Some standard content:
JB | |tt||tablet press tablet punching die
aluminum plastic blister packaging machine
released on 2004-02-05
implemented on 2004-06-01
Reform Committee issued
ICS11.120.30
C92
JB
Pharmaceutical Machinery Industry Standard of the People's Republic of China JB20020-2004
replaced YY0221-1995||tt ||Rotary tablet press
Rotaytabletpress
Released on 2004-02-05
Implemented on 2004-06-01
National Development and Political Reform Commission||tt| |Release
Foreword
1 Scope
2 Normative reference documents
3 Terms and definitions
4 Classification and labeling
5 Requirements
6 test methods
7 inspection rules
8 markings, instructions, packaging and storage
item
times
JB20020—2004| |tt||16
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Foreword
This standard is based on the requirements of the "Good Manufacturing Practice for Drugs" and CB/T1.1--2000, CGB/T1.22002 standardization work guidelines. YY0221-1995 "Rotary Tablet Press" revision. This standard replaces YY02211995 from the date of implementation. Compared with YY0221-1995, the main technical content of this standard has changed as follows: a) The main chapters and clauses of YY0221-1995 have been deleted: Product classification (4.1);
Manufacturing requirements according to prescribed procedures (5.1); || tt||—Safety technical requirements (5.3):
Factory integrity (5.7);
Guaranteed repair, replacement, and return (5.8)
b) Revised YY0221— Main chapters and articles of 1995: Scope (Chapter 1);
Reference standards (Chapter 2);
Terms and definitions (Chapter 3):
Classification and labeling ( Chapter 4):
requirements (Chapter 5);
--Test methods (Chapter 6);
--Inspection rules (Chapter 7).
e) The main chapters and clauses added to this standard:
Structural and material requirements (5.1.5, 5.1.6, 5.1.7); Electrical system safety (5.3); ||tt| | Weight difference limit of tablet press with automatic control system (Table 1): test conditions (6.4.1.1, 6.4.2.1);
Die overload test method (6.4.2.2c); Sampling method for load test (6.4.2.2d): Factory inspection items (Table 2);
Instructions for use (8.2);
- Electrical control system technical documents (8.3.3d). 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: Shanghai Tianyang Jiantai Pharmaceutical Machinery Co., Ltd. The main drafters of this standard: Li Huaqiang and Chen Luzhen. The previous versions of the standards replaced by this standard are: ZBC92005-1987, YY0221-199516
1 range
Rotary tablet press
JB 20020-2004
This standard specifies the terms and definitions, classification and labeling, requirements, test methods, inspection rules and signs, instructions, packaging and storage of rotary tablet presses (hereinafter referred to as tablet presses). This standard is applicable to tablet presses that continuously compress tablets in a rotating manner and the maximum linear speed of the center point of the die hole in the turntable is less than 60m/min.
2 Normative reference documents
The clauses in the following documents become the clauses of this standard through reference in this standard. For dated reference documents, all subsequent amendments (excluding corrigenda) or revisions do not apply to this standard. However, parties 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
GB/T1184-1996 Shape and position tolerances without note of tolerance values ??GB/T1800.4-1999 Limit and fit standard tolerance grade and limit deviation table of holes and shafts GB /T3766 General Technical Conditions for Hydraulic Systems CB5226.1-2002 Mechanical Safety Mechanical and Electrical Equipment Part 1: General Technical Conditions GB/T6388 Transport Packaging Receipt and Delivery Marks
GB/T7935
General Technology for Hydraulic Components Conditions
GB/T9969.1 General instructions for use of industrial products GB/T13306 Labeling
GB/T13384
GB/T16769
General technical conditions for mechanical and electrical product packaging||tt ||Measurement Method for Noise and Sound Pressure Level of Metal Cutting Machine Tools Pharmacopoeia of the People's Republic of China (2000 Edition) Part II National Pharmacopoeia Committee 3 Terms and Definitions
The following terms and definitions apply to this standard. 3.1
punchanddie
A mold composed of an upper punch, a lower punch and a middle die. 3.2
Maximum compression force maximumcompression is the maximum pressure that the tablet press can achieve when compressing tablets. 17
JB20020—2004
3.3
maximumtabletdiameter
Large tablet diameter
The maximum circumscribed circle diameter allowed for compressed tablets. 3.4
Turntable turret
The workbench for installing the die.
3.5
punchhole
The hole for installing the upper and lower punch bodies on the turntable. 3.6
Middle mold hole diehole
The hole for installing the middle mold on the turntable.
3.7
Turntable working surface topofturretwithdie The working surface on the turntable is used for installing the middle mold, feeding materials and discharging the sheets. 3.8
Pressure roller
pressure roller
A roller that provides pressure when compressing tablets.
