Some standard content:
JB | 01Implementation
National Development and Reform Commission Release
ICS11.120.30
C92
JB
Pharmaceutical Machinery Industry Standard of the People's Republic of China JB20005.3—2004 || tt | Implementation
National Development and Reform Commission Release
Qianji·
1 Scope
2 Normative Reference Documents
3 Classification and Labeling||tt| |4 Requirements
5 Test Methods
6 Inspection Rules
7 Marking, Instructions for Use, Packaging and Storage Instructions
Appendix A (Informative Appendix) Type Inspection Test Records List
JB20005.3—2004
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JB20005.32004
Foreword
This standard is based on the Good Manufacturing Practice 》 and the requirements of GB/T1.1-2000, GB/T1.2-2002 standardization work guidelines, revision of YY0235.3-1995 "Glass Infusion Bottle Stopper Reversing Machine". This standard replaces YY0235.31995 from the date of implementation. Compared with YY0235.3-1995, the main content changes of this standard are as follows: a) Clauses 3.1, 3.3.4.2.4.11, 4.12 and other provisions in YY0235.3-1995 are deleted. b) Revised the following clauses in YY0235.3-1995: The technical requirements clauses have been rearranged based on the four steps of verification in the Good Manufacturing Practice for Pharmaceutical Products. The content of "requirements" is classified and put forward in the order of verification; - The test method corresponds to the content of the requirements chapter one-to-one, which enhances the operability of the test method: A pair of inspection rules terms and content of the original standard are revised; - Emphasis on electrical The importance of quality requirements has been revised according to GB5226.1-2002; the noise during one load operation is reduced to 70dB(A). c) Main added clauses:
Added appearance quality requirements (see 4.3): - Added structural requirements (see 4.4);
- Added working conditions chapter (see 4.5.2) : Control functions and protection functions have been added to the functional requirements (see 4.6.3, 4.6.5); clauses corresponding to the requirements have been added to the test methods: The inspection rules specify that the inspection of working conditions is only carried out during type inspection: Added informative Appendix A "Type Inspection Test Record Form". This standard was proposed by the China Pharmaceutical Equipment Industry Association. This standard is under the jurisdiction of the Pharmaceutical Equipment Industry Standardization Technical Committee. This standard was drafted by: Chongqing Jiangshan Pharmaceutical Machinery Co., Ltd. The main drafters of this standard: Sun Jinjian, Zhou Jie, Wang Yuanping, Huang Yun. The previous versions of the standards replaced by this standard are: GB11753.3-1989, YY0235.3-1995. 36
1 scope
Glass infusion bottle capping machine
JB20005. 3—2004
This standard specifies the classification and marking, requirements, test methods, inspection rules and signs, instructions for use, packaging and storage of glass infusion bottle stopper turning machines.
This standard applies to glass infusion bottle tipping machines (hereinafter referred to as tipping 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 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
GB26391990 Bori infusion bottle
GB5226.1-2002 Mechanical safety machinery 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
CB/T13384 General technical conditions for mechanical and electrical product packaging CB/T16769 Metal Cutting machine tool noise sound pressure level measurement method HG2948 Medical infusion rubber bottle stopper
YY/T0216 Pharmaceutical machinery product model preparation method Good Manufacturing Practice for Pharmaceuticals (1998 revised edition) National Medical Products Administration 3 Classification and Labeling||tt ||3.1 Classification
The cork turning machine is divided into gap type and continuous type according to the movement mode. 3.2 Model
3.2.1 The model of the plug turning machine should comply with the regulations of YYT0216-1995. 3.2.2 Model mark:
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JB 20005.3—2004
S
3.2.3 Marking example:
Improved design sequence number (A, B, C)
Specification code: Bottle specifications (100mL, 250mL, 500mL) Type and feature code: Turning (F) Stopper (S) machine Product function code: Infusion machinery
SFS100/500 Type: Indicates that the machine is suitable for glass infusion bottle capping machines with bottle sizes of 100mL~500mL. 4 Requirements
4.1 General
The cork-turning machine should comply with the requirements of this standard and the "Good Manufacturing Practice for Pharmaceutical Products" (1998 revised edition) on the manufacturing of pharmaceutical equipment. 4.2 Material requirements
4.2.1 The external exposed parts of the plug turning machine and the surface of the box should be made of stainless steel or other materials that are stainless and have stable chemical properties. 4.2.2 The material hardness of the plug turning claw should be greater than or equal to HRC50. 4.3 Appearance requirements
4.3.1 The outer surface of the plug turning machine should not have bulges, depressions, roughness and other damage. The appearance of the whole machine should be neat and tidy, with a uniform and glossy paint layer. 4.3.2 The edges of the exposed joint surfaces of components should be neat and even, without obvious misalignment, and there should be no obvious gaps between doors, covers and joint surfaces. 4.4 Structural requirements
4.4.1 The cork turning machine should have a bottleneck positioning device and a lifting device to control the stroke of the turning head. 4.4.2 The bridge of the bottle transport track should have a smooth bottle transport device. 4.4.3 The exposed transmission part of the plug turning machine should have a safety protective cover. 4.4.4 The work surface of the cork turning machine should have a certain vertical height and horizontal adjustment device. 4.4.5 The cork turning machine should have an adjustment and positioning device for the overall lifting of the cork turning head and a single-head fine-tuning device. 4.5 Working conditions
4.5.1 Packaging material requirements: Glass infusion bottles should comply with the requirements of GB2639. Medical infusion rubber stoppers should comply with the requirements of HG2948.
