Some standard content:
ICS11.120.30
C92
JB
Pharmaceutical Machinery Industry Standard of the People's Republic of China JB20003.2—2004
Eye Drops Linkage Line
Cleaning Machine| |tt||Production line for eyedrops-Cleaningmachine2004-02-05 Release
2004-06-01 Implementation
National Development and Reform Commission Release
Foreword·
Scope
Normative references
2
Models and markings
3
Requirements
Test methods
5|| tt||Inspection rules
6
Logo, instructions for use, packaging and storage items
times
JB20003.2—2004
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This standard is proposed by China Pharmaceutical Equipment Industry Association. Former
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: Feng Ruixin, Wang Jinyan, Yuan Jingzhou. 12
1 Fangu
Eye drop linkage line cleaning machine
JB20003.2—2004
This standard specifies the model and marking of eye drop cleaning machine, Requirements, test methods, inspection rules and signs, instructions for use, packaging and storage.
This standard applies to eye drop plastic bottle cleaning machines (hereinafter referred to as cleaning machines). 2 Normative reference documents
The provisions in the following documents become provisions of this standard through reference in this standard. For dated reference documents, all subsequent amendments (excluding corrigenda) or revisions do not apply to this standard. However, parties that reach 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 marks
GB5226.1-2002 Mechanical safety mechanical and electrical equipment Part 1: Technical conditions GB/T6388 Transport, packaging, receipt and delivery marks
GB/T9969.1 General instructions for use of industrial products GB/T10111 Method of random sampling using random numbers 5 signs
GB/T13306
General technical conditions for packaging of mechanical and electrical products
CB/T13384||tt ||GB/T16769
Measurement method of noise sound pressure level of metal cutting machine tools YY/T0216-1995 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 Model and Marking
3.1 Model
The model of the cleaning machine should comply with the regulations of YY/T0216-1995. DLQO
Specification code: Production capacity (pieces/min)/Applicable bottle diameter (mm) Type and feature code: Linked line cleaning machine Product function code: Eye drops machinery
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3.2 Marking examples
4 requirements
4.1 General rules
DL·Q
8022
Bottle diameter is 22mm
The production capacity is 80 pieces/min
Eye drops linkage line·cleaning machine
The design, manufacture, installation, use, repair, maintenance and verification of the cleaning machine should comply with "Good Manufacturing Practice for Drugs" (1998 revised version of relevant principle instructions.
4.2 Working conditions
4.2.1 Ambient temperature: The ambient air temperature for normal operation is 18℃~28℃. 4.2. 2 Humidity: Relative humidity is 50%~60%. 4.2.3 Environmental cleanliness: The cleaning machine should be installed in a 100,000-level clean area. 4.2.4 Water source: purified water, pressure 0.2MPa~0.3MPa; water for injection, The pressure is 0.2MPa~0.3MPa. 4.2.5 Air source: oil-free, water-free, impurity-free, filtered compressed air, the pressure is 0.4MPa~0.6MPa. 4.3 Material requirements
4.3.1 Direct contact Water and gas parts should be made of low-carbon austenitic stainless steel. Stainless steel should have corresponding material certificates. 4.3.2 Other materials should be non-toxic, corrosion-resistant or rust-proof, and have no particle precipitation. ||tt ||4.4.1 The outer surface of the cleaning machine should be flat and smooth, without bulges, depressions, cracks and dead corners, and should be easy to clean and disinfect. 4.4.2 The edges of the exposed joint surfaces of the parts should be neatly hooked and there should be no obvious misalignment. 4.4. .3 The installed nameplates, warning signs, function identification marks and grounding symbols should be clear, complete and durable. 4.5 Structural requirements
4.5.1 Pipe welding shall be hydrogen arc welding, and pipe connections shall be quick-open sanitary joints. . 4.5.2 The cleaning station should be equipped with a transparent cover. 4.5.3 The cleaning machine should have a water outlet. 4.5.4 The water and air sources should have pressure detection devices before use. The cleaning water and air systems should have filtration devices. The filtration precision is: 0.2m for water for injection; 0.45um for purified water; 0.2um for compressed air. There should be an exhaust port on the upper part of the filter and a discharge port on the lower part.
