Some standard content:
JB | 01Implementation
National Development and Reform Commission released
ICS11.120.30
C92
JB
Pharmaceutical Machinery Industry Standard of the People's Republic of China JB20005.2-- 2004
Replacing YY0235.2—1995
Glass infusion bottle filling machine
Glassinfusionbottlefillingmachine2004-02-05 release
2004-06-01 implementation
Released by the National Development and Reform Commission
Foreword
1 Scope
2 Normative Reference Documents
3 Classification and Labeling
4 Requirements
++
5 Test methods
6 Inspection rules
7 Marking, instructions for use, packaging and storage items
Appendix A (informative appendix)
Type inspection test record sheet
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This standard is based on the requirements of the "Good Manufacturing Practice for Pharmaceuticals" and CB/T1.1-2000, GB/T1.2-2002 Standardization Work Guidelines, and is based on YY0235.2-1995 "Glass Infusion Bottle Filling Machine" revision. This standard replaces YY0235.2-1995 from the date of implementation. Compared with YY0235.2-1995, the main contents of this standard have changed as follows: 8) Except for clauses 3.1, 3.3, 4.2.4.11, 4.12 and other provisions in YY0235.2-1995. b) Revised the following clauses in YY0235.2-1995: According to the four steps of verification in the "Good Manufacturing Practice for Pharmaceutical Products", the technical requirements clauses in the original standard have been rearranged. The contents of \requirements\ are classified according to the order of verification; -The test method corresponds one-to-one with the content of the requirements chapter, which enhances the operability of the test method; the terms and content of the inspection rules of the original standard are revised: the electrical quality requirements are emphasized importance, revised according to GB5226.1-2002; the sound of one-load operation is reduced to 70dB(A). c) The main clauses added to this standard:
- Appearance quality requirements (see 4.3):
Structural requirements (see 4.4);
- Filling working conditions (see 4.5 .1, 4.5.2, 4.5.3); - Added control function; display function; protection function (see 4.6.44.6.5.4.6.7); added clauses corresponding to the requirements in the test method; specified in the inspection rules Inspections that specify working conditions are only carried out during type inspection; - Added informative Appendix A "Type Inspection Test Record Form". 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: Chongqing Jiangshan Pharmaceutical Machinery Co., Ltd. The main drafters of this standard: Sun Jinlian, Zhou Jie, Wang Yuanping, Huang Yun. The previous versions of the standard replaced by this standard are: GB11753.21989, YY0235.2-1995. 20
1 scope
Glass infusion bottle filling machine
JB 20005.2-2004
This standard specifies the classification and labeling, requirements, test methods, inspection rules and signs, instructions for use, packaging, and storage of glass infusion bottle filling machines.
This standard applies to glass infusion bottle filling machines (hereinafter referred to as filling 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 to an agreement based on this standard are encouraged to study whether the latest versions of these documents can be used. . For undated referenced documents, the latest edition applies to this standard. CB/T191 Packaging, storage and transportation pictorial mark
GB2639 glass infusion bottle
GB5226.1-2002 Machinery Safety Machinery and Electrical Equipment Part 1: General Technical Conditions GB/T6388 Transport Packaging Receipt and Delivery Mark| | tt | Pressure level measurement method GB/T 16769
and mark
3.1 Classification
The installation classification is divided into two types according to the movement mode: linear type and rotary type. The linear filling machine is represented by CZ, and the rotary filling machine is represented by CH.
3.2 model
3.2.1 The model of the overlay machine should comply with the regulations of YYT0216. 3.2.2 Model mark:
21
JB20005.2—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: (G) installation
[straight (Z) line or return (H) rotation] | | tt | 4 Requirements
4.1 General
The filling machine should comply with the requirements of this standard and the "Good Manufacturing Practice for Pharmaceuticals" (1998 revised edition) on the manufacturing of pharmaceutical equipment. 4.2 Material requirements
4.2 .1 Parts that are in direct contact with liquids and gases should be made of low-carbon austenitic stainless steel or materials that are non-toxic, corrosion-resistant and do not chemically react with the liquid in contact, do not produce adsorption, do not produce particles, and have material certification. Book. 4.2.2 Other materials should be resistant to corrosion, rust-free, and free of particle precipitation. 4.3 Parts that require frequent disinfection should have good heat resistance
4.3.1 Filling. The outer surface of the machine should be free of bulges, dents, uneven roughness and other defects. The appearance of the whole machine should be neat and tidy, with a uniform gloss. 4.3.2 The edges of the exposed joint surfaces of the parts should be neat and even, and there should be no obvious misalignment. There should be no obvious gap between the door, cover and the joint surface
4.4 Structural requirements
4.4.1 The installation should have a bottle feeding device, a bottle inlet and outlet detection device, a bottleneck positioning device, a stepless speed change and Alum control device. 4.4.2 There should be a smooth bottle conveying device at the bridge of the bottle conveying track. 4.4.3 The exposed transmission part of the filling machine should have a safety protection cover. 4.4.4 The conveying device should not pass through clean areas of different levels. . 4.5 Working conditions
4.5.1 The high-level measures of the liquid filling system should be installed. 4.5.2 A filter should be installed before the liquid enters the filling machine. 4.5.3 Cleaning and disinfection requirements: Online cleaning and disinfection facilities should be installed. Or device. The liquid channel should be cleaned and disinfected online before entering normal operation and after get off work.
