JB 20007.5-2004 Oral liquid bottle filling linkage line labeling machine
Some standard content:
JB | Linkage line
Antibiotic glass bottle powder dispensing linkage line
Linear plunger filling machine
Released on 2004-02-05
Implemented on 2004-06-01| |tt||National Development and Reform Commission released
ICS11.120.30
C92
JB
Pharmaceutical Machinery Industry Standard of the People's Republic of China JB20007.5-2004||tt ||Replace YY0217.5—1995
Oral liquid bottle filling linkage line
Labeling machine
Production line for filling oral liquid Labeler2004-02-05 release
2004-06-01 Implementation
Released by the National Development and Reform Commission
Foreword
Scope
1
2 Normative Reference Documents
3 Classification and marking
Requirements
4
5 Test methods
Inspection rules
6
Marking, instructions for use, packaging and storage 7
Item
Times
JB20007.5—2004
44
45
45
45||tt ||46
47
48
49
JB20007.52004
Foreword
This standard is based on the Good Manufacturing Practice for Pharmaceuticals" In accordance with the requirements of GB/T1.1-2000 and GB/T1.2-2002 standardization work guidelines, YY0217.5-1995 "Oral Liquid Bottle Labeling Machine" was revised. This standard replaces YY0217.5-1995 from the date of implementation. Compared with YY0217.5-1995, the main technical content changes of this standard are as follows: the main chapters and clauses of YY0217.5-1995 have been deleted: a)
3.2.3.3;
4.1.2.4. 3.2.4.3.3.4.5.7;
5.6;
6.2.2.2;
7.3;
An additional note.
Revised the main chapters and articles of YY0217.5-1995: b)
Chapter 1;
Chapter 2;
3.1;
4.1, 4.2.4.3, 4.4, 4.5;
5.1, 5.2, 5.3, 5.4, 5.5, 5.11, 5.126.2.1.1, 6.2.2.1b.6.2.2.3;
7.1.2 ,7.2,7.4.
c) Mainly added chapters and clauses in this standard:
See 4.3.2, 4.4.2~4.4.34.5, 4.7.4~4.7.8; see 5.1, 5.3;||tt ||See 6.2.2.3;
See 7.2.
This standard is proposed by China Pharmaceutical Equipment Industry Association. This standard is under the jurisdiction of the Pharmaceutical Equipment Industry Standardization Technical Committee. This standard was drafted by: Beijing Aerospace Wanda High-Tech Development Center. The main drafters of this standard: Shua Jingzhou, Xin Yi, Wang Zhaoli. 44
1 scope
Oral liquid bottle filling linkage
Labeling machine
JB20007.5—-2004
This standard specifies oral liquid Classification and marking, requirements, test methods, inspection rules and signs, instructions for use, packaging, and recommendations for bottle labeling machines.
This standard applies to plastic shed labeling machines for oral liquid bottles (hereinafter referred to as labeling machines). 2 Normative reference documents
The provisions in the following documents become provisions of this standard through their use in this standard. For dated reference documents, all subsequent amendments (excluding corrigenda) or revisions do not apply to this standard. However, parties that reach an agreement based on this standard are encouraged to study whether to use the latest versions of these documents. For undated referenced documents, the latest edition applies to this standard. GB/T191 Pictorial marks for packaging, storage and transportation
GB5226.1-2002 Mechanical safety mechanical and electrical equipment Part 1: General technical conditions GB/T6388 Transport, packaging, receipt and delivery marks
GB/T9969.1 General instructions for industrial products GB/T10111 Random sampling method using random numbers CB/T13306 Label
GB/T13384 General technical conditions for mechanical and electrical product packaging GB/T16769 Metal cutting machine tool noise sound pressure level measurement method YY0056 control Oral liquid bottle
YYT0216 Pharmaceutical Machinery Product Model Preparation Method Good Manufacturing Practice (1998 Revised Edition) State Food and Drug Administration Pharmacopoeia of the People's Republic of China (2000 Edition) National Pharmacopoeia Commission 3 Classification and Labeling
3.1 Classification
Labeling machines are divided into two types: linear type and rotary type according to their movement mode. 3.2 Model
3.2.1 The model of the labeling machine should comply with the regulations of YY/T0216. 3.2.2 Model marking:
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JB20007.5—2004
3.2.3 Marking example:
TN
Controlled oral liquid bottle specifications ( mL)
Product type and feature code: T - label N - adhesive L linkage line
- product function code; Oral liquid machinery YLTN10 type: Indicates that it is suitable for 10mL controlled oral liquid bottles Adhesive labeling machine. 4 Requirements
4.1 Working conditions
4.1.1 Ambient temperature: 15℃~35℃; relative humidity: 50%~65%. 4.1.2 Label paper is single-sided offset paper or coated paper of 60g~70g. 4.1.3 The oral bottles used should comply with the regulations of YY0056. 4.2 Material requirements
The parts in the labeling machine that come into contact with the glue should be made of materials that are stainless, moisture-resistant, corrosion-resistant and chemically stable, and have corresponding material certificates.
