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 JB20021-2004
replaced YY0020-1990||tt ||High speed rotary tablet press
Highspeed rotary tabletpress
Released on 2004-02-05
Implemented on 2004-06-01
Released by the National Development and Reform Commission||tt ||Foreword
1 Scope
2 Normative reference documents
3 Terms and definitions
Classification and labeling
4
5 Requirements
6 test methods
inspection rules
7
marking, instructions for use, packaging and storage 8
item
times||tt ||JB20021—2004
28
29
29
29
31
31
32||tt ||34
35
27
JB20021—2004
Foreword
This standard is based on the "Good Manufacturing Practice for Pharmaceuticals" and GB/T1. 12000, GB/T1.2-2002 Standardization Work Guide requirements, revision of YY0020-1990 "High Speed ??Rotary Tablet Press". This standard replaces YY00201990 from the date of implementation. Compared with YY0020-1990, the main technical content changes of this standard are as follows: a) Chapter 1 adds the maximum linear speed of the center point of the die hole in the turntable. b) Chapter 2 has modified the introductory text, adding YY/T0216, "Pharmacopoeia of the People's Republic of China" and citing current effective standards. c) Chapter 3 has modified the term "work surface\". d) The content of Chapter 5 has changed as follows:
Added safety requirements for electrical systems:
Added requirements for mechanical operation lubrication and speed regulation (see 5.3.5, 5.3.7): "Table 1" in the tableting performance requirements has been modified, and the weight difference limit has been increased from ±6.5% to ±6%; the content of the noise sound pressure level of the double-discharging tablet press has been added. e) The content of test methods in Chapter 6 has been changed as follows: each item corresponds to the content in Chapter 5; material and lubricant inspections have been added:
-mechanical operation test conditions and test methods have been added; tablet quality The difference limit is changed to the method in Appendix I of Part II of the Pharmacopoeia of the People's Republic of China (2000 edition); the noise test method is changed from CB/T3768 to GB/T16769. f) In the inspection rules, the sampling plan for the type inspection prototype is modified. This standard is proposed by the China Pharmaceutical Equipment Industry Association. This standard is under the jurisdiction of the Pharmaceutical Equipment Industry Standardization Technical Committee. The drafting unit of this standard is: Beijing Aerospace Changfeng Co., Ltd. Honghua Pharmaceutical Machinery Branch. The main drafters of this standard are: Haoning and Wang. Rock. 28
1 Scope
High-speed rotary tablet press
JB20021-2004
This standard specifies the terms, definitions and classification of high-speed rotary tablet presses With markings, requirements, test methods, inspection rules and signs, instructions for use, packaging, and storage
This standard applies to high-speed rotary presses with a maximum linear speed of the center point of the die hole in the turntable not less than 60m/min. Tablet press (hereinafter referred to as tablet press).
2 Normative reference documents
The provisions in the following documents become the provisions of this standard through reference in this standard. 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. , the latest version applies to this standard. GB/T191 Packaging, storage and transportation pictorial markings (ervIS0780: 1997) GB/T1184-1996 Shape and position tolerances without tolerance values ??GB5226.1-2002 Mechanical safety mechanical and electrical equipment Part 1 ：General technical conditions (IEC60204-1:2000, IDT)
GB/T6388 Transportation packaging receipt and delivery marks
GB/T9969.1 General instructions for industrial products GB/T10111 using random number paragraphs Random sampling method GB/T13306 Label
CB/T13384 General technical conditions for mechanical and electrical product packaging GB/T16769--1997 Metal cutting machine tool noise sound pressure level measurement method (negISO/DIS230-5-2) YY/T0216 Pharmaceutical Mechanical product model compilation method "Pharmacopoeia of the People's Republic of China" (2000 edition) National Pharmacopoeia Committee 3 Terms and Definitions
The following terms and definitions apply to this standard. 3.1
The number of dies numberofstations
The number of dies in the turntable.
3.2
Maximum Main Operation Pressure The maximum working pressure that the tablet press can achieve when compressing tablets. 29
JB20021—2004
3.3www.bzxz.net
maximum tablettdiameter The maximum circumscribed diameter of the tablet allowed to be compressed. 3.4
Maximum depth of fill
maximumdepthof fill
The maximum depth of adding materials when compressing tablets.
3.5
maximum thickness of tabletsMaximum thickness of tablets
Maximum thickness of flat tablets.
