JB 20003.4-2004 Eye drops linkage line filling, plugging and capping machine
Some standard content:
ICS11.120.30
C92
JB
Pharmaceutical Machinery Industry Standard of the People's Republic of China JB20003.4—2004
Production line for eyedropsFilling & closing machine2004-02-05Promulgated
2004-06-01Implementation
National Development and Reform CommissionPromulgated
Foreword
1Scope
2Normative references
3Model and marking
4Requirements
5Test methods
6Inspection rules
7Marking, instructions for use, packaging and storage
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JB20003.4—2004
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JB20003.4-—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. The drafting unit of this standard: Beijing Aerospace Wanda High-Tech Development Center. The main drafters of this standard: Feng Ruixin, Wang Jinyan, Shuai Jingzhou. 32
1 Scope
Filling, plugging and capping machines for eye drops
JB 20003.4—2004
This standard specifies the type and marking, requirements, test methods, inspection rules and signs, instructions for use, packaging and storage of thin-pack plugging and capping machines for eye drops.
This standard applies to filling, plugging and capping machines for eye drops plastic bottles (hereinafter referred to as filling and capping machines). 2 Normative references
The clauses in the following documents become the clauses of this standard through reference in this standard. For all dated references, all subsequent amendments (excluding errata) or revisions are not applicable to this standard. However, the parties to an agreement based on this standard are encouraged to study whether the latest versions of these documents can be used. For all undated references, the latest versions are applicable to this standard. CB/T191 Pictorial markings for packaging, storage and transportation
GB5226.1--2002 Mechanical safety Mechanical electrical equipment Part 1: General technical conditions CB/T6388 Shipping and receiving markings for transport packaging
CB/T9969.1 General principles for instructions for use of industrial products GB10111 Methods for random sampling using random numbers GB/T13306
Signages
GB/T13384
GB/T 16769
General technical conditions for packaging of electromechanical products
Method for measuring sound pressure level of noise from metal cutting machine tools YY/T0216--1995 Method for compiling and shortening model numbers of pharmaceutical machinery products Good Manufacturing Practice for Pharmaceuticals (1998 revised edition) State Food and Drug Administration Pharmacopoeia of the People's Republic of China (2000 edition) National Pharmacopoeia Committee 3 Models and markings
3.1 Model
The model of the filling and sealing machine shall comply with the provisions of YY/T0216. DL·GO/O
Specification code: Production capacity (pieces/min)/bottle volume (mL) Type and feature code: Linkage line sealing machine Product function code: Eye drop machine
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JB 20003.4-2004
3.2 Marking example
4 Requirements
4.1 General
DL·G
G80/7
Bottle volume 7mL
Production capacity 80 pieces/min
Eye drop linkage line filling and sealing machine
The design, manufacture, installation, use, repair, maintenance and verification of the filling and sealing machine shall comply with the relevant principle instructions of the Good Manufacturing Practice for Pharmaceuticals (1998 revised edition).
4.2 Working conditions
4.2.1 Ambient temperature: The ambient air temperature for normal operation is between 18℃ and 28℃. 4.2.2 Humidity: Relative humidity 50%~60%. 4.2.3 Environmental cleanliness: The potting room should be a clean area of ??10,000 levels. 4.3 Material requirements
4.3.1 Parts that are in direct contact with liquids and gases should be made of low-carbon austenitic stainless steel or non-toxic, corrosion-resistant materials that do not react chemically with the contacting liquid, do not produce adsorption, and do not produce particles. The materials used should have a material certificate. 4.3.2 Other materials should be non-toxic, corrosion-resistant or rust-proof treated, and no particles should be precipitated. 4.3.3 Parts that need to be disinfected frequently should have good heat resistance. 4.4 Appearance requirements
4.4.1 The outer surface of the potting machine should be flat and smooth, without protrusions, depressions, cracks and dead corners, and easy to clean and disinfect. 4.4.2 The edges of the exposed joint surfaces of the parts should be neat and uniform, and there should be no obvious misalignment. 3 The installed nameplates, warning signs, function identification marks and grounding symbols should be clear, complete and durable. 4.4.3