4.5.4 Packaging material requirements: Glass infusion bottles should comply with the requirements of CB2639: Filling. The loading room should be a class 10,000 clean area: the lagging machine and the connected inlet and outlet bottle transfer machines should be installed and work under a local class 100 laminar flow hood
4.6 Functional requirements ||tt| |22
4.6.1 The liquid channel of the filling machine should be capable of online cleaning and disinfection. 4.6.2 The filling machine should be able to meet the production speed requirements and have stepless speed regulation within the specified range JB20005.22004.
4.6.3 The filling machine should be able to assemble 100mL, 250mL, 500mL, etc. glass infusion bottles. The accessories when changing specifications should be simple and reliable, and can be quickly replaced.
4.6.4. Control functions: control the shortage of incoming bottles and detect the count of incoming bottles, control the outgoing bottles to prevent accumulation: control the filling volume and filling error; control the production speed; control the thin packaging process.
4.6.5 Display function: display production speed and total output. 4.6.6 Interlock function:
a) When the following situations occur, the machine should automatically stop: when the incoming bottle is missing or stuck;
—when the outgoing bottle is accumulated or blocked.
b) No filling if the bottle is missing.
Protection function: For filling machines that operate at a speed greater than or equal to 120 bottles/min, a slow start control device should be installed before the bottle feeding device. 4.6.7
4.7 Performance requirements
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 machinery is running normally. 4.7.2 The conveying device should ensure that the bottles enter the filling station accurately, the filling system must not leak, and the movements of each process should be sensitive and accurate. 4.7.3 The noise level during load operation shall not exceed 70dB(A). 4.7.4 The filling volume and filling volume error should comply with the provisions of the "Pharmacopoeia of the People's Republic of China" (2000 edition). The filling error is ±2%. 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 of CB5226.1-2002. 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 GB5226.12002. 4.7.5.4 The protective grounding circuit of the electrical system shall comply with the provisions of 8.2 in GB5226.1-2002. 4.7.5.5 The wiring of the electrical system shall comply with the provisions of Chapter 14 of GB5226.1-2002. 5 Test methods
5.1 Material, appearance and structure inspection
Visual inspection requirements of 4.2, 4.3.1, 4.3.2, 4.4.1~4.4.4. 5.2 Inspection of filling machine documentation and working conditions 5.2.1 Inspection of documentation
Visually inspect the filling machine instruction manual, product certificate, material certificate and instrument calibration certificate. 5.2.2 Working condition test
After the installation is qualified, visually check whether the high-level tank of the filling system is configured. Whether a filter that meets the requirements is installed before the medicinal liquid enters the filling machine.
5.2.3 Confirmation of online cleaning and disinfection of filling machine
a) Confirmation of cleaning wave quality, temperature, and pressure of the cleaning device, and confirmation of control program: b) Online cleaning of the liquid channel of the filling machine ,disinfect. 23
JB20005.2--2004
according to the pharmaceutical process requirements and the operating procedures of the online cleaning device;
Confirmation of cleaning and disinfection effects:
o)| |tt||Confirmation standards: pH=5.0~5.7; conductivity less than or equal to 2.0uS/cm; microorganisms less than or equal to 5CFU/100mL; endotoxin less than 0.25EU/mL
Note 1: Definition of CFU one by one The bacterial colony formed by the multiplication of one or more bacteria after bacterial culture is referred to as CFU, and is usually expressed as a number. Note 2: EU represents endotoxin measurement unit.