3.6
Maximum tablet output
maximum tablet output
The number of tablets that the tablet press can press per hour at the maximum spindle speed. 3.7
Turntable turret
The workbench for installing the die.
3.8
punchholes
The holes for installing punches on the turntable.
3.9
middleholes
The holes for installing the punch on the turntable.
3.10
Turntable working surface topofturretwithdie The working surface on the turntable is used for installing the middle mold, feeding materials and discharging the sheets. 3.11
pressure roller
The roller that provides pressure when compressing tablets.
3.12
upperandlowerpressureshaft
Upper and lower pressure wheel axle
The mandrel for installing the upper and lower pressure wheel.
3.13
The upper and lower guide rails upperand lowerpunch quide are the tracks that enable the upper and lower punches to move up and down. 3.14
Feeder feeder
is a component that enables the material to fully fill the punching hole. 30
4 Classification and Marking
4.1 Model
The tablet press model is in accordance with YY/T0216.
4.2 mark
PG
Marking example:
Improved design serial number: A, B, C
Specification code: expressed by die number||tt ||Type and feature code: G - high-speed rotary function code: P tablet press
PG28B type: represents a high-speed rotary tablet press with a second improved design and a die number of 28. 5 Requirements
5.1 Basic Requirements
JB20021—2004
5.1.1 The outer surface of the tablet press is flat and smooth, with no obvious scratches and no rust; the coating has the same color and luster and cannot be damaged. Bubbles, no shedding. 5.1.2 The studio should be isolated from the outside world, pollution-free, easy to disassemble and clean, and have dust collection and self-locking functions. 5.1.3 The surface of the parts in direct contact with the medicine should be clean, smooth, non-falling, and easy to clean or disinfect. 5.1.4. Parts that are in direct contact with drugs should be made of materials that are corrosion-resistant, do not chemically react with the drugs or do not absorb drug crystals, or are made of materials whose surfaces are coated with corrosion-resistant, heat-resistant, wear-resistant and other coatings. 5.1.5 The lubricating oil used to lubricate the upper and lower punches must not contact the medicine or container. 5.2 Electrical system safety requirements
5.2.1 The continuity of the protective grounding circuit of the electrical system shall comply with the provisions of 19.2 in GB5226.1-2002. 5.2.2 The insulation resistance of the electrical system shall comply with the provisions of 19.3 in GB5226.1-2002. 5.2.3 The withstand voltage of the electrical system shall comply with the provisions of 19.4 in GB5226.1-2002. 5.2.4 The protective grounding circuit of the electrical system should comply with the provisions of 8.2 in CB5226.1--2002. 5.2.5 The buttons of the electrical system should comply with the provisions of 10.2 in GB5226.1-2002. 5.2.6 The indicator lights and indicators of the electrical system should comply with the provisions of 10.3 in GB5226.1-2002. 5.2.7 The markings, warning signs and project codes of the electrical system shall comply with the provisions of Chapter 17 of CB5226.1-2002. 5.3 Mechanical operation requirements
5.3.1 The tablet press runs smoothly without abnormal noise, and the difference between the working temperature rise of the motor, reducer, etc. and the ambient temperature does not exceed 40°C. 5.3.2 The hydraulic system of the tablet press should have good sealing performance. After 4 hours of rated pressure of the system, the pressure difference should be within 0MPa~2MPa. 5.3.3 The end face runout of the working surface of the tablet press turntable should comply with the 8th level accuracy requirements of Table B4 of GB/T1184-1996. 5.3.4 The tablet press should have overload protection function and emergency stop device. 5.3.5 The tablet press should have automatic lubrication or grease lubrication. 5.3.6 The tablet press should have a fault alarm device. 31
JB20021—2004
5.3.7 The main motor and feeding motor of the tablet press should have speed adjustment functions. 5.4 Tablet pressing performance requirements
5.4.1 The tablet press uses two die sizes, the smallest and the largest, for tableting diameters. The movement should be smooth during tableting. 5.4.2 The main pressing force and pre-pressure of the tablet press should be continuously adjustable and have a main pressing force display. 5.4.3 The filling depth of the tablet press should be continuously adjustable. 5.4.4 The tableting output of the tablet press should be continuously adjustable and have a tableting output display function. 5.4.5 The tablet press should have an automatic tablet quality control system, and the limits of tablet weight difference should comply with the provisions of Table 1. Table 1 Limits of Tablet Weight Difference
Average Weight
<0.3g
≥0.3g
5.4.6 The tablet press should have a reject function,|| tt | Should be less than 82dB(A). For double-discharge tablet presses, the noise sound pressure level should be less than 85dB(A).
