JB 20019-2004 Pharmaceutical electronic counting bottle filling machine
Some standard content:
JB |
tablet press tablet punching die
aluminum plastic blister packaging machine
released on 2004-02-05
implemented on 2004-06-01
National Development and Reform Committee issued
ICS11.120.30
C92
JB
Pharmaceutical Machinery Industry Standard of the People's Republic of China JB20019—2004
Pharmaceutical Electronic Counting Bottle Filling Machine| |tt||Electronic drug counting and bottle-filling machine released on 2004-02-05
Implemented on 2004-06-01
Released by the National Development and Reform Commission
Foreword
Scope
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3
4
5
6
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Normative reference document,||tt ||Terms and definitions
Classification and labeling·
Requirements...
Test methods
Inspection rules
Marking, instructions for use, packaging, transportation and Storage items
1998 revised edition), GB/T1.1-2000 and GB/T1.2-2002 standardization work guidelines were formulated.
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: Jiangsu Laser Research Institute Co., Ltd. The main drafters of this standard: Jiang Jialin, Miao Delin, Chen Kemao. 1 Scope
Pharmaceutical electronic counting bottling machine
JB 20019-2004
This standard specifies the terms and definitions, classification and labeling, requirements, test methods, inspection of pharmaceutical electronic counting bottling machine Rules and markings, instructions for use, packaging, transport and storage. This standard applies to pharmaceutical electronic counting bottling machines (hereinafter referred to as bottling machines) that use electronic counting to load solid pharmaceuticals (tablets, pills, gelatin) into medicine bottles.
2 Normative reference documents
The provisions in the following documents are quoted in this standard and become the provisions of this standard. For dated reference documents, all subsequent amendments (excluding errata content) Neither this standard nor its revisions apply. However, parties to an agreement based on this standard are encouraged to investigate whether the latest versions of these documents can be used. For undated referenced documents, the latest edition applies to this standard. CB/T191 Packaging, storage and transportation pictorial mark
CB5226.1-2002 Mechanical safety mechanical and electrical equipment Part 1: General technical conditions GB/T6388 Transport, packaging, receipt and delivery mark
GB/T9969.1 General instructions for use of industrial products Method of random sampling using random numbers GB/T10111
GB/T13306 Labeling
CB/T 16769
Olefin plastic bottles for solid pharmaceutical cases
YY0057
3 Terms and Definitions
The following terms and definitions apply to this standard. 3.1
Intermittent European fitfulmode
performs medicine bottling by means of intermittent transmission motion. 3.2
Continuous successful mode
performs medicine bottling in a continuous transmission motion. 3.3 | | tt | JB 200192004
3.4
Electronic countingelectronic counting
Use electronic technology to measure the quantity of medicines. 3.5
Counting error theerrorofcounting
The percentage of the number of error bottles and the number of sampling bottles. 3.6
Bottle speed ratedspeedofbottle-filling unit time, the number of bottles loaded with medicines. 3.7
Error bottle comeamissthebottle
The number of medicines in the bottle is inconsistent with the set filling amount. 4 Classification and Marking
4.1 Classification
The classification of bottling machines is divided into intermittent type (J) and continuous type (L) according to the bottling method. 4.2 Marking
The model mark of the bottling machine should comply with the following regulations: Zaokou
Improved design sequence number; spell out the letters A, B, and C in Chinese in sequence. Specification code: number of bottling heads/guide medicine path Number, both sets of parameters are represented by Arabic numerals 1, 2, 3
Type code: bottling method J one implicit, L-continuous product function code: electronic counting machine
Marking example
DJ2/16A type: represents the membrane-type double-head 16-channel pharmaceutical electronic counting bottling machine that has undergone the first improved design. 5 Requirements
5.1 Materials
All parts in contact with drugs must be made of austenitic stainless steel or other materials that have been proven to be non-toxic, non-adsorbent, and have stable chemical properties.
