4.5 Capping quality Inspection:
Qualified number of capping
Visually inspect the appearance of the rolled cap. 5.4.6 Noise test:
When the filling mill is running with positive load, use a sound level meter to measure according to the regulations of GB/T16769. 5.4.7 No-load performance test:
After 1 hour of no-load operation, the reduction box should be visually inspected without dripping oil: use a secondary industrial thermometer to check the surface temperature rise of the reduction box and motor. 5.4.8 Capping machine load performance test:
. (2)
The load performance test should be carried out after passing the no-load inspection. During the inspection, it should be gradually adjusted from low-speed operation to high-speed operation. Then it should be stably operated at the rated speed. The continuous operation time should be no less than 30 minutes for confirmation. 5.4.9 Laminar flow purification device cleanliness test: After the laminar flow purification device works for 1 hour, measure according to the regulations in JG/T19. 5.5 Electrical system quality test
5.5.1 The continuity, insulation resistance and withstand voltage inspection 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 8.2, 10.2, 10.3, Chapter 14 and Chapter 14 of CB5226.1-2002 respectively. Check the provisions of Chapter 17. 6 Inspection Rules
6.1 Each filling and rolling machine must pass the quality inspection and be accompanied by a product certificate before it can leave the factory. 6.2 Inspection Classification
38
The inspection of filling and rolling mill is divided into factory inspection and type inspection. 6.2.1 Factory inspection
JB20007.4—2004
6.2.1.1 Factory inspection shall be carried out one by one in accordance with the requirements in Table 1. Only qualified products shall be allowed to leave the factory and shall be accompanied by a product certificate. Table 1 Factory inspection items
Project categories
Second general items
Main items
Inspection items
4.2,4.3,4.4,4.5.1,4.5 .3 | , then submit it for inspection after trimming. If it still fails, it will be judged as a non-conforming product.
6.2.2 Type inspectionbzxz.net
6.2.2.1 Type inspection shall be carried out when one of the following situations occurs: 8) When the product is trial-made or transferred to a factory for production: b) The structure, materials, When there are major changes in the process; c) When the product resumes production after 2 years of suspension: d) When the national quality supervision agency proposes a requirement for type inspection. 6.2.2.2 Sampling:
The prototypes for type inspection shall be selected from 10% of the products that have passed the factory inspection according to the method specified in GB/T10111, and one unit shall be tested. 6.2.2.3 Judgment rules:
If one of the electrical safety performance of protective grounding circuit continuity, insulation resistance, and withstand voltage fails during the type inspection, the product will be judged to have failed the type inspection. If one of the other items is unqualified, the unqualified item should be retested twice. If it is still unqualified, the product will be judged to have failed the type inspection.
7 Marks, Instructions for Use, Packaging and Storage 7.1 Marks
7.1.1 Each filling and rolling machine has a product label fixed at the position specified on the drawing, and the label should comply with the regulations of GB/T13306. 7.1.2 The label of the filling mill should include the following: a) product name and model;
b) manufacturer name;
e) product number and manufacturing date;
d) Main parameters;
e) product standard number.
7.1.3 Storage and transportation markings should comply with the regulations of GB/T191. 7.2 Instructions for use
Product instructions for use shall comply with the provisions of GB/T9969.1. 7.3 Packaging
7.3.1 Product packaging should comply with the regulations of GB/T13384. 39
9. Cleanliness test of laminar flow purification device: After the laminar flow purification device works for 1 hour, measure according to the regulations in JG/T19. 5.5 Electrical system quality test
5.5.1 The continuity, insulation resistance and withstand voltage inspection 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 8.2, 10.2, 10.3, Chapter 14 and Chapter 14 of CB5226.1-2002 respectively. Check the provisions of Chapter 17. 6 Inspection Rules
6.1 Each filling and rolling machine must pass the quality inspection and be accompanied by a product certificate before it can leave the factory. 6.2 Inspection Classification
38
The inspection of filling and rolling mill is divided into factory inspection and type inspection. 6.2.1 Factory inspection
JB20007.4—2004
6.2.1.1 Factory inspection shall be carried out one by one in accordance with the requirements in Table 1. Only qualified products shall be allowed to leave the factory and shall be accompanied by a product certificate. Table 1 Factory inspection items
Project categories
Second general items
Main items
Inspection items
4.2,4.3,4.4,4.5.1,4.5 .3 | , then submit it for inspection after trimming. If it still fails, it will be judged as a non-conforming product.
