Some standard content:
ICS 11.120.30
C92
JB
Pharmaceutical Machinery Industry Standard of the People's Republic of China JB20004—2004
Suppository production line
Suppository pour-in and sealing machine group2004-02-05 released
2004-06-01 implementation
National Development and Reform Commission released
Foreword·
1 Scope
Normative references Documents
2
3 Classification and Marking
4 Requirements
5
Test Methods
6 Inspection Rules
Marks , instruction manual, packaging, transportation and storage items
times
JB 20004--2004
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JB20004—-2004
Foreword
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: Heilongjiang Deere Pharmaceutical Machinery Co., Ltd. , The main drafters of this standard: Lu Zhiqing, Li Hongyan, Gao Chuan, Xu Xingguo, Guo Wansheng. 52
1Scope
Suppository production line
JB 20004-2004
This standard specifies the classification and marking, requirements, test methods, inspection rules and signs of suppository production lines, Instructions for use, packaging, shipping and storage.
This standard applies to suppository production lines.
2 Normative reference documents
The clauses in the following documents become the clauses of this standard through reference in this standard. For dated referenced 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. GB/T191 Packaging, storage and transportation pictorial mark
GB/T16769 Metal cutting machine tool noise sound pressure level measurement method GB/T9969.1 Industrial product function instructions general principles GB5226.1-2002 Mechanical safety mechanical and electrical equipment Part 1: General technical conditions GB/T13306 Labels
GB/T6388 Transportation packaging receipt and delivery signs
GB/T13384 General technical conditions for mechanical and electrical product packaging GB/T10111 Method of random sampling using random numbers YBB0021— 2002 Polyvinyl chloride solid medicinal hard tablets YBB0023 - 2002 PVC/low density polyethylene solid medicinal composite hard tablets YY/T0216 Pharmaceutical machinery product model preparation method Good Manufacturing Practice for Pharmaceuticals (1998 revised edition) National Medical Products Administration 3 Classification and labeling
3.1 Type
The suppository production line is divided into automatic and semi-automatic according to the connection structure. 3.2 Structure
Automatic suppository production line consists of:
a) Suppository shell making part;
b) Suppository filling part;
c) Suppository cold air shaping part; || tt||d) Suppository sealing and cutting parts.
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Semi-automatic suppository production line consists of:
a) suppository filling part;
b) suppository cold air shaping part;| |tt||c) Suppository sealing and cutting parts.
3.3 Unit Model
3.3.1 Model Marking:
The model preparation method is in accordance with YY/T0216. U
Marking example:
G
Improved design serial number: A, B, C
Specification code: Number of perfusion needles
Type feature code: Automatic Z; Semi-automatic B filling and sealing machine
Function code: Suppository machinery
UGZ6A type: represents an automatic suppository production line with 6 filling needles after the first design improvement. UGB6A type: represents a semi-automatic suppository production line with 6 perfusion needles after the first design improvement. 3.4 Basic parameters
The basic parameters of the suppository production line are shown in Table 1.
Table 1 Suppository production line parameters
Item
Production capacity
Loading volume
Loading volume error
Temperature inside the setting box||tt ||Suppository shape
Suppository pitch
4 requirements
Mesh
Semi-automatic suppository production line
Automatic suppository production line
3000 capsules/h ~6000 capsules/h
7200 capsules/h ~ 20000 capsules/h
0.5g ~ 5g
±3%
10℃~20℃||tt| |Bullet type, torpedo type, duckbill type
number
17.5mm±0.01mm (bullet type, torpedo type) 26.25mm±0.01mm (duckbill type)
4.1 The sheet material used in the suppository shell shall comply with the requirements of YBB0021-2002 if it is polyvinyl chloride solid medicinal hard sheet (PVC), and if it is polyvinyl chloride/low density polyethylene solid medicinal composite hard sheet (PVC/LDPE) Comply with YBB0023-2002 requirements. The thickness of the sheet is 0.15mm ± 0.01mmo
4.2 All parts in contact with drugs are made of non-toxic, corrosion-resistant materials that do not chemically change with drugs or absorb drugs. 4.3 Working environment: The temperature is 18℃~26℃, and the relative humidity is 45%~65%. 4.4 The inner and outer surfaces of the filling barrel should be flat and smooth, and the surface roughness Ra value should not be greater than 0.8 μm. The compressed air used in 54
4.5 is clean air that has been dried and filtered. 4.6 Appearance requirements of the complete machine
4.6.1 The surface of sheet metal parts shall not have scratches or uneven defects. 4.6.2 The outer surface should be flat, smooth, without burrs or sharp edges. 4.6.3 Install a sealed transparent protective cover on the production line. 4.7 Assembly quality
4.7.1 Each transmission part should move smoothly, rotate flexibly, operate reliably, and be free from looseness. 4.7.2 The gap between the shell-making mold and the sealing mold should not be greater than 0.05mm. 4.7.3 The transportation stroke error of the suppository shell-making part should not exceed ±0.2mm. 4.7.4 There is no abnormal noise when the entire unit is operating normally, and its operating noise does not exceed 80dB(A). 4.8 Safety requirements for electrical systems
4.8.1 The continuity of the protective grounding circuit of the electrical system shall comply with the provisions of 19.2 in GB5226.1-2002. 4.8.2 The insulation resistance of the electrical system should comply with the provisions of 19.3 in GB5226.1-2002. 4.8.3 The withstand voltage of the electrical system shall comply with the provisions of 19.4 in GB5226.1-2002. 4.8.4 The protective grounding circuit of the electrical system should comply with the provisions of 8.2 in GB5226.1-2002. 4.8.5 The buttons of the electrical system should comply with the provisions of 10.2 in GB5226.1-2002. 4.8.6 The indicators and displays of the electrical system should comply with the provisions of 10.3 in GB5226.1-2002. 4.8.7 The wiring of the electrical system should comply with the provisions of Chapter 14 of GB5226.1-2002. JB 20004—2004