4.5.2 Environmental requirements: The cork turning machine should be installed and operated under a class 100 laminar flow hood. 4.5.3 The quality of the stopper before turning over: after the small head of the rubber stopper enters the glass infusion bottle, its exposed part is less than or equal to 1mum. 4.6 Functional requirements
4.6.1 The plug turning machine should be able to meet the production speed requirements and have stepless speed regulation within the specified range. 4.6.2 The stopper-turning machine should be able to adapt to the stopper-turning of glass infusion bottles of 100mL, 250mL, 500mL, etc. Accessories when changing specifications should be simple, reliable, and quick to replace.
4.6.3 Control function: control the shortage of bottles in the bottle and detect the count of the bottles in the bottle; control the bottle discharge to prevent accumulation; control the whole process of corking. 4.6.4 Interlock function: When the following situations occur, the machine should automatically stop: a) When the inlet bottle is missing or stuck;
b) When the outlet bottle is accumulated or blocked;
38|| tt||c) When the bottle is missing the stopper.
4.6.5 Protection function:
When the speed of the stopper turning machine is greater than or equal to 120 bottles/min, a slow start control device should be installed in front of the bottle feeding device. 4.7 Performance requirements
JB20005.3~-2004
4.7.1 There should be no oil leakage from the reducer oil tank, and the temperature rise should not exceed 35°C. There is no abnormal noise from the whole machine and the machine is running normally. 4.7.2. The conveying device should ensure that the bottle enters the corking station accurately, and the movements of each process are sensitive and accurate. 4.7.3 The noise level during load operation shall not exceed 70dB(A). 4.7.4 Quality of the stopper: After the stopper is turned, the big end of the rubber stopper is flat and compliant with the outer surface of the glass bottle mouth. The bottle mouth and the rubber stopper are free from damage and oil stains. The pass rate of the stopper is greater than or equal to 98%.
4.7.5 Electrical system quality requirements:
4.7.5.1 The continuity of the protective grounding circuit of the electrical system shall comply with the provisions of 19.2 in GB5226.1-2002. 4.7.5.2 The insulation resistance of the electrical system shall comply with the provisions of 19.3 in CB5226.1-2002. 4.7.5.3 The withstand voltage of the electrical system shall comply with the provisions of 19.4 in GB5226.1-2002. 4.7.5.4 The protective grounding circuit of the electrical system shall comply with the provisions of 8.2 in CB5226.1--2002. 4.7.5.5 The wiring of the electrical system shall comply with the provisions of Chapter 14 of CB5226.1-2002. 5 Test methods
5.1 Material, appearance and structure inspection
5.1.1 Visual inspection covers the requirements of 4.2.1, 4.3.1.4.3.2, 4.4.1~4.4.5. 5.1.2 Use a hardness tester to check the hardness of the plug claw. 5.2 Inspection of documents and working conditions of the cork turning machine 5.2.1 Documentation inspection:
Visually inspect the operating instructions, product certificate, material certificate, instrument calibration certificate, etc. of the cork turning machine. 5.2.2 Working condition test:
5.2.2.1 Packaging material confirmation:
Glass infusion bottles are inspected according to the regulations of GB2639. Medical infusion rubber stoppers are inspected according to the regulations of HG2948. 5.2.2.2 Working environment test:
a) Determine the cleanliness of the working environment of the sinus turning machine under dynamic working conditions. b) Select the measurement points according to the diagonal five-point arrangement method, as shown in Figure 1. The measuring point is more than 0.5m away from the wall and 1.2m~1.3m2 away from the ground
Turnover machine
?
Figure 1 Inspection point layout
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JB20005.3—2004
c) Use a dust particle counter to measure the number of particles in the air. 5.2.2.3 Inspection of plug quality; use steel tape or feeler gauge for random inspection and measurement. 5.3 Functional inspection of the cork-turning machine
5.3.1 Production speed test:
Adjust the speed of the cork-turning machine to the designed maximum speed, input bottles with rubber stoppers, and simulate normal production operation for 10 minutes. Run for 30 minutes in total, and use a tachometer or stopwatch to count randomly for 5 minutes; then adjust the transmission device within the specified range and test the speed adjustment effect in the same way as testing the production speed.
5.3.2 Replacement of specification accessories and bottle specification test: Replace the accessories of corresponding packaging specifications, and conduct tests on bottles of 100mL, 250mL, 500mL and other specifications according to the test method for testing production speed.