5.2 Appearance
The outer surface of the bottling machine should be flat, smooth, without burrs, the welds should be smooth and polished, and the metal plating should be evenly coated without defects such as defects or rust. All parts in contact with medicines should be smooth, flat, wear-resistant, easy to clean and have no dead ends. 5.3 Performance
5.3.1 Usage performance
6
JB20019-2004
a) Counting error: The filling amount deviation of the wrong bottle shall not exceed ±1 tablet ( tablets), and the number of bottles with incorrect filling amounts is no more than 1%; b) Stability requirements: the bottling machine should be able to operate smoothly. 5.3.2 Safety performance
5.3.2.1 Electrical safety:
a) The continuity of the protective grounding circuit of the electrical system shall comply with the provisions of 19.2 in CB5226,1-2002: b) Insulation resistance of the electrical system Should comply with the provisions of 19.3 in GB5226.1--2002; c) The attached voltage of the electrical system shall comply with the provisions of 19.4 of GB5226.1-2002: d) The protective grounding circuit of the electrical system shall comply with the provisions of GB5226.1-2002 8.2; e) The markings, warning signs and project codes of electrical systems should comply with the provisions of Chapter 17 of GB5226.1-2002. 5.3.2.2 Operation safety:
a) The bottling machine should have effective operating safety protection devices; b) The installation parts of electrical components should have waterproof and moisture-proof measures. 5.3.3 Performance of electromechanical mechanism
a) The feeding and bottle feeding mechanisms can be adjusted within the applicable scope, and the operation is coordinated and in time: b) The preset and display devices reflect the real-time status of bottling. The instructions are accurate and clear; c) The fault alarm system should be able to realize electromechanical interlocking and automatically stop bottle feeding and bottling; d) The seals of pneumatic components are not allowed to leak oil or air. 5.3.4 Noise
During no-load operation, the mechanical noise sound pressure level shall not be greater than 82dB(A). 5.3.5 Online and linkage
The bottling machine should have an online and linkage interface, which can receive the fault signal of the upstream or downstream equipment and decide to stop the operation. 6 Test Methods
6.1 Material Inspection
Provide material information of parts and components in contact with bottled drugs, one copy for each production batch. When the material cannot be proved, the corresponding material test should be carried out Method testing.
6.2 Appearance Inspection
Use visual inspection and hand feeling methods to inspect the appearance quality of the bottling machine. 6.3 Performance test
6.3.1 Usage performance test
6.3.1.1 Test conditions:
a) Power supply:
AC voltage: 220×(1±10% )V,Frequency: 50×(1±2%)Hz or AC voltage: 380×(1±10%)V, frequency: 50×(1±2%)Hb) Ambient temperature: 0℃~40℃; ||tt| |c) Environmental humidity: RH65% (at 20°C) d) Requirements for bottled drugs: Qualified drugs that have been processed. The single-head bottling machine test uses (0~2) hard capsules or soft capsules of corresponding specifications; the multi-head bottling machine test uses (5.5~8) mm plain tablets; e) Bottle volume: glue bottled The quantity is 50 tablets/bottle, and the tablet bottle quantity is 100 tablets/bottle: f) Requirements for packaging containers: Use solid pharmaceutical polyolefin plastic bottles or glass bottles that are suitable for the test drug variety and bottle quantity and comply with the provisions of YY0057 , the main part of the shape is cylindrical or square prism; g) Test quantity: 1000 bottles × 3:
h) Bottling speed: the upper limit of the rating. | |tt | Check the bottle volume one by one, and count the bottle volume to find out b)
The wrong number of bottles and the deviation of the bottle volume in the medicine bottle; the counting error is calculated according to formula (1):
8= (X /100)×100%
where:
8—counting error;
X—actual error number of bottles, bottles.
e) Repeat the test three times according to the above test steps, and take the average value of the three times. 6.3.1.3 Stability test:
a) Make necessary adjustments and settings to the electromechanical mechanism of the bottling machine: b) The running time of the bottling machine shall not be less than 30min: c) The bottling speed value is calculated according to formula (2) ：0=m/n
where:
v-bottling speed value, bottles/min, the value is an integer; n-bottling machine running time when testing rated bottling speed, min; m
The number of bottles filled within a period of time. If the last bottle is not filled enough, it will not be counted. d) Repeat the test three times according to the above test steps, and take the average value of the three times. The average value should be equal to the upper limit of the rated speed: e) Observe the smoothness of the operation of the bottling machine, and there is no bottle inversion, bottle blocking, or leakage. 6.3.2 Safety performance test
6.3.2.1 Electrical safety test:
(1)
(2)
a) Continuity of electrical system protective grounding circuit , insulation resistance and withstand voltage tests shall be carried out in accordance with the provisions of 19.2, 19.3 and 19.4 in GB5226.1-2002 respectively:
b) The protective grounding circuit, markings, warning signs and project codes of the electrical system shall be in accordance with CB5226. 1-2002 8.2, Chapter 17 regulations for inspection.
