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 JB20007.1--2004|| tt||Replacing YY0217.1—1995
Oral liquid bottle filling linkage line
Productionline for filling oral liquid2004-02-05 release
2004-06-01 implementation
National Released by the Development and Reform Commission
Foreword
1
Scope
Normative reference documents
2
3 Classification and tags: || tt||Requirements...
4
5
Test method
6
Inspection rules·
Item
Times
JB 20007.1—-2004
5
6
JB 20007.1—-2004
Foreword
This standard is based on the "Drug Production "Quality Management Specifications" and the requirements of GB/T1.1-2000, GB/T1.2-2002 Standardization Work Guidelines, and the revision of YY0217.1-1995 "Oral Liquid Filling Linkage Line". This standard replaces YY0217.1-1995 from the date of implementation. Compared with YY0217.1-1995, the main technical content changes of this standard are as follows: a) The main chapters of YY0217.1-1995 are deleted, clauses: -3.2.3.3;
4.1.2, 4.3.2.4. 3.3, 4.6;
—5.25.3.1,5.7,5.8.
b) Revised the main chapters and articles of YY0217.1-1995: Chapter 1,
Chapter 2;
-3.1;
4.1, 4.2, 4.3, 4.4, 4.5;
-5.1.5.3.5.4, 5.5.5.6.5.9, 5.12;6.2.1.1.6.2.2.1b.6.2.2.3.
e) The main additions to this standard Chapters and articles:
See 4.3.24.4.4.5, 4.7.4~4.7.8;—See 5.1;
—See 6.2.2.3.
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. 4
1 Scope
Oral liquid bottle filling linkage line
JB20007.1—2004
This standard specifies the classification and marking of oral liquid bottle filling linkage line , requirements, test methods and inspection rules. This standard applies to oral liquid bottle filling linkage lines (hereinafter referred to as linkage lines). 2 Normative reference documents
The provisions in the following documents are incorporated into the provisions of this standard by reference in this standard. For dated reference documents, all subsequent amendments (excluding corrigenda) or revisions do not apply to this standard. However, parties that reach an agreement based on this standard are encouraged to study whether 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 principles of industrial product instructions for use 1 Method of random sampling using random numbers GB/T 10111
GB/T13306
5 Signs
CB/T13384 General technical conditions for mechanical and electrical product packaging GB /T16769 Metal cutting machine tool noise sound pressure level measurement method JB 20007.2—2004
Oral liquid bottle filling linkage line ultrasonic cleaning machine JB20007.3-2004 Oral liquid bottle filling linkage line type sterilization dryer JB20007 .4—2004 Oral liquid bottle filling linkage line capping machine JB20007.5—2004 Oral liquid bottle filling linkage line labeling machine
YYT0216 Pharmaceutical machinery product model compilation method YY0056 controlled oral liquid bottle||tt| |YY0131 Tear-off aluminum cap for liquid bottle
Good Manufacturing Practice for Pharmaceutical Products (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 The model of the linkage line should comply with the regulations of YY/T0216. 3.2 Model marking
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JB20007.1—2004
3.3 Marking example
Main parameters: Production capacity (bottle/h)/controlled oral liquid bottle specifications (mL ) Product type and feature code: L--Linkage line product function code: Indicates oral liquid machinery YL15000/10 type: Indicates oral wave filling linkage line with a production capacity of 15,000 bottles/h (10mL tube bottles). 4 Requirements
4.1 Working conditions
4.1.1 Ambient temperature: 18℃~28℃.
4.1.2 Ambient air cleanliness: Class 100,000. 4.1.3 Use water source:
complies with the relevant regulations in the "Pharmacopoeia of the People's Republic of China" (2000 edition), and the pressure is 0.2MPa~0.4MPa. 4.1.4 Use gas source:
should be oil-free, water-free and impurity-free, filtered by 20um grade, and the pressure should be 0.35MPa~0.5MPa. 4.1.5 Oral liquid bottles should comply with the regulations of YY0056. 4.1.6 Aluminum caps for oral liquids should comply with the requirements of YY0131. 4.2 Material requirements
Parts in the linkage line that are in contact with water and chemical liquids should be made of stainless, non-toxic, corrosion-resistant and chemically stable materials, and have corresponding material certificates.