5.3.3 Control function test:
Before the cork turning machine leaves the factory, it is tested by simulating normal production procedures. 5.3.4 Chain function test:
a) Fault simulation test: Remove the bottles at the entrance of the bottle inlet star wheel or jam the star wheel, and observe that the machine should automatically stop; b) There will be a lot of accumulation at the bottle outlet The bottle may block the bottle conveying track, and the observation machine shall automatically stop: c) Input the bottle with missing plug into the bottle feeding star wheel, and the observation machine shall automatically stop. 5.3.5 Protection function test:
When the stopper speed is greater than or equal to 120 bottles/min, if more than 10 bottles are taken out in front of the bottle auger, the auger speed should be reduced to 60 bottles using a tachometer. /min, when the bottle enters the auger, the auger should return to high speed. 5.4 Performance inspection of the plug turning machine
5.4.1 No-load test:
Start the plug turning machine under no load, run the speed from low to high for 2 hours, and place a secondary industrial thermometer on the top of the reducer oil tank shell 10 minutes, measure the temperature rise of the reducer oil tank. There was no oil leakage from the reducer by visual inspection, and there was no abnormal noise by ear. 5.4.2 Load test:
After the no-load test of the plug turning machine is qualified, the load test will be performed. The manufacturer uses the highest production speed during the test, inputs bottles with rubber stoppers pressed into them, and simulates normal production procedures for a total of 30 minutes. Visually check that the bottle feeding is in place, and the movements of each process are clear and accurate. 5.4.3 Noise test:
When the plug turning machine is working, the machine noise shall be tested according to the provisions of GB/T16769. 5.4.4 Trapped quality test:
The manufacturer simulates normal production procedures at the designed optimum speed for testing, and randomly and continuously selects 600 re-corked bottles. The quality of the re-corked bottles is visually inspected and qualified according to formula (1). rate calculation. Pass rate of overturning:
5.4.5 Electrical system quality inspection:
Number of bottles passing the test
Total number of bottles tested
X100%
.( 1)
5.4.5.1 The continuity, insulation resistance and withstand voltage tests of the protective grounding circuit of the electrical system shall be carried out in accordance with the provisions of 19.2, 19.3 and 19.4 of CB5226.1-2002 respectively. 5.4.5.2 The protective grounding circuit and wiring requirements of the electrical system shall be carried out in accordance with the provisions of 8.2 and Chapter 14 of GB5226.1-2002 respectively.
6 Inspection Rules
6.1 General Principles of Inspection
JB20005.3—2004
6.1.1 Each plug turning machine shall be inspected and qualified by the inspection department of the manufacturing unit in accordance with this standard Before it can leave the factory, the manufacturer will issue a product certificate.
6.1.2 Inspection of documentation and working conditions of the cork turning machine (i.e. installation confirmation test) is only conducted during type inspection. 6.2 Inspection Category
The inspection of the cork turning machine is divided into factory inspection and type inspection. 6.2.1 Factory inspection:
6.2.1.1 Factory inspection should be carried out one by one according to the terms in Table 1. Table 1 Factory inspection items of cork turning machine
Item category
General items
Main items
6.2.1.2 Judgment rules:
Inspection items||tt ||4.2, 4.3, 4.4.1, 4.4.2, 4.4.4, 4.4.5, 4.6.1, 4.6.24.4.3,4.6.34.6.5,4.7.14.7.4,4.7.5.1~4.7. 5.5 If two general items are unqualified or one major item is unqualified during inspection, they will be deemed as unqualified products. Inspection location
manufacturing plant
manufacturing plant
6.2.1.3 If any unqualified product is found during the factory inspection of each plug-turning machine, it will be returned to the workshop for repair and will be re-inspected after repair. If the product fails to meet the standards, it will be judged as a substandard product and will not be allowed to leave the factory. | |tt | When there is a major change in the process; 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 verification. 6.2.2.2 Type inspection item content and requirements: All technical requirements of this standard should be comprehensively quality assessed and reviewed. During each test, the chief inspector should fill in the test record form. After the test is completed, the person in charge of the project will review and sign, and the chief technical person in charge will approve it. Please refer to Appendix A for the type inspection test record sheet. 6.2.2.3 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. 6.2.2.4 Judgment rules:
If any of the electrical safety performance of the 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 there are unqualified items in other items, the unqualified items should be re-inspected twice. If they are still unqualified, the type inspection will be judged as unqualified.
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5 The wiring of the electrical system should comply with the provisions of Chapter 14 of CB5226.1-2002. 5 Test methods
5.1 Material, appearance and structure inspection
5.1.1 Visual inspection covers the requirements of 4.2.1, 4.3.1.4.3.2, 4.4.1~4.4.5. 5.1.2 Use a hardness tester to check the hardness of the plug claw. 5.2 Inspection of documents and working conditions of the cork turning machine 5.2.1 Documentation inspection:
Visually inspect the operating instructions, product certificate, material certificate, instrument calibration certificate, etc. of the cork turning machine. 5.2.2 Working condition test:
5.2.2.1 Packaging material confirmation:
Glass infusion bottles are inspected according to the regulations of GB2639. Medical infusion rubber stoppers are inspected according to the regulations of HG2948. 5.2.2.2 Working environment test:
a) Determine the cleanliness of the working environment of the sinus turning machine under dynamic working conditions. b) Select the measurement points according to the diagonal five-point arrangement method, as shown in Figure 1. The measuring point is more than 0.5m away from the wall and 1.2m~1.3m2 away from the ground
Turnover machine
?