Sampling points: After the cleaning and disinfection procedures are completed, samples are taken at each discharge point and sent to the laboratory for testing. Inspection method: Conductivity test method: Use a conductivity meter to test the conductivity of the sampled liquid. pH value test method: Use pH test paper to disperse into the sample liquid, and then compare the test paper with the pH value color guide to confirm whether it is qualified. Microbial testing method: Use the culture membrane filtration method to determine the content of microorganisms in the sampled liquid. Endotoxin testing method: Follow the bacterial endotoxin testing method in Appendix XIE of the "Pharmacopoeia of the People's Republic of China" (2000 edition). 5.2.4 Packaging material confirmation
Glass infusion bottles are inspected according to the regulations of GB2639. 5.2.5 Working environment test
5.2.5.1 Determine the cleanliness of the filling machine working environment under dynamic working conditions. 5.2.5.2 Select the measurement points according to the diagonal five-point arrangement method, as shown in Figure 1. ?
Filling machine
@
Figure 1 Inspection point layout
The measuring point is more than 0.5m away from the wall and 1.2m~1.3m away from the ground5.2.5.3 Use a dust particle counter to measure the number of particles in the air. 5.3 Filling machine function inspection
5.3.1 Confirmation of structure that can realize online cleaning and disinfection 3
@
Analysis from the structure and filling principle proves that the liquid channel of the filling machine has no There are no dead ends, no mechanical friction, and online cleaning and disinfection can be achieved. 5.3.2 Production speed test
Adjust the speed of the filling machine to the designed maximum speed, fill the bottles, use drinking water instead of the filling liquid, after 30 minutes of load operation, count for 5 minutes with a tachometer or stopwatch. Then adjust the transmission device within the specified range and test the speed adjustment effect using the same method as testing the production speed.
5.3.3 Replacement of accessories and bottle specification test Replace accessories of corresponding specifications, and conduct tests on bottles of 100mL, 250mL, 500mL and other specifications according to the test method for testing production speed.
5.3.4 Control function test
24
Before the machine is installed and shipped from the factory, drinking water should be used instead of the filling liquid to simulate normal production procedures for testing. 5.3.5 Chain function test
JB20005.22004
a) Remove the bottle in front of the inlet of the bottle star wheel or block the star wheel, and observe that the machine should automatically stop: b) Remove the bottle from the star wheel entrance If there are many bottles accumulated at the bottle or the bottle feeding track is blocked, observe that the machine should automatically stop; e) Remove the bottle from the bottle pressing star wheel and observe that the corresponding filling needle should be empty of liquid. 5.3.6 Protection function test
When the filling machine speed is greater than or equal to 120 bottles/min, when more than 10 bottles are taken 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 Installation performance inspection
5.4.1 No-load test
Start the installation with no load, run the speed from low to high for 2 hours, use a secondary industrial thermometer to be placed on the top of the reducer oil tank shell for 10 minutes, and measure the oil tank temperature rise. 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 filling machine passes the no-load test, perform the load test. During the test, the manufacturer used the highest production speed, used drinking water instead of filling liquid, fed the bottles, and simulated normal production procedures for 30 minutes to check that the bottles were in place, the filling system did not leak, and the process movements were sensitive and accurate.
5.4.3 Noise test
When the filling machine is working, test the machine noise according to the provisions of GB/T16769. 5.4.4 Filling volume and filling volume error test
Use drinking water instead of the filling liquid, run the machine at the maximum production speed designed for 30 minutes, and randomly and continuously take out bottles filled with liquid equal to the number of filling heads. Use a measuring cup to measure filling quantity and tolerance. 5.4.5 Electrical system quality inspection
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 GB5226.1-2002 respectively.
5.4.5.2 The protective grounding circuit and wiring requirements of the electrical system shall be 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
6.1.1 Each filling machine shall be inspected by the inspection department of the manufacturing unit according to this standard before it can leave the factory, and the product shall be issued by the manufacturer. Certificate of conformity.
6.1.2 Please note that installation documentation and working condition testing (i.e. installation confirmation test) are only conducted during type inspection. 6.2 Inspection Classification
The inspection of filling machines 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. 25
3. The noise level during load operation shall not exceed 70dB(A). 4.7.4 The filling volume and filling volume error should comply with the provisions of the "Pharmacopoeia of the People's Republic of China" (2000 edition). The loading error is ±2%. 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 of CB5226.1-2002. 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 GB5226.12002. 4.7.5.4 The protective grounding circuit of the electrical system shall comply with the provisions of 8.2 in GB5226.1-2002. 4.7.5.5 The wiring of the electrical system shall comply with the provisions of Chapter 14 of GB5226.1-2002. 5 Test methods
5.1 Material, appearance and structure inspection
Visual inspection requirements of 4.2, 4.3.1, 4.3.2, 4.4.1~4.4.4. 5.2 Inspection of filling machine documentation and working conditions 5.2.1 Inspection of documentation
Visually inspect the filling machine instruction manual, product certificate, material certificate and instrument calibration certificate. 5.2.2 Working condition test
After the installation is qualified, visually check whether the high-level tank of the filling system is configured. Whether a filter that meets the requirements is installed before the medicinal liquid enters the filling machine.
