Some standard content:
JB | |Rolling mode soft capsule machine
Capsule tablet printing machine
Released on 2004-02-05
Implemented on 2004-06-01
National Development and Reform Commission||tt ||Release
ICS11.120.30
C92
JB
Pharmaceutical Machinery Industry Standard of the People's Republic of China JB20028—2004
replaces YY0135—1993||tt ||Capsule and tablet printer
Capsuleandtabletprinter
Released on 2004-02-05
Implemented on 2004-06-01
National Development and Reform Commission
Released
Foreword
1 Scope
2 Normative reference documents
3 Terms and definitions
4 Classification and labeling
5 Requirements|| tt||6 Test methods
Inspection rules
8 Marking, packaging, transportation and storage
Since
times
JB20028—2004||tt| |46
47
47
47
48
48
50
52
S3
45
JB200282004
Foreword
This standard is based on the "Good Manufacturing Practice for Drugs" and CB/T1.1-2000, GB/1.2-2002 standardization work In accordance with the requirements of the guideline, the revision of YY/T0135-1993 "Capsule and Tablet Printing Machine". This standard replaces YY/T0315-1993 from the date of implementation. Compared with YY/T0135--1993, the main contents of this standard have changed as follows: a) The main chapters and clauses of YY/T0315-1993 have been deleted: Assembly requirements (4.6);
Metal plating parts requirements (4.8. 3);
—paint (4.8.4).
b) Revised the main chapters and articles of YY/T0315-1993: Noise index (4.5.4);
Printing pass rate (4.7);
Noise test method ( 5.3);
Type inspection (6.2.2.1).
c) The main chapters and clauses added to this standard:
materials and components (see 5.3);
operating performance (see 5.4);
printing quality Added printing defect identification (see 5.5.1): printing defect inspection and judgment (see 6.5);
production capacity measurement method (see 6.6).
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: Suzhou Xinneng Mechanical and Electrical Equipment Co., Ltd. The main author of this standard is: Zhou Hongyu.
The previous versions of the standard replaced by this standard are: YY/T0315-1993.46
1 scope
Capsule and tablet printing machine
JB20028-2004|| tt||This standard specifies the terms and definitions, classification and labeling, requirements, test methods, inspection rules and markings, packaging, transportation and storage of capsule and tablet printers.
This standard applies to capsule and tablet printing machines for gravure printing (hereinafter referred to as printing machines). 2 Normative reference documents
The provisions in the following documents become provisions of this standard through reference in this standard. For dated referenced documents, all subsequent amendments (excluding corrigenda) or revisions do not apply to this standard. However, parties to 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 mark
GB1002 Types, basic parameters and dimensions of single-phase plugs and sockets for household and similar purposes
CB/T2411 Plastic Shore hardness test method CB5226.1-2002 Mechanical Safety Mechanical and electrical equipment Part 1: General technical conditions CB/T6388 Transportation, packaging, receipt and delivery marks
CB/T7932
General technical conditions for pneumatic systems
CB/T9969.1 Industrial product use General provisions of instructions GB/T13306 Labels
CB/T13384 General technical conditions for mechanical and electrical product packaging 5 General provisions of industrial product guarantee documents
CB/T 14436
Method for determination of noise and sound pressure level of metal cutting machine tools GB /T16769
CB16798-1997 Food Machinery Safety and Hygiene 3 Terms and Definitions
The following terms and definitions apply to this standard. 3.1
Printingdefect
Various defects that appear in capsules and tablets after printing. 3.2
printing qualification rate printing qualification rate is the qualification rate of capsules and tablets after printing.
47
JB20028—2004
4 Classification and labeling
4.1 Product classification
4.1.1 Printing machines are divided into five types according to the feeding structure type (See Table 1). Table 1 Feeding structure type and code
Feeding type code
Feeding form
Structure diagram
Print
Object
Hard capsule|| tt||Soft capsules
Tablets
B
Wrinkle type
D
Soft channel type
L
Flat chain type
9/
Hollow rubber, filled capsule
P
Disk type
Guangzhou shape
$3mm~ 12nm
4.1.2
printers are divided into specifications according to their average production capacity, including 200, 120, 80, 40, and 20 (see Table 2). Table 2 Production capacity and code
Specification code
Production capacity
4.2 mark
4.2.1 Model:
200
> 150 ~250
120
> 90 ~ 150
80bzxZ.net
>60 ~90
40
30~60||tt| |The printer model consists of product function code, feeding type code, feature code and specification code. Specification code: (See Table 2)
G
Rolling simplified form
Thousand grains (pieces)/h
20
30||tt| |Feature code, special models for hard capsules are not represented, general models suitable for hard, soft capsules and tablets are represented by "T".
Feeding structure type code: (see Table 1)
Product function code: printing machinery
4.2.2 Model example:
YPT-80 type: indicates average production It is a general-purpose capsule and tablet printing machine with a capacity of 80 capsules (tablets)/h and a disc-feeding format. YL-120 type: represents a flat chain feeding hard capsule printing machine with an average production capacity of 120 thousand capsules (tablets)/h. 5 Requirements
5.1 Working conditions
The printer should be able to work normally under the following conditions: 48
a) Ambient temperature: 5°C~35C;
b) Relative humidity: 50%~60%;
c) Power supply voltage: 220V±22V;
d) Power frequency: 50Hz±1Hz;
e) Atmospheric pressure: 86kPa~106kPa ;
f) There is no strong electromagnetic interference around.