4.8.8 The markings, warning signs and project codes of electrical systems shall comply with the provisions of Chapter 17 of GB5226.1—2002. 4.9 Performance requirements
4.9.1 For the suppository shell-making part, the suppository shell belt should be firmly welded, the bubble shape and mouth should be full, and the wall thickness should be uniform. 4.9.2 Bullet type (torpedo type) and duckbill type suppository replacement molds can be produced in one machine. Filled drugs should be stored in an insulated barrel within the temperature range that meets the drug requirements, and the pipeline for transporting the liquid medicine should be smooth and leak-free. 4.9.3
During filling, the medicine shall not drip outside the suppository shell. 4.9.4
4.9.5 The filling head can be quickly disassembled and easy to clean. Parts in contact with the filling barrel and the drug can be cleaned and disinfected in place. 4.9.6 Cold air setting ensures that the medicine is in a solid state after setting, and the cold water source should be equipped with an adjustable cold water temperature unit. 4.9.7 The sealing is tight and the batch number is clear. The cutting position should be accurate and the edges should be continuous and neat. 4.9.81
4.9.9 The temperature control accuracy of preheating and welding molds for suppository shell making is ±2°C; the temperature control accuracy of preheating and sealing molds for suppository sealing parts is ±2°C.
4.9.10. The pneumatic system and water cooling system of the entire unit should be smooth and there should be no leakage. 5 Test methods
5.1 The medicinal sheet used in the suppository shell tape should comply with the regulations of YYB0021-2002 or YYB0023-2002. 5.2 The materials of parts in contact with drugs have material certificates. If there is no material certificate, the manufacturer should inspect and confirm the materials. 5.3 Check the temperature and humidity of the working environment with a thermometer and hygrometer. 5.4 The roughness of the inner and outer surfaces of the filling barrel shall be compared and inspected with comparative samples. 55
JB 20004—2004
5.5 Use visual inspection to check whether there are filters, dryers and filtered and dried air sources. 5.6 The appearance and outer surface of the complete machine shall be inspected by visual inspection. 5.7 Assembly quality
5.7.1 Dry running test:
The dry running test time shall not be less than 2h, and observe the rotation of each action and the operation of the machine. 5.7.2 Use a feeler gauge to detect the gap between the shell-making mold and the sealing mold. 5.7.3 Use a vernier caliper to detect the shell-making conveying stroke. 5.7.4 Noise test:
During normal operation, use a sound level meter to detect the working noise of the production line in accordance with the provisions of GB/T16769. 5.8 Electrical system safety test methods
5.8.1 The continuity, insulation resistance, and withstand voltage tests of the protective grounding circuit of the electrical system shall be tested in accordance with the provisions of 19.2, 19.3, and 19.4 of GB5226.1-2002 respectively.
5.8.2 The protective grounding circuit, buttons, indicators and displays, wiring, markings, warning signs and project codes of the electrical system shall be in accordance with GB5226.1-2002 8.2, 10.2, 10.3, Chapter 14 and Check the provisions of Chapter 17. 5.9 Load test
Test the performance during the load test, and the load test should be no less than 2 hours. 5.9.1 Welding test of suppository shells:
Take 5 suppository shells and inject colored water into the shells with an injection needle. After 30 minutes, check whether there is leakage around the bubble shape. 5.9.2 Use the sensory method to check whether the bubble shape of the suppository shell is full, whether the bubble mouth is full, and whether the wall thickness is even. By visual inspection, bullet-type (torpedo-type) and duckbill-type suppository shells can be produced in one machine. 5.9.3 Use visual inspection to check whether there is leakage in the pipeline transporting the liquid medicine. 5.9.4 Loading error test:
Take a plate of finished suppositories, cut along the edge of the bubble with scissors, take out the suppositories, weigh them individually with an electronic balance, and take the average value. Calculate the error according to formula (1).
Loading quantity error = [(M standard - M real)/M standard] × 100%... In the formula:
M real - represents the actual quality;
M standard - Indicates standard quality.
.*+ (1)
5.9.5 Use visual inspection to check whether the filling head can be quickly disassembled and easy to clean, and whether the parts in contact with the filling barrel and the drug can be cleaned and disinfected in place.
5.9.6 Use sensory method to check whether the drug is in solid form after being finalized. 5.9.7 Sealing tightness test:
Take a plate of finished suppository and repeatedly fold it three times at the sealed filling port to observe whether the sealing area is cracked. 5.9.8 Use visual inspection to inspect the shearing position and edge alignment. 5.9.9 Use a thermometer to measure the preheating of the shell-making part, the temperature control accuracy of the welding mold, the preheating of the sealing part, and the temperature control accuracy of the sealing mold, and compare them with the preset temperatures. || tt | The pneumatic system is supplied with compressed air at working pressure, and the sensory method is used to check whether there is air leakage. 6 Inspection Rules
The inspection of the suppository production line is divided into factory inspection and type inspection 6.1 Factory inspection
JB 20004--2004
6.1.1 Before leaving the factory, the suppository production line shall be based on Table 2 and factory parameters. It is stipulated that each unit should be inspected one by one, and those that pass the test will be allowed to leave the factory, and a product certificate will be attached.