6 Test Methods
6.1 Basic Requirements Inspection
6.1.1 Visually and tactilely inspect the appearance, working chamber and surface quality of the tablet press. 6.1.2 Visually and tactilely check the isolation, dust collection, and self-locking functions of the tablet press working room from the outside world. 6.1.3 Visually and tactilely inspect the surface quality of the parts in direct contact with the drug. 6.1.4 Check the parts and materials that are in direct contact with drugs against the material list. 6.1.5 Check the lubricating oil instruction manual against the design documents, and perform chemical testing on the lubricating oil if necessary. 6.2 Electrical system safety inspection
6.2.1 According to the test method specified in 19.2 of GB5226.1-2002, check the continuity of the protective grounding circuit of the electrical system. 6.2.2 According to the test method specified in 19.3 of GB5226.1-2002, measure the insulation resistance of the electrical system. 6.2.3 Measure the withstand voltage of the electrical system according to the test method specified in 19.4 of GB5226.1-2002. 6.2.4 According to the provisions of 8.2 in GB5226.1-2002, check the protective grounding circuit of the electrical system. 6.2.5 According to the provisions of 10.2 in GB5226.1-2002, check the buttons of the electrical system. 6.2.6 According to the provisions of 10.3 in GB5226.1-2002, check the indicator lights and displays of the electrical system. 6.2.7 According to the provisions of Chapter 17 of GB5226.1-2002, check the markings, warning signs and project codes of the electrical system. 6.3 Mechanical operation test
6.3.1 Test conditions
6.3.1.1 All tablet presses shall undergo a 4-hour no-load mechanical operation test without powder loading. 6.3.1.2 The speed adjustment change of the turntable should be carried out in sequence from low speed to high speed. 6.3.1.3 Test environment:
32
a) Altitude below 1000m;
b) Temperature 10℃~35℃:
c) Relative humidity 45%~ 65%.
6.3.1.4 Test speed and running time:
30% of the maximum speed, 1h;
a)
b) 70% of the maximum speed, 1.5h;
Maximum speed, 1.5h.
c)
6.3.2 Mechanical operation test method:
Start the tablet press at 30% of the maximum speed, and observe the operation status of the tablet press after continuous operation for 1 hour. 6.3.2.1
Start the tablet press at 70% of the maximum speed, and check after 1.5 hours of continuous operation: 6.3.2.2
a)
Observe the operating status of the tablet press: || tt||Adjust the pressure of the hydraulic system of the tablet press to the rated value, and check the pressure difference after 1.5 hours; b)
JB20021—2004
Fix the magnetometer bracket to the fixed platform of the tablet press , install the dial indicator, point the dial indicator pointer to the end face of the turntable, and measure the runout of the end face of the turntable;
Press the protection switch and observe the overload protection function of the tablet press; press Turn off the emergency stop switch and observe the emergency stop device. At this time, the main motor d)
and functional parts should be powered off and stopped immediately: visually observe the automatic lubrication system or grease lubrication of the tablet press: each lubrication point should be able to operate on time . Appropriate amount of oil injection: Check the connections of each component, no oil leakage is allowed, and the system will not return oil; f) Simulate a fault, visually observe and listen to the working status of the tablet press fault alarm device: ) Press the speed adjustment button of the main motor or the feeding motor and observe the speed adjustment functions of the main motor and the feeding motor. 6.3.2.3 After working at 70% of the maximum speed for 1.5 hours, and then working continuously at the maximum speed for 1.5 hours, measure the temperature of the motor and reducer, and calculate the temperature rise according to equation (1):
At=t-to| |tt||In the formula:
A—temperature rise,:
—-actually measured component temperature, ℃:
o——actually measured ambient temperature, ℃.