5.2.3 Filling machine online cleaning and disinfection confirmation
a) Confirmation of cleaning wave quality, temperature, and pressure of the cleaning device, and confirmation of control program: b) Online cleaning of the liquid channel of the filling machine ,disinfect. 23
JB20005.2--2004
according to the pharmaceutical process requirements and the operating procedures of the online cleaning device;
Confirmation of cleaning and disinfection effects:
o)| |tt||Confirmation standards: pH=5.0~5.7; conductivity less than or equal to 2.0uS/cm; microorganisms less than or equal to 5CFU/100mL; endotoxin less than 0.25EU/mL
Note 1: Definition of CFU one by one The bacterial colony formed by the multiplication of one or more bacteria after bacterial culture is referred to as CFU, and is usually expressed as a number. Note 2: EU represents endotoxin measurement unit.
Sampling points: After the cleaning and disinfection procedures are completed, samples are taken at each discharge point and sent to the laboratory for testing. Inspection method: Conductivity test method: Use a conductivity meter to test the conductivity of the sampled liquid. pH value test method: Use pH test paper to disperse into the sample liquid, and then compare the test paper with the pH value color guide to confirm whether it is qualified. Microbial test method: Use culture membrane filtration method to determine the content of microorganisms in the sampled liquid. Endotoxin test method: According to the bacterial endotoxin test method in Appendix XIE of the "Pharmacopoeia of the People's Republic of China" (2000 edition). 5.2.4 Packaging material confirmation
Glass infusion bottles are inspected according to the regulations of GB2639. 5.2.5 Working environment test
5.2.5.1 Determine the cleanliness of the filling machine working environment under dynamic working conditions. 5.2.5.2 Select the measurement points according to the diagonal five-point arrangement method, as shown in Figure 1. ?
Filling machine
@
Figure 1 Inspection point layout
The measuring point is more than 0.5m away from the wall and 1.2m~1.3m away from the ground5.2.5.3 Use a dust particle counter to measure the number of particles in the air. 5.3 Filling machine function inspection
5.3.1 Confirmation of structure that can realize online cleaning and disinfection 3
@
Analysis from the structure and filling principle proves that the liquid channel of the filling machine has no There are no dead ends, no mechanical friction, and online cleaning and disinfection can be achieved. 5.3.2 Production speed test
Adjust the speed of the filling machine to the designed maximum speed, fill the bottles, use drinking water instead of the filling liquid, after 30 minutes of load operation, count for 5 minutes with a tachometer or stopwatch. Then adjust the transmission device within the specified range and test the speed adjustment effect using the same method as testing the production speed.
5.3.3 Replacement of accessories and bottle specification test Replace accessories of corresponding specifications, and conduct tests on bottles of 100mL, 250mL, 500mL and other specifications according to the test method for testing production speed.
5.3.4 Control function test
24
Before the machine is installed and shipped from the factory, drinking water should be used instead of the filling liquid to simulate normal production procedures for testing. 5.3.5 Chain function test
JB20005.22004
a) Remove the bottle in front of the inlet of the bottle star wheel or block the star wheel, and observe that the machine should automatically stop: b) Remove the bottle from the star wheel entrance If there are many bottles accumulated at the bottle or the bottle feeding track is blocked, observe that the machine should automatically stop; e) Remove the bottle from the bottle pressing star wheel and observe that the corresponding filling needle should be empty of liquid. 5.3.6 Protection function test
When the filling machine speed is greater than or equal to 120 bottles/min, when more than 10 bottles are taken 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 Installation performance inspection
5.4.1 No-load test
Start the installation with no load, run the speed from low to high for 2 hours, use a secondary industrial thermometer to be placed on the top of the reducer oil tank shell for 10 minutes, and measure the oil tank temperature rise. 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 filling machine passes the no-load test, perform the load test. During the test, the manufacturer used the highest production speed, used drinking water instead of the filling liquid, fed the bottles, and simulated normal production procedures for 30 minutes to check that the bottles were in place, the filling system did not leak, and the process movements were sensitive and accurate.
5.4.3 Noise test
When the filling machine is working, test the machine noise according to the provisions of GB/T16769. 5.4.4 Filling volume and filling volume error test
Use drinking water instead of the filling liquid, run the machine at the maximum production speed designed for 30 minutes, and randomly and continuously take out bottles filled with liquid equal to the number of filling heads. Use a measuring cup to measure filling quantity and tolerance. 5.4.5 Electrical system quality inspection
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 GB5226.1-2002 respectively.