4.3 Appearance requirements
4.3.1 The outer surface of the labeling machine should be flat and smooth, without defects such as unevenness, burrs and obvious scratches. 4.3.2 The nameplates, warning signs, function identification marks and grounding symbols installed on the labeling machine should be complete, effective, durable, and clear and easy to remember.
4.4 Structural requirements
4.4.1 The labeling machine should have a bottle transport mechanism, a label storage and supply mechanism, a glue supply mechanism, a label typing mechanism and an electronic control system. 4.4.2 The labeling machine should be equipped with a transparent protective cover and a glue box. 4.4.3 The labeling machine should have a vertical height adjustment device. 4.5 Functional requirements
4.5.1 The labeling machine should meet the production speed requirements, and the speed is adjustable within the specified range. 4.5.2 Control function:
should be able to control the speed of supplying and absorbing tickets.
4.5.3 Display function:
Display labeling speed and total output.
4.5.4 Chain function:
has the functions of no labeling without a bottle, no glue brushing without a label, and no batch number printing without a bottle. 4.5.5 Protection function:
When the protective cover is opened, it should automatically stop.
4.6 Performance requirements
46
4.6.1 Labeling quality requirements: Labels must be flat, straight, and highly consistent; typed clearly. 4.6.2 The damage rate is less than 1%.
4.6.3 The labeling pass rate is greater than 92%.
4.6.4 The labeling error is less than 0.8mm
4.6.5 The noise of the labeling machine during load operation is not greater than 80dB(A). 4.6.6 No-load performance:
4.6.6.1 There should be no oil leakage from the reduction gearbox after no-load operation. 4.6.6.2 After no-load operation, the surface temperature rise of the reduction gearbox should not exceed 35%°C. JB20007.5-2004
4.6.7 Load performance: When the labeling machine is under load, the movements of each process should be sensitive and reliable; there should be no air leakage at the joints of each pipeline. 4.7 Safety requirements for electrical systems
4.7.1 The continuity of the protective grounding circuit of the electrical system shall comply with the provisions of 19.2 in CB5226.1-2002. 4.7.2 The insulation resistance of the electrical system shall comply with the provisions of 19.3 in CB5226.1-2002. 4.7.3 The withstand voltage of the electrical system should comply with the provisions of 19.4 in CB5226.1-2002. 4.7.4 The protective grounding circuit of the electrical system should comply with the provisions of 8.2 in GB5226.1-2002. 4.7.5 The buttons of the electrical system should comply with the provisions of 10.2 in GB5226.12002. 4.7.6 The indicator lights and displays of the electrical system should comply with the provisions of 10.3 in CB5226.1-2002. 4.7.7 The wiring of the electrical system should comply with the provisions of Chapter 14 of GB5226.1-2002. 4.7.8 The markings, warning signs and project codes of the electrical system should comply with the provisions of Chapter 17 of GB5226.1-2002. 5 Test methods
5.1 Working condition inspection
Visually inspect the label paper quality.
5.2 Material, appearance and structure inspection
Visually inspect the material certification information, machine appearance and structure of the materials used in the labeling machine: 5.3 Functional test
5.3.1 Production speed determination:|| tt||After the labeling machine is running under load, use a stopwatch to count for 5 minutes at the rated speed to detect the production speed. 5.3.2 Control function test:
Before the labeling machine leaves the factory, use a white label to simulate the normal production process for control function testing. 5.3.3 Display function test:
Visually display the production speed and total quantity in real time. 5.3.4 Chain function test:
Remove bottles from the bottle delivery auger and test the chain function daily. 5.3.5 Protection function test:
When the labeling machine is working normally, it should automatically stop when the protective cover is opened. 5.4 Performance inspection
5.4.1 Labeling quality inspection:
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JB20007.52004
After the labeling machine is working normally, take samples to visually inspect the labeling quality. 5.4.2 Determination of bottle breakage rate:
After the labeling machine operates normally, at rated speed, count the total number of broken bottles and the total number of bottles entered after continuous operation for 30 minutes. Calculate according to formula (1): bottle breakage rate (% )=
5.4.3 Labeling pass rate determination:
Total number of broken bottles
Total number of entered bottles
X100
(1)||tt| |After the labeling machine works normally, at the rated speed, count the total number of qualified bottles and the total number of bottles produced after continuous operation for 30 minutes, and calculate according to formula (2):
Qualification rate (%) three
5.4 .4 Labeling error inspection:
Total number of qualified bottles
Total number of bottles produced
Calipers check labeling errors. 5.4.5 Noise test:
After the labeling machine is in normal operation, use a sound level meter to measure according to the regulations of CB/T16769. 5.4.6 No-load performance test:
a) After 1 hour of no-load operation, visually inspect the oil leakage of the reduction gearbox; b) After 1 hour of no-load operation, use a secondary industrial thermometer to inspect the reduction gearbox and motor. Surface temperature rise. 5.4.7 Load performance test;
(2)
The load performance test should be carried out after passing the no-load inspection, and gradually adjust from low-speed operation to high-speed operation, and then run at rated speed for 1 hour. , confirmed by visual inspection.
