Some standard content:
JB
Pharmaceutical Machinery Industry Standard of the People's Republic of China JB20014~20018—2004
Medicinal boiling granulator
Wet mixing granulator
High-efficiency coating machine
Water chestnut coating machine
Swinging granulator
2004-02-05
2004-06-01 implementation
National Development and Reform Commission issued
ICS11. 120.30
C92
JB
Pharmaceutical Machinery Industry Standard of the People's Republic of China JB20015—2004
Replaces YY0256—1997
Wet type mixing granulator
Wet type mixing granulator
Published on 2004-02-05
Implemented on 2004-06-01
National Development and Reform Commission Issued
Foreword…
1 Scope
2 Normative references
3 Terms and definitions
4 Classification and marking
5 Requirements
Test methods
6
7
Inspection rules
8 Marking, instructions, packaging and storage
Contents
JB20015—2004
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15
JB20015—20Q4
Foreword
This standard is a revision of YY0256—1997 “Wet Mixing Granulator” according to the requirements of “Good Manufacturing Practice for Pharmaceuticals” and GB/T1.1—2000 and GB/T1.2—2002 standardization work guidelines. This standard replaces YY0256—1997 from the date of implementation. Compared with YY0256-1997, the main technical content of this standard has been changed as follows: a) The main chapters and clauses of YY0256-1997 have been deleted: basic requirements (4.1);
welding parts requirements (4.1.4);
assembly quality requirements (4.2);
- working conditions (4.3);
- coating requirements (4.6.3).
b) The main chapters and clauses of YY0256-1997 have been revised: reference standards (Chapter 2):
requirements (Chapter 4);
test methods (Chapter 5);
inspection rules (Chapter 6).
e) The main chapters and clauses added to this standard are:
Terms and definitions (Chapter 3);
Structure and materials (5.1.3.5.1.4, 5.1.5, 5.1.7); Operation control safety (5.2);
-Electrical system safety (5.3);
Instruction manual (8.2);
Electrical control system technical documents (8.3.3d). 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 Shanghai Tianxiang Jiantai Pharmaceutical Machinery Co., Ltd. The main drafters of this standard are Li Huaqiang and Chen Luzhen. 16
1 Scope
Wet Mixing Granulator
JB20015-2004
This standard specifies the terms and definitions, classification and marking, requirements, test methods, inspection rules and marking, instructions, packaging and storage of wet mixing granulators.
This standard applies to fixed cylinder type and mobile cylinder type wet mixing granulators (hereinafter referred to as granulators). 2 Normative References
The clauses in the following documents become the clauses of this standard through reference in this standard. For any dated referenced document, all subsequent amendments (excluding errata) or revisions are not applicable to this standard. However, the parties to the agreement based on this standard are encouraged to study whether the latest versions of these documents can be used. For any undated referenced document, the latest version shall apply to this standard. CB/T191 Packaging, storage and transportation pictorial marking
GB5226.1-2002 Mechanical safety Mechanical and electrical equipment Part 1: General technical conditions GB/T6388 Transport packaging delivery and receipt marking
GB/T9969.1 Industrial product instruction manual General provisions GB/T10610 Product geometry technical specification Surface structure Wheel mat method Rules and methods for evaluating surface structure Signs
GB/T 13306
GB/T13384 General technical conditions for packaging of electromechanical products GB/T16769
3 Terms and definitions
Method for measuring the sound pressure level of noise from metal cutting machine tools The following terms and definitions apply to this standard. 3.1
Fixed cylinder type fixedbowl
The container for mixed materials is a fixed type.
3.2
Movable cylinder type movablebowl
The container for mixed materials is a lifting and moving type. 3.3
Stirrer
A rotating device that fully aligns the materials.