Table 2 Factory Inspection Items
Item Category
General Performance
Main Performance
Inspection Items
4.2,4.4,4.6,4.7 .1,4.9.3,4.9.104.5,4.7.2,4.7.3,4.7.4,4.8,4.9.1,4.9.2,4.9.4,4.9.5,4.9.6,4.9.7,4.9 .8,4.9.96.1.1.1 Factory parameter inspection
a) Production capacity: automatic suppository production line: 7200 capsules/h~20000 capsules/h; semi-automatic suppository production line: 3000 capsules/h~6000 capsules/h. b) Loading error: ±3%.
6.1.2 During the inspection process, if any unqualified items are found in the suppository production line, it should be returned for repair. After repair, it should be re-inspected. If it is still unqualified, the product will be deemed to be unqualified.
6.2 Type inspection
6.2.1 Type inspection shall be carried out in any of the following situations: a) When the important structural design, process or material changes of the product may affect the product performance and safety; b ) When the factory inspection results are significantly different from the last type test; c) When the national quality supervision agency proposes type inspection requirements. 6.2.2 Type inspection items include all requirements of this standard. 6.2.3 Sampling:
For type inspection, 10% (depending on the situation) shall be selected from the qualified products of the manufacturer according to the method specified in GB/T10111, and one unit shall be tested. 6.2.4 Judgment rules:
During the type inspection process, if any of the electrical safety performance of the protective grounding circuit continuity, insulation resistance, and withstand voltage fails, the prototype will be judged to be unqualified. If one of the other properties is unqualified, double sampling will be carried out to test the unqualified items. If the item is still unqualified, the product will be judged to have failed the type inspection.
7 Logo, instructions for use, packaging, transportation and storage 7.1 Logo
7.1.1 The product should have a product label fixed at the position specified on the drawing, and the label should comply with the regulations of GB/T13306. The sign should include the following content:
a) Product name and model;
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b) Main parameters;
c) Manufacturer's name;
d) Factory number;
e) Factory date;
f) Product standard number.
7.1.2 The words and signs on the outer wall of the packaging box should be clear. 7.1.2.1 Storage and transportation signs should comply with the provisions of GB/T191, including the words or signs of "handle with care", "upward" and "no tumbling". 7.1.2.2 The transportation packaging receipt and delivery mark should comply with the provisions of GB/T6388 and include the following content: a) product name and model;
b) delivery date;
c) wooden box appearance Size;
d) Net weight and gross weight;
e) Name of shipping and receiving station;
f) Shipping and receiving unit.
7.2 Instructions for use
Product instructions for use shall comply with the provisions of GB/T9969.1. Instructions for use shall include the following contents: a) Product model and name, name of the manufacturing unit, address, postal code and contact number ;b) Implemented product standards;
c) Working conditions, power supply, climate environment (such as temperature and humidity, atmospheric pressure, air cleanliness), etc.; d) The main structure, performance, specifications, uses, and precautions of the product matters, warnings and reminder instructions, and safety measures; e) product handling, installation, usage instructions and illustrations; f) product maintenance and upkeep.
7.3 Packaging
The packaging of the product should comply with the regulations of GB/T13384, and the following documents should be attached in the packaging box: a) Packing list;
b) Factory certificate;|| tt||c) Product instruction manual.
7.4 Before product packaging, the machine should be wiped clean and a protective cover should be put on each. 7.5 Transportation should comply with the relevant requirements for railway, highway, and waterway transportation. 7.6 After the product is packed, it should be stored in a dry and ventilated place without corrosive gas, and should not be stored in the open air. 58
1. Dry running test:
The dry running test time shall not be less than 2 hours, and observe the rotation of each action and the operation of the machine. 5.7.2 Use a feeler gauge to detect the gap between the shell-making mold and the sealing mold. 5.7.3 Use a vernier caliper to detect the shell-making conveying stroke. 5.7.4 Noise test:
During normal operation, use a sound level meter to detect the working noise of the production line in accordance with the provisions of GB/T16769. 5.8 Electrical system safety test methods
5.8.1 The continuity, insulation resistance, and withstand voltage tests of the protective grounding circuit of the electrical system shall be tested in accordance with the provisions of 19.2, 19.3, and 19.4 of GB5226.1-2002 respectively.
5.8.2 The protective grounding circuit, buttons, indicators and displays, wiring, markings, warning signs and project codes of the electrical system shall be in accordance with GB5226.1-2002 8.2, 10.2, 10.3, Chapter 14 and Check the provisions of Chapter 17. 5.9 Load test
Test the performance during the load test, and the load test should be no less than 2 hours. 5.9.1 Welding test of suppository shells:
Take 5 suppository shells and inject colored water into the shells with an injection needle. After 30 minutes, check whether there is leakage around the bubble shape. 5.9.2 Use the sensory method to check whether the bubble shape of the suppository shell is full, whether the bubble mouth is full, and whether the wall thickness is even. By visual inspection, bullet-type (torpedo-type) and duckbill-type suppository shells can be produced in one machine. 5.9.3 Use visual inspection to check whether there is leakage in the pipeline transporting the liquid medicine. 5.9.4 Loading error test:
Take a plate of finished suppositories, cut along the edge of the bubble with scissors, take out the suppositories, weigh them individually with an electronic balance, and take the average value. Calculate the error according to formula (1).