5.5 Electrical system quality inspection
5.5.1 The continuity, insulation resistance and withstand voltage inspection of the protective grounding circuit of the electrical system shall be tested in accordance with the provisions of 19.2, 19.3 and 19.4 in GB5226.1-2002 respectively. .
5.5.2 The protective grounding circuit, buttons, indicators and displays, wiring, markings, warning signs and project codes of the electrical system shall be in accordance with GB5226.1-2002 8.2, 10.2, 10.3, Chapter 14 and Check the provisions of Chapter 17. 6 Inspection Rules
6.1 Each labeling machine must pass the quality inspection and be accompanied by a product certificate before it can leave the factory. 6.2 Inspection Classification
The inspection of labeling machines is divided into factory inspection and type inspection. 6.2.1 Factory inspection
6.2.1.1 Factory inspection shall be carried out one by one according to the requirements in Table 1. Only qualified products shall be allowed to leave the factory and shall be accompanied by a product certificate. Table 1 Factory inspection items
Project category
General items
Main items
48
Inspection items
4.2,4.3,4.4, 4.5.1,4.5.3
4.5.2,4.5.4,4.5.5,4.6.1~4.6.5,4.7JB20007.5-2004
6.2.1.2 Labeling machine in During the inspection process, if unqualified products are found, they should be returned for trimming and then submitted for inspection. If they are still unqualified, they will be deemed unqualified.
6.2.2 Type inspection
6.2.2.1 Type inspection shall be carried out when one of the following situations occurs: a) When the product is trial-made or transferred to a factory for production: b) The structure, materials, When there are major changes in the process: c) When the product resumes production after 2 years of suspension; d) When the national quality supervision agency proposes a requirement for type inspection. 6.2.2.2 Sampling:
The prototypes for type inspection shall be 10% selected from the products that have passed the factory inspection according to the method specified in GB/T10111. At least three samples shall be selected and one shall be tested.
6.2.2.3 Judgment Rules
During the type inspection, if the electrical safety performance of the protective grounding circuit is slightly continuous, and the insulation resistance and withstand voltage are unqualified, the product will be judged to have failed the type inspection. If one of the other items fails, the unqualified item should be retested twice. If it still fails, the product will be judged to have failed the type inspection.
7 logo, instruction manual, packaging and storage
7.1 logo
7.1.1 Each labeling machine fixes the product label according to the position specified on the drawing, and the label should comply with CB/T13306 Provisions. 7.1.2 The label of the labeling machine should include the following: a) Product name and model:
b) Manufacturer name:
c) Product number and manufacturing date;
d ) Main parameters;
e) Product standard number.
7.1.3 This shipping mark should comply with the regulations of CB/T191. 7.2 Instructions for use
Product instructions for use shall comply with the provisions of GB/T9969.1. 7.3 Packaging
7.3.1 Product packaging should comply with the regulations of CB/T13384. 7.3.2 The packaging box should have the following accompanying documents: a) product certificate;
b) product instruction manual;
e) packing list;
d) list of accompanying accessories:
e) Material certificate and instrumentation inspection certificate specified in this standard. 7.4 Storage
49
3 Labeling pass rate measurement:
Total number of broken bottles
Total number of incoming bottles
At the rated speed, count the total number of qualified bottles and the total number of bottles produced after continuous operation for 30 minutes, and calculate according to formula (2):
Qualification rate (%) three
5.4.4 Labeling error inspection: || tt||Total number of qualified bottles
Total number of bottles produced
5.4.5 Noise test:
After the labeling machine is in normal operation, use a sound level meter to measure according to the regulations of CB/T16769. 5.4.6 No-load performance test:
a) After 1 hour of no-load operation, visually inspect the oil leakage of the reduction gearbox; b) After 1 hour of no-load operation, use a secondary industrial thermometer to inspect the reduction gearbox and motor. Surface temperature rise. 5.4.7 Load performance test;
(2)
The load performance test should be carried out after passing the no-load inspection, and gradually adjust from low-speed operation to high-speed operation, and then run at rated speed for 1 hour. , confirmed by visual inspection.