4.6.1 Production speed requirements:
The cleaning machine should be able to meet the production speed requirements, be adjustable within the specified range, and be able to display the production speed. 4.6.2 Flushing effect requirements: ||tt ||The cleaning fluid should fill the inner and outer walls of the bottle and rinse thoroughly. 14
4.6.3 Protection function:
4.6.3.1 When the main motor fails, it should automatically stop and alarm. 4.6.3.2. When the bottle feeding device is short of bottles or stuck, it should automatically stop and alarm. 4.7 Performance requirements
4.7.1 No-load performance:
No-load operation is flexible, smooth and unobstructed, and there are no abnormalities in the electrical control system. 4.7.2 Load performance:
JB20003.2—2004
During load operation, it should be ensured that the bottle feeding is in place, and the cleaning and bottle dispensing stations move flexibly and accurately: there should be no air at the pipe connections , liquid leakage; there is no liquid leakage from the whole machine.
4.7.3 Cleaning quality requirements:
There should be no stains or flow marks on the surface of the cleaned bottle; after filling with water for injection, there should be no foreign matter in the bottle, and the clarity pass rate is equal to 100%.
4.7.4 Noise requirements:
The load operating noise sound pressure level shall not exceed 70dB(A). 4.8 Electrical system safety requirements
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 voltage resistance 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 Electrical system buttons should comply with the provisions of 10.2 in GB5226.1-2002. 4.8.6 The electrical system indicators and displays should comply with the provisions of 10.3 in GB5226.1-2002. 4.8.7 The electrical system wiring shall comply with the provisions of Chapter 14 of GB5226.1-2002. 4.8.8 Electrical system markings, warning signs and project codes shall comply with the provisions of Chapter 17 of GB5226.1-2002. 5 Test methods
5.1 Technical document inspection
Use sensory method to check the cleaning machine instruction manual, product certificate, material certificate and main instrument calibration certificate. 5.2 Working condition inspection
5.2.1 Temperature and humidity inspection:
Use a thermometer and hygrometer to measure the temperature and humidity of the working environment of the cleaning machine. 5.2.2 Water source and air source inspection:
Use a 2.5-level pressure gauge to check the water source and air source pressure. 5.3 Material, appearance and structure inspection
Visually inspect the material certification information of the materials used, the appearance and structure of the machine. 5.4 Functional test
5.4.1 Production speed test:
Adjust the speed of the cleaning machine to the designed maximum speed, input the bottle (without adding cleaning gas or liquid), and after 30 minutes of load operation, use the rotation table 15
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or stopwatch counts for 5 minutes. Adjust the operating speed within the specified range, and test the speed adjustment effect by testing the production speed. 5.4.2 Washing effect test:
Remove the filtering device of the cleaning liquid, use drinking water instead of the cleaning liquid to directly supply the cleaning machine, and visually check that the cleaning liquid can fill the inner and outer walls of the bottle.
5.4.3 Protection function test:
5.4.3.1 Touch the main motor fault sensing element. 5.4.3.2 Touch the fault sensing element of the bottle feeding device. 5.5 Performance test
5.5.1 No-load test:
Start the cleaning machine with no load and run the speed from low to high for 2 hours. 5.5.2 Load test:
After the cleaning machine passes the no-load test, perform a load test. During the test, the highest production speed was used, the filtration device of the cleaning fluid was removed, drinking water was used instead of the cleaning fluid to directly supply the cleaning machine, fed into bottles, and the normal production process was simulated for 30 minutes. 5.5.3 Cleaning quality test:
The cleaning machine works according to normal procedures, visually inspect the surface of the bottle after cleaning; fill the bottle with water for injection, and check the clarity under the clarity tester.
5.5.4 Noise test:
The cleaning machine is tested in accordance with the regulations of GB/T16769 with a sound level meter under the highest production speed and load operation state. 5.6 Electrical system testing
5.6.1 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 CB5226.1-2002 respectively.