3.9
Guide rail cam
The part that makes the punch move up and down.
3.10
Feeder feeder
The part that enables the material to fully fill the mold hole. 4 Classification and Marking
4.1 Type
Through the rotation of the turntable, the granular materials that meet certain requirements flow into the middle mold through the feeder, and are processed by multiple pairs of dies evenly distributed on the turntable. Under the action of the pressing wheel, the material is pressed into tablets. 4.2 Model
4.2.1 Model preparation
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ZPUOO
4.2.1.1 Marking example:
Improved design sequence number (A, B, C )
Punch die number
JB200202004
Feature code (indicated by the first capital letter of Chinese Pinyin indicating the feature, if there is no feature, it will not be indicated)
Product functional characteristics Code name: Rotary tablet press a) ZP35A: Indicates a rotary tablet press with a punching die number of 35 after the first improved design: b) ZPH16: A rotary tablet press that presses ring-shaped tablets and a punching die number of 16 machine; 2PK37: indicates a rotary tablet press with automatic control function and a punching die number of 37; e)
d) ZPY21: indicates a rotary tablet press that can press special-shaped tablets and a punching die number of 21. 5 Requirements
5.1 Appearance, structure and material
5.1.1 The outer surface of the tablet press should be flat and smooth, without obvious scratches or corrosion; the coating should be consistent in color, without bubbles, and without falling off. 5.1.2 The edges of the external joint surface of the tablet press should be neatly and evenly hooked, and there should be no obvious misalignment. There should be no obvious gaps between the door, cover and joint surface.
5.1.3 All operating parts and external fasteners should be treated with surface rust prevention. 5.1.4. The control and adjustment mechanism of the tablet press should have schematic signs or explanatory text on the adjustment range, scale indication, purpose and direction of rotation. 5.1.5 The tableting studio should be isolated from the outside world and the transmission mechanism. The window should have good visibility and be easy to open and close. 5.1.6 The turntable working surface and surrounding parts in contact with the drug are easy to disassemble, and the surface should be smooth and clean to facilitate cleaning, disinfection, and mold replacement. 5.1.7 The parts in the tablet press that are in direct contact with the drug should be made of non-toxic, rust-resistant, and non-contaminated materials, or the surface of the material should be sprayed or plated with a protective layer that is resistant to corrosion, time-wearing, and non-toxic. 5.2 Quality of main parts
5.2.1 Turntable:
a) The interaxiality of the upper and lower punch holes to the die holes shall not be lower than the requirements of GB/T1184-1996 Table B4 Level 8. b) The limit deviation value of the upper and lower punch holes and the middle die hole size shall not be lower than the H8 regulations in GB/T1800.4-1999 Basic Hole System. c) The surface roughness Ra value of the upper and lower punch holes should not be greater than 1.6um. 5.2.2 Guide rail:
a) The surface roughness Ra value of the contact surface with the punch should not be greater than 1.6μum. b) The heat treatment hardness of the surface in contact between the steel guide rail and the punch is HRC (58~62). 5.2.3 Pressure wheel:
a) The coaxiality of the outer circle axis to the center of the hole axis shall not be lower than that specified in GB/T1184-1996 Table B4 Level 8. b) The heat treatment hardness of the outer surface is HRC (60~64). 5.3 Electrical system safety
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JB20020-2004
5.3.1 The continuity of the protective grounding of the electrical system shall comply with the provisions of 19.2 in GB5226.1-2002. 5.3.2 The insulation resistance of the electrical system shall comply with the provisions of 19.3 in GB5226.1-2002. 5.3.3 The withstand voltage of the electrical system shall comply with the provisions of 19.4 of CB5226.1-2002. 5.3.4 The protective grounding circuit of the electrical system should comply with the provisions of 8.2 in GB5226.1-2002. 5.3.5 The buttons of the electrical system should comply with the provisions of 10.2 in GB5226.1-2002. 5.3.6 The indicators and displays of the electrical system should comply with the provisions of 10.3 in GB5226.1-2002. 5.3.7 The wiring of the electrical system should comply with the provisions of Chapter 14 of CB5226.1-2002. 5.3.8 The markings, warning signs and project codes of the electrical system shall comply with the provisions of Chapter 17 of GB5226.1-2002. 5.4 Sexual Clothing
5.4.1 All moving parts of the tablet press should operate smoothly without looseness or abnormal noise. 5.4.2 The dial or indicator needle used to adjust the sheet thickness and filling depth should rotate flexibly, indicate clearly, and be able to return to zero position. 5.4.3 Tablet presses with hydraulic systems should comply with the requirements of CB/T3766, and there should be no leakage or component damage during operation.