6.4 Tablet compression performance test
6.4.1 Test conditions:
6.4.1.1 The tablet compression performance test can only be carried out after passing the mechanical operation test. 6.4.1.2 The die size for the test is the minimum and maximum tableting diameters. . (1)
6.4.1.3 The starch used in the test should comply with the relevant provisions of Part II of the "Pharmacopoeia of the People's Republic of China" (2000 edition). After granulation, its particle size is 1.3mm~0.85mm (equivalent to 16 The uniform scoop blank particles (mesh ~ 24 mesh) are used as raw materials. Magnesium stearate or sodium alginate additives are allowed to be added, and the fine powder content does not exceed 30%.
6.4.1.4 Tablet pressing performance test running time shall not be less than 2hg6.4.1.5 Test environment:
a) Altitude below 1000m;
33
The provisions of Chapter 17 of 1-2002. 5.3 Mechanical operation requirements
5.3.1 The tablet press runs smoothly without abnormal noise, and the difference between the working temperature rise of the motor, reducer, etc. and the ambient temperature does not exceed 40°C. 5.3.2 The hydraulic system of the tablet press should have good sealing performance. After 4 hours of rated pressure of the system, the pressure difference should be within 0MPa~2MPa. 5.3.3 The end face runout of the working surface of the tablet press turret should comply with the 8th level accuracy requirements of Table B4 of GB/T1184-1996. 5.3.4 The tablet press should have overload protection function and emergency stop device. 5.3.5 The tablet press should have automatic lubrication or grease lubrication. 5.3.6 The tablet press should have a fault alarm device. 31
JB20021—2004
5.3.7 The main motor and feeding motor of the tablet press should have speed adjustment functions. 5.4 Tablet pressing performance requirements
5.4.1 The tablet press uses two die sizes, the smallest and the largest, for tableting diameters. The movement should be smooth during tableting. 5.4.2 The main pressing force and pre-pressure of the tablet press should be continuously adjustable and have a main pressing force display. 5.4.3 The filling depth of the tablet press should be continuously adjustable. 5.4.4 The tableting output of the tablet press should be continuously adjustable and have a tableting output display function. 5.4.5 The tablet press should have an automatic tablet quality control system, and the limits of tablet weight difference should comply with the provisions of Table 1. Table 1 Limits of Tablet Weight Difference
Average Weight
<0.3g
≥0.3g
5.4.6 The tablet press should have a reject function,|| tt | Should be less than 82dB(A). For double-discharge tablet presses, the noise sound pressure level should be less than 85dB(A).
6 Test Methods
6.1 Basic Requirements Inspection
6.1.1 Visually and tactilely inspect the appearance, working chamber and surface quality of the tablet press. 6.1.2 Visually and tactilely check the isolation, dust collection, and self-locking functions of the tablet press working room from the outside world. 6.1.3 Visually and tactilely inspect the surface quality of the parts in direct contact with the drug. 6.1.4 Check the parts and materials that are in direct contact with drugs against the material list. 6.1.5 Check the lubricating oil instruction manual against the design documents, and perform chemical testing on the lubricating oil if necessary. 6.2 Electrical system safety inspection
6.2.1 According to the test method specified in 19.2 of GB5226.1-2002, check the continuity of the protective grounding circuit of the electrical system. 6.2.2 According to the test method specified in 19.3 of GB5226.1-2002, measure the insulation resistance of the electrical system. 6.2.3 Measure the withstand voltage of the electrical system according to the test method specified in 19.4 of GB5226.1-2002. 6.2.4 According to the provisions of 8.2 in GB5226.1-2002, check the protective grounding circuit of the electrical system. 6.2.5 According to the provisions of 10.2 in GB5226.1-2002, check the buttons of the electrical system. 6.2.6 According to the provisions of 10.3 in GB5226.1-2002, check the indicators and displays of the electrical system. 6.2.7 According to the provisions of Chapter 17 of GB5226.1-2002, check the markings, warning signs and project codes of the electrical system. 6.3 Mechanical operation test
6.3.1 Test conditions
6.3.1.1 All tablet presses shall undergo a 4-hour no-load mechanical operation test without powder loading. 6.3.1.2 The speed adjustment change of the turntable should be carried out in sequence from low speed to high speed. 6.3.1.3 Test environment:
32
a) Altitude below 1000m;
b) Temperature 10℃~35℃:
c) Relative humidity 45%~ 65%.
