Some standard content:
JB
Pharmaceutical Machinery Industry Standard of the People's Republic of China JB20007.1~20007.5—2004
JB20008.1~20008.3—2004
JB20009—2004
Oral liquid bottle filling line
Antibiotic glass bottle powder filling line
Linear plunger filling machine
Published on 2004-02-05
2004-06-01 implementation
National Development and Reform Commission issued
ICS11.120.30
C92
JB
People's Republic of China Pharmaceutical Machinery Industry Standard JB20009--2004
Replace YY0225-1995
Linear plunger filling machine
Linearplunger pistontypefilling machine2004-02-05 issued
2004-06-01 implementation
National Development and Reform Commission issued
Foreword
1
Scope
2 Normative references
3 Classification and marking
4 Requirements
5 Test methods
6 Inspection rules
7
Marking, packaging, transportation and storage
Contents
JB20009—2004
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JB200092004
Foreword
This standard is a revision of YY0225-1995 (Linear Column Filling Machine) in accordance with the requirements of Good Manufacturing Practice for Pharmaceuticals and GB/T1.1-2000 and CB/T1.2-2002 Standardization Work Guidelines. This standard replaces YY0225-1995 from the date of implementation. Compared with YY0225-1995, the main changes in this standard are as follows; a) The basic specifications and basic parameters in the "Product Classification" chapter have been cancelled. b) According to the requirements of Good Manufacturing Practice for Pharmaceuticals, the relevant clauses in the original standard have been modified and supplemented. c) Requirements for safety, performance and working conditions have been added and supplemented. d) The test method clause has been added, which is operational, and the test method corresponds to the content of the chapter one by one. This standard is proposed by China Pharmaceutical Equipment Industry Association. This standard is under the jurisdiction of the Pharmaceutical Equipment Industry Standardization Technical Committee. The drafting unit of this standard: Changsha Zhengzhong Pharmaceutical Machinery Factory. The main drafter of this standard: Kang Jun.
The previous versions of the standards replaced by this standard are: GB9817-1988, YY0225-1995.82
1 Scope
Linear plunger filling machine
JB20009-2004
This standard specifies the classification and marking, requirements, test methods, inspection rules and marking, packaging, transportation and storage of linear plunger filling machine products.
This standard applies to linear plunger filling machines (hereinafter referred to as filling machines). 2 Normative references
The clauses contained in the following documents become the clauses of this standard through reference in this standard. For all dated referenced documents, all subsequent amendments (excluding errata) or revisions are not applicable 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 all undated referenced documents, the latest versions are applicable to this standard. GB/T191 Pictorial signs for packaging, storage and transportation
CB5226.1-2002 Safety of machinery Mechanical and electrical equipment Part 1: General technical conditions GB/T9969.1 General principles for instruction manuals of industrial products Method for random sampling using random numbers GB/T10111
GB/T13306
Signages
GB/T13384
GB/T 16769
General technical conditions for packaging of electromechanical products
Method for measuring sound pressure level of noise from metal cutting machine tools YY/T0216 Method for compiling product models of pharmaceutical machinery Pharmacopoeia of the People's Republic of China (2000 edition) National Pharmacopoeia Committee Good Manufacturing Practice for Pharmaceuticals (1998 revised edition) State Food and Drug Administration 3 Classification and marking
3.1 Type
Linear plunger filling machine, including bottle unscrambling mechanism, nozzle, metering pump and electrical control box, etc. 3.2 Model
The model shall comply with the provisions of YY/T0216.
GCB
Improvement design sequence number (A, B)
Specification code: Indicated by the number of filling heads
Type and characteristic code: Indicates metering pump
Product function code: Indicates normal pressure filling machine 83
JB20009—2004
Marking side
GCB4B type: Indicates a normal pressure filling machine with 4 filling heads after the second improvement design. 4 Requirements
4.1 General
Linear plunger filling machines shall comply with the relevant requirements for equipment manufacturing in the "Good Manufacturing Practice for Pharmaceuticals" (1998 revised edition). 4.2 Material requirements
4.2.1 Parts directly in contact with the liquid medicine shall be made of ultra-low carbon stainless steel or chemically stable, non-toxic, wear-resistant and corrosion-resistant materials, and have material certificates.