Loading quantity error = [(M standard - M real)/M standard] × 100%... In the formula:
M real - represents the actual quality;
M standard - Indicates standard quality.
.*+ (1)
5.9.5 Use visual inspection to check whether the filling head can be quickly disassembled and easy to clean, and whether the parts in contact with the filling barrel and the drug can be cleaned and disinfected in place.
5.9.6 Use sensory method to check whether the drug is in solid form after being finalized. 5.9.7 Sealing tightness test:
Take a plate of finished suppository and repeatedly fold it three times at the sealed filling port to observe whether the sealing area is cracked. 5.9.8 Use visual inspection to inspect the shearing position and edge alignment. 5.9.9 Use a thermometer to measure the preheating of the shell-making part, the temperature control accuracy of the welding mold, the preheating of the sealing part, and the temperature control accuracy of the sealing mold, and compare them with the preset temperatures. || tt | The pneumatic system is supplied with compressed air at working pressure, and the sensory method is used to check whether there is air leakage. 6 Inspection Rules
The inspection of the suppository production line is divided into factory inspection and type inspection 6.1 Factory inspection
JB 20004--2004
6.1.1 Before leaving the factory, the suppository production line shall be based on Table 2 and factory parameters. It is stipulated that each unit should be inspected one by one, and those that pass the test will be allowed to leave the factory, and a product certificate will be attached.
Table 2 Factory Inspection Items
Item Category
General Performance
Main Performance
Inspection Items
4.2,4.4,4.6,4.7 .1,4.9.3,4.9.104.5,4.7.2,4.7.3,4.7.4,4.8,4.9.1,4.9.2,4.9.4,4.9.5,4.9.6,4.9.7,4.9 .8,4.9.96.1.1.1 Factory parameter inspection
a) Production capacity: automatic suppository production line: 7200 capsules/h~20000 capsules/h; semi-automatic suppository production line: 3000 capsules/h~6000 capsules/h. b) Loading error: ±3%.
6.1.2 During the inspection process, if any unqualified items are found in the suppository production line, it should be returned for repair. After repair, it should be re-inspected. If it is still unqualified, the product will be deemed to be unqualified.
6.2 Type inspection
6.2.1 Type inspection shall be carried out in any of the following situations: a) When the important structural design, process or material changes of the product may affect the product performance and safety; b ) When the factory inspection results are significantly different from the last type test; c) When the national quality supervision agency proposes type inspection requirements. 6.2.2 Type inspection items include all requirements of this standard. 6.2.3 Sampling:
For type inspection, 10% (depending on the situation) are selected from the qualified products of the manufacturer according to the method specified in GB/T10111, and one unit is tested. 6.2.4 Judgment rules:
During the type inspection process, if any of the electrical safety performance of the protective grounding circuit continuity, insulation resistance, and withstand voltage fails, the prototype will be judged to be unqualified. If one of the other properties is unqualified, double sampling will be carried out to test the unqualified items. If the item is still unqualified, the product will be judged to have failed the type inspection.
7 Logo, instructions for use, packaging, transportation and storage 7.1 Logo
7.1.1 The product should have a product label fixed at the position specified on the drawing, and the label should comply with the regulations of GB/T13306. The sign should include the following content:
a) Product name and model;
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b) Main parameters;
c) Manufacturer's name;
d) Factory number;
e) Factory date;
f) Product standard number.
7.1.2 The words and signs on the outer wall of the packaging box should be clear. 7.1.2.1 Storage and transportation signs should comply with the provisions of GB/T191, including the words or signs of "handle with care", "upward" and "no tumbling". 7.1.2.2 The transportation packaging receipt and delivery mark should comply with the regulations of GB/T6388 and include the following content: a) product name and model;
b) delivery date;
c) wooden box appearance Size;
d) Net weight and gross weight;
e) Name of shipping and receiving station;
f) Shipping and receiving unit.
7.2 Instructions for use
Product instructions for use shall comply with the provisions of GB/T9969.1. Instructions for use shall include the following contents: a) Product model and name, name of the manufacturing unit, address, postal code and contact number ;b) Implemented product standards;
c) Working conditions, power supply, climate environment (such as temperature and humidity, atmospheric pressure, air cleanliness), etc.; d) The main structure, performance, specifications, uses, and precautions of the product matters, warnings and reminder instructions, and safety measures; e) product handling, installation, usage instructions and illustrations; f) product maintenance and upkeep.
7.3 Packaging
The packaging of the product should comply with the regulations of GB/T13384, and the following documents should be attached in the packaging box: a) Packing list;
b) Factory certificate;|| tt||c) Product instruction manual.