5.4.4 For tablet presses with tablet pressing force display, the main tablet pressing force should be able to display different pressures according to changes in tablet thickness. 5.4.5 The tablet press should have a die overload protection function and should have an emergency stop device. 5.4.6 The circular runout of the working surface of the tablet press turntable should comply with the requirements of Level 8 of Table B4 of GB/T1184-1996. 5.4.7 The temperature rise of the bearings when the tablet press is running under no load should not exceed 35°C. 5.4.8 When the tablet press is running at no load, it should run smoothly without friction, and the sound pressure level noise should not be greater than 82dB(A). 5.4.9 The weight difference limit of pharmaceutical tablets shall be as specified in Table 1. Table 1 Pharmaceutical Tablet Weight Difference Limit
Average Weight of Tablets
g
0.3
≥0.3
6 Test Methods||tt| |6.1 Appearance, structure and material inspection
Weight difference limit % of tablet press without automatic control system
± 7.5
±5.0
Visual inspection outside the tablet press Surface and coating quality. 6.1.1
6.1.2 Visually inspect the external joint surface of the tablet press and the quality of the door, cover and joint surface. 6.1.3 Visually inspect the surface quality of operating parts and exposed violet fasteners. 6.1.4 Visually inspect the marking instructions of the control and adjustment mechanism. There is an automatic control system tablet press with a weight difference limit of ±6.0
±4.0
6.1.5 Visually inspect the isolation status of the tableting studio and the visibility and opening and closing status of the window. Visually and manually inspect the surface quality and disassembly and assembly conditions of the turntable working surface and surrounding parts that come into contact with the drug. 6.1.6
6.1.7 Check the raw material certificate or chemical analysis report of the parts that are in direct contact with the drug, or the certification information of the coating material, 6.2 Quality inspection of the main parts
6.2.1 Turntable:| |tt||a) Use the certified self-made special measuring shaft and measuring sleeve to check the coaxiality of the upper and lower punch holes to the die holes. 20
b) Use an inner diameter dial indicator or an inner diameter micrometer to measure the dimensional error of the upper and lower punch holes and the middle die hole. Use roughness comparison blocks to check the surface roughness of the upper and lower punch holes. 6.2.2 Guide rail:
Use the roughness comparison sample block to check the surface roughness in contact with the punch. a)
b) Use a Burawoy hardness tester to check the surface hardness of the steel guide rail in contact with the punch. 6.2.3 Pressure wheel:
Use the pipe wall dry ruler to measure the coaxiality error between the outer circle axis and the center of the hole axis. a)
Use a Bouvet hardness tester to check the heat treatment hardness of the outer surface. b)
6.3 Electrical system safety inspection
JB20020—2004
6.3.1 The protective grounding continuity, insulation resistance, and withstand voltage tests of the electrical system are in accordance with GB5226.1--2002 Test according to the provisions of 19.2, 19.3 and 19.4.
6.3.2 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. 6.4 Performance inspection
6.4.1 No-load test:
6.4.1.1 Test conditions:
&) The turntable speed adjustment should be carried out in sequence from low speed to high speed: b) Operation time 4h, One-half of the turntable operates at maximum speed for 2 hours, and the turntable operates at maximum speed for 2 hours. 6.4.1.2 Inspection items:
Visual inspection of the operating conditions of each moving part; a)
Visual and manual inspection of the operating conditions of the sheet thickness and filling depth dial or indicator needle; b) ||tt ||c) For tablet presses with hydraulic systems, the pressure resistance test of hydraulic cylinder pressure vessels shall be carried out according to the test method of GB/T7935. Use a dial indicator with a magnetic iron seat to measure the circumferential runout of a point at the largest circumference on the working surface of the turntable. d)
e) Use a digital thermometer or point thermometer to measure the operating temperature rise of the spindle bearing, and calculate it according to formula (1). At=t-to
where:
At—temperature rise, C;
—measured part temperature, ℃;
to—measured ambient temperature, ℃ .