5.4.5.2 The protective grounding circuit and wiring requirements of the electrical system shall be 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
6.1.1 Each filling machine shall be inspected by the inspection department of the manufacturing unit according to this standard before it can leave the factory, and the product shall be issued by the manufacturer. Certificate of conformity.
6.1.2 Please note that installation documentation and working condition testing (i.e. installation confirmation test) are only conducted during type inspection. 6.2 Inspection Classification
The inspection of filling machines 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. 25
3. The noise level during load operation shall not exceed 70dB(A). 4.7.4 The filling volume and filling volume error should comply with the provisions of the "Pharmacopoeia of the People's Republic of China" (2000 edition). The loading error is ±2%. 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 of CB5226.1-2002. 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 GB5226.12002. 4.7.5.4 The protective grounding circuit of the electrical system shall comply with the provisions of 8.2 in GB5226.1-2002. 4.7.5.5 The wiring of the electrical system shall comply with the provisions of Chapter 14 of GB5226.1-2002. 5 Test methods
5.1 Material, appearance and structure inspection
Visual inspection requirements of 4.2, 4.3.1, 4.3.2, 4.4.1~4.4.4. 5.2 Inspection of filling machine documentation and working conditions 5.2.1 Inspection of documentation
Visually inspect the filling machine instruction manual, product certificate, material certificate and instrument calibration certificate. 5.2.2 Working condition test
After the installation is qualified, visually check whether the high-level tank of the filling system is configured. Whether a filter that meets the requirements is installed before the medicinal liquid enters the filling machine.
5.2.3 Filling machine online cleaning and disinfection confirmation
a) Confirmation of cleaning wave quality, temperature, and pressure of the cleaning device, and confirmation of control program: b) Online cleaning of the liquid channel of the filling machine ,disinfect. 23
JB20005.2--2004
according to the pharmaceutical process requirements and the operating procedures of the online cleaning device;
Confirmation of cleaning and disinfection effects:
o)| |tt||Confirmation standards: pH=5.0~5.7; conductivity less than or equal to 2.0uS/cm; microorganisms less than or equal to 5CFU/100mL; endotoxin less than 0.25EU/mL
Note 1: Definition of CFU one by one The bacterial colony formed by the multiplication of one or more bacteria after bacterial culture is referred to as CFU, and is usually expressed as a number. Note 2: EU represents endotoxin measurement unit.
Sampling points: After the cleaning and disinfection procedures are completed, samples are taken from each discharge point and sent to the laboratory for testing. Inspection method: Conductivity test method: Use a conductivity meter to test the conductivity of the sampled liquid. pH value test method: Use pH test paper to disperse into the sample liquid, and then compare the test paper with the pH value color guide to confirm whether it is qualified. Microbial test method: Use culture membrane filtration method to determine the content of microorganisms in the sampled liquid. Endotoxin test method: According to the bacterial endotoxin test method in Appendix XIE of the "Pharmacopoeia of the People's Republic of China" (2000 edition). 5.2.4 Packaging material confirmation
Glass infusion bottles are inspected according to the regulations of GB2639. 5.2.5 Working environment test
5.2.5.1 Determine the cleanliness of the filling machine working environment under dynamic working conditions. 5.2.5.2 Select the measurement points according to the diagonal five-point arrangement method, as shown in Figure 1. ?
Filling machine
@
Figure 1 Inspection point layout
The measuring point is more than 0.5m away from the wall and 1.2m~1.3m away from the ground5.2.5.3 Use a dust particle counter to measure the number of particles in the air. 5.3 Filling machine function inspection
5.3.1 Confirmation of structure that can realize online cleaning and disinfection 3
@
Analysis from the structure and filling principle proves that the liquid channel of the filling machine has no There are no dead ends, no mechanical friction, and online cleaning and disinfection can be achieved. 5.3.2 Production speed test
Adjust the speed of the filling machine to the designed maximum speed, fill the bottles, use drinking water instead of the filling liquid, after 30 minutes of load operation, count for 5 minutes with a tachometer or stopwatch. Then adjust the transmission device within the specified range and test the speed adjustment effect using the same method as testing the production speed.
5.3.3 Replacement of accessories and bottle specification test Replace accessories of corresponding specifications, and conduct tests on bottles of 100mL, 250mL, 500mL and other specifications according to the test method for testing production speed.