Figure 1 Inspection point layout
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JB20005.3—2004
c) Use a dust particle counter to measure the number of particles in the air. 5.2.2.3 Inspection of plug quality; use steel tape or feeler gauge for random inspection and measurement. 5.3 Functional inspection of the cork-turning machine
5.3.1 Production speed test:
Adjust the speed of the cork-turning machine to the designed maximum speed, input bottles with rubber stoppers, and simulate normal production operation for 10 minutes. Run for 30 minutes in total, and use a tachometer or stopwatch to count randomly for 5 minutes; then adjust the transmission device within the specified range and test the speed adjustment effect in the same way as testing the production speed.
5.3.2 Replacement of specification accessories and bottle specification test: Replace the accessories of corresponding packaging specifications, and conduct tests on bottles of 100mL, 250mL, 500mL and other specifications according to the test method for testing production speed.
5.3.3 Control function test:
Before the cork turning machine leaves the factory, it is tested by simulating normal production procedures. 5.3.4 Chain function test:
a) Fault simulation test: Remove the bottles at the entrance of the bottle inlet star wheel or jam the star wheel, and observe that the machine should automatically stop; b) There will be a lot of accumulation at the bottle outlet The bottle may block the bottle conveying track, and the observation machine shall automatically stop: c) Input the bottle with missing plug into the bottle feeding star wheel, and the observation machine shall automatically stop. 5.3.5 Protection function test:
When the stopper speed is greater than or equal to 120 bottles/min, if more than 10 bottles are taken out in front of the bottle auger, the auger speed should be reduced to 60 bottles using a tachometer. /min, when the bottle enters the auger, the auger should return to high speed. 5.4 Performance inspection of the plug turning machine
5.4.1 No-load test:
Start the plug turning machine under no load, run the speed from low to high for 2 hours, and place a secondary industrial thermometer on the top of the reducer oil tank shell 10 minutes, measure the temperature rise of the reducer oil tank. There was no oil leakage from the reducer by visual inspection, and there was no abnormal noise by ear. 5.4.2 Load test:
After the no-load test of the plug turning machine is qualified, the load test will be performed. The manufacturer uses the highest production speed during the test, inputs bottles with rubber stoppers pressed into them, and simulates normal production procedures for a total of 30 minutes. Visually check that the bottle feeding is in place, and the movements of each process are clear and accurate. 5.4.3 Noise test:
When the plug turning machine is working, the machine noise shall be tested according to the provisions of GB/T16769. 5.4.4 Trapped quality test:
The manufacturer simulates normal production procedures at the designed optimum speed for testing, and randomly and continuously selects 600 re-corked bottles. The quality of the re-corked bottles is visually inspected and qualified according to formula (1). rate calculation. Pass rate of overturning:
5.4.5 Electrical system quality inspection:
Number of bottles passing the test
Total number of bottles tested
X100%
.( 1)
5.4.5.1 The continuity, insulation resistance and withstand voltage tests of the protective grounding circuit of the electrical system shall be carried out in accordance with the provisions of 19.2, 19.3 and 19.4 of CB5226.1-2002 respectively. 5.4.5.2 The protective grounding circuit and wiring requirements of the electrical system shall be carried out in accordance with the provisions of 8.2 and Chapter 14 of GB5226.1-2002 respectively.
6 Inspection Rules
6.1 General Principles of Inspection
JB20005.3—2004
6.1.1 Each plug turning machine shall be inspected and qualified by the inspection department of the manufacturing unit in accordance with this standard Before it can leave the factory, the manufacturer will issue a product certificate.
6.1.2 Inspection of documentation and working conditions of the cork turning machine (i.e. installation confirmation test) is only conducted during type inspection. 6.2 Inspection Category
The inspection of the cork turning machine is divided into factory inspection and type inspection. 6.2.1 Factory inspection:
6.2.1.1 Factory inspection should be carried out one by one according to the terms in Table 1. Table 1 Factory inspection items of cork turning machine
Item category
General items
Main items
6.2.1.2 Judgment rules:
Inspection items||tt ||4.2, 4.3, 4.4.1, 4.4.2, 4.4.4, 4.4.5, 4.6.1, 4.6.24.4.3,4.6.34.6.5,4.7.14.7.4,4.7.5.1~4.7. 5.5 If two general items are unqualified or one major item is unqualified during inspection, they will be deemed as unqualified products. Inspection location
manufacturing plant
manufacturing plant
6.2.1.3 If any unqualified product is found during the factory inspection process, each plug-turning machine will be returned to the workshop for repair and re-inspected after repair. If the product fails to meet the standards, it will be judged as a substandard product and will not be allowed to leave the factory.