6.3.1.4 Test speed and running time:
30% of the maximum speed, 1h;
a)
b) 70% of the maximum speed, 1.5h;
Maximum speed, 1.5h.
c)
6.3.2 Mechanical operation test method:
Start the tablet press at 30% of the maximum speed, and observe the operation status of the tablet press after continuous operation for 1 hour. 6.3.2.1
Start the tablet press at 70% of the maximum speed, and check after 1.5 hours of continuous operation: 6.3.2.2
a)
Observe the operating status of the tablet press: || tt||Adjust the pressure of the hydraulic system of the tablet press to the rated value, and check the pressure difference after 1.5 hours; b)
JB20021—2004
Fix the magnetometer bracket to the fixed platform of the tablet press , install the dial indicator, point the dial indicator pointer to the end face of the turntable, and measure the runout of the end face of the turntable;
Press the protection switch and observe the overload protection function of the tablet press; press Turn off the emergency stop switch and observe the emergency stop device. At this time, the main motor d)
and functional parts should be powered off and stopped immediately: visually observe the automatic lubrication system or grease lubrication of the tablet press: each lubrication point should be able to operate on time . Appropriate amount of oil injection: Check the connections of each component, no oil leakage is allowed, and the system will not return oil; f) Simulate a fault, visually observe and listen to the working status of the tablet press fault alarm device: ) Press the speed adjustment button of the main motor or the feeding motor and observe the speed adjustment functions of the main motor and the feeding motor. 6.3.2.3 After working at 70% of the maximum speed for 1.5 hours, and then working continuously at the maximum speed for 1.5 hours, measure the temperature of the motor and reducer, and calculate the temperature rise according to equation (1):
At=t-to| |tt||In the formula:
A—temperature rise,:
—-actually measured component temperature, ℃:
o——actually measured ambient temperature, ℃.
6.4 Tablet compression performance test
6.4.1 Test conditions:
6.4.1.1 The tablet compression performance test can only be carried out after passing the mechanical operation test. 6.4.1.2 The die size for the test is the minimum and maximum tableting diameters. . (1)
6.4.1.3 The starch used in the test should comply with the relevant provisions of Part II of the "Pharmacopoeia of the People's Republic of China" (2000 edition). After granulation, its particle size is 1.3mm~0.85mm (equivalent to 16 The uniform scoop blank particles (mesh ~ 24 mesh) are used as raw materials. Magnesium stearate or sodium alginate additives are allowed to be added, and the fine powder content does not exceed 30%.
6.4.1.4 Tablet pressing performance test running time shall not be less than 2hg6.4.1.5 Test environment:
a) Altitude below 1000m;
33
The provisions of Chapter 17 of 1-2002. 5.3 Mechanical operation requirements
5.3.1 The tablet press runs smoothly without abnormal noise, and the difference between the working temperature rise of the motor, reducer, etc. and the ambient temperature does not exceed 40°C. 5.3.2 The hydraulic system of the tablet press should have good sealing performance. After 4 hours of rated pressure of the system, the pressure difference should be within 0MPa~2MPa. 5.3.3 The end face runout of the working surface of the tablet press turret should comply with the 8th level accuracy requirements of Table B4 of GB/T1184-1996. 5.3.4 The tablet press should have overload protection function and emergency stop device. 5.3.5 The tablet press should have automatic lubrication or grease lubrication. 5.3.6 The tablet press should have a fault alarm device. 31
JB20021—2004
5.3.7 The main motor and feeding motor of the tablet press should have speed adjustment functions. 5.4 Tablet pressing performance requirements
5.4.1 The tablet press uses two die sizes of the minimum and maximum tableting diameters. The movement should be smooth during tableting. 5.4.2 The main pressing force and pre-pressure of the tablet press should be continuously adjustable and have a main pressing force display. 5.4.3 The filling depth of the tablet press should be continuously adjustable. 5.4.4 The tableting output of the tablet press should be continuously adjustable and have a tableting output display function. 5.4.5 The tablet press should have an automatic tablet quality control system, and the limits of tablet weight difference should comply with the provisions of Table 1. Table 1 Limits of Tablet Weight Difference
Average Weight
<0.3g
≥0.3g
5.4.6 The tablet press should have a reject function,|| tt | Should be less than 82dB(A). For double-discharge tablet presses, the noise sound pressure level should be less than 85dB(A).