5.3.4 Control function test
24
Before the machine is installed and shipped from the factory, drinking water should be used instead of the filling liquid to simulate normal production procedures for testing. 5.3.5 Chain function test
JB20005.22004
a) Remove the bottle in front of the inlet of the bottle star wheel or block the star wheel, and observe that the machine should automatically stop: b) Remove the bottle from the star wheel entrance If there are many bottles accumulated at the bottle or the bottle feeding track is blocked, observe that the machine should automatically stop; e) Remove the bottle from the bottle pressing star wheel and observe that the corresponding filling needle should be empty of liquid. 5.3.6 Protection function test
When the filling machine speed is greater than or equal to 120 bottles/min, if more than 10 bottles are taken 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 Installation performance inspection
5.4.1 No-load test
Start the installation with no load, run the speed from low to high for 2 hours, use a secondary industrial thermometer to be placed on the top of the reducer oil tank shell for 10 minutes, and measure the oil tank temperature rise. 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 filling machine passes the no-load test, perform the load test. During the test, the manufacturer used the highest production speed, used drinking water instead of filling liquid, fed the bottles, and simulated normal production procedures for 30 minutes to check that the bottles were in place, the filling system did not leak, and the process movements were sensitive and accurate.
5.4.3 Noise test
When the filling machine is working, test the machine noise according to the regulations of GB/T16769. 5.4.4 Filling volume and filling volume error test
Use drinking water instead of the filling liquid, run the machine at the maximum production speed designed for 30 minutes, and randomly and continuously take out bottles filled with liquid equal to the number of filling heads. Use a measuring cup to measure filling quantity and tolerance. 5.4.5 Electrical system quality inspection
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 GB5226.1-2002 respectively.
5.4.5.2 The protective grounding circuit and wiring requirements of the electrical system shall be 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
6.1.1 Each filling machine shall be inspected by the inspection department of the manufacturing unit according to this standard before it can leave the factory, and the product shall be issued by the manufacturer. Certificate of conformity.
6.1.2 Please note that installation documentation and working condition testing (i.e. installation confirmation test) are only conducted during type inspection. 6.2 Inspection Classification
The inspection of filling machines 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. 25
2--2004
OK;
Cleaning and disinfection effect confirmation:
o)
Confirmation standard: pH=5.0~5.7; conductivity less than or equal to 2.0uS/ cm; microorganisms are less than or equal to 5CFU/100mL; endotoxins are less than 0.25EU/mL
Note 1: The definition of CFU - a bacterial colony formed by one or more bacterial colonies after bacterial culture, referred to as CFU , usually expressed as a number. Note 2: EU represents endotoxin measurement unit.
Sampling points: After the cleaning and disinfection procedures are completed, samples are taken from each discharge point and sent to the laboratory for testing. Inspection method: Conductivity test method: Use a conductivity meter to test the conductivity of the sampled liquid. pH test method: Use pH test paper to disperse into the sample liquid, and then compare the test paper with the pH color guide to confirm whether it is qualified. Microbial test method: Use culture membrane filtration method to determine the content of microorganisms in the sampled liquid. Endotoxin test method: According to the bacterial endotoxin test method in Appendix XIE of the "Pharmacopoeia of the People's Republic of China" (2000 edition). 5.2.4 Packaging material confirmation
Glass infusion bottles are inspected according to the regulations of GB2639. 5.2.5 Working environment test
5.2.5.1 Determine the cleanliness of the filling machine working environment under dynamic working conditions. 5.2.5.2 Select the measurement points according to the diagonal five-point arrangement method, as shown in Figure 1. ?
Filling machine
@
Figure 1 Inspection point layout
The measuring point is more than 0.5m away from the wall and 1.2m~1.3m away from the ground5.2.5.3 Use a dust particle counter to measure the number of particles in the air. 5.3 Filling machine function inspection
5.3.1 Confirmation of structure that can realize online cleaning and disinfection 3
@
Analysis from the structure and filling principle proves that the liquid channel of the filling machine has no There are no dead ends, no mechanical friction, and online cleaning and disinfection can be achieved. 5.3.2 Production speed test
Adjust the speed of the filling machine to the designed maximum speed, fill the bottles, use drinking water instead of the filling liquid, after 30 minutes of load operation, count for 5 minutes with a tachometer or stopwatch. Then adjust the transmission device within the specified range and test the speed adjustment effect using the same method as testing the production speed. www.bzxz.net
5.3.3 Replacement of accessories and bottle specification test Replace accessories of corresponding specifications, and conduct tests on bottles of 100mL, 250mL, 500mL and other specifications according to the test method for testing production speed.