5.6.2 The protective grounding circuit, buttons, indicators and displays, wiring, markings, warning signs and project codes of the electrical system shall be in accordance with Chapter 8.2, 10.2, 10.3 and Chapter 14 of CB5226.1-2002 respectively. Check with the provisions of Chapter 17. 6 Inspection Rules
6.1 Inspection Categories
The inspection of disinfection machines is divided into factory inspection and type inspection. 6.2 Factory inspection
6.2.1 Each cleaning machine must pass the inspection by the inspection department of the manufacturing unit before it can leave the factory. It should be accompanied by a product certificate when leaving the factory. 6.2.2 Factory inspection shall be carried out one by one according to the provisions in Table 1. Table 1 Cleaning machine factory inspection items
Item category
General items
Main items
Inspection items
4.2, 4.3, 4.4, 4.5.2, 4.5.3, 4.5.44.5.1,4.5.5,4.6,4.7,4.8
6.2.3 If the cleaning machine is found to be unqualified during the factory inspection, it will be returned for repair. If it is still unqualified after repair, Products judged to be unqualified will not be allowed to leave the factory. || tt | , when there are major changes in materials and processes; c) when the product resumes production after 2 years of suspension: d) when the national quality supervision agency proposes a requirement for type inspection; e) when the pharmaceutical manufacturer conducts equipment certification. 6.3.2 Type inspection items:
Type inspection shall conduct a comprehensive quality assessment and review of all technical requirements of this standard. 6.3.3 Sampling rules:
JB20003.2—2004
The prototypes for type inspection shall be selected from 10% of the products that have passed the factory inspection, and one unit shall be tested. The sampling method shall be carried out in accordance with the provisions of GB/T10111.
6.3.4 Judgment rules:
When all inspection results in the vehicle type inspection meet the requirements of this standard, the vehicle is deemed to have passed the type inspection. During the inspection, if one of the electrical safety performance parameters of protective grounding circuit continuity, insulation resistance, and withstand voltage is found to be unqualified, the product will be deemed to have failed the type inspection. If other performance is found to be unqualified, it is allowed to double the sampling and test the unqualified items. If the inspection results still do not meet the requirements of this standard, the type inspection will be judged to be unqualified.
7 Logo, Instructions for Use, Packaging and Storage 7.1 Logo
7.1.1 Each cleaning machine should have a product label fixed in a location that is not easily damaged and is obvious. The size and technical requirements of the sign shall comply with the provisions of GB/T13306.
7.1.2 The cleaning machine label should include the following: a) product model and name;
b) main parameters; bzxZ.net
c) product number and manufacturing date: ||tt| |d) Manufacturer’s name and trademark:
e) Product standard number.
7.1.3 Packaging, storage and transportation marking shall be carried out in accordance with the provisions of GB/T191, and 7.1.4 Transport, packaging, receipt and delivery marking shall be carried out in accordance with the provisions of GB/T6388. 7.2 Instructions for use
The instructions for use of the product shall comply with the provisions of GB/T9969.1, and the instructions for the electrical part shall comply with the provisions of 18.2 in GB5226.1-2002.
7.3 Packaging
7.3.1 The packaging of the cleaning machine should be carried out in accordance with the regulations of GB/T13384. 7.3.2 The following documents should be included in the packaging box:
a) Product instruction manual, foundation installation drawing; 17
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b) Product certificate of conformity;|| tt||e) Packing list;
d) Material certificate, instrumentation, sensor, etc. calibration certificate specified in this standard. 7.4 Storage
7.4.1 The storage validity period of the cleaning machine packaging is 6 months from the date of shipment. The cleaning machine should be stored in a dry room or under a shed, and should not be tilted or pressed heavily. 7.4.2
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1 Type inspection should be carried out when any of the following situations occurs: a) When the product is trial-shaped or transferred to a factory for production; b) When there are major changes in the structure, materials, and processes of the product; c) When the product resumes production after 2 years of suspension: d) When the national quality supervision agency puts forward requirements for type inspection; e) When pharmaceutical manufacturers conduct equipment certification. 6.3.2 Type inspection items:
Type inspection shall conduct a comprehensive quality assessment and review of all technical requirements of this standard. 6.3.3 Sampling rules:
JB20003.2—2004
The prototypes for type inspection shall be selected from 10% of the products that have passed the factory inspection, and one unit shall be tested. The sampling method shall be carried out in accordance with the provisions of GB/T10111.
6.3.4 Judgment rules:
When all inspection results in the vehicle type inspection meet the requirements of this standard, the vehicle is deemed to have passed the type inspection. During the inspection, if one of the electrical safety performance parameters of protective grounding circuit continuity, insulation resistance, and withstand voltage is found to be unqualified, the product will be deemed to have failed the type inspection. If other performance is found to be unqualified, it is allowed to double the sampling and test the unqualified items. If the inspection results still do not meet the requirements of this standard, the type inspection will be judged to be unqualified.