4.3 Appearance requirements
4.3.1 The outer surface of the linkage line 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 linkage line should be complete, effective, durable, clear and easy to remember.
4.4 The linkage line consists of the following units, and each unit should comply with the corresponding standards. 4.4.1 Ultrasonic cleaning machines should comply with the regulations of JB20007.2-2004. 4.4.2 The tunnel sterilization dryer should comply with the regulations of JB20007.3-2004. 4.4.3 The oral liquid filling and capping machine should comply with the regulations of JB20007.4-2004. 4.4.4 The labeling machine should comply with the regulations of JB20007.5-2004. 4.4.5 Single-machine indirect balancing device.
4.5 Functional requirements
4.5.1 The liquid channel of the linkage line should be able to achieve online cleaning and disinfection. 4.5.2 The linkage line should meet the production speed requirements, and the speed is adjustable within the specified range. 4.5.3 Each unit of the linkage line has detection, alarm and control functions. 4.6 Performance requirements
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4.6.1 The loading error should not be greater than +2% of the standard error. 4.6.2 The damage rate should not be greater than 2%.
4.6.3 The pass rate of capping shall not be less than 98%. JB20007.1—2004
4.6.4 The linkage line should have no abnormal noise during load operation; its noise sound pressure should not be greater than 82dB(A). 4.6.5 No-load performance of the linkage line:
4.6.5.1 Each reduction box should have no oil leakage after the linkage line runs without load. 4.6.5.2 After no-load operation, the surface temperature rise of the reduction gearbox should not exceed 35°C. 4.6.6 Load performance:
When the linkage line is under load, the connection between individual machines should be smooth and reliable; the monitoring system should be coordinated and stable: packaging materials should be delivered in a timely manner and accurately in place.
4.7 Electrical system safety requirements
4.7.1 The continuity of the protective grounding circuit of the electrical system shall comply with the provisions of 19.2 in GB5226.1-2002. 4.7.2 The insulation resistance of the electrical system should comply with the provisions of 19.3 in GB5226.1-2002. 4.7.3 The withstand voltage of the electrical system shall comply with the provisions of 19.4 in GB5226.1-2002. 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 GB5226.1-2002. 4.7.6 The indicators and displays of the electrical system should comply with the provisions of 10.3 in GB5226.1--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 test
5.1.1 Use a 2.5-level pressure gauge to check the water source and air source pressure. 5.1.2 Measure bottles and aluminum caps according to YY0056 and YY0131. 5.2 Material, appearance and structure inspection
Visually inspect the material certification data, machine appearance and structure of the materials used in the cleaning machine. 5.3 Functional test
Simulation test on the function of the linkage line, liquid channel, online cleaning and linkage control performance. 5.4 Performance inspection
5.4.1 Determination of filling error: Www.bzxZ.net
Use a standard measuring cup (or balance) to sample and measure. 5.4.2 Determination of the damage rate:
When the linkage line is running at normal load and rated speed, count the total number of broken bottles and the total number of bottles entered in each unit of the linkage line for 30 minutes, and calculate according to formula (1):
Broken bottle rate (%) =
5.4.3 Determination of capping pass rate:
Total number of broken bottles in each single machine
Total number of bottles entered
x100||tt| |(1)
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JB 20007.1—2004
When the linkage line is running at normal load and rated speed, count the qualified number of capping and the total number of bottles in 30 minutes. According to formula (2 ) Calculate the capping pass rate (%):
5.4.4 Noise test:
The number of capping passes
The total number of bottles
×100
When the load is operating normally, the linkage line shall be measured with a sound level meter in accordance with the provisions of GB/T16769. 5.4.5 No-load performance test of the linkage line:
(2)
After each unit of the linkage line is in place and adjusted, conduct the linkage no-load test. During the test, it should be adjusted from low-speed operation to high-speed operation. After stably operating continuously at rated speed for 1 hour, visually inspect the leakage and use a secondary industrial thermometer to detect the temperature rise. 5.4.6 Linkage line load performance test:
The linkage line load performance test should be carried out after passing the no-load test. During the test, the operation should be gradually adjusted from low speed to high speed, and then stabilized at the rated speed. The continuous operation time should be no less than 30 minutes to measure the smoothness of operation and work coordination. 5.5 Electrical system quality inspection
5.5.1 The continuity of the protective grounding circuit of the electrical system, insulation resistance, and withstand voltage inspection shall be tested in accordance with the provisions of 19.2, 19.3 and 19.4 of CB5226.1-2002 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 17 of GB5226.12002 respectively. 6. Inspection rules
6.1 Each linkage line 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 the linkage line 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
Item categories
General items
Main items
Inspection items
4.2,4.3,4.4,4.5.1,4.5. 2
4.5.3, 4.7.1~4.7.8
6.2.1.2 During the inspection process of the linkage line, if unqualified products are found, they should be returned for repair, and then submitted for inspection after repair. If it is still unqualified, it will be deemed as unqualified product.