5.3.4 Control function test
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Before the machine is installed and shipped from the factory, drinking water should be used instead of the filling liquid to simulate normal production procedures for testing. 5.3.5 Chain function test
JB20005.22004
a) Remove the bottle in front of the inlet of the bottle star wheel or block the star wheel, and observe that the machine should automatically stop: b) Remove the bottle from the star wheel entrance If there are many bottles accumulated at the bottle or the bottle feeding track is blocked, observe that the machine should automatically stop; e) Remove the bottle from the bottle pressing star wheel and observe that the corresponding filling needle should be empty of liquid. 5.3.6 Protection function test
When the filling machine speed is greater than or equal to 120 bottles/min, when more than 10 bottles are taken 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 Installation performance inspection
5.4.1 No-load test
Start the installation with no load, run the speed from low to high for 2 hours, use a secondary industrial thermometer to be placed on the top of the reducer oil tank shell for 10 minutes, and measure the oil tank temperature rise. 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 filling machine passes the no-load test, perform the load test. During the test, the manufacturer used the highest production speed, used drinking water instead of the filling liquid, fed the bottles, and simulated normal production procedures for 30 minutes to check that the bottles were in place, the filling system did not leak, and the process movements were sensitive and accurate.
5.4.3 Noise test
When the filling machine is working, test the machine noise according to the regulations of GB/T16769. 5.4.4 Filling volume and filling volume error test
Use drinking water instead of the filling liquid, run the machine at the maximum production speed designed for 30 minutes, and randomly and continuously take out bottles filled with liquid equal to the number of filling heads. Use a measuring cup to measure filling quantity and tolerance. 5.4.5 Electrical system quality inspection
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 GB5226.1-2002 respectively.
5.4.5.2 The protective grounding circuit and wiring requirements of the electrical system shall be 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
6.1.1 Each filling machine shall be inspected by the inspection department of the manufacturing unit according to this standard before it can leave the factory, and the product shall be issued by the manufacturer. Certificate of conformity.
6.1.2 Please note that installation documentation and working condition testing (i.e. installation confirmation test) are only conducted during type inspection. 6.2 Inspection Classification
The inspection of filling machines 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. 25
2--2004
OK;
Cleaning and disinfection effect confirmation:
o)
Confirmation standard: pH=5.0~5.7; conductivity less than or equal to 2.0uS/ cm; microorganisms are less than or equal to 5CFU/100mL; endotoxins are less than 0.25EU/mL
Note 1: The definition of CFU - a bacterial colony formed by one or more bacterial colonies after bacterial culture, referred to as CFU , usually expressed as a number. Note 2: EU represents endotoxin measurement unit.
Sampling points: After the cleaning and disinfection procedures are completed, samples are taken from each discharge point and sent to the laboratory for testing. Inspection method: Conductivity test method: Use a conductivity meter to test the conductivity of the sampled liquid. pH test method: Use pH test paper to disperse into the sample liquid, and then compare the test paper with the pH color guide to confirm whether it is qualified. Microbial test method: Use culture membrane filtration method to determine the content of microorganisms in the sampled liquid. Endotoxin test method: According to the bacterial endotoxin test method in Appendix XIE of the "Pharmacopoeia of the People's Republic of China" (2000 edition). 5.2.4 Packaging material confirmation
Glass infusion bottles are inspected according to the regulations of GB2639. 5.2.5 Working environment test
5.2.5.1 Determine the cleanliness of the filling machine working environment under dynamic working conditions. 5.2.5.2 Select the measurement points according to the diagonal five-point arrangement method, as shown in Figure 1. ?
Filling machine
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Figure 1 Inspection point layout
The measuring point is more than 0.5m away from the wall and 1.2m~1.3m away from the ground5.2.5.3 Use a dust particle counter to measure the number of particles in the air. 5.3 Filling machine function inspection
5.3.1 Confirmation of structure that can realize online cleaning and disinfection 3
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Analysis from the structure and filling principle proves that the liquid channel of the filling machine has no There are no dead ends, no mechanical friction, and online cleaning and disinfection can be achieved. 5.3.2 Production speed test
Adjust the speed of the filling machine to the designed maximum speed, fill the bottles, use drinking water instead of the filling liquid, after 30 minutes of load operation, count for 5 minutes with a tachometer or stopwatch. Then adjust the transmission device within the specified range and test the speed adjustment effect using the same method as testing the production speed.
5.3.3 Replacement of accessories and bottle specification test Replace accessories of corresponding specifications, and conduct tests on bottles of 100mL, 250mL, 500mL and other specifications according to the test method for testing production speed.