7.4 Before product packaging, the machine should be wiped clean and a protective cover should be put on each. 7.5 Transportation should comply with the relevant requirements for railway, highway, and waterway transportation. 7.6 After the product is packed, it should be stored in a dry and ventilated place without corrosive gas, and should not be stored in the open air. 58
1. Dry running test:
The dry running test time shall not be less than 2 hours, and observe the rotation of each action and the operation of the machine. 5.7.2 Use a feeler gauge to detect the gap between the shell-making mold and the sealing mold. 5.7.3 Use a vernier caliper to detect the shell-making conveying stroke. 5.7.4 Noise test:
During normal operation, use a sound level meter to detect the working noise of the production line in accordance with the provisions of GB/T16769. 5.8 Electrical system safety test methods
5.8.1 The continuity, insulation resistance, and withstand voltage tests of the protective grounding circuit of the electrical system shall be tested in accordance with the provisions of 19.2, 19.3, and 19.4 of GB5226.1-2002 respectively.
5.8.2 The protective grounding circuit, buttons, indicators and displays, wiring, markings, warning signs and project codes of the electrical system shall be in accordance with GB5226.1-2002 8.2, 10.2, 10.3, Chapter 14 and Check the provisions of Chapter 17. 5.9 Load test
Test the performance during the load test, and the load test should be no less than 2 hours. 5.9.1 Welding test of suppository shells:
Take 5 suppository shells and inject colored water into the shells with an injection needle. After 30 minutes, check whether there is leakage around the bubble shape. 5.9.2 Use the sensory method to check whether the bubble shape of the suppository shell is full, whether the bubble mouth is full, and whether the wall thickness is even. By visual inspection, bullet-type (torpedo-type) and duckbill-type suppository shells can be produced in one machine. 5.9.3 Use visual inspection to check whether there is leakage in the pipeline transporting the liquid medicine. 5.9.4 Loading error test:
Take a plate of finished suppositories, cut along the edge of the bubble with scissors, take out the suppositories, weigh them individually with an electronic balance, and take the average value. Calculate the error according to formula (1).
Loading quantity error = [(M standard - M real)/M standard] × 100%... In the formula:
M real - represents the actual quality;
M standard - Indicates standard quality.
.*+ (1)
5.9.5 Use visual inspection to check whether the filling head can be quickly disassembled and easy to clean, and whether the parts in contact with the filling barrel and the drug can be cleaned and disinfected in place.
5.9.6 Use sensory method to check whether the drug is in solid form after being finalized. 5.9.7 Sealing tightness test:
Take a plate of finished suppository and repeatedly fold it three times at the sealed filling port to observe whether the sealing area is cracked. 5.9.8 Use visual inspection to inspect the shearing position and edge alignment. 5.9.9 Use a thermometer to measure the preheating of the shell-making part, the temperature control accuracy of the welding mold, the preheating of the sealing part, and the temperature control accuracy of the sealing mold, and compare them with the preset temperatures. || tt | The pneumatic system is supplied with compressed air at working pressure, and the sensory method is used to check whether there is air leakage. 6 Inspection Rules
The inspection of the suppository production line is divided into factory inspection and type inspection 6.1 Factory inspection
JB 20004--2004
6.1.1 Before leaving the factory, the suppository production line shall be based on Table 2 and factory parameters. It is stipulated that each unit should be inspected one by one, and those that pass the test will be allowed to leave the factory, and a product certificate will be attached.
Table 2 Factory Inspection Items
Item Category
General Performance
Main Performance
Inspection Items
4.2,4.4,4.6,4.7 .1,4.9.3,4.9.104.5,4.7.2,4.7.3,4.7.4,4.8,4.9.1,4.9.2,4.9.4,4.9.5,4.9.6,4.9.7,4.9 .8,4.9.96.1.1.1 Factory parameter inspection
a) Production capacity: automatic suppository production line: 7200 capsules/h~20000 capsules/h; semi-automatic suppository production line: 3000 capsules/h~6000 capsules/h. b) Loading error: ±3%.
6.1.2 During the inspection process, if any unqualified items are found in the suppository production line, it should be returned for repair. After repair, it should be re-inspected. If it is still unqualified, the product will be deemed to be unqualified.
6.2 Type inspection
6.2.1 Type inspection shall be carried out in any of the following situations: a) When the important structural design, process or material changes of the product may affect the product performance and safety; b ) When the factory inspection results are significantly different from the last type test; c) When the national quality supervision agency proposes type inspection requirements. 6.2.2 Type inspection items include all requirements of this standard. 6.2.3 Sampling:
For type inspection, 10% (depending on the situation) are selected from the qualified products of the manufacturer according to the method specified in GB/T10111, and one unit is tested. 6.2.4 Judgment rules:
During the type inspection process, if any of the electrical safety performance of the protective grounding circuit continuity, insulation resistance, and withstand voltage fails, the prototype will be judged to be unqualified. If one of the other properties is unqualified, double sampling will be carried out to test the unqualified items. If the item is still unqualified, the product will be judged to have failed the type inspection.
7 Logo, instructions for use, packaging, transportation and storage 7.1 Logo
7.1.1 The product should have a product label fixed at the position specified on the drawing, and the label should comply with the regulations of GB/T13306. The sign should include the following content:
a) Product name and model;
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b) Main parameters;
c) Manufacturer's name;
d) Factory number;
e) Factory date;
f) Product standard number.
7.1.2 The words and signs on the outer wall of the packaging box should be clear. 7.1.2.1 Storage and transportation signs should comply with the provisions of GB/T191, including the words or signs of "handle with care", "upward" and "no tumbling". 7.1.2.2 The transportation packaging receipt and delivery mark should comply with the provisions of GB/T6388 and include the following content: a) product name and model;
b) delivery date;
c) wooden box appearance Size;
d) Net weight and gross weight;
e) Name of shipping and receiving station;
f) Shipping and receiving unit.