5.2 Appearance and structure
JB20028—2004
5.2.1 The outer shell surface of the printer should be smooth and smooth, without obvious scratches, deformation and other defects. The surface of the coating roller should be uniform in color, and no bottoming, loss of gloss, blistering, wrinkles, sagging, scratches, thorns, etc. are allowed. 5.2.2 Various texts and symbols on the printer control panel should be correct, clear and eye-catching. Markings and warning signs should comply with the provisions of Chapter 17 of CB5226.1-2002. 5.2.3. The printing machine should adopt continuously variable speed, and the transmission part should have reliable protection devices. The casters should be flexible to turn, easy to push and pull, and have no harsh noise.
5.2.4 The fonts and symbols of the printing steel mold of the printing machine should be arranged neatly, with consistent depth, clear and unmistakable, without any writing defects, and should cooperate well with the rubber wheels.
5.2.5 The parts, components and firmware of the printer should be installed correctly and the contact should be reliable. 5.3 Materials and components
The materials and components used in the printer should meet the following requirements and have certification documents or quality assurance documents: a) Transmission parts, printing steel molds and other parts that are in direct contact with capsules and tablets The materials should comply with the provisions of GB16798; b) the concave plate wheel should be made of wear-resistant materials; the printing rubber wheel should be made of non-toxic, oil-resistant and grease-resistant rubber, with a Shore hardness of 15~50: d) buttons, Indicators and displays should comply with the provisions of 10.2 and 10.3 in GB5226.1-2002. The power plug type should comply with the regulations of CB1002;
e) The accuracy of the instrument used should not be less than 2.5, and the numbers on the display are not allowed to have shortage of strokes or unclear display; f) Pneumatic components should comply with GB /T7932 regulations. 5.4 Operating performance
The printer motor operates at a frequency of 50Hz. Each transmission mechanism operates flexibly and smoothly. The capsules or tablets are positioned correctly, and there is no mechanical sound caused by jamming, intermittent operation and irregular belts. There must be no leakage in the compressed air filter device, pressure reducing valve and gas line joints. Connections and fasteners must not be loose.
5.5 Printing quality
5.5.1 Printing defects:
Glue decay, appearance defects and printing defects after tablet printing are shown in Table 3. Any single capsule or tablet with any major defect will be deemed unqualified. A single capsule or tablet with more than one minor defect shall be deemed unqualified. 5.5.2 Printing pass rate:
The printing by the printer should be clear and complete, with uniform color and correct position, and the printing pass rate should not be less than 99.5% (except for quality reasons of capsules and tablets themselves).
49
JB20028—2004
Project
Outside
View
Defects
Defects
Seal
Word
Missing
Defect
Print object
Capsule
Capsule tablet
Capsule
Gel Italy, tablets
5.6 production capacity
Defect name
Single section
Luke
Reprint
Wood seal
Printing left and right
Position difference
Print top and bottom
Position difference
After printing
Wiping off
Printing rubber wheel||tt| |Ink marks on
Strong speed
Print line
Table 3 Appearance, printing defect judgment
Defect identification
Single section after capsule printing| |tt||The shell after printing on the capsule
Several times of printing
There is no printing after passing through the printing machine
More than one letter is pressed together after the final lock. More than one letter is not printed, and one letter or less is pressed after final locking. There is one letter or less that is not printed, but the printing is legible
After printing, more than half of the height of the letters is not printed. Less than half of the height of the last letters is not printed, but the printing is legible. The printing is removed from the capsules and tablets and is greater than or equal to 1 letter. The width of the printed glue is less than 1 letter and is erased from the tablets, but the printing is legible. The glue fades after printing, and there are military marks on the tablets covering the text, and the printing is difficult to read. There are traces on the glue after printing, and the writing is visible on the tablets, but the printing is legible. There are small wall spots on the capsules and tablets with a diameter greater than or equal to 0.8mm. After the glue fades, there are small spots on the tablets, the diameter is less than 0.8mmn The glue changes after printing, there is a line on the tablets passing through the capsule, after the tablets are printed on the capsule, the writing on the tablets is dark or light, the printing depth
printing The production capacity of the machine should comply with the requirements in Table 2. 5.7 Noise
The noise sound pressure level of the printer when operating under no load should not be greater than 85dB(A). 5.8 Wiring
The wiring of the electrical system of the printer should comply with the provisions of Chapter 14 of GB5226.1-2002. 5.9 Continuity of the protective grounding circuit
The continuity of the protective grounding circuit of the printer shall comply with the provisions of 19.2 in GB5226.1--2002. 5.10 Insulation resistance
The insulation resistance of the electrical system shall comply with the provisions of 19.3 in GB5226.12002. 5.11 Withstand voltage
The withstand voltage of the electrical system should comply with the provisions of 19.4 in GB5226.1-2002. 6 Test method
6.1 Test conditions
In addition to the requirements of 5.1, it should also meet the following regulations; a) The air source pressure is not less than 0.6MPa; the working pressure is 0.4MPa; 50||tt| |Defect Category
Major
Minor
Major
Minor
Required
Major
Huan Want||tt || Main | Certify or adopt food-grade specifications that comply with national standards; the variable frequency speed regulator should be set at the working frequency under the best working condition; the variable voltage speed regulator should be set at the working voltage under the best working condition.