6 Test Methods
6.1 Basic Requirements Inspection
6.1.1 Visually and tactilely inspect the appearance, working chamber and surface quality of the tablet press. 6.1.2 Visually and tactilely check the isolation, dust collection, and self-locking functions of the tablet press working room from the outside world. 6.1.3 Visually and tactilely inspect the surface quality of the parts in direct contact with the drug. 6.1.4 Check the parts and materials that are in direct contact with drugs against the material list. 6.1.5 Check the lubricating oil instruction manual against the design documents, and perform chemical testing on the lubricating oil if necessary. 6.2 Electrical system safety inspection
6.2.1 According to the test method specified in 19.2 of GB5226.1-2002, check the continuity of the protective grounding circuit of the electrical system. 6.2.2 According to the test method specified in 19.3 of GB5226.1-2002, measure the insulation resistance of the electrical system. 6.2.3 Measure the withstand voltage of the electrical system according to the test method specified in 19.4 of GB5226.1-2002. 6.2.4 According to the provisions of 8.2 in GB5226.1-2002, check the protective grounding circuit of the electrical system. 6.2.5 According to the provisions of 10.2 in GB5226.1-2002, check the buttons of the electrical system. 6.2.6 According to the provisions of 10.3 in GB5226.1-2002, check the indicators and displays of the electrical system. 6.2.7 According to the provisions of Chapter 17 of GB5226.1-2002, check the markings, warning signs and project codes of the electrical system. 6.3 Mechanical operation test
6.3.1 Test conditions
6.3.1.1 All tablet presses shall undergo a 4-hour no-load mechanical operation test without powder loading. 6.3.1.2 The speed adjustment of the turntable should be carried out in sequence from low speed to high speed. 6.3.1.3 Test environment:
32
a) Altitude below 1000m;
b) Temperature 10℃~35℃:
c) Relative humidity 45%~ 65%.
6.3.1.4 Test speed and running time:
30% of the maximum speed, 1h;
a)
b) 70% of the maximum speed, 1.5h;
Maximum speed, 1.5h.
c)
6.3.2 Mechanical operation test method:
Start the tablet press at 30% of the maximum speed, and observe the operation status of the tablet press after continuous operation for 1 hour. 6.3.2.1
Start the tablet press at 70% of the maximum speed, and check after 1.5 hours of continuous operation: 6.3.2.2
a)
Observe the operating status of the tablet press: || tt||Adjust the pressure of the hydraulic system of the tablet press to the rated value, and check the pressure difference after 1.5 hours; b)
JB20021—2004
Fix the magnetometer bracket to the fixed platform of the tablet press , install the dial indicator, point the dial indicator pointer to the end face of the turntable, and measure the runout of the end face of the turntable;
Press the protection switch and observe the overload protection function of the tablet press; press Turn off the emergency stop switch and observe the emergency stop device. At this time, the main motor d)
and functional parts should be powered off and stopped immediately: visually observe the automatic lubrication system or grease lubrication of the tablet press: each lubrication point should be able to operate on time . Appropriate amount of oil injection: Check the connections of each component, no oil leakage is allowed, and the system will not return oil; f) Simulate a fault, visually observe and listen to the working status of the tablet press fault alarm device: ) Press the speed adjustment button of the main motor or the feeding motor and observe the speed adjustment functions of the main motor and the feeding motor. 6.3.2.3 After working at 70% of the maximum speed for 1.5 hours, and then working continuously at the maximum speed for 1.5 hours, measure the temperature of the motor and reducer, and calculate the temperature rise according to equation (1):
At=t-to| |tt||In the formula:
A—temperature rise,:
—-actually measured component temperature, ℃:
o——actually measured ambient temperature, ℃.
6.4 Tablet compression performance test
6.4.1 Test conditions:
6.4.1.1 The tablet compression performance test can only be carried out after passing the mechanical operation test. 6.4.1.2 The die size for the test is the minimum and maximum tableting diameters. . (1)
6.4.1.3 The starch used in the test should comply with the relevant provisions of Part 2 of the "Pharmacopoeia of the People's Republic of China" (2000 edition). After granulation, its particle size is 1.3mm~0.85mm (equivalent to 16 The uniform scoop blank particles (mesh ~ 24 mesh) are used as raw materials. Magnesium stearate or sodium alginate additives are allowed to be added, and the fine powder content does not exceed 30%.