7.2 Instructions for use
Product instructions for use shall comply with the provisions of GB/T9969.1. Instructions for use shall include the following contents: a) Product model and name, name of the manufacturing unit, address, postal code and contact number ;b) Implemented product standards;
c) Working conditions, power supply, climate environment (such as temperature and humidity, atmospheric pressure, air cleanliness), etc.; d) The main structure, performance, specifications, uses, and precautions of the product matters, warnings and reminder instructions, and safety measures; e) product handling, installation, usage instructions and illustrations; f) product maintenance and upkeep.
7.3 Packaging
The packaging of the product should comply with the regulations of GB/T13384, and the following documents should be attached in the packaging box: a) Packing list;
b) Factory certificate;|| tt||c) Product instruction manual.
7.4 Before product packaging, the machine should be wiped clean and a protective cover should be put on each. 7.5 Transportation should comply with the relevant requirements for railway, highway, and waterway transportation. 7.6 After the product is packed, it should be stored in a dry and ventilated place without corrosive gas, and should not be stored in the open air. 58
4. Loading error test:
Take a plate of finished suppositories, cut along the edge of the bubble with scissors, take out the suppositories, weigh them individually with an electronic balance, and take the average value. Calculate the error according to formula (1).
Loading quantity error = [(M standard - M real)/M standard] × 100%... In the formula:
M real - represents the actual quality;
M standard - Indicates standard quality.
.*+ (1)
5.9.5 Use visual inspection to check whether the filling head can be quickly disassembled and easy to clean, and whether the parts in contact with the filling barrel and the drug can be cleaned and disinfected in place.
5.9.6 Use sensory method to check whether the drug is in solid form after being finalized. 5.9.7 Sealing tightness test:
Take a plate of finished suppository and repeatedly fold it three times at the sealed filling port to observe whether the sealing area is cracked. 5.9.8 Use visual inspection to inspect the shearing position and edge alignment. 5.9.9 Use a thermometer to measure the preheating of the shell-making part, the temperature control accuracy of the welding mold, the preheating of the sealing part, and the temperature control accuracy of the sealing mold, and compare them with the preset temperatures. || tt | The pneumatic system is supplied with compressed air at working pressure, and the sensory method is used to check whether there is air leakage. 6 Inspection Rules
The inspection of the suppository production line is divided into factory inspection and type inspection 6.1 Factory inspection
JB 20004--2004
6.1.1 Before leaving the factory, the suppository production line shall be based on Table 2 and factory parameters. It is stipulated that each unit should be inspected one by one, and those that pass the test will be allowed to leave the factory, and a product certificate will be attached.
Table 2 Factory Inspection Items
Item Category
General Performance
Main Performance
Inspection Items
4.2,4.4,4.6,4.7 .1,4.9.3,4.9.104.5,4.7.2,4.7.3,4.7.4,4.8,4.9.1,4.9.2,4.9.4,4.9.5,4.9.6,4.9.7,4.9 .8,4.9.96.1.1.1 Factory parameter inspection
a) Production capacity: automatic suppository production line: 7200 capsules/h~20000 capsules/h; semi-automatic suppository production line: 3000 capsules/h~6000 capsules/h. b) Loading error: ±3%.
6.1.2 During the inspection process, if any unqualified items are found in the suppository production line, it should be returned for repair. After repair, it should be re-inspected. If it is still unqualified, the product will be deemed to be unqualified.
6.2 Type inspection
6.2.1 Type inspection shall be carried out in any of the following situations: a) When the important structural design, process or material changes of the product may affect the product performance and safety; b ) When the factory inspection results are significantly different from the last type test; c) When the national quality supervision agency proposes type inspection requirements. 6.2.2 Type inspection items include all requirements of this standard. 6.2.3 Sampling:
For type inspection, 10% (depending on the situation) are selected from the qualified products of the manufacturer according to the method specified in GB/T10111, and one unit is tested. 6.2.4 Judgment rules:
During the type inspection process, if any of the electrical safety performance of the protective grounding circuit continuity, insulation resistance, and withstand voltage fails, the prototype will be judged to be unqualified. If one of the other properties is unqualified, double sampling will be carried out to test the unqualified items. If the item is still unqualified, the product will be judged to have failed the type inspection.
7 Logo, instructions for use, packaging, transportation and storage 7.1 Logo
7.1.1 The product should have a product label fixed at the position specified on the drawing, and the label should comply with the regulations of GB/T13306. The sign should include the following content:
a) Product name and model;
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b) Main parameters;
c) Manufacturer's name;
d) Factory number;
e) Factory date;
f) Product standard number.
7.1.2 The words and signs on the outer wall of the packaging box should be clear. 7.1.2.1 Storage and transportation signs should comply with the provisions of GB/T191, including the words or signs of "handle with care", "upward" and "no tumbling". 7.1.2.2 The transportation packaging receipt and delivery mark should comply with the provisions of GB/T6388 and include the following content: a) product name and model;
b) delivery date;
c) wooden box appearance Size;
d) Net weight and gross weight;
e) Name of shipping and receiving station;
f) Shipping and receiving unit.