4.5 Structural requirements
4.5.1 The filling machine should have a bottle positioning device.
4.5.2 When changing the filling specifications, the accessories that need to be replaced should be simple, reliable, and quick to replace. 4.5.3 The capping head assembly can be replaced as a whole, quickly and conveniently. 4.5.4 The filling machine should have a height adjustment device. 4.5.5 The part above the table of the filling machine should have a safety cover. 4.6 Functional requirements
4.6.1 Production speed requirements:
The filling machine should meet the production speed requirements, be adjustable within the specified range, and be able to display the production speed. 4.6.2 Filling quantity requirements:
The filling machine can meet the filling quantities of different specifications. 4.6.3 Interlocking function:
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It has the function of not filling if there is no bottle, not dropping the cap if there is no plug. 4.7 Performance requirements
4.7.1 No-load performance:
No-load operation is flexible, stable and unobstructed, and there is no abnormality in the electrical control system. 4.7.2 Load performance:
JB 20003.4—2004
When running under load, the conveying device should ensure that the bottles are in place, and the filling, plugging, capping and capping stations should move flexibly and accurately. 4.7.3 Pipeline requirements:
The pipeline connection is tight, there should be no gas or liquid leakage at the connection, and there should be no dripping phenomenon on the filling needle. 4.7.4 Filling volume and filling volume error:
The filling volume and filling volume error should comply with the provisions of the "Pharmacopoeia of the People's Republic of China" (2000 edition). 4.7.5 Requirements for plugging and capping:
The plugging is in place, the capping is timely and accurate, the bottle cap is straight and firm after capping, and the surface is not damaged. 4.7.6 Product qualification rate:
The qualification rate of the filling machine is greater than or equal to 98%. 4.7.7 Noise:
The sound pressure level of the load operation noise is not greater than 70dB(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 of GB5226.1-2002. 4.8.2 The insulation resistance of the electrical system shall comply with the provisions of 19.3 of GB5226.1-2002. 4.8.3 The withstand voltage of the electrical system shall comply with the provisions of 19.4 of GB5226.1-2002. 4.8.4 The protective grounding circuit of the electrical system shall comply with the provisions of 8.2 of GB5226.1-2002. 4.8.5 The buttons of the electrical system shall comply with the provisions of 10.2 of CB5226.1-2002. 4.8.6 The indicator lights and displays of the electrical system shall comply with the provisions of 10.3 of GB5226.1-2002. The wiring of the electrical system shall comply with the provisions of Chapter 14 of GB5226.1-2002. 4.8.7
4.8.8 The markings, warning signs and project codes of the electrical system shall comply with the provisions of Chapter 17 of GB5226.1-2002. 5 Test methods
5.1 Technical document inspection
Use the sensory method to check the manual, product certificate, material certificate and calibration certificate of the main instruments and meters of the filling machine. 5.2 Working condition inspection
Use a thermometer and a hygrometer to measure the temperature and humidity of the working environment of the filling machine. 5.3 Material, appearance and structure inspection
Visually inspect the material certification data of the materials used, the appearance and structure of the machine. 5.4 Functional inspection
5.4.1 Production speed test:
Adjust the filling machine speed to the designed maximum speed, input bottles, replace the liquid medicine with drinking water, run the machine under load for 30 minutes, and count for 5 minutes with a tachometer or stopwatch. Adjust the operating speed within the specified range, and test the speed adjustment effect by testing the production speed method. 35
JB20003.4—2004
5.4.2 Loading capacity test:
Use the sensory method of measuring instruments.
5.4.3 Loading and falling cap lotus lock test:
Remove the bottle from the bottle entry dial of the filling and sealing machine, and observe that the liquid needle does not fill with liquid when the empty bottle station reaches the filling station. : No plug is supplied at the stoppering station. Observe that the machine does not drop the cap when the bottle without stopper reaches the capping station. 5.5 Performance inspection
5.5.1 No-load test:
Start the potting machine without load and run the speed from low to high for 2 hours to confirm the operation and control functions. 5.5.2 Load test:
After the no-load test of the closed machine is qualified, the load test is carried out. During the test, the highest production speed was used, drinking water was used instead of liquid medicine, bottles were input, and normal production procedures were simulated for 30 minutes to measure the operation and control functions of each filling and sealing station. 5.5.3 Pipeline test:
Use drinking water instead of liquid medicine, simulate normal production procedures, and observe the pipeline connections and filling needles. 5.5.4 Filling volume and filling volume error test:
The filling volume and filling volume error should be tested in accordance with the provisions of the "Pharmacopoeia of the People's Republic of China" (2000 edition). 5.5.5 Plugging and capping test:
Use sensory method to test.