6.2.2 Type inspection:
6.2.2.1 Type inspection shall be carried out when one of the following situations occurs: a) When the product is trial-made or transferred to the factory for production; b) The structure, material, When there is a major change in the process; 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 verification. 6.2.2.2 Type inspection item content and requirements: All technical requirements of this standard should be comprehensively quality assessed and reviewed. During each test, the chief inspector should fill in the test record form. After the test is completed, the person in charge of the project will review and sign, and the chief technical person in charge will approve it. Please refer to Appendix A for the type inspection test record sheet. 6.2.2.3 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. 6.2.2.4 Judgment rules:
If any of the electrical safety performance of the 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 there are unqualified items in other items, the unqualified items should be re-inspected twice. If they are still unqualified, the type inspection will be judged as unqualified.
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5 The wiring of the electrical system should comply with the provisions of Chapter 14 of CB5226.1-2002. 5 Test methods
5.1 Material, appearance and structure inspection
5.1.1 Visual inspection covers the requirements of 4.2.1, 4.3.1.4.3.2, 4.4.1~4.4.5. 5.1.2 Use a hardness tester to check the hardness of the plug claw. 5.2 Inspection of documents and working conditions of the cork turning machine 5.2.1 Documentation inspection:
Visually inspect the operating instructions, product certificate, material certificate, instrument calibration certificate, etc. of the cork turning machine. 5.2.2 Working condition test:
5.2.2.1 Packaging material confirmation:
Glass infusion bottles are inspected according to the regulations of GB2639. Medical infusion rubber stoppers are inspected according to the regulations of HG2948. 5.2.2.2 Working environment test:
a) Determine the cleanliness of the working environment of the sinus turning machine under dynamic working conditions. b) Select the measurement points according to the diagonal five-point arrangement method, as shown in Figure 1. The measuring point is more than 0.5m away from the wall and 1.2m~1.3m2 away from the ground
Turnover machine
?
Figure 1 Inspection point layout
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JB20005.3—2004
c) Use a dust particle counter to measure the number of particles in the air. 5.2.2.3 Inspection of plug quality; use steel tape or feeler gauge for random inspection and measurement. 5.3 Functional inspection of the cork-turning machine
5.3.1 Production speed test:
Adjust the speed of the cork-turning machine to the designed maximum speed, input bottles with rubber stoppers, and simulate normal production operation for 10 minutes. Run for 30 minutes in total, and use a tachometer or stopwatch to count randomly for 5 minutes; then adjust the transmission device within the specified range and test the speed adjustment effect in the same way as testing the production speed.
5.3.2 Replacement of specification accessories and bottle specification test: Replace the accessories of corresponding packaging specifications, and conduct tests on bottles of 100mL, 250mL, 500mL and other specifications according to the test method for testing production speed.
5.3.3 Control function test:
Before the cork turning machine leaves the factory, the normal production procedure is simulated for testing. 5.3.4 Chain function test:
a) Fault simulation test: remove the bottles at the entrance of the bottle inlet star wheel or block the star wheel, and observe that the machine should automatically stop; b) There will be a lot of accumulation at the bottle outlet Bottles may block the bottle conveying track, and the observation machine shall automatically stop: c) Input bottles with missing plugs into the bottle feeding star wheel, and the observation machine shall automatically stop. 5.3.5 Protection function test:
When the speed of the stopper is greater than or equal to 120 bottles/min, if more than 10 bottles are taken out in front of the bottle entering auger, the auger speed should be reduced to 60 bottles using a tachometer. /min, when the bottle enters the auger, the auger should return to high speed. 5.4 Performance inspection of the plug turning machine
5.4.1 No-load test:
Start the plug turning machine under no load, run the speed from low to high for 2 hours, and place a secondary industrial thermometer on the top of the reducer oil tank shell 10 minutes, measure the temperature rise of the reducer oil tank. There was no oil leakage from the reducer by visual inspection, and there was no abnormal noise by ear. 5.4.2 Load test:
After the no-load test of the plug turning machine is qualified, the load test will be performed. The manufacturer uses the highest production speed during the test, inputs bottles with rubber stoppers pressed into them, and simulates normal production procedures for a total of 30 minutes. Visually check that the bottle feeding is in place, and the movements of each process are clear and accurate. 5.4.3 Noise test:
When the plug turning machine is working, test the machine noise according to the provisions of GB/T16769. 5.4.4 Trapped quality test:
The manufacturer simulates normal production procedures at the designed optimum speed for testing, randomly and continuously selects 600 re-corked bottles, visually inspects the re-corked quality and passes the test according to formula (1) rate calculation. Pass rate of overturning:
5.4.5 Electrical system quality inspection:
Number of qualified bottles
Total number of bottles tested
X100%
.( 1)
5.4.5.1 The continuity, insulation resistance and withstand voltage tests of the protective grounding circuit of the electrical system shall be carried out in accordance with the provisions of 19.2, 19.3 and 19.4 in CB5226.1-2002 respectively. 5.4.5.2 The protective grounding circuit and wiring requirements of the electrical system shall be carried out in accordance with the provisions of 8.2 and Chapter 14 of GB5226.1-2002 respectively.
6 Inspection Rules
6.1 General Principles of Inspection
JB20005.3—2004
6.1.1 Each plug turning machine shall be inspected and qualified by the inspection department of the manufacturing unit in accordance with this standard Before it can leave the factory, the manufacturer will issue a product certificate.