6.3.2.2 Operational safety test:
a) Check the effectiveness of safety protection devices around high-speed machinery and live parts that operators cannot avoid during normal operation and are easily accessible;| |tt||b), check the effectiveness of waterproof and moisture-proof measures for the installation parts of electrical components. 8
6.3.3 Electromechanical mechanism performance test
6.3.3.1 Adjustability test of feeding and bottle feeding mechanisms: JB20019-2004
a) Appropriate adjustments according to the variety and specifications of the drug Adjustable parts of the feeding mechanism, observe the physical film and arrangement of the drugs during the unloading process;
b) According to the condition of the medicine bottles used, appropriately adjust the adjustable parts of the bottle feeding mechanism, and observe the bottle feeding mechanism The operation status of the bottle feeding action.
6.3.3.2 Test of preset and display devices: Check whether the preset device can set the bottle volume arbitrarily within the specified range: Check whether the display device can reflect the real-time status of drug bottling of the bottling machine.
6.3.3.3 Test of fault alarm system:
a) Simulation test of bottle shortage alarm: During the normal counting and bottling operation of the bottling machine, if the bottle feeding is manually blocked, the machine should be able to issue an alarm instructions, and automatically stop filling in advance; b) Simulation test of bottle blocking alarm: During the normal counting and bottling operation of the bottling machine, a certain number of medicine bottles are artificially piled on the conveyor belt, causing an impact on the filling, and the machine The alarm system should be able to issue alarm instructions and automatically stop filling in advance: Simulation test of drug counting sensor: During the normal counting and bottling operation of the bottling machine, the drug counting sensor c)
detector head is manually blocked , the speed shift time is not less than 1s, the machine should be able to issue alarm instructions and automatically stop loading in advance. 6.3.3.4 Test for oil leakage and air leakage from the seals of pneumatic components: Use absorbent cotton to gently wipe around the seals of the pneumatic components and observe whether the absorbent cotton is full of oil; apply soapy water on the seals of the pneumatic components to seal place and check for air leakage. 6.3.4 Mechanical noise test
When the mechanical sound is no-load and running at high speed, the sound level meter should be used according to the method of CB/T16769. 6.3.5 Simulation test of online and linkage interfaces After the online and linkage interfaces receive simulated fault signals, the bottling machine should be able to receive simulation instructions and shut down. 7 Inspection Rules
7.1 Inspection Categories
Bottle machine inspection is divided into factory inspection and type inspection. 7.2 Factory inspection
7.2.1 Factory inspection items are shown in Table 1.
Table 1 Factory Inspection Items
Item Category
Material
Appearance
Performance Characteristics
7.2.2 Judgment Rules: ||tt ||Inspection items
5.1
5.2
5.3.1,5.3.2,5.3.3,5.3.5
The bottling machine should be inspected by the quality inspection department of the creation unit Each unit is inspected one by one and can only leave the factory after passing the inspection. It should be accompanied by an inspection certificate when leaving the factory 9
1 Test on the adjustability of feeding and bottle feeding mechanisms: JB20019-2004
a) Appropriately adjust the adjustable parts of the feeding mechanism according to the types and specifications of the drugs, and observe the physical slices and arrangement of the drugs during the unloading process ;wwW.bzxz.Net
b) According to the condition of the medicine bottles used, appropriately adjust the adjustable parts of the bottle feeding mechanism and observe the operation of the bottle feeding action of the bottle feeding mechanism.
6.3.3.2 Test of preset and display devices: Check whether the preset device can set the bottle volume arbitrarily within the specified range: Check whether the display device can reflect the real-time status of drug bottling of the bottling machine.