5.5.6 Filling qualification rate test:
The cat sealing machine simulates the normal production process for testing, randomly and continuously selects 600 filling bottles, checks the sealing quality and conducts the qualification rate according to formula (1) calculate.
Product qualification rate:
5.5.7 Noise test:
Number of qualified bottles
Total number of bottles tested
X100%
The potting machine is tested with a sound level meter in accordance with the regulations of CB/T16769 at the highest production speed and load operation. 5.6 Electrical system testing
(1)
5.6.1 The continuity, insulation resistance, and withstand voltage tests of the protective grounding circuit of the electrical system shall be in accordance with the provisions of 19.2, 19.3, and 19.4 of CB5226.1-2002 respectively. Perform testing.
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 GB5226.1-2002 8.2, 10.2, 10.3, Chapter 14 and Check the provisions of Chapter 17. 6 Inspection Rules
6.1 Inspection Categories
The inspection of potting machines is divided into factory inspection and type inspection. 6.2 Factory inspection
6.2.1 Each filling and sealing machine should be inspected 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. 36
Project Category
General Projects
Main Projects
Table 1 Potting Machine Factory Inspection Items
Inspection Items
JB 20003.4— 2004
4.2,4.3,4.4,4.5.1,4.5.2,4.5.34.5.4, 4.5.5, 4.6, 4.7, 4.8
6.2.3 Potting machine in factory inspection If a substandard product is found, it will be returned for repair. If it is still unqualified after repair, it will be judged as a substandard product and will not be allowed to leave the factory.
6.3 Type inspection
6.3.1 Type inspection shall be carried out when one of the following situations occurs: a) When the product is trial-formulated or transferred to a factory for production; b) The structure, material, and process of the product have significant differences. When there is a major change; c) When the product resumes production after 2 years of suspension; d) When the national quality supervision agency proposes a request for type inspection: when the pharmaceutical manufacturer conducts equipment certification. e)
6.3.2 Type inspection items:
Type inspection shall conduct comprehensive quality assessment and review of all technical requirements of this standard. 6.3.3 Sampling rules:
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 is carried out according to GB/T10111. 6.3.4 Judgment rules:
When all inspection results in the type inspection meet the requirements of this standard, the type inspection is judged to be qualified. During the inspection, if any of the electrical safety performance of protective grounding circuit continuity, insulation resistance, and withstand voltage fails, the product will be deemed to have failed the type inspection. If other performance is found to be unqualified, double sampling is allowed to 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 potting 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 label of the filling machine should include the following: a) product model and name;
b) main parameters;
e)
product number and manufacturing Issue date:
d) Manufacturer’s name and trademark;
e) Product standard number.
7.1.3 Packaging, storage and transportation markings shall comply with the provisions of CB/T191. 7.1.4 The transportation and packaging receipt and delivery markings shall be in accordance with the provisions of GB/T6388. 7.2 Instructions for use
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The product instructions for use shall comply with the provisions of GB/T9969.1, and the instructions for the electrical part shall comply with GB5226.1-2002 18.2 Regulation.
7.3 Packaging
7.3.1 The packaging of the potting machine should be carried out in accordance with the regulations of GB/T13384. The following documents should be enclosed in the packaging box:
7.3.2
a) Product instruction manual, foundation installation drawing; b) Product certificate of conformity;
e)
d )bzxZ.net
Packing list;
The material certificate, instrument and sensor calibration certificate specified in this standard. 7.4 Storage
7.4.1 The storage validity period of the filling and sealing machine packaging is 6 months from the date of shipment. The potting 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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2. Factory inspection shall be carried out on a unit-by-unit basis according to the terms in Table 1. 36
Project Category
General Projects
Main Projects
Table 1 Potting Machine Factory Inspection Items
Inspection Items
JB 20003.4— 2004
4.2,4.3,4.4,4.5.1,4.5.2,4.5.34.5.4, 4.5.5, 4.6, 4.7, 4.8
6.2.3 Potting machine in factory inspection If a substandard product is found, it will be returned for repair. If it is still unqualified after repair, it will be judged as a substandard product and will not be allowed to leave the factory.