6.2 Appearance and Structural Inspection
The appearance and structure of the printing press shall be inspected by sensory methods. 6.3 Inspection of materials and components
6.3.1 Inspect the quality assurance and certification documents of materials and components used in the printing machine. 6.3.2 The hardness of the printing rubber wheel shall be measured in accordance with the provisions of GB/T2411. 6.4 Operation performance test
The printer first runs for 2 hours under no-load conditions. Then it is switched to load and runs at high speed. After stable operation for 5 minutes, visually observe the smoothness of the movement of the transmission mechanism and the movement positioning of the glue or tablets. Situation 6.5 Printing quality test
6.5.1 Appearance and printing defects:
Test for printing defects when the printer is in normal working condition. Let's use the method of segmented random numbers, taking about 200 capsules each time, taking a total of 2,000 capsules (tablets), and selecting the capsules (tablets) with unqualified printing. 6.5.2 Calculation of the printing pass rate:
Count the capsules (tablets) that fail to be printed, and calculate the printing pass rate according to formula (1): P(%)=2000-A
2000| |tt|| In the formula:
P - printing pass rate, %:
(piece). Note: This test is allowed to be conducted at the user unit. 6.6 Production Capacity Measurement
(1)
Start up the printing machine, adjust the continuously variable speed with a transducer or voltage regulator, so that the printing machine is in the best working condition, and wait until the operation is stable before running under load , record the number of tablets (capsules) printed in 5 minutes to calculate its actual production capacity. 6.7 Sound measurement
When the printing machine is running at no load, measure its operating noise according to the method of CBT16769. 6.8 Electrical system wiring inspection
The wiring of the printer's electrical system shall be inspected in accordance with the provisions of Chapter 14 of GB5226.1-2002. 6.9 Continuity test of the protective grounding circuit of the electrical system The continuity test of the protective grounding circuit of the printer's electrical system shall be carried out in accordance with the provisions of 19.2 in GB5226.1-2002. 6.10 Measurement of insulation resistance of electrical system
The insulation resistance of the electrical system of the printer shall be carried out in accordance with the provisions of 19.3 in GB5226.1-2002. 6.11 Determination of insulation withstand voltage of electrical system
The insulation withstand voltage test of the printer's electrical system shall be carried out in accordance with the provisions of 19.4 in GB5226.1-2002. 51
3 Materials and components
The materials and components used in the printer should meet the following requirements, and have certification documents or quality assurance documents: a) Transmission parts, printing steel molds and other parts that are in direct contact with capsules and tablets The materials should comply with the provisions of GB16798; b) the concave plate wheel should be made of wear-resistant materials; the printing rubber wheel should be made of non-toxic, oil-resistant and grease-resistant rubber, with a Shore hardness of 15~50: d) buttons, Indicators and displays should comply with the provisions of 10.2 and 10.3 in GB5226.1-2002. The power plug type should comply with the regulations of CB1002;
e) The accuracy of the instrument used should not be less than 2.5, and the numbers on the display are not allowed to have shortage of strokes or unclear display; f) Pneumatic components should comply with GB /T7932 regulations. 5.4 Operating performance
The printer motor operates at a frequency of 50Hz. Each transmission mechanism operates flexibly and smoothly. The capsules or tablets are positioned correctly, and there is no mechanical sound caused by jamming, intermittent operation and irregular belts. There must be no leakage in the compressed air filter device, pressure reducing valve and gas line joints. Connections and fasteners must not be loose.
5.5 Printing quality
5.5.1 Printing defects:
Glue decay, appearance defects and printing defects after tablet printing are shown in Table 3. Any single capsule or tablet with any major defect will be deemed unqualified. A single capsule or tablet with more than one minor defect shall be deemed unqualified. 5.5.2 Printing pass rate:
The printing by the printer should be clear and complete, with uniform color and correct position, and the printing pass rate should not be less than 99.5% (except for quality reasons of capsules and tablets themselves).