6.1.2 Inspection of documentation and working conditions of the stopper (i.e. installation confirmation test) is only conducted during type inspection. 6.2 Inspection Category
The inspection of the cork turning machine is divided into factory inspection and type inspection. 6.2.1 Factory inspection:
6.2.1.1 Factory inspection should be carried out one by one according to the terms in Table 1. Table 1 Factory inspection items of cork turning machine
Item category
General items
Main items
6.2.1.2 Judgment rules:
Inspection items||tt ||4.2, 4.3, 4.4.1, 4.4.2, 4.4.4, 4.4.5, 4.6.1, 4.6.24.4.3,4.6.34.6.5,4.7.14.7.4,4.7.5.1~4.7. 5.5 If two general items are unqualified or one major item is unqualified during inspection, they will be deemed as unqualified products. Inspection location
manufacturing plant
manufacturing plant
6.2.1.3 If any unqualified product is found during the factory inspection process, each plug-turning machine will be returned to the workshop for repair and re-inspected after repair. If the product fails to meet the standards, it will be judged as a substandard product and will not be allowed to leave the factory. | |tt | When there is a major change in the process; 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 verification. 6.2.2.2 Type inspection item content and requirements: All technical requirements of this standard should be comprehensively quality assessed and reviewed. During each test, the chief inspector should fill in the test record form. After the test is completed, the person in charge of the project will review and sign, and the chief technical person in charge will approve it. Please refer to Appendix A for the type inspection test record sheet. 6.2.2.3 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. 6.2.2.4 Judgment rules:
During the type inspection, if any one of the continuity, insulation resistance and withstand voltage of the protective grounding circuit of the electrical safety performance fails, the product will be judged to have failed the type inspection. If there are unqualified items in other items, the unqualified items should be re-inspected twice. If they are still unqualified, the type inspection will be judged as unqualified.
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1 Production speed test:
Adjust the stopper turning machine speed to the designed maximum speed, input bottles with rubber stoppers, simulate normal production operation for 10 minutes, run cumulatively for 30 minutes, and use a tachometer or stopwatch to randomly count for 5 minutes ; Then adjust the transmission device within the specified range and test the speed adjustment effect using the same method as testing the production speed.
5.3.2 Replacement of specification accessories and bottle specification test: Replace the accessories of corresponding packaging specifications, and conduct tests on bottles of 100mL, 250mL, 500mL and other specifications according to the test method for testing production speed.
5.3.3 Control function test:
Before the cork turning machine leaves the factory, the normal production procedure is simulated for testing. 5.3.4 Chain function test:
a) Fault simulation test: Remove the bottles at the entrance of the bottle inlet star wheel or jam the star wheel, and observe that the machine should automatically stop; b) There will be a lot of accumulation at the bottle outlet The bottle may block the bottle conveying track, and the observation machine shall automatically stop: c) Input the bottle with missing plug into the bottle feeding star wheel, and the observation machine shall automatically stop. 5.3.5 Protection function test:
When the stopper speed is greater than or equal to 120 bottles/min, if more than 10 bottles are taken out in front of the bottle auger, the auger speed should be reduced to 60 bottles using a tachometer. /min, when the bottle enters the auger, the auger should return to high speed. 5.4 Performance inspection of the plug turning machine www.bzxz.net
5.4.1 No-load test:
Start the plug turning machine under no load, run the speed from low to high for 2 hours, and place a secondary industrial thermometer on the top of the reducer oil tank shell 10 minutes, measure the temperature rise of the reducer oil tank. There was no oil leakage from the reducer by visual inspection, and there was no abnormal noise by ear. 5.4.2 Load test:
After the no-load test of the plug turning machine is qualified, the load test will be performed. The manufacturer uses the highest production speed during the test, inputs bottles with rubber stoppers pressed into them, and simulates normal production procedures for a total of 30 minutes. Visually check that the bottle feeding is in place, and the movements of each process are clear and accurate. 5.4.3 Noise test:
When the plug turning machine is working, the machine noise shall be tested according to the provisions of GB/T16769. 5.4.4 Trapped quality test:
The manufacturer simulates normal production procedures at the designed optimum speed for testing, and randomly and continuously selects 600 re-corked bottles. The quality of the re-corked bottles is visually inspected and qualified according to formula (1). rate calculation. Pass rate of overturning:
5.4.5 Electrical system quality inspection:
Number of bottles passing the test
Total number of bottles tested
X100%
.( 1)
5.4.5.1 The continuity, insulation resistance and withstand voltage tests of the protective grounding circuit of the electrical system shall be carried out in accordance with the provisions of 19.2, 19.3 and 19.4 of CB5226.1-2002 respectively. 5.4.5.2 The protective grounding circuit and wiring requirements of the electrical system shall be carried out in accordance with the provisions of 8.2 and Chapter 14 of GB5226.1-2002 respectively.
6 Inspection Rules
6.1 General Principles of Inspection
JB20005.3—2004
6.1.1 Each plug turning machine shall be inspected and qualified by the inspection department of the manufacturing unit in accordance with this standard Before it can leave the factory, the manufacturer will issue a product certificate.