5.5 Electrical system quality inspection
5.5.1 The continuity, insulation resistance and withstand voltage inspection of the protective grounding circuit of the electrical system shall be tested in accordance with the provisions of 19.2, 19.3 and 19.4 in GB5226.1-2002 respectively. .
5.5.2 The protective grounding circuit, buttons, indicators and displays, wiring, markings, warning signs and project codes of the electrical system shall be in accordance with 8.2, 10.2, 10.3, Chapter 14 and Chapter 14 of GB5226.1-2002 respectively. Check the provisions of Chapter 17. 6 Inspection Rules
6.1 Each labeling machine must pass the quality inspection and be accompanied by a product certificate before it can leave the factory. 6.2 Inspection Classification
The inspection of labeling machines is divided into factory inspection and type inspection. 6.2.1 Factory inspection
6.2.1.1 Factory inspection shall be carried out one by one according to the requirements in Table 1. Only qualified products shall be allowed to leave the factory and shall be accompanied by a product certificate. Table 1 Factory inspection items
Project category
General items
Main items
48
Inspection items
4.2,4.3,4.4, 4.5.1,4.5.3
4.5.2,4.5.4,4.5.5,4.6.1~4.6.5,4.7JB20007.5-2004
6.2.1.2 Labeling machine in During the inspection process, if unqualified products are found, they should be returned for trimming and then submitted for inspection. If they are still unqualified, they will be deemed unqualified.
6.2.2 Type inspection
6.2.2.1 Type inspection shall be carried out when one of the following situations occurs: a) When the product is trial-made or transferred to a factory for production: b) The structure, materials, When there are major changes in the process: c) When the product resumes production after 2 years of suspension; d) When the national quality supervision agency proposes a requirement for type inspection. 6.2.2.2 Sampling:
The prototypes for type inspection shall be 10% selected from the products that have passed the factory inspection according to the method specified in GB/T10111. At least three samples shall be selected and one shall be tested.
6.2.2.3 Judgment Rules
During the type inspection, if the electrical safety performance of the protective grounding circuit is slightly continuous, and the insulation resistance and withstand voltage are unqualified, the product will be judged to have failed the type inspection. If one of the other items fails, the unqualified item should be retested twice. If it still fails, the product will be judged to have failed the type inspection.
7 logo, instruction manual, packaging and storage
7.1 logo
7.1.1 Each labeling machine fixes the product label according to the position specified on the drawing, and the label should comply with CB/T13306 Provisions. 7.1.2 The label of the labeling machine should include the following: a) Product name and model:
b) Manufacturer name:
c) Product number and manufacturing date;
d ) Main parameters;
e) Product standard number.
7.1.3 This shipping mark should comply with the regulations of CB/T191. 7.2 Instructions for use
Product instructions for use shall comply with the provisions of GB/T9969.1. 7.3 Packaging
7.3.1 Product packaging should comply with the regulations of CB/T13384. 7.3.2 The packaging box should have the following accompanying documents: a) product certificate;
b) product instruction manual;
e) packing list;
d) list of accompanying accessories:
e) Material certificate and instrumentation inspection certificate specified in this standard. 7.4 Storage
49
3 Labeling pass rate measurement:
Total number of broken bottles
Total number of incoming bottles
At the rated speed, count the total number of qualified bottles and the total number of bottles produced after continuous operation for 30 minutes, and calculate according to formula (2):
Qualification rate (%) three
5.4.4 Labeling error inspection: || tt||Total number of qualified bottles
Total number of bottles produced
5.4.5 Noise test:
After the labeling machine is in normal operation, use a sound level meter to measure according to the regulations of CB/T16769. 5.4.6 No-load performance test: Www.bzxZ.net
a) After 1 hour of no-load operation, visually inspect the oil leakage of the reduction gearbox; b) After 1 hour of no-load operation, use a secondary industrial thermometer to inspect the reduction gearbox and motor. Surface temperature rise. 5.4.7 Load performance test;
(2)
The load performance test should be carried out after passing the no-load inspection, and gradually adjust from low-speed operation to high-speed operation, and then run at rated speed for 1 hour. , confirmed by visual inspection.