6.4.1.4 Tablet compression performance test running time shall not be less than 2hg6.4.1.5 Test environment:
a) Altitude below 1000m;
33
3. Visually and tactilely inspect the surface quality of the parts in direct contact with the drugs. 6.1.4 Check the parts and materials that are in direct contact with drugs against the material list. 6.1.5 Check the lubricating oil instruction manual against the design documents, and perform chemical testing on the lubricating oil if necessary. 6.2 Electrical system safety inspection
6.2.1 According to the test method specified in 19.2 of GB5226.1-2002, check the continuity of the protective grounding circuit of the electrical system. 6.2.2 According to the test method specified in 19.3 of GB5226.1-2002, measure the insulation resistance of the electrical system. 6.2.3 Measure the withstand voltage of the electrical system according to the test method specified in 19.4 of GB5226.1-2002. 6.2.4 According to the provisions of 8.2 in GB5226.1-2002, check the protective grounding circuit of the electrical system. 6.2.5 According to the provisions of 10.2 in GB5226.1-2002, check the buttons of the electrical system. 6.2.6 According to the provisions of 10.3 in GB5226.1-2002, check the indicators and displays of the electrical system. 6.2.7 According to the provisions of Chapter 17 of GB5226.1-2002, check the markings, warning signs and project codes of the electrical system. 6.3 Mechanical operation test
6.3.1 Test conditions
6.3.1.1 All tablet presses shall undergo a 4-hour no-load mechanical operation test without powder loading. 6.3.1.2 The speed adjustment change of the turntable should be carried out in sequence from low speed to high speed. 6.3.1.3 Test environment:
32
a) Altitude below 1000m;
b) Temperature 10℃~35℃:
c) Relative humidity 45%~ 65%.
6.3.1.4 Test speed and running time:
30% of the maximum speed, 1h;
a)
b) 70% of the maximum speed, 1.5h;
Maximum speed, 1.5h.
c)
6.3.2 Mechanical operation test method:
Start the tablet press at 30% of the maximum speed, and observe the operation status of the tablet press after continuous operation for 1 hour. 6.3.2.1
Start the tablet press at 70% of the maximum speed, and check after 1.5 hours of continuous operation: 6.3.2.2
a)
Observe the operating status of the tablet press: || tt||Adjust the pressure of the hydraulic system of the tablet press to the rated value, and check the pressure difference after 1.5 hours; b)
JB20021—2004
Fix the magnetometer bracket to the fixed platform of the tablet press , install the dial indicator, point the dial indicator pointer to the end face of the turntable, and measure the runout of the end face of the turntable;
Press the protection switch and observe the overload protection function of the tablet press; press Turn off the emergency stop switch and observe the emergency stop device. At this time, the main motor d)
and functional parts should be powered off and stopped immediately: visually observe the automatic lubrication system or grease lubrication of the tablet press: each lubrication point should be able to operate on time . Appropriate amount of oil injection: Check the connections of each component, no oil leakage is allowed, and the system will not return oil; f) Simulate a fault, visually observe and listen to the working status of the tablet press fault alarm device: ) Press the speed adjustment button of the main motor or the feeding motor and observe the speed adjustment functions of the main motor and the feeding motor. 6.3.2.3 After working at 70% of the maximum speed for 1.5 hours, then continuously working at the maximum speed for 1.5 hours, measure the temperature of the motor and reducer, and calculate the temperature rise according to formula (1):
At=t-to| |tt||In the formula:
A—temperature rise,:
—-actually measured component temperature, ℃:
o——actually measured ambient temperature, ℃.
6.4 Tablet compression performance test
6.4.1 Test conditions:
6.4.1.1 The tablet compression performance test can only be carried out after passing the mechanical operation test. 6.4.1.2 The die size for the test is the minimum and maximum tableting diameters. . (1)
6.4.1.3 The starch used in the test should comply with the relevant provisions of Part 2 of the "Pharmacopoeia of the People's Republic of China" (2000 edition). After granulation, its particle size is 1.3mm~0.85mm (equivalent to 16 The uniform scooped blank particles (mesh ~ 24 mesh) are used as raw materials. Magnesium stearate or sodium alginate additives are allowed to be added, and the fine powder content does not exceed 30%.