6.1.2 Inspection of documentation and working conditions of the cork turning machine (i.e. installation confirmation test) is only conducted during type inspection. 6.2 Inspection Category
The inspection of the cork turning machine is divided into factory inspection and type inspection. 6.2.1 Factory inspection:
6.2.1.1 Factory inspection should be carried out one by one according to the terms in Table 1. Table 1 Factory inspection items of cork turning machine
Item category
General items
Main items
6.2.1.2 Judgment rules:
Inspection items||tt ||4.2, 4.3, 4.4.1, 4.4.2, 4.4.4, 4.4.5, 4.6.1, 4.6.24.4.3,4.6.34.6.5,4.7.14.7.4,4.7.5.1~4.7. 5.5 If two general items are unqualified or one major item is unqualified during inspection, they will be deemed as unqualified products. Inspection location
manufacturing plant
manufacturing plant
6.2.1.3 If any unqualified product is found during the factory inspection of each plug-turning machine, it will be returned to the workshop for repair and will be re-inspected after repair. If the product fails to meet the standards, it will be judged as a substandard product and will not be allowed to leave the factory. | |tt | When there is a major change in the process; 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 verification. 6.2.2.2 Type inspection item content and requirements: All technical requirements of this standard should be comprehensively quality assessed and reviewed. During each test, the chief inspector should fill in the test record form. After the test is completed, the person in charge of the project will review and sign, and the chief technical person in charge will approve it. Please refer to Appendix A for the type inspection test record sheet. 6.2.2.3 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. 6.2.2.4 Judgment rules:
If any of the electrical safety performance of the 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 there are unqualified items in other items, the unqualified items should be re-inspected twice. If they are still unqualified, the type inspection will be judged as unqualified.
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1 Production speed test:
Adjust the stopper turning machine speed to the designed maximum speed, input bottles with rubber stoppers, simulate normal production operation for 10 minutes, run cumulatively for 30 minutes, and use a tachometer or stopwatch to randomly count for 5 minutes ; Then adjust the transmission device within the specified range and test the speed adjustment effect using the same method as testing the production speed.
5.3.2 Replacement of specification accessories and bottle specification test: Replace the accessories of corresponding packaging specifications, and conduct tests on bottles of 100mL, 250mL, 500mL and other specifications according to the test method for testing production speed.
5.3.3 Control function test:
Before the cork turning machine leaves the factory, the normal production procedure is simulated for testing. 5.3.4 Chain function test:
a) Fault simulation test: Remove the bottles at the entrance of the bottle inlet star wheel or jam the star wheel, and observe that the machine should automatically stop; b) There will be a lot of accumulation at the bottle outlet The bottle may block the bottle conveying track, and the observation machine shall automatically stop: c) Input the bottle with missing plug into the bottle feeding star wheel, and the observation machine shall automatically stop. 5.3.5 Protection function test:
When the stopper speed is greater than or equal to 120 bottles/min, if more than 10 bottles are taken out in front of the bottle auger, the auger speed should be reduced to 60 bottles using a tachometer. /min, when the bottle enters the auger, the auger should return to high speed. 5.4 Performance inspection of the plug turning machine
5.4.1 No-load test:
Start the plug turning machine under no load, run the speed from low to high for 2 hours, and place a secondary industrial thermometer on the top of the reducer oil tank shell 10 minutes, measure the temperature rise of the reducer oil tank. There was no oil leakage from the reducer by visual inspection, and there was no abnormal noise by ear. 5.4.2 Load test:
After the no-load test of the plug turning machine is qualified, the load test will be performed. The manufacturer uses the highest production speed during the test, inputs bottles with rubber stoppers pressed into them, and simulates normal production procedures for a total of 30 minutes. Visually check that the bottle feeding is in place, and the movements of each process are clear and accurate. 5.4.3 Noise test:
When the plug turning machine is working, the machine noise shall be tested according to the provisions of GB/T16769. 5.4.4 Trapped quality test:
The manufacturer simulates normal production procedures at the designed optimum speed for testing, and randomly and continuously selects 600 re-corked bottles. The quality of the re-corked bottles is visually inspected and qualified according to formula (1). rate calculation. Pass rate of overturning:
5.4.5 Electrical system quality inspection:
Number of bottles passing the test
Total number of bottles tested
X100%
.( 1)
5.4.5.1 The continuity, insulation resistance and withstand voltage tests of the protective grounding circuit of the electrical system shall be carried out in accordance with the provisions of 19.2, 19.3 and 19.4 of CB5226.1-2002 respectively. 5.4.5.2 The protective grounding circuit and wiring requirements of the electrical system shall be carried out in accordance with the provisions of 8.2 and Chapter 14 of GB5226.1-2002 respectively.
6 Inspection Rules
6.1 General Principles of Inspection
JB20005.3—2004
6.1.1 Each plug turning machine shall be inspected and qualified by the inspection department of the manufacturing unit in accordance with this standard Before it can leave the factory, the manufacturer will issue a product certificate.