5.5 Electrical system quality inspection
5.5.1 The continuity, insulation resistance and withstand voltage inspection of the protective grounding circuit of the electrical system shall be tested in accordance with the provisions of 19.2, 19.3 and 19.4 in GB5226.1-2002 respectively. .
5.5.2 The protective grounding circuit, buttons, indicators and displays, wiring, markings, warning signs and project codes of the electrical system shall be in accordance with GB5226.1-2002 8.2, 10.2, 10.3, Chapter 14 and Check the provisions of Chapter 17. 6 Inspection Rules
6.1 Each labeling machine must pass the quality inspection and be accompanied by a product certificate before it can leave the factory. 6.2 Inspection Classification
The inspection of labeling machines is divided into factory inspection and type inspection. 6.2.1 Factory inspection
6.2.1.1 Factory inspection shall be carried out one by one according to the requirements in Table 1. Only qualified products shall be allowed to leave the factory and shall be accompanied by a product certificate. Table 1 Factory inspection items
Project category
General items
Main items
48
Inspection items
4.2,4.3,4.4, 4.5.1,4.5.3
4.5.2,4.5.4,4.5.5,4.6.1~4.6.5,4.7JB20007.5-2004
6.2.1.2 Labeling machine in During the inspection process, if unqualified products are found, they should be returned for trimming and then submitted for inspection. If they are still unqualified, they will be deemed unqualified.
6.2.2 Type inspection
6.2.2.1 Type inspection shall be carried out when one of the following situations occurs: a) When the product is trial-made or transferred to a factory for production: b) The structure, materials, When there are major changes in the process: c) When the product resumes production after 2 years of suspension; d) When the national quality supervision agency proposes a requirement for type inspection. 6.2.2.2 Sampling:
The prototypes for type inspection shall be 10% selected from the products that have passed the factory inspection according to the method specified in GB/T10111. At least three samples shall be selected and one shall be tested.
6.2.2.3 Judgment Rules
During the type inspection, if the electrical safety performance of the protective grounding circuit is slightly continuous, and the insulation resistance and withstand voltage are unqualified, the product will be judged to have failed the type inspection. If one of the other items fails, the unqualified item should be retested twice. If it still fails, the product will be judged to have failed the type inspection.
7 logo, instruction manual, packaging and storage
7.1 logo
7.1.1 Each labeling machine fixes the product label according to the position specified on the drawing, and the label should comply with CB/T13306 Provisions. 7.1.2 The label of the labeling machine should include the following: a) Product name and model:
b) Manufacturer name:
c) Product number and manufacturing date;
d ) Main parameters;
e) Product standard number.
7.1.3 This shipping mark should comply with the regulations of CB/T191. 7.2 Instructions for use
Product instructions for use shall comply with the provisions of GB/T9969.1. 7.3 Packaging
7.3.1 Product packaging should comply with the regulations of CB/T13384. 7.3.2 The packaging box should have the following accompanying documents: a) product certificate;
b) product instruction manual;
e) packing list;
d) list of accompanying accessories:
e) Material certificate and instrumentation inspection certificate specified in this standard. 7.4 Storage
49
2. The label of the labeling machine should include the following: a) Product name and model:
b) Manufacturer name:
c) Product number and manufacturing date;
d) Main Parameter;
e) product standard number.
7.1.3 This shipping mark should comply with the regulations of CB/T191. 7.2 Instructions for use
Product instructions for use shall comply with the provisions of GB/T9969.1. 7.3 Packaging
7.3.1 Product packaging should comply with the regulations of CB/T13384. 7.3.2 The packaging box should have the following accompanying documents: a) product certificate;
b) product instruction manual;
e) packing list;
d) list of accompanying accessories:
e) Material certificate and instrumentation inspection certificate specified in this standard. 7.4 Storage
49
2. The label of the labeling machine should include the following: a) Product name and model:
b) Manufacturer name:
c) Product number and manufacturing date;
d) Main Parameter;
e) product standard number.
7.1.3 This shipping mark should comply with the regulations of CB/T191. 7.2 Instructions for use
Product instructions for use shall comply with the provisions of GB/T9969.1. 7.3 Packaging
7.3.1 Product packaging should comply with the regulations of CB/T13384. 7.3.2 The packaging box should have the following accompanying documents: a) product certificate;
b) product instruction manual;
e) packing list;
d) list of accompanying accessories:
e) Material certificate and instrumentation inspection certificate specified in this standard. 7.4 Storage
49
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