3.4
Granulating knife
granulatingknife
17
JB200152004
A rotating device that cuts the mixed materials into granules. 4 Classification and labeling
4.1 Classification
A device that mixes the medicinal powdered materials with a certain amount of liquid into a uniform material through a stirring paddle, and then cuts the materials into wet granules by a high-speed rotating granulating knife. According to its structural type, it can be divided into fixed cylinder type and mobile cylinder type. 4.2 Marking
4.2.1 Model compilation:
HS
Improved design serial number (A, B, C)
Main parameters: cylinder volume (nominal volume), L-product feature code: G-fixed cylinder type, Y-mobile type Product type code: wet mixing granulation
Product function code: mixing granulator
4.2.2 Marking examples:
a) HILSG250A: indicates a fixed cylinder wet mixing granulator with a cylinder volume of 250L after the first improved design; b) HILSG300: indicates a fixed cylinder wet mixing granulator with a cylinder volume of 300L; HLSY150: indicates a mobile cylinder wet mixing granulator with a cylinder volume of 150L. c
5 Requirements
5.1 Appearance, structure and material
5.1.1 The appearance of the pelletizer should be flat and smooth, and the edges of the exposed joint surface should be neat and should not be misaligned. 5.1.2 All operating parts and exposed fasteners should be treated with surface anti-rust. 5.1.3 The cylinder body and cylinder cover of the pelletizer should be airtight and easy to open and close; there should be an observation window, a feeding port and an exhaust hole on the cylinder cover, and the exhaust hole should be equipped with a filter.
5.1.4 The inner wall of the cylinder body, the stirring paddle and the pelletizing knife surface should have no dead angle, be flat and smooth, and the surface roughness Ra value should not be greater than 0.8μm. 5.1.5 The stirring case and pelletizing knife should be easy to disassemble and use; the gap between the bottom plane of the stirring blade of the fixed cylinder pelletizer and the bottom surface of the pelletizing cylinder is 0.5mm~2.0mm; the gap between the bottom plane of the stirring paddle of the mobile cylinder pelletizer and the bottom surface of the pelletizing cylinder is not more than 5.0mm. 5.1.6 The cylinder of the granulator should be easy to discharge and clean, without dead corners or fouling. 5.1.7 The materials of the parts in the granulator that come into contact with the drug should be made of non-toxic, corrosion-resistant materials that do not pollute the drug. 5.2 Operation and control safety
5.2.1 The opening and closing of the cylinder cover of the fixed cylinder granulator should be equipped with a warning device, and the cylinder cover should be locked well after opening, and should not be overturned or shifted. 5.2.2 When the cylinder cover of the fixed cylinder granulator is opened, the motors of the agitator and the granulator knife should be in the power-off state. 5.2.3 When the cylinder of the mobile cylinder granulator is lifted vertically, there should be a warning device, and the cylinder should be locked well after the lifting stops. 5.2.4 When the cylinder of the mobile cylinder pelletizer leaves the working position, the motors of the stirring paddle and the pelletizing knife should be in the power-off state. 5.3 Electrical system safety
18
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 in GB5226.1-2002. 5.3.4 The protective grounding circuit of the electrical system shall comply with the provisions of 8.2 in GB5226.1-2002. 5.3.5 The buttons of the electrical system shall comply with the provisions of 10.2 in CB5226.1-2002. 5.3.6 The indicator lights and displays of the electrical system shall comply with CB5226.The provisions of 10.3 in 1-2002. 5.3.7 The wiring of the electrical system should comply with the provisions of Chapter 14 of GB5226.1-2002. JB200152004
5.3.8 The markings, warning signs and project codes of electrical systems should comply with the provisions of Chapter 17 of GB5226.1-2002. 5.4 Performance
5.4.1 The granulator should operate smoothly without looseness, vibration, jamming, etc. 5.4.2 The speed of the mixing paddle and granulating knife of the granulator is adjustable. 5.4.3 The temperature rise on the surface of the bearing shell of the mixing paddle shaft and chopper shaft of the granulator should not exceed 40°C. 5.4.4 There should be no abnormal noise when the granulator is running, and the sound pressure level of its no-load operation should not be greater than 85dB(A). 5.4.5 There should be no oil leakage from the mixing paddle and the supporting body of the granulating knife rotating shaft into the cylinder of the granulator. 5.4.6 The discharging device of the granulator should be sealed when closed, and no leakage of powder or liquid is allowed. 5.4.7 For granulators that adopt a water cooling structure, the cooling system should not leak. 5.4.8 The finished product indicators are shown in Table 1.