6.1.2 Inspection of documentation and working conditions of the cork turning machine (i.e. installation confirmation test) is only conducted during type inspection. 6.2 Inspection Category
The inspection of the cork turning machine is divided into factory inspection and type inspection. 6.2.1 Factory inspection:
6.2.1.1 Factory inspection should be carried out one by one according to the terms in Table 1. Table 1 Factory inspection items of cork turning machine
Item category
General items
Main items
6.2.1.2 Judgment rules:
Inspection items||tt ||4.2, 4.3, 4.4.1, 4.4.2, 4.4.4, 4.4.5, 4.6.1, 4.6.24.4.3,4.6.34.6.5,4.7.14.7.4,4.7.5.1~4.7. 5.5 If two general items are unqualified or one major item is unqualified during inspection, they will be deemed as unqualified products. Inspection location
manufacturing plant
manufacturing plant
6.2.1.3 If any unqualified product is found during the factory inspection of each plug-turning machine, it will be returned to the workshop for repair and will be re-inspected after repair. If the product fails to meet the standards, it will be judged as a substandard product and will not be allowed to leave the factory. | |tt | When there is a major change in the process; 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 verification. 6.2.2.2 Type inspection item content and requirements: All technical requirements of this standard should be comprehensively quality assessed and reviewed. During each test, the chief inspector should fill in the test record form. After the test is completed, the person in charge of the project will review and sign, and the chief technical person in charge will approve it. Please refer to Appendix A for the type inspection test record sheet. 6.2.2.3 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. 6.2.2.4 Judgment rules:
During the type inspection, if any one of the continuity, insulation resistance and withstand voltage of the protective grounding circuit of the electrical safety performance fails, the product will be judged to have failed the type inspection. If there are unqualified items in other items, the unqualified items should be re-inspected twice. If they are still unqualified, the type inspection will be judged as unqualified.
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1. Factory inspection should be carried out on a unit-by-unit basis according to the terms in Table 1. Table 1 Factory inspection items of cork turning machine
Item category
General items
Main items
6.2.1.2 Judgment rules:
Inspection items||tt ||4.2, 4.3, 4.4.1, 4.4.2, 4.4.4, 4.4.5, 4.6.1, 4.6.24.4.3,4.6.34.6.5,4.7.14.7.4,4.7.5.1~4.7. 5.5 If two general items are unqualified or one major item is unqualified during inspection, they will be deemed as unqualified products. Inspection location
manufacturing plant
manufacturing plant
6.2.1.3 If any unqualified product is found during the factory inspection of each plug-turning machine, it will be returned to the workshop for repair and will be re-inspected after repair. If the product fails to meet the standards, it will be judged as a substandard product and will not be allowed to leave the factory. | |tt | When there is a major change in the process; 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 verification. 6.2.2.2 Type inspection item content and requirements: All technical requirements of this standard should be comprehensively quality assessed and reviewed. During each test, the chief inspector should fill in the test record form. After the test is completed, the person in charge of the project will review and sign, and the chief technical person in charge will approve it. Please refer to Appendix A for the type inspection test record sheet. 6.2.2.3 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. 6.2.2.4 Judgment rules:
If any of the electrical safety performance of the 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 there are unqualified items in other items, the unqualified items should be re-inspected twice. If they are still unqualified, the type inspection will be judged as unqualified.
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1. Factory inspection should be carried out on a unit-by-unit basis according to the terms in Table 1. Table 1 Factory inspection items of cork turning machine
Item category
General items
Main items
6.2.1.2 Judgment rules:
Inspection items||tt ||4.2, 4.3, 4.4.1, 4.4.2, 4.4.4, 4.4.5, 4.6.1, 4.6.24.4.3,4.6.34.6.5,4.7.14.7.4,4.7.5.1~4.7. 5.5 If two general items are unqualified or one major item is unqualified during inspection, they will be deemed as unqualified products. Inspection location
manufacturing plant
manufacturing plant
6.2.1.3 If any unqualified product is found during the factory inspection process, each plug-turning machine will be returned to the workshop for repair and re-inspected after repair. If the product fails to meet the standards, it will be judged as a substandard product and will not be allowed to leave the factory.
6.2.2 Type inspection:
6.2.2.1 Type inspection shall be carried out when one of the following situations occurs: a) When the product is trial-made or transferred to the factory for production; b) The structure, material, When there is a major change 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; e) When the pharmaceutical manufacturer conducts equipment verification. 6.2.2.2 Type inspection item content and requirements: All technical requirements of this standard should be comprehensively quality assessed and reviewed. During each test, the chief inspector should fill in the test record form. After the test is completed, the person in charge of the project will review and sign, and the chief technical person in charge will approve it. Please refer to Appendix A for the type inspection test record sheet. 6.2.2.3 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. 6.2.2.4 Judgment rules:
During the type inspection, if any one of the continuity, insulation resistance and withstand voltage of the protective grounding circuit of the electrical safety performance fails, the product will be judged to have failed the type inspection. If there are unqualified items in other items, the unqualified items should be re-inspected twice. If they are still unqualified, the type inspection will be judged as unqualified.
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