6.4.2 Load test:
6.4.2.1 Test conditions:
a) Conducted after no-load test;
(1)
b ) Test materials: dry dextrin granules or granular materials with similar properties with a granulated particle size of 0.85mm~0.18mm (equivalent to 20 mesh~80 mesh) and a fine powder content of no more than 30%. Stearic acid is allowed to be added. Magnesium or sodium alginate additive; c) The test tablets are round tablets. When the diameter of the disc is greater than 13mm, the test is carried out for 1 hour at half the maximum speed of the machine; when the diameter of the disc is less than or equal to 13mm, the test is carried out for 1 hour at the maximum speed of the machine. 6.4.2.2 Inspection items:
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2 Guide rail:
a) The surface roughness Ra value of the contact surface with the punch should not be greater than 1.6μum. b) The heat treatment hardness of the surface in contact between the steel guide rail and the punch is HRC (58~62). 5.2.3 Pressure wheel:
a) The coaxiality of the outer circle axis to the center of the hole axis shall not be lower than that specified in GB/T1184-1996 Table B4 Level 8. b) The heat treatment hardness of the outer surface is HRC (60~64). 5.3 Electrical system safety
19
JB20020-2004
5.3.1 The continuity of the protective grounding of the electrical system shall comply with the provisions of 19.2 in GB5226.1-2002. 5.3.2 The insulation resistance of the electrical system shall comply with the provisions of 19.3 in GB5226.1-2002. 5.3.3 The withstand voltage of the electrical system shall comply with the provisions of 19.4 of CB5226.1-2002. 5.3.4 The protective grounding circuit of the electrical system should comply with the provisions of 8.2 in GB5226.1-2002. 5.3.5 The buttons of the electrical system should comply with the provisions of 10.2 in GB5226.1-2002. 5.3.6 The indicators and displays of the electrical system should comply with the provisions of 10.3 in GB5226.1-2002. 5.3.7 The wiring of the electrical system shall comply with the provisions of Chapter 14 of CB5226.1-2002. 5.3.8 The markings, warning signs and project codes of the electrical system shall comply with the provisions of Chapter 17 of GB5226.1-2002. 5.4 Sexual Wear
5.4.1 All moving parts of the tablet press should operate smoothly without looseness or abnormal noise. 5.4.2 The dial or indicator needle used to adjust the sheet thickness and filling depth should rotate flexibly, indicate clearly, and be able to return to zero position. 5.4.3 Tablet presses with hydraulic systems should comply with the requirements of CB/T3766, and there should be no leakage or component damage during operation.
5.4.4 For tablet presses with tablet pressing force display, the main tablet pressing force should be able to display different pressures according to changes in tablet thickness. 5.4.5 The tablet press should have a die overload protection function and should have an emergency stop device. 5.4.6 The circular runout of the working surface of the tablet press turntable should comply with the requirements of Level 8 of Table B4 of GB/T1184-1996. 5.4.7 The temperature rise of the bearings when the tablet press is running under no load should not exceed 35°C. 5.4.8 When the tablet press is running at no load, it should run smoothly without friction, and the sound pressure level noise should not be greater than 82dB(A). 5.4.9 The weight difference limit of pharmaceutical tablets shall be as specified in Table 1. Table 1 Pharmaceutical Tablet Weight Difference Limit
Average Weight of Tablets
g
0.3
≥0.3
6 Test Methods||tt| |6.1 Appearance, structure and material inspection
Weight difference limit % of tablet press without automatic control system
± 7.5
±5.0
Visual inspection outside the tablet press Surface and coating quality. 6.1.1
6.1.2 Visually inspect the external joint surface of the tablet press and the quality of the door, cover and joint surface. 6.1.3 Visually inspect the surface quality of operating parts and exposed violet fasteners. 6.1.4 Visually inspect the marking instructions of the control and adjustment mechanism. There is an automatic control system tablet press with a weight difference limit of ±6.0
±4.0
6.1.5 Visually inspect the isolation status of the tableting studio and the visibility and opening and closing status of the window. Visually and manually inspect the surface quality and disassembly and assembly conditions of the turntable working surface and surrounding parts that are in contact with the drug. 6.1.6
6.1.7 Check the raw material certificate or chemical analysis report of the parts that are in direct contact with the drug, or the certification information of the coating material, 6.2 Quality inspection of the main parts
6.2.1 Turntable:| |tt||a) Use the certified self-made special measuring shaft and measuring sleeve to check the coaxiality of the upper and lower punch holes to the die holes. 20
b) Use an inner diameter dial indicator or an inner diameter micrometer to measure the dimensional error of the upper and lower punch holes and the middle die hole. Use roughness comparison blocks to check the surface roughness of the upper and lower punch holes. 6.2.2 Guide rail:
Use the roughness comparison sample block to check the surface roughness in contact with the punch. a)
b) Use a Burawoy hardness tester to check the surface hardness of the steel guide rail in contact with the punch. 6.2.3 Pressure wheel:
Use the pipe wall dry ruler to measure the coaxiality error between the outer circle axis and the center of the hole axis. a)
Use a Bouvet hardness tester to check the heat treatment hardness of the outer surface. b)
6.3 Electrical system safety inspection
JB20020—2004
6.3.1 The protective grounding continuity, insulation resistance, and withstand voltage tests of the electrical system are in accordance with GB5226.1--2002 Test according to the provisions of 19.2, 19.3 and 19.4.