Table 1 Finished product indicators (blank particles after drying) particle size.mam
0.850.15
6 Test methods
6.1 Appearance, structure and material inspection||tt ||Fine powder content (particle size less than 0.15mm), %e30
6.1.1 Visually inspect the appearance quality of the granulator, as well as the surface quality of operating parts and exposed fasteners. 6.1.2 Visually and manually inspect the sealing and opening and closing conditions of the granulator cylinder and cylinder head, as well as the structural condition of the cylinder head. 6.1.3 Inspect the surface quality of the inner wall of the cylinder, mixing slurry and granulating knife according to the procedures specified in GB/T10610. 6.1.4 Manually check the disassembly and assembly status of the mixing paddle and granulating knife, and use a feeler gauge or a self-made plug that has passed the inspection to measure the gap between the bottom plane of the mixing blade and the bottom surface of the granulating tank. 6.1.5 Inject clean water into the cylinder of the granulator until there is no discharge port, open the discharge port, and visually inspect the discharge of clean water and whether there is water accumulation in the cylinder.
6.1.6 Check the raw material certificate or chemical analysis report of parts that are in direct contact with drugs. 6.2 Operation control safety inspection
6.2.1 Visual and manual inspection of the warning status when the cylinder head of the fixed cylinder granulator is opened and closed, and the locking status of the cylinder head after it is opened.
6.2.2 Visually check the power outage status of the stirring paddle and granulating knife motors of the fixed-cylinder granulator when the cylinder cover is opened. 6.2.3 Visually and manually inspect the warning status of the mobile cylinder granulator cylinder when it moves vertically, and the locking 19
JB 20015—2004
condition after the cylinder stops moving.
6.2.4 Visually inspect the power outage of the motors of the mixing and granulating knife when the cylinder of the mobile cylinder granulator is in the high-open working position. 6.3 Electrical system safety inspection
6.3.1 The protective grounding continuity, insulation resistance, and withstand voltage tests of the electrical system shall be tested in accordance with the provisions of 19.2, 19.3, and 19.4 in GB5226.12002 respectively.
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 test
6.4.1 No-load test:
6.4.1.1 Test conditions:
a) The mixing speed of the granulator and the speed of the granulating knife are adjusted from low speed to high speed. ;b) Run at rated maximum speed for 1 hour.
6.4.1.2 Inspection items:
a) Visually check the operation of each moving part: b) Visually and manually check the speed adjustment of the mixing paddle and granulating knife: use a thermometer to test the mixing The surface temperature of the bearing shell of the paddle and granulating knife rotating shaft is calculated according to equation (1) to obtain the surface temperature e
liters.
At=t-to'
where:
——temperature rise, ℃;
t——measured part temperature, ℃;
to--actually measured ambient temperature, ℃.
d) Visually check the oil seepage at the supporting body of the mixing paddle and granulating knife rotating shaft in the cylinder. e) Inject clean water so that the water level submerges the discharge port, and check the sealing condition of the cylinder discharge port when it is closed. (1)
f) Input cooling water with a pressure of no less than 0.2MPa into the water cooling pipe of the granulator, plug the other end, and check the sealing condition of the water cooling system.
6.4.2 Load test:
6.4.2.1 Test conditions:
a) Only conducted during type test. It can also be conducted at the user's site; b) After no-load test Carry out;
c) The test materials are mainly medicinal starch, dextrin, water, etc.: d) The test time is limited to one-time preparation of materials.
6.4.2.2 Inspection items:
a) Start the granulator, adjust the stirring slurry and granulating knife speed to the maximum, and use a sound level meter to test the noise according to GB/T16769. b) Add medicinal starch and auxiliary materials according to the effective volume of the granulator, and conduct tests according to the granulation process. The wet granules are dried in an oven and the finished product indicators are checked. || tt | Spread them evenly in the baking tray, put them in the oven, and dry them at 70°C (the moisture content of the particles after drying is not more than 2%). Then sieve it with a No. 6 drug sieve (sieve hole diameter 0.15mm) and measure it with a scale. Use equation (2) to calculate the percentage of fine powder content in each group, and then use equation (3) to calculate the average percentage of fine powder content in the five groups. X
G
||H.
Mass, many;
G
H——Average fine powder content percentage of five groups: -Number of particle groups, n=5;
i
Particle group number ,i=12,3.4.5.