49
JB20028—2004
Project
Outside
View
Defects
Defects
Seal
Word
Missing
Defect
Print object
Capsule
Capsule tablet
Capsule
Gel Italy, tablets
5.6 production capacity
Defect name
Single section
Luke
Reprint
Wood seal
Printing left and right
Position difference
Print top and bottom
Position difference
After printing
Wiping off
Printing rubber wheel||tt| |Ink marks on
Strong speed
Print line
Table 3 Appearance, printing defect judgment
Defect identification
Single section after capsule printing| |tt||The shell after printing on the capsule
Several times of printing
There is no printing after passing through the printing machine
More than one letter is pressed together after the final lock. More than one letter is not printed, and one letter or less is pressed after final locking. There is one letter or less that is not printed, but the printing is legible
After printing, more than half of the height of the letters is not printed. Less than half of the height of the last letters is not printed, but the printing is legible. The printing is removed from the capsules and tablets and is greater than or equal to 1 letter. The width of the printed glue is less than 1 letter and is erased from the tablets, but the printing is legible. After printing, the glue fades, and there are military marks on the tablets covering the text, and the printing is not easy to read. After printing, there are traces on the glue, and there are measurement marks on the tablets, but the printing is legible. After printing, there are small wall spots on the capsules and tablets, the diameter of which is greater than or equal to 0.8mm. The glue fades, there are small spots on the tablets, the diameter is less than 0.8mmn The glue changes after printing, there is a line on the tablets passing through the capsule, the capsules are after printing on the tablets, the writing on the tablets is dark or light, the printing depth
printing The production capacity of the machine should comply with the requirements in Table 2. 5.7 Noise
The noise sound pressure level of the printer when operating under no load should not be greater than 85dB(A). 5.8 Wiring
The wiring of the electrical system of the printer should comply with the provisions of Chapter 14 of GB5226.1-2002. 5.9 Continuity of the protective grounding circuit
The continuity of the protective grounding circuit of the printer shall comply with the provisions of 19.2 in GB5226.1--2002. 5.10 Insulation resistance
The insulation resistance of the electrical system shall comply with the provisions of 19.3 in GB5226.12002. 5.11 Withstand voltage
The withstand voltage of the electrical system should comply with the provisions of 19.4 in GB5226.1-2002. 6 Test method
6.1 Test conditions
In addition to the requirements of 5.1, it should also meet the following regulations; a) The air source pressure is not less than 0.6MPa; the working pressure is 0.4MPa; 50||tt| |Defect Category
Major
Minor
Major
Minor
Required
Major
Huan Want||tt || Main | Certify or adopt food-grade specifications that comply with national standards; the variable frequency speed regulator should be set at the working frequency under the best working condition; the variable voltage speed regulator should be set at the working voltage under the best working condition.
6.2 Appearance and Structural Inspection
The appearance and structure of the printing press shall be inspected by sensory methods. 6.3 Inspection of materials and components
6.3.1 Inspect the quality assurance and certification documents of materials and components used in the printing machine. 6.3.2 The hardness of the printing rubber wheel shall be measured in accordance with the provisions of GB/T2411. 6.4 Operation performance test
The printer first runs for 2 hours under no-load conditions. Then it is switched to load and runs at high speed. After stable operation for 5 minutes, visually observe the smoothness of the movement of the transmission mechanism and the movement positioning of the glue or tablets. Situation 6.5 Printing quality test
6.5.1 Appearance and printing defects:
Test for printing defects when the printer is in normal working condition. Let's use the method of segmented random numbers, taking about 200 capsules each time, taking a total of 2,000 capsules (tablets), and selecting the capsules (tablets) with unqualified printing. 6.5.2 Calculation of the printing pass rate:
Count the capsules (tablets) that fail to be printed, and calculate the printing pass rate according to formula (1): P(%)=2000-A
2000| |tt|| In the formula:
P - printing pass rate, %:
(piece). Note: This test is allowed to be conducted at the user unit. 6.6 Production Capacity Measurement
(1)
Start up the printing machine, adjust the continuously variable speed with a transducer or voltage regulator, so that the printing machine is in the best working condition, and wait until the operation is stable before running under load , record the number of tablets (capsules) printed in 5 minutes to calculate its actual production capacity. 6.7 Sound measurement
When the printing machine is running at no load, measure its operating noise according to the method of CBT16769. 6.8 Electrical system wiring inspection
The wiring of the printer's electrical system shall be inspected in accordance with the provisions of Chapter 14 of GB5226.1-2002. 6.9 Continuity test of the protective grounding circuit of the electrical system The continuity test of the protective grounding circuit of the printer's electrical system shall be carried out in accordance with the provisions of 19.2 in GB5226.1-2002. 6.10 Measurement of insulation resistance of electrical system
The insulation resistance of the electrical system of the printer shall be carried out in accordance with the provisions of 19.3 in GB5226.1-2002. 6.11 Determination of insulation withstand voltage of electrical system
The insulation withstand voltage test of the printer's electrical system shall be carried out in accordance with the provisions of 19.4 in GB5226.1-2002. 51
3 Materials and components
The materials and components used in the printer should meet the following requirements, and have certification documents or quality assurance documents: a) Transmission parts, printing steel molds and other parts that are in direct contact with capsules and tablets The materials should comply with the provisions of GB16798; b) the concave plate wheel should be made of wear-resistant materials; the printing rubber wheel should be made of non-toxic, oil-resistant and grease-resistant rubber, with a Shore hardness of 15~50: d) buttons, Indicators and displays should comply with the provisions of 10.2 and 10.3 in GB5226.1-2002. The power plug type should comply with the regulations of CB1002;
e) The accuracy of the instrument used should not be less than 2.5, and the numbers on the display are not allowed to have shortage of strokes or unclear display; f) Pneumatic components should comply with GB /T7932 regulations. 5.4 Operating performance
The printer motor operates at a frequency of 50Hz. Each transmission mechanism operates flexibly and smoothly. The capsules or tablets are positioned correctly, and there is no mechanical sound caused by jamming, intermittent operation and irregular belts. There must be no leakage in the compressed air filter device, pressure reducing valve and gas line joints. Connections and fasteners must not be loose.
5.5 Printing quality
5.5.1 Printing defects:
Glue decay, appearance defects and printing defects after tablet printing are shown in Table 3. Any single capsule or tablet with any major defect will be deemed unqualified. A single capsule or tablet with more than one minor defect shall be deemed unqualified. 5.5.2 Printing pass rate:
The printing by the printer should be clear and complete, with uniform color and correct position, and the printing pass rate should not be less than 99.5% (except for quality reasons of capsules and tablets themselves).