4.2.2 Other materials shall be corrosion-resistant, rust-free and free of particle precipitation. 4.3 Working conditions
4.3.1 Power supply conditions:
Voltage: AC380(1±10%)VFrequency: 50Hz±2%4.3.2 Packaging materials shall meet the following specifications and dimensions:Specifications: (25~1000)mL
Maximum height: 260mm; Maximum outer diameter: 105mm4.3.3 Environmental requirements: The filling machine shall be installed in a clean area of ??300,000 grade. 4.3.4 The filling concentration ratio shall not exceed 1.4.4.4 Appearance quality requirements
4.4.1 The outer surface shall be flat and smooth, without burrs or sharp edges. 4.4.2 The surface paint layer is tight and evenly glossy, and the non-machined surface of the inner cavity is treated with anti-rust. 4.5 Functional requirements
4.5.1 The lag filling machine should be able to meet the production speed requirements, and have stepless speed regulation within the specified range, control function, and control the production speed. 4.5.2 Protection interlocking function:
a) When the following situations occur, it should automatically stop. 1) When the bottle inlet is missing or the bottle is stuck:
2) When the bottle outflow is piled up or blocked.
b) No filling if there is a lack of bottles.
4.6 Performance requirements
4.6.1 The reducer shall not leak, and its temperature rise shall not exceed 35℃. 4.6.2 The filling system structure should be simple, easy to disassemble and assemble, easy to clean and disinfect, and without seepage or dripping. 4.6.3 The filling volume and filling volume error of the lag filling machine shall comply with the relevant provisions of Appendix XF in the "Pharmacopoeia of the People's Republic of China" (2000 edition). 4.6.4 The bottle conveying mechanism should move smoothly, and the bottle stopper should move flexibly and reliably. 4.6.5 The noise level of the filling machine under load operation shall not exceed 75dB(A). 4.6.6 Quality requirements for electrical system:
4.6.6.1 The continuity of the protective grounding circuit of the electrical system shall comply with the provisions of 19.2 of GB5226.1-2002. 4.6.6.2 The insulation resistance of the electrical system shall comply with the provisions of 19.3 of GB5226.1--2002. 84
4.6.6.3 The withstand voltage of the electrical system shall comply with the provisions of 19.4 of CB5226.1-2002. 4.6.6.4 The protective grounding circuit of the electrical system shall comply with the provisions of 8.2 of GB5226.1-2002. 4.6.6.5 The buttons of the electrical system shall comply with the provisions of 10.2 of CB5226.1-2002. 4.6.6.6 The indicator lights of the electrical system shall comply with the provisions of 10.3 of GB5226.1-2002. 4.6.6.7 The wiring of the electrical system shall comply with the provisions of Chapter 14 of GB5226.1-2002. 4.6.6.8 The markings and warning signs of the electrical system shall comply with the provisions of Chapter 17 of GB5226.12002. 5 Test methods
5.1 Material and appearance inspection
Visual inspection.
5.2 Document and working condition inspection
5.2.1 Document inspection
Visual inspection of the filling machine's instruction manual, product certificate and material certificate. 5.2.2 Working condition inspection
5.2.2.1 Power supply inspection shall be carried out with a clamp meter. 5.2.2.2 Use a steel tape measure or other general measuring tools to inspect the size of the packaging material. 5.2.3 Working environment test
5.2.3.1 Determine the cleanliness of the filling machine working environment under dynamic working conditions. JB20009-2004
5.2.3.2 Diagonal five-point arrangement method is used to select the measurement point. As shown in Figure 1, the measurement point is more than 0.5m away from the wall and 1.2m~1.3m away from the ground.
②
?
Installed
?
Figure 1
5.2.3.3 Use dust particle counter to measure the number of particles in the air . 5.2.4 Full concentration detection using hydrometer
5.3 Filling machine function detection
5.3.1 Production speed detection
?
?
Adjust the speed of the filling machine to the highest speed, use water instead of liquid medicine, and inject it into the bottle. After simulating the normal production process for 30 minutes, count with a stopwatch for 5 minutes. Then adjust the speed through the variable speed device within the production speed range of the machine, and measure Confirm the speed adjustment function. 5.3.2 Control function test
Use drinking water to simulate normal production filling and conduct control function test. 5.3.3 Protection chain function test
a) Remove the bottle in front of the entrance of the bottle star wheel and observe that the machine should automatically stop; 85
JB 200092004
b) Simulate the machine If a bottle is stuck, the observation machine should automatically stop; c) If there are many bottles piled up at the bottle outlet, the observation machine should automatically stop; d) Simulate the machine's bottle shortage situation, and the observation machine should not fill. 5.4 Filling machine performance testing
5.4.1 No-load test
Start the filling machine and run it for 2 hours under no load. Place a secondary industrial thermometer on the outer shell of the reducer oil tank for 10 minutes to measure the temperature rise of the oil tank; There was no visual leakage in the filling system, no oil leakage in the reducer, and no abnormal noise. 5.4.2 Load test
After the installed machine is qualified without load, the load test shall be carried out. During the test at the manufacturer, the highest speed was used, drinking water was used instead of liquid medicine, bottles were entered, and the operation was simulated for 30 minutes in a normal production process. Check whether the bottle feeding is in place, the filling is leak-free, and the process movements are flexible and in place. 5.4.3 Filling accuracy inspection
Each bottle with the same volume as the first filling is randomly and continuously selected and inspected using a standard measuring cup. It should comply with the provisions of Appendix XF in the "Pharmacopoeia of the People's Republic of China" (2000 edition).