7 Inspection Rules
Granulators are divided into factory inspection and type inspection. Only products that pass the factory inspection can be delivered as qualified products. 7.1 Factory inspection
7.1.1 Before leaving the factory, the granulator should be inspected one by one according to the regulations in Table 2. Table 2 Inspection items
Project category
General performance
Main performance
Inspection items
5.1,5.2.2,5.2.4,5.3.4 ,5.3.5,5.3.6,5.3.7,5.3.8,5.4.1,5.4.2,5.4.3, 5.4.4, 5.4.6, 5.4.7
5.2.1,5.2 .3,5.3.1,5.3.2,5.3.3,5.4.5(2)
(3)
7.1.2 During the inspection process of each granulator, if a If the item fails to pass, it will be returned for repair. If it still fails, the product will be judged to be unqualified and will not leave the factory.
7.2 Type Inspection
7.2.1 When the granulator is in one of the following situations, it should undergo type inspection together with the machine user, and conduct quality assessment and evaluation on all requirements of this standard.
a) Trial design and identification of new products or old products for conversion to production: b) After formal production, if there are major changes in structure, materials, and processes, product performance may be affected; c) After the product has been discontinued for a long time, the Production; d) The factory inspection results are significantly different from the last type inspection: e) The national quality supervision agency proposes a requirement for type inspection. 7.2.2 Judgment and re-inspection rules:
One prototype for type inspection shall be selected from the products that have passed the factory inspection. During the inspection, if the operation control safety requirements specified in 5.2.121
4.5 There must be no oil from the mixing paddle and the granulating knife rotating shaft support body seeping into the cylinder of the granulator. 5.4.6 The discharging device of the granulator should be sealed when closed, and no leakage of powder or liquid is allowed. 5.4.7 For granulators that adopt a water cooling structure, the cooling system should not leak. 5.4.8 The finished product indicators are shown in Table 1.
Table 1 Finished product indicators (blank particles after drying) particle size.mam
0.850.15
6 Test methods
6.1 Appearance, structure and material inspection||tt ||Fine powder content (particle size less than 0.15mm), %e30
6.1.1 Visually inspect the appearance quality of the granulator, as well as the surface quality of operating parts and exposed fasteners. 6.1.2 Visually and manually inspect the sealing and opening and closing conditions of the granulator cylinder and cylinder head, as well as the structural condition of the cylinder head. 6.1.3 Inspect the surface quality of the inner wall of the cylinder, mixing slurry and granulating knife according to the procedures specified in GB/T10610. 6.1.4 Manually check the disassembly and assembly status of the mixing paddle and granulating knife, and use a feeler gauge or a self-made plug that has passed the inspection to measure the gap between the bottom plane of the mixing blade and the bottom surface of the granulating tank. 6.1.5 Inject clean water into the cylinder of the granulator until there is no discharge port, open the discharge port, and visually inspect the discharge of clean water and whether there is water accumulation in the cylinder.
6.1.6 Check the raw material certificate or chemical analysis report of parts that are in direct contact with drugs. 6.2 Operation control safety inspection
6.2.1 Visual and manual inspection of the warning status when the cylinder head of the fixed cylinder granulator is opened and closed, and the locking status of the cylinder head after it is opened.
6.2.2 Visually check the power outage status of the stirring paddle and granulating knife motors of the fixed-cylinder granulator when the cylinder cover is opened. 6.2.3 Visually and manually inspect the warning status of the mobile cylinder granulator cylinder when it moves vertically, and the locking 19
JB 20015—2004
condition after the cylinder stops moving.
6.2.4 Visually inspect the power outage of the motors of the mixing and granulating knife when the cylinder of the mobile cylinder granulator is in the high-open working position. 6.3 Electrical system safety inspection
6.3.1 The protective grounding continuity, insulation resistance, and withstand voltage tests of the electrical system shall be tested in accordance with the provisions of 19.2, 19.3, and 19.4 in GB5226.12002 respectively.
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 test
6.4.1 No-load test:
6.4.1.1 Test conditions:
a) Adjust the mixing speed of the granulator and the speed of the granulating knife from low speed to high speed. ;b) Run at rated maximum speed for 1 hour.