7.2 Instructions for use
Product instructions for use shall comply with the provisions of GB/T9969.1. Instructions for use shall include the following contents: a) Product model and name, name of the manufacturing unit, address, postal code and contact number ;b) Implemented product standards;
c) Working conditions, power supply, climate environment (such as temperature and humidity, atmospheric pressure, air cleanliness), etc.; d) The main structure, performance, specifications, uses, and precautions of the product matters, warnings and reminder instructions, and safety measures; e) product handling, installation, usage instructions and illustrations; f) product maintenance and upkeep.
7.3 Packaging
The packaging of the product should comply with the regulations of GB/T13384, and the following documents should be attached in the packaging box: a) Packing list;
b) Factory certificate;|| tt||c) Product instruction manual.
7.4 Before product packaging, the machine should be wiped clean and a protective cover should be put on each. 7.5 Transportation should comply with the relevant requirements for railway, highway, and waterway transportation. 7.6 After the product is packed, it should be stored in a dry and ventilated place without corrosive gas, and should not be stored in the open air. 58
4. Loading error test:
Take a plate of finished suppositories, cut along the edge of the bubble with scissors, take out the suppositories, weigh them individually with an electronic balance, and take the average value. Calculate the error according to formula (1).
Loading quantity error = [(M standard - M real)/M standard] × 100%... In the formula:
M real - represents the actual quality;
M standard - Indicates standard quality.
.*+ (1)
5.9.5 Use visual inspection to check whether the filling head can be quickly disassembled and easy to clean, and whether the parts in contact with the filling barrel and the drug can be cleaned and disinfected in place.
5.9.6 Use sensory method to check whether the drug is in solid form after being finalized. 5.9.7 Sealing tightness test:
Take a plate of finished suppository and repeatedly fold it three times at the sealed filling port to observe whether the sealing area is cracked. 5.9.8 Use visual inspection to inspect the shearing position and edge alignment. 5.9.9 Use a thermometer to measure the preheating of the shell-making part, the temperature control accuracy of the welding mold, the preheating of the sealing part, and the temperature control accuracy of the sealing mold, and compare them with the preset temperatures. || tt | The pneumatic system is supplied with compressed air at working pressure, and the sensory method is used to check whether there is air leakage. 6 Inspection Rules
The inspection of the suppository production line is divided into factory inspection and type inspection 6.1 Factory inspection
JB 20004--2004
6.1.1 Before leaving the factory, the suppository production line shall be based on Table 2 and factory parameters. It is stipulated that each unit should be inspected one by one, and those that pass the test will be allowed to leave the factory, and a product certificate will be attached.
Table 2 Factory Inspection Items
Item Category
General Performance
Main Performance
Inspection Items
4.2,4.4,4.6,4.7 .1,4.9.3,4.9.104.5,4.7.2,4.7.3,4.7.4,4.8,4.9.1,4.9.2,4.9.4,4.9.5,4.9.6,4.9.7,4.9 .8,4.9.96.1.1.1 Factory parameter inspection
a) Production capacity: automatic suppository production line: 7200 capsules/h~20000 capsules/h; semi-automatic suppository production line: 3000 capsules/h~6000 capsules/h. b) Loading error: ±3%.
6.1.2 During the inspection process, if any unqualified items are found in the suppository production line, it should be returned for repair. After repair, it should be re-inspected. If it is still unqualified, the product will be deemed to be unqualified.
6.2 Type inspection
6.2.1 Type inspection shall be carried out in any of the following situations: a) When the important structural design, process or material changes of the product may affect the product performance and safety; b ) When the factory inspection results are significantly different from the last type test; c) When the national quality supervision agency proposes type inspection requirements. 6.2.2 Type inspection items include all requirements of this standard. 6.2.3 Sampling:
For type inspection, 10% (depending on the situation) are selected from the qualified products of the manufacturer according to the method specified in GB/T10111, and one unit is tested. 6.2.4 Judgment rules:
During the type inspection process, if any of the electrical safety performance of the protective grounding circuit continuity, insulation resistance, and withstand voltage fails, the prototype will be judged to be unqualified. If one of the other properties is unqualified, double sampling will be carried out to test the unqualified items. If the item is still unqualified, the product will be judged to have failed the type inspection.
7 Logo, instructions for use, packaging, transportation and storage 7.1 Logo
7.1.1 The product should have a product label fixed at the position specified on the drawing, and the label should comply with the regulations of GB/T13306. The sign should include the following content:
a) Product name and model;
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JB 20004—2004
b) Main parameters;
c) Manufacturer's name;
d) Factory number;
e) Factory date;
f) Product standard number.
7.1.2 The words and signs on the outer wall of the packaging box should be clear. 7.1.2.1 Storage and transportation signs should comply with the provisions of GB/T191, including the words or signs of "handle with care", "upward" and "no tumbling". 7.1.2.2 The transportation packaging receipt and delivery mark should comply with the provisions of GB/T6388 and include the following content: a) product name and model;
b) delivery date;
c) wooden box appearance Size;
d) Net weight and gross weight;
e) Name of shipping and receiving station;
f) Shipping and receiving unit.