6.4.1.4 Tablet compression performance test running time shall not be less than 2hg6.4.1.5 Test environment:
a) Altitude below 1000m;
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3. Visually and tactilely inspect the surface quality of the parts in direct contact with the drugs. 6.1.4 Check the parts and materials that are in direct contact with drugs against the material list. 6.1.5 Check the lubricating oil instruction manual against the design documents, and perform chemical testing on the lubricating oil if necessary. 6.2 Electrical system safety inspection
6.2.1 According to the test method specified in 19.2 of GB5226.1-2002, check the continuity of the protective grounding circuit of the electrical system. 6.2.2 According to the test method specified in 19.3 of GB5226.1-2002, measure the insulation resistance of the electrical system. 6.2.3 Measure the withstand voltage of the electrical system according to the test method specified in 19.4 of GB5226.1-2002. 6.2.4 According to the provisions of 8.2 in GB5226.1-2002, check the protective grounding circuit of the electrical system. 6.2.5 According to the provisions of 10.2 in GB5226.1-2002, check the buttons of the electrical system. 6.2.6 According to the provisions of 10.3 in GB5226.1-2002, check the indicator lights and displays of the electrical system. 6.2.7 According to the provisions of Chapter 17 of GB5226.1-2002, check the markings, warning signs and project codes of the electrical system. 6.3 Mechanical operation test
6.3.1 Test conditions
6.3.1.1 All tablet presses shall undergo a 4-hour no-load mechanical operation test without powder loading. 6.3.1.2 The speed adjustment change of the turntable should be carried out in sequence from low speed to high speed. 6.3.1.3 Test environment:
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a) Altitude below 1000m;
b) Temperature 10℃~35℃:
c) Relative humidity 45%~ 65%.
6.3.1.4 Test speed and running time:
30% of the maximum speed, 1h;
a)
b) 70% of the maximum speed, 1.5h;
Maximum speed, 1.5h.
c)
6.3.2 Mechanical operation test method:
Start the tablet press at 30% of the maximum speed, and observe the operation status of the tablet press after continuous operation for 1 hour. 6.3.2.1
Start the tablet press at 70% of the maximum speed, and check after 1.5 hours of continuous operation: 6.3.2.2
a)
Observe the operating status of the tablet press: || tt||Adjust the pressure of the hydraulic system of the tablet press to the rated value, and check the pressure difference after 1.5 hours; b)
JB20021—2004
Fix the magnetometer bracket to the fixed platform of the tablet press , install the dial indicator, point the dial indicator pointer to the end face of the turntable, and measure the runout of the end face of the turntable;
Press the protection switch and observe the overload protection function of the tablet press; press Turn off the emergency stop switch and observe the emergency stop device. At this time, the main motor d)
and functional parts should be powered off and stopped immediately: visually observe the automatic lubrication system or grease lubrication of the tablet press: each lubrication point should be able to operate on time . Appropriate amount of oil injection: Check the connections of each component, no oil leakage is allowed, and the system will not return oil; f) Simulate a fault, visually observe and listen to the working status of the tablet press fault alarm device: ) Press the speed adjustment button of the main motor or the feeding motor and observe the speed adjustment functions of the main motor and the feeding motor. 6.3.2.3 After working at 70% of the maximum speed for 1.5 hours, and then working continuously at the maximum speed for 1.5 hours, measure the temperature of the motor and reducer, and calculate the temperature rise according to equation (1):
At=t-to| |tt||In the formula:
A—temperature rise,:
—-actually measured component temperature, ℃:
o——actually measured ambient temperature, ℃.
6.4 Tablet compression performance test
6.4.1 Test conditions:
6.4.1.1 The tablet compression performance test can only be carried out after passing the mechanical operation test. 6.4.1.2 The die size for the test is the minimum and maximum tableting diameters. . (1)
6.4.1.3 The starch used in the test should comply with the relevant provisions of Part II of the "Pharmacopoeia of the People's Republic of China" (2000 edition). After granulation, its particle size is 1.3mm~0.85mm (equivalent to 16 The uniform scoop blank particles (mesh ~ 24 mesh) are used as raw materials. Magnesium stearate or sodium alginate additives are allowed to be added, and the fine powder content does not exceed 30%.
6.4.1.4 Tablet pressing performance test running time shall not be less than 2hg6.4.1.5 Test environment:
a) Altitude below 1000m;
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4 The tableting performance test running time shall not be less than 2hg6.4.1.5 Test environment:
a) Altitude below 1000m;
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4 The tableting performance test running time shall not be less than 2hg6.4.1.5 Test environment:
a) Altitude below 1000m;
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