6.2.2 Type inspection
6.2.2.1 Type inspection shall be carried out when one of the following situations occurs: 8) When the product is trial-made or transferred to a factory for production: b) The structure, materials, When there are major changes in the process; c) When the product resumes production after 2 years of suspension: d) When the national quality supervision agency proposes a requirement for type inspection. 6.2.2.2 Sampling:
The prototypes for type inspection shall be selected from 10% of the products that have passed the factory inspection according to the method specified in GB/T10111, and one unit shall be tested. 6.2.2.3 Judgment rules:
If one of the electrical safety performance of protective grounding circuit continuity, insulation resistance, and withstand voltage fails during the type inspection, the product will be judged to have failed the type inspection. If one of the other items is unqualified, the unqualified item should be retested twice. If it is still unqualified, the product will be judged to have failed the type inspection.
7 Marks, Instructions for Use, Packaging and Storage 7.1 Marks
7.1.1 Each filling and rolling machine has a product label fixed at the position specified on the drawing, and the label should comply with the regulations of GB/T13306. 7.1.2 The label of the filling mill should include the following: a) product name and model;
b) manufacturer name;
e) product number and manufacturing date;
d) Main parameters;
e) product standard number.
7.1.3 Storage and transportation markings should comply with the regulations of GB/T191. 7.2 Instructions for use
Product instructions for use shall comply with the provisions of GB/T9969.1. 7.3 Packaging
7.3.1 Product packaging should comply with the regulations of GB/T13384. 39
9. Cleanliness test of laminar flow purification device: After the laminar flow purification device works for 1 hour, measure according to the regulations in JG/T19. 5.5 Electrical system quality test
5.5.1 The continuity, insulation resistance and withstand voltage inspection 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 8.2, 10.2, 10.3, Chapter 14 and Chapter 14 of CB5226.1-2002 respectively. Check the provisions of Chapter 17. 6 Inspection Rules
6.1 Each filling and rolling machine must pass the quality inspection and be accompanied by a product certificate before it can leave the factory. 6.2 Inspection Classification
38
The inspection of filling and rolling mill is divided into factory inspection and type inspection. 6.2.1 Factory inspection
JB20007.4—2004
6.2.1.1 Factory inspection shall be carried out one by one in accordance with the requirements in Table 1. Only qualified products shall be allowed to leave the factory and shall be accompanied by a product certificate. Table 1 Factory inspection items
Project categories
Second general items
Main items
Inspection items
4.2,4.3,4.4,4.5.1,4.5 .3 | , then submit it for inspection after trimming. If it still fails, it will be judged as a non-conforming product.
6.2.2 Type inspection
6.2.2.1 Type inspection shall be carried out when one of the following situations occurs: 8) When the product is trial-made or transferred to a factory for production: b) The structure, materials, When there are major changes in the process; c) When the product resumes production after 2 years of suspension: d) When the national quality supervision agency proposes a requirement for type inspection. 6.2.2.2 Sampling:
The prototypes for type inspection shall be selected from 10% of the products that have passed the factory inspection according to the method specified in GB/T10111, and one unit shall be tested. 6.2.2.3 Judgment rules:
If one of the electrical safety performance of protective grounding circuit continuity, insulation resistance, and withstand voltage fails during the type inspection, the product will be judged to have failed the type inspection. If one of the other items is unqualified, the unqualified item should be retested twice. If it is still unqualified, the product will be judged to have failed the type inspection.
7 Marks, Instructions for Use, Packaging and Storage 7.1 Marks
7.1.1 Each filling and rolling machine is fixed with a product label according to the position specified on the drawing, and the label shall comply with the regulations of GB/T13306. 7.1.2 The label of the filling mill should include the following: a) product name and model;
b) manufacturer name;
e) product number and manufacturing date;
d) Main parameters;
e) product standard number.
7.1.3 Storage and transportation markings should comply with the regulations of GB/T191. 7.2 Instructions for use
Product instructions for use shall comply with the provisions of GB/T9969.1. 7.3 Packaging
7.3.1 Product packaging should comply with the regulations of GB/T13384. 39
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