7.2 Instructions for use
Product instructions for use shall comply with the provisions of GB/T9969.1. Instructions for use shall include the following contents: a) Product model and name, name of the manufacturing unit, address, postal code and contact number ;b) Implemented product standards;
c) Working conditions, power supply, climate environment (such as temperature and humidity, atmospheric pressure, air cleanliness), etc.; d) The main structure, performance, specifications, uses, and precautions of the product matters, warnings and reminder instructions, and safety measures; e) product handling, installation, usage instructions and illustrations; f) product maintenance and upkeep.
7.3 Packaging
The packaging of the product should comply with the regulations of GB/T13384, and the following documents should be attached in the packaging box: a) Packing list;
b) Factory certificate;|| tt||c) Product instruction manual.
7.4 Before product packaging, the machine should be wiped clean and a protective cover should be put on each. 7.5 Transportation should comply with the relevant requirements for railway, highway, and waterway transportation. 7.6 After the product is packed, it should be stored in a dry and ventilated place without corrosive gas, and should not be stored in the open air. 58
4 Judgment rules:
During the type inspection process, if any of the electrical safety performance of the protective grounding circuit continuity, insulation resistance, and withstand voltage fails, the prototype will be judged to be unqualified. If one of the other properties is unqualified, double sampling will be carried out to test the unqualified items. If the item is still unqualified, the product will be judged to have failed the type inspection.
7 Logo, instructions for use, packaging, transportation and storage 7.1 Logo
7.1.1 The product should have a product label fixed at the position specified on the drawing, and the label should comply with the regulations of GB/T13306. The sign should include the following content:
a) Product name and model;
57
JB 20004—2004
b) Main parameters;
c) Manufacturer's name;
d) Factory number; www.bzxz.net
e) Factory date;
f) Product standard number.
7.1.2 The words and signs on the outer wall of the packaging box should be clear. 7.1.2.1 Storage and transportation signs should comply with the provisions of GB/T191, including the words or signs of "handle with care", "upward" and "no tumbling". 7.1.2.2 The transportation packaging receipt and delivery mark should comply with the provisions of GB/T6388 and include the following content: a) product name and model;
b) delivery date;
c) wooden box appearance Size;
d) Net weight and gross weight;
e) Name of shipping and receiving station;
f) Shipping and receiving unit.
7.2 Instructions for use
Product instructions for use shall comply with the provisions of GB/T9969.1. Instructions for use shall include the following contents: a) Product model and name, name of the manufacturing unit, address, postal code and contact number ;b) Implemented product standards;
c) Working conditions, power supply, climate environment (such as temperature and humidity, atmospheric pressure, air cleanliness), etc.; d) The main structure, performance, specifications, uses, and precautions of the product matters, warnings and reminder instructions, and safety measures; e) product handling, installation, usage instructions and illustrations; f) product maintenance and upkeep.
7.3 Packaging
The packaging of the product should comply with the regulations of GB/T13384, and the following documents should be attached in the packaging box: a) Packing list;
b) Factory certificate;|| tt||c) Product instruction manual.
7.4 Before product packaging, the machine should be wiped clean and a protective cover should be put on each. 7.5 Transportation should comply with the relevant requirements for railway, highway, and waterway transportation. 7.6 After the product is packed, it should be stored in a dry and ventilated place without corrosive gas, and should not be stored in the open air. 58
4 Judgment rules:
During the type inspection process, if any of the electrical safety performance of the protective grounding circuit continuity, insulation resistance, and withstand voltage fails, the prototype will be judged to be unqualified. If one of the other properties is unqualified, double sampling will be carried out to test the unqualified items. If the item is still unqualified, the product will be judged to have failed the type inspection.
7 Logo, instructions for use, packaging, transportation and storage 7.1 Logo
7.1.1 The product should have a product label fixed at the position specified on the drawing, and the label should comply with the regulations of GB/T13306. The sign should include the following content:
a) Product name and model;
57
JB 20004—2004
b) Main parameters;
c) Manufacturer's name;
d) Factory number;
e) Factory date;
f) Product standard number.
7.1.2 The words and signs on the outer wall of the packaging box should be clear. 7.1.2.1 Storage and transportation signs should comply with the provisions of GB/T191, including the words or signs of "handle with care", "upward" and "no tumbling". 7.1.2.2 The transportation packaging receipt and delivery mark should comply with the provisions of GB/T6388 and include the following content: a) product name and model;
b) delivery date;
c) wooden box appearance Size;
d) Net weight and gross weight;
e) Name of shipping and receiving station;
f) Shipping and receiving unit.
7.2 Instructions for use
Product instructions for use shall comply with the provisions of GB/T9969.1. Instructions for use shall include the following contents: a) Product model and name, name of the manufacturing unit, address, postal code and contact number ;b) Implemented product standards;
c) Working conditions, power supply, climate environment (such as temperature and humidity, atmospheric pressure, air cleanliness), etc.; d) The main structure, performance, specifications, uses, and precautions of the product matters, warnings and reminder instructions, and safety measures; e) product handling, installation, usage instructions and illustrations; f) product maintenance and upkeep.
7.3 Packaging
The packaging of the product should comply with the regulations of GB/T13384, and the following documents should be attached in the packaging box: a) Packing list;
b) Factory certificate;|| tt||c) Product instruction manual.
7.4 Before product packaging, the machine should be wiped clean and a protective cover should be put on each. 7.5 Transportation should comply with the relevant requirements for railway, highway, and waterway transportation. 7.6 After the product is packed, it should be stored in a dry and ventilated place without corrosive gas, and should not be stored in the open air. 58
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