6.3.2 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. 6.4 Performance inspection
6.4.1 No-load test:
6.4.1.1 Test conditions:
&) The turntable speed adjustment should be carried out in sequence from low speed to high speed: b) Operation time 4h, One-half of the turntables run at maximum speed for 2 hours, and the turntable at maximum speed runs for 2 hours. 6.4.1.2 Inspection items:
Visual inspection of the operating conditions of each moving part; a)
Visual and manual inspection of the operating conditions of the sheet thickness and filling depth dial or indicator needle; b) ||tt ||c) For tablet presses with hydraulic systems, the pressure resistance test of hydraulic cylinder pressure vessels shall be carried out according to the test method of GB/T7935. Use a dial indicator with a magnetic iron seat to measure the circumferential runout of a point at the largest circumference on the working surface of the turntable. d)
e) Use a digital thermometer or point thermometer to measure the operating temperature rise of the spindle bearing, and calculate it according to formula (1). At=t-to
where:
At—temperature rise, C;
—measured part temperature, ℃;
to—measured ambient temperature, ℃ .
6.4.2 Load test:
6.4.2.1 Test conditions:
a) Conducted after no-load test;
(1)
b ) Test materials: dry dextrin granules or granular materials with similar properties with a granulated particle size of 0.85mm~0.18mm (equivalent to 20 mesh~80 mesh) and a fine powder content of no more than 30%. Stearic acid is allowed to be added. Magnesium or sodium alginate additive; c) The test tablets are round tablets. When the diameter of the disc is greater than 13mm, the test is carried out for 1 hour at half the maximum speed of the machine; when the diameter of the disc is less than or equal to 13mm, the test is carried out for 1 hour at the maximum speed of the machine. 6.4.2.2 Inspection items:
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2 Guide rail:
a) The surface roughness Ra value of the surface in contact with the punch rod shall not be greater than 1.6μum. b) The heat treatment hardness of the surface of the steel guide rail in contact with the punch rod is HRC (58~62). 5.2.3 Press wheel:
a) The coaxiality of the outer circle axis to the hole axis center shall not be lower than the 8th level specified in Table B4 of GB/T1184-1996. b) The heat treatment hardness of the outer circle surface is HRC (60~64). 5.3 Electrical system safety
19
JB20020—2004
5.3.1 The continuity of the protective grounding of the electrical system shall comply with the provisions of 19.2 in GB5226.1-2002. 5.3.2 The insulation resistance of the electrical system shall comply with the provisions of 19.3 of GB5226.1-2002. 5.3.3 The withstand voltage of the electrical system shall comply with the provisions of 19.4 of CB5226.1-2002. 5.3.4 The protective grounding circuit of the electrical system shall comply with the provisions of 8.2 of GB5226.1-2002. 5.3.5 The buttons of the electrical system shall comply with the provisions of 10.2 of GB5226.1-2002. 5.3.6 The indicator lights and displays of the electrical system shall comply with the provisions of 10.3 of GB5226.1-2002. 5.3.7 The wiring of the electrical system shall comply with the provisions of Chapter 14 of CB5226.1-2002. 5.3.8 The markings, warning signs and project codes of the electrical system shall comply with the provisions of Chapter 17 of GB5226.1-2002. 5.4 Sex service
5.4.1 The moving parts of the tablet press should run smoothly, without looseness, abnormal noise, etc. 5.4.2 The dial or indicator needle used to adjust the thickness of the tablet and the filling depth should rotate flexibly, indicate clearly, and be able to return to zero. 5.4.3 Tablet presses with hydraulic systems should comply with the requirements of CB/T3766, and there should be no leakage or component damage during operation.