49
JB20028—2004
Project
Outside
View
Defects
Defects
Seal
Word
Missing
Defect
Print object
Capsule
Capsule tablet
Capsule
Gel Italy, tablets
5.6 production capacity
Defect name
Single section
Luke
Reprint
Wood seal
Printing left and right
Position difference
Print top and bottom
Position difference
After printing
Wiping off
Printing rubber wheel||tt| |Ink marks on
Strong speed
Print line
Table 3 Appearance, printing defect judgment
Defect identification
Single section after capsule printing| |tt||The shell after printing on the capsule
Several times of printing
There is no printing after passing through the printing machine
More than one letter is pressed together after the final lock. More than one letter is not printed, and one letter or less is pressed after final locking. There is one letter or less that is not printed, but the printing is legible
After printing, more than half of the height of the letters is not printed. Less than half of the height of the last letters is not printed, but the printing is legible. The printing is removed from the capsules and tablets and is greater than or equal to 1 letter. The width of the printed glue is less than 1 letter and is erased from the tablets, but the printing is legible. The glue fades after printing, and there are military marks on the tablets covering the text, and the printing is difficult to read. There are traces on the glue after printing, and the writing is visible on the tablets, but the printing is legible. There are small wall spots on the capsules and tablets with a diameter greater than or equal to 0.8mm. After the glue fades, there are small spots on the tablets, the diameter is less than 0.8mmn The glue changes after printing, there is a line on the tablets passing through the capsule, after the tablets are printed on the capsule, the writing on the tablets is dark or light, the printing depth
printing The production capacity of the machine should comply with the requirements in Table 2. 5.7 Noise
The noise sound pressure level of the printer when operating under no load should not be greater than 85dB(A). 5.8 Wiring
The wiring of the electrical system of the printer should comply with the provisions of Chapter 14 of GB5226.1-2002. 5.9 Continuity of the protective grounding circuit
The continuity of the protective grounding circuit of the printer shall comply with the provisions of 19.2 in GB5226.1--2002. 5.10 Insulation resistance
The insulation resistance of the electrical system shall comply with the provisions of 19.3 in GB5226.12002. 5.11 Withstand voltage
The withstand voltage of the electrical system should comply with the provisions of 19.4 in GB5226.1-2002. 6 Test method
6.1 Test conditions
In addition to the requirements of 5.1, it should also meet the following regulations; a) The air source pressure is not less than 0.6MPa; the working pressure is 0.4MPa; 50||tt| |Defect Category
Major
Minor
Major
Minor
Required
Major
Huan Want||tt || Main | Certify or adopt food-grade specifications that comply with national standards; the variable frequency speed regulator should be set at the working frequency under the best working condition; the variable voltage speed regulator should be set at the working voltage under the best working condition.
6.2 Appearance and Structural Inspection
The appearance and structure of the printing press shall be inspected by sensory methods. 6.3 Inspection of materials and components
6.3.1 Inspect the quality assurance and certification documents of materials and components used in the printing machine. 6.3.2 The hardness of the printing rubber wheel shall be measured in accordance with the provisions of GB/T2411. 6.4 Operation performance test
The printer first runs for 2 hours under no-load conditions. Then it is switched to load and runs at high speed. After stable operation for 5 minutes, visually observe the smoothness of the movement of the transmission mechanism and the movement positioning of the glue or tablets. Situation 6.5 Printing quality test
6.5.1 Appearance and printing defects:
Test for printing defects when the printer is in normal working condition. Let's use the method of segmented random numbers, taking about 200 capsules each time, taking a total of 2,000 capsules (tablets), and selecting the capsules (tablets) with unqualified printing. 6.5.2 Calculation of the printing pass rate:
Count the capsules (tablets) that fail to be printed, and calculate the printing pass rate according to formula (1): P(%)=2000-A
2000| |tt|| In the formula:
P - printing pass rate, %:
(piece). Note: This test is allowed to be conducted at the user unit. 6.6 Production Capacity Measurement
(1)
Start up the printing machine, adjust the continuously variable speed with a transducer or voltage regulator, so that the printing machine is in the best working condition, and wait until the operation is stable before running under load , record the number of tablets (capsules) printed in 5 minutes to calculate its actual production capacity. 6.7 Sound measurement
When the printing machine is running at no load, measure its operating noise according to the method of CBT16769. 6.8 Electrical system wiring inspection
The wiring of the printer's electrical system shall be inspected in accordance with the provisions of Chapter 14 of GB5226.1-2002. 6.9 Continuity test of the protective grounding circuit of the electrical system The continuity test of the protective grounding circuit of the printer's electrical system shall be carried out in accordance with the provisions of 19.2 in GB5226.1-2002. 6.10 Measurement of insulation resistance of electrical system
The insulation resistance of the electrical system of the printer shall be carried out in accordance with the provisions of 19.3 in GB5226.1-2002. 6.11 Determination of insulation withstand voltage of electrical system
The insulation withstand voltage test of the printer's electrical system shall be carried out in accordance with the provisions of 19.4 in GB5226.1-2002. 51
5% (except for quality reasons of capsules and tablets).