6.2.2 Type inspection
6.2.2.1 Type inspection shall be carried out when one of the following situations a) When the product is trial-made and transferred to the factory for production: b) The structure, material and process of the product have When there are major changes: 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:
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JB 20007.12004
The prototypes for type inspection shall be selected from 10% of the products that have passed the factory inspection according to the method specified in CB/T10111. At least three units shall be selected. Test one.
6.2.2.3 Judgment rules:
If any of the electrical safety performance of protective grounding circuit continuity, insulation resistance, and withstand voltage fails during type inspection, the product will be judged to have failed the type inspection. If one of the other items is unqualified, the unqualified item should be retested twice. If it is still unqualified, the product will be judged to have failed the type inspection.
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The inspection shall be carried out according to the provisions of 8.2, 10.2, 10.3, Chapter 14 and Chapter 17 of 12002. 6 Inspection Rules
6.1 Each linkage line 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 the linkage line 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
Item categories
General items
Main items
Inspection items
4.2,4.3,4.4,4.5.1,4.5. 2
4.5.3, 4.7.1~4.7.8
6.2.1.2 During the inspection process of the linkage line, if unqualified products are found, they should be returned for repair, and then submitted for inspection after repair. If it is still unqualified, it will be deemed as unqualified product.
6.2.2 Type inspection
6.2.2.1 Type inspection shall be carried out when one of the following situations a) When the product is trial-made and transferred to the factory for production: b) The structure, material and process of the product have When there are major changes: 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:
8
JB 20007.12004
The prototypes for type inspection shall be selected from 10% of the products that have passed the factory inspection according to the method specified in CB/T10111. At least three units shall be selected. Test one.
6.2.2.3 Judgment rules:
If any of the electrical safety performance of protective grounding circuit continuity, insulation resistance, and withstand voltage fails during type inspection, the product will be judged to have failed the type inspection. If one of the other items is unqualified, the unqualified item should be retested twice. If it is still unqualified, the product will be judged to have failed the type inspection.
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The inspection shall be carried out according to the provisions of 8.2, 10.2, 10.3, Chapter 14 and Chapter 17 of 12002. 6 Inspection Rules
6.1 Each linkage line 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 the linkage line 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
Item categories
General items
Main items
Inspection items
4.2,4.3,4.4,4.5.1,4.5. 2
4.5.3, 4.7.1~4.7.8
6.2.1.2 During the inspection process of the linkage line, if unqualified products are found, they should be returned for repair, and then submitted for inspection after repair. If it is still unqualified, it will be deemed as unqualified product.
6.2.2 Type inspection
6.2.2.1 Type inspection shall be carried out when one of the following situations a) When the product is trial-made and transferred to the factory for production: b) The structure, material and process of the product have When there are major changes: 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:
8
JB 20007.12004
Samples for type inspection shall be selected from 10% of the products that have passed the factory inspection according to the method specified in CB/T10111. At least three units shall be selected. Test one.
6.2.2.3 Judgment rules:
If any of the electrical safety performance of protective grounding circuit continuity, insulation resistance, and withstand voltage fails during type inspection, the product will be judged to have failed the type inspection. If one of the other items is unqualified, the unqualified item should be retested twice. If it is still unqualified, the product will be judged to have failed the type inspection.
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