5.3.4 Control function test
24
Before the machine is installed and shipped from the factory, drinking water should be used instead of the filling liquid to simulate normal production procedures for testing. 5.3.5 Chain function test
JB20005.22004
a) Remove the bottle in front of the inlet of the bottle star wheel or block the star wheel, and observe that the machine should automatically stop: b) Remove the bottle from the star wheel entrance If there are many bottles accumulated at the bottle or the bottle feeding track is blocked, observe that the machine should automatically stop; e) Remove the bottle from the bottle pressing star wheel and observe that the corresponding filling needle should be empty of liquid. 5.3.6 Protection function test
When the filling machine speed is greater than or equal to 120 bottles/min, when more than 10 bottles are taken 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 Installation performance inspection
5.4.1 No-load test
Start the installation with no load, run the speed from low to high for 2 hours, use a secondary industrial thermometer to be placed on the top of the reducer oil tank shell for 10 minutes, and measure the oil tank temperature rise. 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 filling machine passes the no-load test, perform the load test. During the test, the manufacturer used the highest production speed, used drinking water instead of the filling liquid, fed the bottles, and simulated normal production procedures for 30 minutes to check that the bottles were in place, the filling system did not leak, and the process movements were sensitive and accurate.
5.4.3 Noise test
When the filling machine is working, test the machine noise according to the provisions of GB/T16769. 5.4.4 Filling volume and filling volume error test
Use drinking water instead of the filling liquid, run the machine at the maximum production speed designed for 30 minutes, and randomly and continuously take out bottles filled with liquid equal to the number of filling heads. Use a measuring cup to measure filling quantity and tolerance. 5.4.5 Electrical system quality inspection
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 GB5226.1-2002 respectively.
5.4.5.2 The protective grounding circuit and wiring requirements of the electrical system shall be 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
6.1.1 Each filling machine shall be inspected by the inspection department of the manufacturing unit according to this standard before it can leave the factory, and the product shall be issued by the manufacturer. Certificate of conformity.
6.1.2 Please note that installation documentation and working condition testing (i.e. installation confirmation test) are only conducted during type inspection. 6.2 Inspection Classification
The inspection of filling machines 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. 25
1 No-load test
Start the installation without load, run the speed from low to high for 2 hours, place a secondary industrial thermometer on the top of the reducer oil tank shell for 10 minutes, and measure the temperature rise of the 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 filling machine passes the no-load test, perform the load test. During the test, the manufacturer used the highest production speed, used drinking water instead of the filling liquid, fed the bottles, and simulated normal production procedures for 30 minutes to check that the bottles were in place, the filling system did not leak, and the process movements were sensitive and accurate.
5.4.3 Noise test
When the filling machine is working, test the machine noise according to the regulations of GB/T16769. 5.4.4 Filling volume and filling volume error test
Use drinking water instead of the filling liquid, run the machine at the maximum production speed designed for 30 minutes, and randomly and continuously take out bottles filled with liquid equal to the number of filling heads. Use a measuring cup to measure filling quantity and tolerance. 5.4.5 Electrical system quality inspection
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 GB5226.1-2002 respectively.
5.4.5.2 The protective grounding circuit and wiring requirements of the electrical system shall be 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
6.1.1 Each filling machine shall be inspected by the inspection department of the manufacturing unit according to this standard before it can leave the factory, and the product shall be issued by the manufacturer. Certificate of conformity.
6.1.2 Please note that installation documentation and working condition testing (i.e. installation confirmation test) are only conducted during type inspection. 6.2 Inspection Classification
The inspection of filling machines 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. 25
1 No-load test
Start the installation without load, run the speed from low to high for 2 hours, place a secondary industrial thermometer on the top of the reducer oil tank shell for 10 minutes, and measure the temperature rise of the 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 filling machine passes the no-load test, perform the load test. During the test, the manufacturer used the highest production speed, used drinking water instead of the filling liquid, fed the bottles, and simulated normal production procedures for 30 minutes to check that the bottles were in place, the filling system did not leak, and the process movements were sensitive and accurate.
5.4.3 Noise test
When the filling machine is working, test the machine noise according to the regulations of GB/T16769. 5.4.4 Filling volume and filling volume error test
Use drinking water instead of the filling liquid, run the machine at the maximum production speed designed for 30 minutes, and randomly and continuously take out bottles filled with liquid equal to the number of filling heads. Use a measuring cup to measure filling quantity and tolerance. 5.4.5 Electrical system quality inspection
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 GB5226.1-2002 respectively.
5.4.5.2 The protective grounding circuit and wiring requirements of the electrical system shall be 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
6.1.1 Each filling machine shall be inspected by the inspection department of the manufacturing unit according to this standard before it can leave the factory, and the product shall be issued by the manufacturer. Certificate of conformity.
6.1.2 Please note that installation documentation and working condition testing (i.e. installation confirmation test) are only conducted during type inspection. 6.2 Inspection Classification
The inspection of filling machines 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. 25
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