6.3 Type inspection
6.3.1 Type inspection shall be carried out when one of the following situations occurs: a) When the product is trial-formulated or transferred to a factory for production; b) The structure, material, and process of the product have significant differences. When there is a major change; c) When the product resumes production after 2 years of suspension; d) When the national quality supervision agency proposes a request for type inspection: when the pharmaceutical manufacturer conducts equipment certification. e)
6.3.2 Type inspection items:
Type inspection shall conduct comprehensive quality assessment and review of all technical requirements of this standard. 6.3.3 Sampling rules:
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 is carried out according to GB/T10111. 6.3.4 Judgment rules:
When all inspection results in the type inspection meet the requirements of this standard, the type inspection is judged to be qualified. During the inspection, if any of the electrical safety performance of protective grounding circuit continuity, insulation resistance, and withstand voltage fails, the product will be deemed to have failed the type inspection. If other performance is found to be unqualified, double sampling is allowed to 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 potting 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 label of the filling machine should include the following: a) product model and name;
b) main parameters;
e)
product number and manufacturing Issue date:
d) Manufacturer’s name and trademark;
e) Product standard number.
7.1.3 Packaging, storage and transportation markings shall comply with the provisions of CB/T191. 7.1.4 The transportation and packaging receipt and delivery markings shall be in accordance with the provisions of GB/T6388. 7.2 Instructions for use
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JB 20003.4—2004
The product instructions for use shall comply with the provisions of GB/T9969.1, and the instructions for the electrical part shall comply with GB5226.1-2002 18.2 Regulation.
7.3 Packaging
7.3.1 The packaging of the potting machine should be carried out in accordance with the regulations of GB/T13384. The following documents should be enclosed in the packaging box:
7.3.2
a) Product instruction manual, foundation installation drawing; b) Product certificate of conformity;
e)
d )
Packing list;
The material certificate, instrument and sensor calibration certificate specified in this standard. 7.4 Storage
7.4.1 The storage validity period of the filling and sealing machine packaging is 6 months from the date of shipment. The potting 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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2. Factory inspection shall be carried out on a unit-by-unit basis according to the terms in Table 1. 36
Project Category
General Projects
Main Projects
Table 1 Potting Machine Factory Inspection Items
Inspection Items
JB 20003.4— 2004
4.2,4.3,4.4,4.5.1,4.5.2,4.5.34.5.4, 4.5.5, 4.6, 4.7, 4.8
6.2.3 Potting machine in factory inspection If a substandard product is found, it will be returned for repair. If it is still unqualified after repair, it will be judged as a substandard product and will not be allowed to leave the factory.
6.3 Type inspection
6.3.1 Type inspection shall be carried out when one of the following situations occurs: a) When the product is trial-formulated or transferred to a factory for production; b) The structure, material, and process of the product have significant differences. When there is a major change; c) When the product resumes production after 2 years of suspension; d) When the national quality supervision agency proposes a request for type inspection: when the pharmaceutical manufacturer conducts equipment certification. e)
6.3.2 Type inspection items:
Type inspection shall conduct comprehensive quality assessment and review of all technical requirements of this standard. 6.3.3 Sampling rules:
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 is carried out according to GB/T10111. 6.3.4 Judgment rules:
When all inspection results in the type inspection meet the requirements of this standard, the type inspection is judged to be qualified. During the inspection, if any of the electrical safety performance of protective grounding circuit continuity, insulation resistance, and withstand voltage fails, the product will be deemed to have failed the type inspection. If other performance is found to be unqualified, double sampling is allowed to 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 potting 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 label of the filling machine should include the following: a) product model and name;
b) main parameters;
e)
product number and manufacturing Issue date:
d) Manufacturer’s name and trademark;
e) Product standard number.
7.1.3 Packaging, storage and transportation markings shall comply with the provisions of CB/T191. 7.1.4 The transportation and packaging receipt and delivery markings shall be in accordance with the provisions of GB/T6388. 7.2 Instructions for use
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JB 20003.4—2004
The product instructions for use shall comply with the provisions of GB/T9969.1, and the instructions for the electrical part shall comply with 18.2 of GB5226.1-2002 Regulation.
7.3 Packaging
7.3.1 The packaging of the potting machine should be carried out in accordance with the regulations of GB/T13384. The following documents should be enclosed in the packaging box:
7.3.2
a) Product instruction manual, foundation installation drawing; b) Product certificate of conformity;
e)
d )
Packing list;
The material certificate, instrument and sensor calibration certificate specified in this standard. 7.4 Storage
7.4.1 The storage validity period of the filling and sealing machine packaging is 6 months from the date of shipment. The potting 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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