5.4.4 Electrical system quality inspection
5.4.4.1 The test methods for continuity, insulation, voltage resistance and protective grounding circuit of the electrical system protective grounding circuit are in accordance with GB5226.1-2002 19.2~19.4 and testing specified in 8.2. 5.4.4.2 The buttons, indicator lights, wiring, markings, and warning signs of the electrical system shall be visually inspected in accordance with the provisions of 10.2, 10.3, Chapter 14, and Chapter 17 of GB5226.1.
5.4.5 Noise detection
After the filling machine load is running normally, use a sound level meter to conduct the test specified in GB/T16769. 6 Inspection Rules
6.1 Each delayed loading machine must pass the inspection by the quality inspection department of the manufacturing unit and be accompanied by a product certificate before it can leave the factory. 6.2 The filling machine is divided into factory inspection and type inspection. 6.2.1 Factory inspection
6.2.1.1 After factory inspection, it shall be carried out one by one according to the requirements in Table 1. Table 1 Factory inspection items
Item category
General performance
Main performance
6.2.2 Type inspection
Inspection items
4.2, 4.5, 4.6.6.5, 4.6.6.6, 4.6.6.7, 4.6.6.84.6.1,4.6.2,4.6.3,4.6.4,4.6.5,4.6.6.1,4.6.6.2,4.6.6.3,4.6. 6.46.2.2.1 Type inspection shall be carried out under the following circumstances: a) Trial making or factory transfer for production;
When there are major changes in design and process:
b)| |tt||c) When the product resumes production after a long-term suspension: when the national quality supervision agency requests type inspection. d)
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6.2.2.2 Type inspection items conduct comprehensive quality assessment and review of all technical requirements of this standard. JB 20009-2004
6.2.2.3 The prototype for type inspection shall be 10% selected from the products that have passed the factory inspection according to the method specified in GB/T10111. During the inspection, if one of the main performances of the continuity, insulation, and withstand voltage of the electrical system protective grounding circuit is unqualified, it is a defective product. If one of the other properties is unqualified, the unqualified item should be retested twice. If it is still unqualified, it will be judged as unqualified in type inspection. 7 Marking, packaging, transportation and storage
7.1 Marking
7.1.1 Each filling machine shall have a fixed product label according to the position specified on the drawing. The label shall comply with the regulations of GB/T13306. The content of the sign is as follows:
a) product name and model;
manufacturer name:
b)
factory number and date;
d) The main technical parameters.
7.1.2 The text and logo on the appearance of the packaging box should be clear, comply with the regulations of GB/T191, and have the following content: a) Product name and model;
b) Delivery date: || tt | | e) | Storage and transportation symbols should indicate "Handle with care", "Afraid of getting wet", "Do not turn upside down", etc. 7.2 Product instructions for use should comply with the regulations of GB/T9969.1. 7.3 Packaging
The packaging of the product should comply with the regulations of CB/T13384, and the following documents should be included in the box: a) Product certificate;
b) Product manual:
c) Packing list .
7.4 Transportation
Transportation shall be in accordance with the provisions of the contract and shall be firmly fixed on the transportation vehicle during transportation. Rolling and collision are strictly prohibited. 7.5 Storage
After the source is installed and packed, it should be stored in a dry, well-ventilated or sheltered place without corrosive gas. 87
2. The buttons, indicator lights, wiring, markings, and warning signs of the electrical system shall be visually inspected in accordance with the provisions of 10.2, 10.3, Chapter 14, and Chapter 17 of GB5226.1.
5.4.5 Noise detectionwww.bzxz.net
After the filling machine load is running normally, use a sound level meter to conduct the test specified in GB/T16769. 6 Inspection Rules
6.1 Each delayed loading machine must pass the inspection by the quality inspection department of the manufacturing unit and be accompanied by a product certificate before it can leave the factory. 6.2 The filling machine is divided into factory inspection and type inspection. 6.2.1 Factory inspection
6.2.1.1 After factory inspection, it shall be carried out one by one according to the requirements in Table 1. Table 1 Factory inspection items
Item category
General performance
Main performance
6.2.2 Type inspection
Inspection items
4.2, 4.5, 4.6.6.5, 4.6.6.6, 4.6.6.7, 4.6.6.84.6.1,4.6.2,4.6.3,4.6.4,4.6.5,4.6.6.1,4.6.6.2,4.6.6.3,4.6. 6.46.2.2.1 Type inspection shall be carried out under the following circumstances: a) Trial making or factory transfer for production;
When there are major changes in design and process:
b)| |tt||c) When the product resumes production after a long-term suspension: when the national quality supervision agency requests type inspection. d)
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6.2.2.2 Type inspection items conduct comprehensive quality assessment and review of all technical requirements of this standard. JB 20009-2004
6.2.2.3 The prototype for type inspection shall be 10% selected from the products that have passed the factory inspection according to the method specified in GB/T10111. During the inspection, if one of the main performances of the continuity, insulation, and withstand voltage of the electrical system's protective grounding circuit is unqualified, it is a defective product. If one of the other properties is unqualified, the unqualified item should be retested twice. If it is still unqualified, it will be judged as unqualified in type inspection. 7 Marking, packaging, transportation and storage
7.1 Marking
7.1.1 Each filling machine shall have a fixed product label according to the position specified on the drawing. The label shall comply with the regulations of GB/T13306. The content of the sign is as follows:
a) product name and model;
manufacturer name:
b)
factory number and date;
d) The main technical parameters.