49
JB20028—2004
Project
Outside
View
Defects
Defects
Seal
Word
Missing
Defect
Print object
Capsule
Capsule tablet
Capsule
Gel Italy, tablets
5.6 production capacity
Defect name
Single section
Luke
Reprint
Wood seal
Printing left and right
Position difference
Print top and bottom
Position difference
After printing
Wiping off
Printing rubber wheel||tt| |Ink marks on
Strong speed
Print line
Table 3 Appearance, printing defect judgment
Defect identification
Single section after capsule printing| |tt||The shell after printing on the capsule
Several times of printing
There is no printing after passing through the printing machine
More than one letter is pressed together after the final lock. More than one letter is not printed, and one letter or less is pressed after final locking. There is one letter or less that is not printed, but the printing is legible
After printing, more than half of the height of the letters is not printed. Less than half of the height of the last letters is not printed, but the printing is legible. The printing is removed from the capsules and tablets and is greater than or equal to 1 letter. The width of the printed glue is less than 1 letter and is erased from the tablets, but the printing is legible. After printing, the glue fades, and there are military marks on the tablets covering the text, and the printing is not easy to read. After printing, there are traces on the glue, and there are measurement marks on the tablets, but the printing is legible. After printing, there are small wall spots on the capsules and tablets, the diameter of which is greater than or equal to 0.8mm. After the glue fades, there are small spots on the tablets, the diameter is less than 0.8mmn The glue changes after printing, there is a line on the tablets passing through the capsule, after the tablets are printed on the capsule, the writing on the tablets is dark or light, the printing depth
printing The production capacity of the machine should comply with the requirements in Table 2. 5.7 Noise
The noise sound pressure level of the printer when operating under no load should not be greater than 85dB(A). 5.8 Wiring
The wiring of the electrical system of the printer should comply with the provisions of Chapter 14 of GB5226.1-2002. 5.9 Continuity of the protective grounding circuit
The continuity of the protective grounding circuit of the printer shall comply with the provisions of 19.2 in GB5226.1--2002. 5.10 Insulation resistance
The insulation resistance of the electrical system shall comply with the provisions of 19.3 in GB5226.12002. 5.11 Withstand voltage
The withstand voltage of the electrical system should comply with the provisions of 19.4 in GB5226.1-2002. 6 Test method
6.1 Test conditions
In addition to the requirements of 5.1, it should also meet the following regulations; a) The air source pressure is not less than 0.6MPa; the working pressure is 0.4MPa; 50||tt| |Defect Category
Major
Minor
Major
Minor
Required
Major
Huan Want||tt || Main | Certify or adopt food-grade specifications that comply with national standards; the variable frequency speed regulator should be set at the working frequency under the best working condition; the variable voltage speed regulator should be set at the working voltage under the best working condition.
6.2 Appearance and Structural Inspection
The appearance and structure of the printing press shall be inspected by sensory methods. 6.3 Inspection of materials and components
6.3.1 Inspect the quality assurance and certification documents of materials and components used in the printing machine. 6.3.2 The hardness of the printing rubber wheel shall be measured in accordance with the provisions of GB/T2411. 6.4 Operation performance test
The printer first runs for 2 hours under no-load conditions. Then it is switched to load and runs at high speed. After stable operation for 5 minutes, visually observe the smoothness of the movement of the transmission mechanism and the movement positioning of the glue or tablets. Situation 6.5 Printing quality test
6.5.1 Appearance and printing defects:
Test for printing defects when the printer is in normal working condition. Let's use the method of segmented random numbers, taking about 200 capsules each time, taking a total of 2,000 capsules (tablets), and selecting the capsules (tablets) with unqualified printing. 6.5.2 Calculation of the printing pass rate:
Count the capsules (tablets) that fail to be printed, and calculate the printing pass rate according to formula (1): P(%)=2000-A
2000| |tt|| In the formula:
P - printing pass rate, %:
(piece). Note: This test is allowed to be conducted at the user unit. 6.6 Production Capacity Measurement
(1)
Start up the printing machine, adjust the continuously variable speed with a transducer or voltage regulator, so that the printing machine is in the best working condition, and wait until the operation is stable before running under load , record the number of tablets (capsules) printed in 5 minutes to calculate its actual production capacity. 6.7 Sound measurement
When the printing machine is running at no load, measure its operating noise according to the method of CBT16769. 6.8 Electrical system wiring inspection
The wiring of the printer's electrical system shall be inspected in accordance with the provisions of Chapter 14 of GB5226.1-2002. 6.9 Continuity test of the protective grounding circuit of the electrical system The continuity test of the protective grounding circuit of the printer's electrical system shall be carried out in accordance with the provisions of 19.2 in GB5226.1-2002. 6.10 Measurement of insulation resistance of electrical system
The insulation resistance of the electrical system of the printer shall be carried out in accordance with the provisions of 19.3 in GB5226.1-2002. 6.11 Determination of insulation withstand voltage of electrical system
The insulation withstand voltage test of the printer's electrical system shall be carried out in accordance with the provisions of 19.4 in GB5226.1-2002. 51
5% (except for quality reasons of capsules and tablets).