5.4.4 For tablet presses with tablet force display, the main tablet force should be able to display different pressures according to the change of tablet thickness. 5.4.5 The tablet press should have a die overload protection function and an emergency stop device. 5.4.6 The circular runout of the tablet press turntable working surface should comply with the provisions of GB/T1184-1996 Table B4 Level 8. 5.4.7 The bearing temperature rise of the tablet press when running without load should not exceed 35℃. 5.4.8 When the tablet press is running without load, it should run smoothly without friction, and the sound pressure level should not exceed 82dB (A). 5.4.9 The weight difference limit of pharmaceutical tablets shall be as specified in Table 1. Table 1 Weight difference limit of pharmaceutical tablets
Average weight of tablets
g
0.3
≥0.3
6 Test method
6.1 Appearance, structure and material inspection
Weight difference limit of tablet press without automatic control system%
± 7.5
±5.0
Visually inspect the outer surface of the tablet press and the quality of the coating. 6.1.1
6.1.2 Visually inspect the surface quality of the tablet press and the surface quality of the door, cover and joint surface. 6.1.3 Visually inspect the surface quality of the operating parts and exposed purple firmware. 6.1.4 Visually inspect the markings and instructions of the control and adjustment mechanism. The weight difference limit of the tablet press with automatic control system is ±6.0
±4.0
6.1.5 Visually check the isolation condition of the tablet press room and the visibility and opening and closing condition of the window. Visually and manually check the surface quality and disassembly and assembly condition of the turntable working surface and the surrounding parts in contact with the drug. 6.1.6
6.1.7 Check the raw material material certificate or chemical analysis report of the parts in direct contact with the drug, or the certification information of the coating material. 6.2 Quality inspection of main parts
6.2.1 Turntable:
a) Use the self-made special measuring shaft and measuring sleeve that have passed the inspection to check the coaxiality of the upper and lower punch holes to the center die hole. 20
b) Use the internal diameter dial indicator or internal diameter micrometer to measure the size error of the upper and lower punch holes and the center die hole. Use the roughness comparison sample to check the surface roughness of the upper and lower punch holes. 6.2.2 Guide rail:
Use roughness comparison sample to check the surface roughness in contact with the punch. a)
b) Use Brinell hardness tester to check the surface hardness of the steel guide rail in contact with the punch. 6.2.3 Press wheel:
Use pipe wall dry micrometer to measure the coaxiality error of the outer circle axis to the hole axis center. a)
Use Brinell hardness tester to check the heat treatment hardness of the outer circle surface. b)
6.3 Electrical system safety inspectionwww.bzxz.net
JB20020—2004
6.3.1 The protective grounding continuity, insulation resistance and withstand voltage test of the electrical system shall be tested in accordance with the provisions of 19.2, 19.3 and 19.4 of GB5226.1--2002 respectively.
6.3.2 The protective grounding circuit, buttons, indicator lights and displays, wiring, markings, warning signs and project codes of the electrical system shall be inspected in accordance with the provisions of 8.2, 10.2, 10.3, Chapter 14 and Chapter 17 of GB5226.1-2002. 6.4 Performance inspection
6.4.1 No-load test:
6.4.1.1 Test conditions:
&) The turntable speed adjustment shall be carried out from low speed to high speed: b) The operation time is 4h, of which half of the turntable runs at the maximum speed for 2h and the turntable runs at the maximum speed for 2h. 6.4.1.2 Inspection items:
Visually inspect the operating conditions of each moving part; a)
Visually and manually inspect the operating conditions of the tablet thickness and filling depth dial or indicator needle; b)
c) For tablet presses with hydraulic systems, perform pressure resistance tests on hydraulic cylinder pressure vessels according to the test method of GB/T7935. Use a dial indicator with a magnetic iron holder to measure the circumferential runout of a point at the maximum circumference on the working surface of the turntable. d)
e) Use a digital thermometer or a point thermometer to measure the operating temperature rise of the spindle bearing and calculate it according to formula (1). At=t-to
Where:
At—temperature rise, C;
——actually measured part temperature, ℃;
to—actually measured ambient temperature, ℃.
6.4.2 Load test:
6.4.2.1 Test conditions:
a) Conducted after the empty load test;
(1)
b) Test materials: The particle size after granulation is 0.85mm~0.18mm (equivalent to 20 mesh~80 mesh), the fine powder content does not exceed 30% of dextrin dry particles or granular materials with similar properties, and magnesium stearate or sodium alginate additives are allowed; c) The test tablet is a round tablet. When the diameter of the round tablet is greater than 13mm, the test is carried out at half the maximum speed of the machine for 1h; when the diameter of the round tablet is less than or equal to 13mm, the test is carried out at the maximum speed of the machine for 1h. 6.4.2.2 Inspection items:
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5. The tablet press should have a die overload protection function and should have an emergency stopping device. 5.4.6 The circular runout of the working surface of the tablet press turntable should comply with the requirements of Level 8 of Table B4 of GB/T1184-1996. 5.4.7 The temperature rise of the bearings when the tablet press is running under no load should not exceed 35°C. 5.4.8 When the tablet press is running at no load, it should run smoothly without friction, and the sound pressure level noise should not be greater than 82dB(A). 5.4.9 The weight difference limit of pharmaceutical tablets shall be as specified in Table 1. Table 1 Pharmaceutical Tablet Weight Difference Limit
Average Weight of Tablets
g
0.3
≥0.3
6 Test Methods||tt| |6.1 Appearance, structure and material inspection
Weight difference limit % of tablet press without automatic control system
± 7.5
±5.0
Visual inspection outside the tablet press Surface and coating quality. 6.1.1