6.3.3.3 Test of fault alarm system:
a) Simulation test of bottle shortage alarm: During the normal counting and bottling operation of the bottling machine, if the bottle feeding is manually blocked, the machine should be able to issue an alarm instructions, and automatically stop filling in advance; b) Simulation test of bottle blocking alarm: During the normal counting and bottling operation of the bottling machine, a certain number of medicine bottles are artificially piled on the conveyor belt, causing an impact on the filling, and the machine The alarm system should be able to issue alarm instructions and automatically stop filling in advance: Simulation test of drug counting sensor: During the normal counting and bottling operation of the bottling machine, the drug counting sensor c)
detector head is manually blocked , the speed shift time is not less than 1s, the machine should be able to issue alarm instructions and automatically stop loading in advance. 6.3.3.4 Test for oil leakage and air leakage from the seals of pneumatic components: Use absorbent cotton to gently wipe around the seals of the pneumatic components and observe whether the absorbent cotton is full of oil; apply soapy water on the seals of the pneumatic components to seal place and check for air leakage. 6.3.4 Mechanical noise test
When the mechanical sound is no-load and running at high speed, the sound level meter should be used according to the method of CB/T16769. 6.3.5 Simulation test of online and linkage interfaces After the online and linkage interfaces receive simulated fault signals, the bottling machine should be able to receive simulation instructions and shut down. 7 Inspection Rules
7.1 Inspection Categories
Bottle machine inspection is divided into factory inspection and type inspection. 7.2 Factory inspection
7.2.1 Factory inspection items are shown in Table 1.
Table 1 Factory Inspection Items
Item Category
Material
Appearance
Performance Characteristics
7.2.2 Judgment Rules: ||tt ||Inspection items
5.1
5.2
5.3.1,5.3.2,5.3.3,5.3.5
The bottling machine should be inspected by the quality inspection department of the creation unit Each unit is inspected one by one and can only leave the factory after passing the inspection. It should be accompanied by inspection certificate 9
1 Test on the adjustability of feeding and bottle feeding mechanisms: JB20019-2004
a) Appropriately adjust the adjustable parts of the feeding mechanism according to the types and specifications of the drugs, and observe the physical slices and arrangement of the drugs during the unloading process ;
b) According to the condition of the medicine bottles used, appropriately adjust the adjustable parts of the bottle feeding mechanism and observe the operation of the bottle feeding action of the bottle feeding mechanism.
6.3.3.2 Test of preset and display devices: Check whether the preset device can set the bottle volume arbitrarily within the specified range: Check whether the display device can reflect the real-time status of drug bottling of the bottling machine.
6.3.3.3 Test of fault alarm system:
a) Simulation test of bottle shortage alarm: During the normal counting and bottling operation of the bottling machine, if the bottle feeding is manually blocked, the machine should be able to issue an alarm instructions, and automatically stop filling in advance; b) Simulation test of bottle blocking alarm: During the normal counting and bottling operation of the bottling machine, a certain number of medicine bottles are artificially piled on the conveyor belt, causing an impact on the filling, and the machine The alarm system should be able to issue alarm instructions and automatically stop filling in advance: Simulation test of drug counting sensor: During the normal counting and bottling operation of the bottling machine, the drug counting sensor c)
detector head is manually blocked , the speed shift time is not less than 1s, the machine should be able to issue alarm instructions and automatically stop loading in advance. 6.3.3.4 Test for oil leakage and air leakage from the seals of pneumatic components: Use absorbent cotton to gently wipe around the seals of the pneumatic components and observe whether the absorbent cotton is full of oil; apply soapy water on the seals of the pneumatic components to seal place and check for air leakage. 6.3.4 Mechanical noise test
When the mechanical sound is no-load and running at high speed, the sound level meter should be used according to the method of CB/T16769. 6.3.5 Simulation test of online and linkage interfaces After the online and linkage interfaces receive simulated fault signals, the bottling machine should be able to receive simulation instructions and shut down. 7 Inspection Rules
7.1 Inspection Categories
Bottle machine inspection is divided into factory inspection and type inspection. 7.2 Factory inspection
7.2.1 Factory inspection items are shown in Table 1.
Table 1 Factory Inspection Items
Item Category
Material
Appearance
Performance Characteristics
7.2.2 Judgment Rules: ||tt ||Inspection items
5.1
5.2
5.3.1,5.3.2,5.3.3,5.3.5
The bottling machine should be inspected by the quality inspection department of the creation unit Each unit is inspected one by one and can only leave the factory after passing the inspection. It should be accompanied by an inspection certificate when leaving the factory 9
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