7.1.2 The text and logo on the appearance of the packaging box should be clear, comply with the regulations of GB/T191, and have the following content: a) Product name and model;
b) Delivery date: || tt | | e) | Storage and transportation symbols should indicate "Handle with care", "Afraid of getting wet", "Do not turn upside down", etc. 7.2 Product instructions for use should comply with the regulations of GB/T9969.1. 7.3 Packaging
The packaging of the product should comply with the regulations of CB/T13384, and the following documents should be included in the box: a) Product certificate;
b) Product manual:
c) Packing list .
7.4 Transportation
Transportation According to the provisions of the contract, it should be firmly fixed on the transportation vehicle during transportation, and rolling and collision are strictly prohibited. 7.5 Storage
After the source is installed and packed, it should be stored in a dry, well-ventilated or sheltered place without corrosive gas. 87
2. The buttons, indicator lights, wiring, markings, and warning signs of the electrical system shall be visually inspected in accordance with the provisions of 10.2, 10.3, Chapter 14, and Chapter 17 of GB5226.1.
5.4.5 Noise detection
After the filling machine load is running normally, use a sound level meter to conduct the test specified in GB/T16769. 6 Inspection Rules
6.1 Each delayed loading machine must pass the inspection by the quality inspection department of the manufacturing unit and be accompanied by a product certificate before it can leave the factory. 6.2 The filling machine is divided into factory inspection and type inspection. 6.2.1 Factory inspection
6.2.1.1 After factory inspection, it shall be carried out one by one according to the requirements in Table 1. Table 1 Factory inspection items
Item category
General performance
Main performance
6.2.2 Type inspection
Inspection items
4.2, 4.5, 4.6.6.5, 4.6.6.6, 4.6.6.7, 4.6.6.84.6.1,4.6.2,4.6.3,4.6.4,4.6.5,4.6.6.1,4.6.6.2,4.6.6.3,4.6. 6.46.2.2.1 Type inspection shall be carried out under the following circumstances: a) Trial making or factory transfer for production;
When there are major changes in design and process:
b)| |tt||c) When the product resumes production after a long-term suspension: when the national quality supervision agency requests type inspection. d)
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6.2.2.2 Type inspection items conduct comprehensive quality assessment and review of all technical requirements of this standard. JB 20009-2004
6.2.2.3 The prototype for type inspection shall be 10% selected from the products that have passed the factory inspection according to the method specified in GB/T10111. During the inspection, if one of the main performances of the continuity, insulation, and withstand voltage of the electrical system protective grounding circuit is unqualified, it is a defective product. If one of the other properties is unqualified, the unqualified item should be retested twice. If it is still unqualified, it will be judged as unqualified in type inspection. 7 Marking, packaging, transportation and storage
7.1 Marking
7.1.1 Each filling machine shall have a fixed product label according to the position specified on the drawing. The label shall comply with the regulations of GB/T13306. The content of the sign is as follows:
a) product name and model;
manufacturer name:
b)
factory number and date;
d) The main technical parameters.
7.1.2 The text and logo on the appearance of the packaging box should be clear, comply with the regulations of GB/T191, and have the following content: a) Product name and model;
b) Delivery date: || tt | | e) | Storage and transportation symbols should indicate "Handle with care", "Afraid of getting wet", "Do not turn upside down", etc. 7.2 Product instructions for use should comply with the regulations of GB/T9969.1. 7.3 Packaging
The packaging of the product should comply with the regulations of CB/T13384, and the following documents should be included in the box: a) Product certificate;
b) Product manual:
c) Packing list .
7.4 Transportation
Transportation shall be in accordance with the provisions of the contract and shall be firmly fixed on the transportation vehicle during transportation. Rolling and collision are strictly prohibited. 7.5 Storage
After the source is installed and packed, it should be stored in a dry, well-ventilated or sheltered place without corrosive gas. 87
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