6.1.2 Visually inspect the external joint surface of the tablet press and the quality of the door, cover and joint surface. 6.1.3 Visually inspect the surface quality of operating parts and exposed violet fasteners. 6.1.4 Visually inspect the marking instructions of the control and adjustment mechanism. There is an automatic control system tablet press with a weight difference limit of ±6.0
±4.0
6.1.5 Visually inspect the isolation status of the tableting studio and the visibility and opening and closing status of the window. Visually and manually inspect the surface quality and disassembly and assembly conditions of the turntable working surface and surrounding parts that are in contact with the drug. 6.1.6 | |tt||a) Use the certified self-made special measuring shaft and measuring sleeve to check the coaxiality of the upper and lower punch holes to the die holes. 20
b) Use an inner diameter dial indicator or an inner diameter micrometer to measure the dimensional error of the upper and lower punch holes and the middle die hole. Use roughness comparison blocks to check the surface roughness of the upper and lower punch holes. 6.2.2 Guide rail:
Use the roughness comparison sample block to check the surface roughness in contact with the punch. a)
b) Use a Burawoy hardness tester to check the surface hardness of the steel guide rail in contact with the punch. 6.2.3 Pressure wheel:
Use the pipe wall dry ruler to measure the coaxiality error between the outer circle axis and the center of the hole axis. a)
Use a Bouvet hardness tester to check the heat treatment hardness of the outer surface. b)
6.3 Electrical system safety inspection
JB20020—2004
6.3.1 The protective grounding continuity, insulation resistance, and withstand voltage tests of the electrical system are in accordance with GB5226.1--2002 Test according to the provisions of 19.2, 19.3 and 19.4.
6.3.2 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. 6.4 Performance inspection
6.4.1 No-load test:
6.4.1.1 Test conditions:
&) The turntable speed adjustment should be carried out in sequence from low speed to high speed: b) Operation time 4h, One-half of the turntables run at maximum speed for 2 hours, and the turntable at maximum speed runs for 2 hours. 6.4.1.2 Inspection items:
Visual inspection of the operating conditions of each moving part; a)
Visual and manual inspection of the operating conditions of the sheet thickness and filling depth dial or indicator needle; b) ||tt ||c) For tablet presses with hydraulic systems, the pressure resistance test of hydraulic cylinder pressure vessels shall be carried out according to the test method of GB/T7935. Use a dial indicator with a magnetic iron seat to measure the circumferential runout of a point at the largest circumference on the working surface of the turntable. d)
e) Use a digital thermometer or point thermometer to measure the operating temperature rise of the spindle bearing, and calculate it according to formula (1). At=t-to
where:
At—temperature rise, C;
—measured part temperature, ℃;
to—measured ambient temperature, ℃ .
6.4.2 Load test:
6.4.2.1 Test conditions:
a) Conducted after no-load test;
(1)
b ) Test materials: dry dextrin granules or granular materials with similar properties with a granulated particle size of 0.85mm~0.18mm (equivalent to 20 mesh~80 mesh) and a fine powder content not exceeding 30%. Stearic acid is allowed to be added. Magnesium or sodium alginate additive; c) The test tablets are round tablets. When the diameter of the disc is greater than 13mm, the test is carried out for 1 hour at half the maximum speed of the machine; when the diameter of the disc is less than or equal to 13mm, the test is carried out for 1 hour at the maximum speed of the machine. 6.4.2.2 Inspection items:
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5. The tablet press should have a die overload protection function and should have an emergency stopping device. 5.4.6 The circular runout of the working surface of the tablet press turntable should comply with the requirements of Level 8 of Table B4 of GB/T1184-1996. 5.4.7 The temperature rise of the bearings when the tablet press is running under no load should not exceed 35°C. 5.4.8 When the tablet press is running at no load, it should run smoothly without friction, and the sound pressure level noise should not be greater than 82dB(A). 5.4.9 The weight difference limit of pharmaceutical tablets shall be as specified in Table 1. Table 1 Pharmaceutical Tablet Weight Difference Limit
Average Weight of Tablets
g
0.3
≥0.3
6 Test Methods||tt| |6.1 Appearance, structure and material inspection
Weight difference limit % of tablet press without automatic control system
± 7.5
±5.0
Visual inspection outside the tablet press Surface and coating quality. 6.1.1
6.1.2 Visually inspect the external joint surface of the tablet press and the quality of the door, cover and joint surface. 6.1.3 Visually inspect the surface quality of operating parts and exposed violet fasteners. 6.1.4 Visually inspect the marking instructions of the control and adjustment mechanism. There is an automatic control system tablet press with a weight difference limit of ±6.0
±4.0
6.1.5 Visually inspect the isolation status of the tableting studio and the visibility and opening and closing status of the window. Visually and manually inspect the surface quality and disassembly and assembly conditions of the turntable working surface and surrounding parts that are in contact with the drug. 6.1.6 | |tt||a) Use the self-made special measuring shaft and measuring sleeve that have passed the inspection to check the coaxiality of the upper and lower punch holes to the die holes. 20
b) Use an inner diameter dial indicator or an inner diameter micrometer to measure the dimensional error of the upper and lower punch holes and the middle die hole. Use roughness comparison blocks to check the surface roughness of the upper and lower punch holes. 6.2.2 Guide rail:
Use the roughness comparison sample block to check the surface roughness in contact with the punch. a)
b) Use a Burawoy hardness tester to check the surface hardness of the steel guide rail in contact with the punch. 6.2.3 Pressure wheel:
Use the pipe wall dry ruler to measure the coaxiality error between the outer circle axis and the center of the hole axis. a)
Use a Bouvet hardness tester to check the heat treatment hardness of the outer surface. b)
6.3 Electrical system safety inspection
JB20020—2004
6.3.1 The protective grounding continuity, insulation resistance, and withstand voltage tests of the electrical system are in accordance with GB5226.1--2002 Test according to the provisions of 19.2, 19.3 and 19.4.