49
JB20028—2004
Project
Outside
View
Defects
Defects
Seal
Word
Missing
Defect
Print object
Capsule
Capsule tablet
Capsule
Gel Italy, tablets
5.6 production capacity
Defect name
Single section
Luke
Reprint
Wood seal
Printing left and right
Position difference
Print top and bottom
Position difference
After printing
Wiping off
Printing rubber wheel||tt| |Ink marks on
Strong speed
Print line
Table 3 Appearance, printing defect judgment
Defect identification
Single section after capsule printing| |tt||The shell after printing on the capsule
Several times of printing
There is no printing after passing through the printing machine
More than one letter is pressed together after the final lock. More than one letter is not printed, and one letter or less is pressed after final locking. There is one letter or less that is not printed, but the printing is legible
After printing, more than half of the height of the letters is not printed. Less than half of the height of the last letters is not printed, but the printing is legible. The printing is removed from the capsules and tablets and is greater than or equal to 1 letter. The width of the printed glue is less than 1 letter and is erased from the tablets, but the printing is legible. After printing, the glue fades, and there are military marks on the tablets covering the text, and the printing is not easy to read. After printing, there are traces on the glue, and there are measurement marks on the tablets, but the printing is legible. After printing, there are small wall spots on the capsules and tablets, the diameter of which is greater than or equal to 0.8mm. After the glue fades, there are small spots on the tablets, the diameter is less than 0.8mmn The glue changes after printing, there is a line on the tablets passing through the capsule, after the tablets are printed on the capsule, the writing on the tablets is dark or light, the printing depth
printing The production capacity of the machine should comply with the requirements in Table 2. 5.7 Noise
The noise sound pressure level of the printer when operating under no load should not be greater than 85dB(A). 5.8 Wiring
The wiring of the electrical system of the printer should comply with the provisions of Chapter 14 of GB5226.1-2002. 5.9 Continuity of the protective grounding circuit
The continuity of the protective grounding circuit of the printer shall comply with the provisions of 19.2 in GB5226.1--2002. 5.10 Insulation resistance
The insulation resistance of the electrical system shall comply with the provisions of 19.3 in GB5226.12002. 5.11 Withstand voltage
The withstand voltage of the electrical system should comply with the provisions of 19.4 in GB5226.1-2002. 6 Test method
6.1 Test conditions
In addition to the requirements of 5.1, it should also meet the following regulations; a) The air source pressure is not less than 0.6MPa; the working pressure is 0.4MPa; 50||tt| |Defect Category
Major
Minor
Major
Minor
Required
Major
Huan Want||tt || Main | Certify or adopt food-grade specifications that comply with national standards; the variable frequency speed regulator should be set at the working frequency under the best working condition; the variable voltage speed regulator should be set at the working voltage under the best working condition.
6.2 Appearance and Structural Inspection
The appearance and structure of the printing press shall be inspected by sensory methods. 6.3 Inspection of materials and components
6.3.1 Inspect the quality assurance and certification documents of materials and components used in the printing machine. 6.3.2 The hardness of the printing rubber wheel shall be measured in accordance with the provisions of GB/T2411. 6.4 Operation performance test
The printer first runs for 2 hours under no-load conditions. Then it is switched to load and runs at high speed. After stable operation for 5 minutes, visually observe the smoothness of the movement of the transmission mechanism and the movement positioning of the glue or tablets. Situation 6.5 Printing quality test
6.5.1 Appearance and printing defects:
Test for printing defects when the printer is in normal working condition. Let's use the method of segmented random numbers, taking about 200 capsules each time, taking a total of 2,000 capsules (tablets), and selecting the capsules (tablets) with unqualified printing. 6.5.2 Calculation of the printing pass rate:
Count the capsules (tablets) that fail to be printed, and calculate the printing pass rate according to formula (1): P(%)=2000-A
2000| |tt|| In the formula:
P - printing pass rate, %:
(piece). Note: This test is allowed to be conducted at the user unit. 6.6 Production Capacity Measurement
(1)
Start up the printing machine, adjust the continuously variable speed with a transducer or voltage regulator, so that the printing machine is in the best working condition, and wait until the operation is stable before running under load , record the number of tablets (capsules) printed in 5 minutes to calculate its actual production capacity. 6.7 Sound measurement
When the printing machine is running at no load, measure its operating noise according to the method of CBT16769. 6.8 Electrical system wiring inspection
The wiring of the printer's electrical system shall be inspected in accordance with the provisions of Chapter 14 of GB5226.1-2002. 6.9 Continuity test of the protective grounding circuit of the electrical system The continuity test of the protective grounding circuit of the printer's electrical system shall be carried out in accordance with the provisions of 19.2 in GB5226.1-2002. 6.10 Measurement of insulation resistance of electrical system
The insulation resistance of the electrical system of the printer shall be carried out in accordance with the provisions of 19.3 in GB5226.1-2002. 6.11 Determination of insulation withstand voltage of electrical system
The insulation withstand voltage test of the printer's electrical system shall be carried out in accordance with the provisions of 19.4 in GB5226.1-2002. 51
4 regulations. 6 Test method
6.1 Test conditions
In addition to the requirements of 5.1, it should also meet the following regulations; a) The air source pressure is not less than 0.6MPa; the working pressure is 0.4MPa; 50||tt| |Defect Category
Major
Minor
Major
Minor
Required
Major
Huan Want||tt || Main | Certify or adopt food-grade specifications that comply with national standards; the variable frequency speed regulator should be set at the working frequency under the best working condition; the variable voltage speed regulator should be set at the working voltage under the best working condition.