7 Logo, Instructions for Use, Packaging and Storage 7.1 Logo
7.1.1 Each cleaning machine should have a product label fixed in a location that is not easily damaged and is obvious. The size and technical requirements of the sign shall comply with the provisions of GB/T13306.
7.1.2 The cleaning machine label should include the following: a) product model and name;
b) main parameters;
c) product number and manufacturing date: ||tt| |d) Manufacturer’s name and trademark:
e) Product standard number.
7.1.3 Packaging, storage and transportation marking shall be carried out in accordance with the provisions of GB/T191, and 7.1.4 Transport, packaging, receipt and delivery marking shall be carried out in accordance with the provisions of GB/T6388. 7.2 Instructions for use
The instructions for use of the product shall comply with the provisions of GB/T9969.1, and the instructions for the electrical part shall comply with the provisions of 18.2 in GB5226.1-2002.
7.3 Packaging
7.3.1 The packaging of the cleaning machine should be carried out in accordance with the regulations of GB/T13384. 7.3.2 The following documents should be included in the packaging box:
a) Product instruction manual, foundation installation drawing; 17
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b) Product certificate of conformity;|| tt||e) Packing list;
d) Material certificate, instrumentation, sensor, etc. calibration certificate specified in this standard. 7.4 Storage
7.4.1 The storage validity period of the cleaning machine packaging is 6 months from the date of shipment. The cleaning machine should be stored in a dry room or under a shed, and should not be tilted or pressed heavily. 7.4.2
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1 Type inspection should be carried out when any of the following situations occurs: a) When the product is trial-shaped or transferred to a factory for production; b) When there are major changes in the structure, materials, and processes of the product; c) When the product resumes production after 2 years of suspension: d) When the national quality supervision agency puts forward requirements for type inspection; e) When pharmaceutical manufacturers conduct equipment certification. 6.3.2 Type inspection items:
Type inspection shall conduct a comprehensive quality assessment and review of all technical requirements of this standard. 6.3.3 Sampling rules:
JB20003.2—2004
The prototypes for type inspection shall be selected from 10% of the products that have passed the factory inspection, and one unit shall be tested. The sampling method shall be carried out in accordance with the provisions of GB/T10111.
6.3.4 Judgment rules:
When all inspection results in the vehicle type inspection meet the requirements of this standard, the vehicle is deemed to have passed the type inspection. During the inspection, if one of the electrical safety performance parameters of protective grounding circuit continuity, insulation resistance, and withstand voltage is found to be unqualified, the product will be deemed to have failed the type inspection. If other performance is found to be unqualified, it is allowed to double the sampling and test the unqualified items. If the inspection results still do not meet the requirements of this standard, the type inspection will be judged to be unqualified.
7 Logo, Instructions for Use, Packaging and Storage 7.1 Logo
7.1.1 Each cleaning machine should have a product label fixed in a location that is not easily damaged and is obvious. The size and technical requirements of the sign shall comply with the provisions of GB/T13306.
7.1.2 The cleaning machine label should include the following: a) product model and name;
b) main parameters;
c) product number and manufacturing date: ||tt| |d) Manufacturer’s name and trademark:
e) Product standard number.
7.1.3 Packaging, storage and transportation marking shall be carried out in accordance with the provisions of GB/T191, and 7.1.4 Transport, packaging, receipt and delivery marking shall be carried out in accordance with the provisions of GB/T6388. 7.2 Instructions for use
The product instructions for use shall comply with the provisions of GB/T9969.1, and the instructions for the electrical part shall comply with the provisions of 18.2 in GB5226.1-2002.
7.3 Packaging
7.3.1 The packaging of the cleaning machine should be carried out in accordance with the regulations of GB/T13384. 7.3.2 The following documents should be included in the packaging box:
a) Product instruction manual, foundation installation drawing; 17
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b) Product certificate of conformity;|| tt||e) Packing list;
d) Material certificate, instrumentation, sensor, etc. calibration certificate specified in this standard. 7.4 Storage
7.4.1 The storage validity period of the cleaning machine packaging is 6 months from the date of shipment. The cleaning machine should be stored in a dry room or under a shed, and should not be tilted or pressed heavily. 7.4.2
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