6.3.2 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. 6.4 Performance inspection
6.4.1 No-load test:
6.4.1.1 Test conditions:
&) The turntable speed adjustment should be carried out in sequence from low speed to high speed: b) Operation time 4h, One-half of the turntables run at maximum speed for 2 hours, and the turntable at maximum speed runs for 2 hours. 6.4.1.2 Inspection items:
Visual inspection of the operating conditions of each moving part; a)
Visual and manual inspection of the operating conditions of the sheet thickness and filling depth dial or indicator needle; b) ||tt ||c) For tablet presses with hydraulic systems, the pressure resistance test of hydraulic cylinder pressure vessels shall be carried out according to the test method of GB/T7935. Use a dial indicator with a magnetic iron seat to measure the circumferential runout of a point at the largest circumference on the working surface of the turntable. d)
e) Use a digital thermometer or point thermometer to measure the operating temperature rise of the spindle bearing, and calculate it according to formula (1). At=t-to
where:
At—temperature rise, C;
—measured part temperature, ℃;
to—measured ambient temperature, ℃ .
6.4.2 Load test:
6.4.2.1 Test conditions:
a) Conducted after no-load test;
(1)
b ) Test materials: dry dextrin granules or granular materials with similar properties with a granulated particle size of 0.85mm~0.18mm (equivalent to 20 mesh~80 mesh) and a fine powder content not exceeding 30%. Stearic acid is allowed to be added. Magnesium or sodium alginate additive; c) The test tablets are round tablets. When the diameter of the disc is greater than 13mm, the test is carried out for 1 hour at half the maximum speed of the machine; when the diameter of the disc is less than or equal to 13mm, the test is carried out for 1 hour at the maximum speed of the machine. 6.4.2.2 Inspection items:
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C;
——The measured part temperature, ℃;
to——The measured ambient temperature, ℃.
6.4.2 Load test:
6.4.2.1 Test conditions:
a) Conducted after no-load test;
(1)
b ) Test materials: dry dextrin granules or granular materials with similar properties with a granulated particle size of 0.85mm~0.18mm (equivalent to 20 mesh~80 mesh) and a fine powder content not exceeding 30%. Stearic acid is allowed to be added. Magnesium or sodium alginate additive; c) The test tablets are round tablets. When the diameter of the disc is greater than 13mm, the test is carried out for 1 hour at half the maximum speed of the machine; when the diameter of the disc is less than or equal to 13mm, the test is carried out for 1 hour at the maximum speed of the machine. 6.4.2.2 Inspection items:
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C;
——The measured part temperature, ℃;
to——The measured ambient temperature, ℃.
6.4.2 Load test:
6.4.2.1 Test conditions:
a) Conducted after no-load test;
(1)
b ) Test materials: dry dextrin granules or granular materials with similar properties with a granulated particle size of 0.85mm~0.18mm (equivalent to 20 mesh~80 mesh) and a fine powder content not exceeding 30%. Stearic acid is allowed to be added. Magnesium or sodium alginate additive; c) The test tablets are round tablets. When the diameter of the disc is greater than 13mm, the test is carried out for 1 hour at half the maximum speed of the machine; when the diameter of the disc is less than or equal to 13mm, the test is carried out for 1 hour at the maximum speed of the machine. 6.4.2.2 Inspection items:
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