6.2 Appearance and Structural Inspection
The appearance and structure of the printing press shall be inspected by sensory methods. 6.3 Inspection of materials and components
6.3.1 Inspect the quality assurance and certification documents of materials and components used in the printing machine. 6.3.2 The hardness of the printing rubber wheel shall be measured in accordance with the provisions of GB/T2411. 6.4 Operation performance test
The printer first runs for 2 hours under no-load conditions. Then it is switched to load and runs at high speed. After stable operation for 5 minutes, visually observe the smoothness of the movement of the transmission mechanism and the movement positioning of the glue or tablets. Situation 6.5 Printing quality test
6.5.1 Appearance and printing defects:
Test for printing defects when the printer is in normal working condition. Let's use the method of segmented random numbers, taking about 200 capsules each time, taking a total of 2,000 capsules (tablets), and selecting the capsules (tablets) with unqualified printing. 6.5.2 Calculation of the printing pass rate:
Count the capsules (tablets) that fail to be printed, and calculate the printing pass rate according to formula (1): P(%)=2000-A
2000| |tt|| In the formula:
P - printing pass rate, %:
(piece). Note: This test is allowed to be conducted at the user unit. 6.6 Production Capacity Measurement
(1)
Start up the printing machine, adjust the continuously variable speed with a transducer or voltage regulator, so that the printing machine is in the best working condition, and wait until the operation is stable before running under load , record the number of tablets (capsules) printed in 5 minutes to calculate its actual production capacity. 6.7 Sound measurement
When the printing machine is running at no load, measure its operating noise according to the method of CBT16769. 6.8 Electrical system wiring inspection
The wiring of the printer's electrical system shall be inspected in accordance with the provisions of Chapter 14 of GB5226.1-2002. 6.9 Continuity test of the protective grounding circuit of the electrical system The continuity test of the protective grounding circuit of the printer's electrical system shall be carried out in accordance with the provisions of 19.2 in GB5226.1-2002. 6.10 Measurement of insulation resistance of electrical system
The insulation resistance of the electrical system of the printer shall be carried out in accordance with the provisions of 19.3 in GB5226.1-2002. 6.11 Determination of insulation withstand voltage of electrical system
The insulation withstand voltage test of the printer's electrical system shall be carried out in accordance with the provisions of 19.4 in GB5226.1-2002. 51
4. 6 Test method
6.1 Test conditions
In addition to the requirements of 5.1, the following provisions shall also be met; a) The air source pressure shall not be less than 0.6MPa; the working pressure shall be 0.4MPa; 50
Defect category
Major
Minor
Major
Minor
Major
Important
Major
Important
Important
Major
Important
Important
JB20028—2004
b) The color (ink) used shall be FDA-certified or of food-grade specifications that meet national standards; the frequency converter shall be set to the operating frequency under the best working condition; the voltage converter shall be set to the operating voltage under the best working condition.
6.2 Appearance and structure inspection
The appearance and structure of the printer are inspected by sensory methods. 6.3 Inspection of materials and components
6.3.1 Check the quality assurance and qualification certification documents of the materials and components used in the printer. 6.3.2 The hardness test of the printing rubber wheel shall be carried out in accordance with the provisions of GB/T2411. 6.4 Running performance test
The printer is first run under no-load conditions for 2 hours. Then it is switched to high-speed operation with load. After stable operation for 5 minutes, the smoothness of the movement of the transmission mechanism and the movement and positioning of the rubber or tablets are observed by visual method. 6.5 Printing quality test
6.5.1 Appearance and printing defects:
The printing defect test is carried out under the normal working state of the printer. Use the method of segmented random number selection, take about 200 capsules each time, and take a total of 2000 capsules (tablets), and select the capsules (tablets) with unqualified printing. 6.5.2 Calculation of printing pass rate:
Count the number of capsules (tablets) with unqualified printing and calculate the printing pass rate according to formula (1): P (%) = 2000-A
2000
Where:
P——printing pass rate, %:
x100
4——number of capsules or tablets with unqualified printing (including missed printing), grains (tablets). Note: This test is allowed to be carried out in the user unit. 6.6 Production capacity measurement
(1)
Start the printer and adjust the stepless speed with a transformer or voltage regulator to put the printer in the best working state. After the operation is stable, run the printer under load and record the number of tablets (capsules) printed in 5 minutes to calculate its actual production capacity. 6.7 Sound measurement
When the printer is running at no load, measure its working noise according to the method of CBT16769. 6.8 Inspection of electrical system wiring
The wiring of the electrical system of the printer shall be inspected in accordance with the provisions of Chapter 14 of GB5226.1-2002. 6.9 Continuity test of the protective grounding circuit of the electrical system The continuity test of the protective grounding circuit of the electrical system of the printer shall be carried out in accordance with the provisions of 19.2 of GB5226.1-2002. 6.10 Determination of insulation resistance of the electrical system
The insulation resistance of the electrical system of the printer shall be carried out in accordance with the provisions of 19.3 of GB5226.1-2002. 6.11 Determination of insulation withstand voltage of the electrical system
The insulation withstand voltage test of the electrical system of the printer shall be carried out in accordance with the provisions of 19.4 of GB5226.1-2002. 51
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