6.4.1.2 Inspection items:
a) Visually check the operation of each moving part: b) Visually and manually check the speed adjustment of the mixing paddle and granulating knife: test the mixing with a thermometer The surface temperature of the bearing shell of the paddle and granulating knife rotating shaft is calculated according to equation (1) to obtain the surface temperature e
liters.
At=t-to'
where:
——temperature rise, ℃;
t——measured part temperature, ℃;
to--actually measured ambient temperature, ℃.
d) Visually check the oil seepage at the supporting body of the mixing paddle and granulating knife rotating shaft in the cylinder. e) Inject clean water so that the water level submerges the discharge port, and check the sealing condition of the cylinder discharge port when it is closed. (1)
f) Input cooling water with a pressure of no less than 0.2MPa into the water cooling pipe of the granulator, plug the other end, and check the sealing condition of the water cooling system.
6.4.2 Load test:
6.4.2.1 Test conditions:
a) Only conducted during type test. It can also be conducted at the user's site; b) After no-load test Carry out;
c) The test materials are mainly medicinal starch, dextrin, water, etc.: d) The test time is limited to one-time preparation of materials.
6.4.2.2 Inspection items:
a) Start the granulator, adjust the stirring slurry and granulating knife speed to the maximum, and use a sound level meter to test the noise according to GB/T16769. b) Add medicinal starch and auxiliary materials according to the effective volume of the granulator, and conduct tests according to the granulation process. The wet granules are dried in an oven and the finished product indicators are checked. || tt | Spread them evenly in the baking tray, put them in the oven, and dry them at 70°C (the moisture content of the particles after drying is not more than 2%). Then sieve it with a No. 6 drug sieve (sieve hole diameter 0.15mm) and measure it with a scale. Use equation (2) to calculate the percentage of fine powder content in each group, and then use equation (3) to calculate the average percentage of fine powder content in the five groups. X
G
||H.
Mass, many;
G
H——Average fine powder content percentage of five groups: -Number of particle groups, n=5;
i
Particle group number ,i=12,3.4.5.
7 Inspection Rules
Granulators are divided into factory inspection and type inspection. Only products that pass the factory inspection can be delivered as qualified products. 7.1 Factory inspection
7.1.1 Before leaving the factory, the granulator should be inspected one by one according to the regulations in Table 2. Table 2 Inspection items
Project category
General performance
Main performance
Inspection items
5.1,5.2.2,5.2.4,5.3.4 ,5.3.5,5.3.6,5.3.7,5.3.8,5.4.1,5.4.2,5.4.3, 5.4.4, 5.4.6, 5.4.7
5.2.1,5.2 .3,5.3.1,5.3.2,5.3.3,5.4.5(2)
(3)
7.1.2 During the inspection process of each granulator, if a If the item fails to pass, it will be returned for repair. If it still fails, the product will be judged to be unqualified and will not leave the factory.
7.2 Type Inspection
7.2.1 When the granulator is in one of the following situations, it should undergo type inspection together with the machine user, and conduct quality assessment and evaluation on all requirements of this standard.
a) Trial design and identification of new products or old products for conversion to production: b) After formal production, if there are major changes in structure, materials, and processes, product performance may be affected; c) After the product has been discontinued for a long time, the Production; d) The factory inspection results are significantly different from the last type inspection: e) The national quality supervision agency proposes a requirement for type inspection. 7.2.2 Judgment and re-inspection rules:
One prototype for type inspection shall be randomly selected from the products that have passed the factory inspection. During the inspection, if the operation control safety requirements specified in 5.2.121
4.5 There must be no oil from the mixing paddle and the granulating knife rotating shaft support body seeping into the cylinder of the granulator. 5.4.6 The discharging device of the granulator should be sealed when closed, and no leakage of powder or liquid is allowed. 5.4.7 For granulators that adopt a water cooling structure, the cooling system should not leak. 5.4.8 The finished product indicators are shown in Table 1.
Table 1 Finished product indicators (blank particles after drying) particle size.mam
0.850.15
6 Test methods
6.1 Appearance, structure and material inspection||tt ||Fine powder content (particle size less than 0.15mm), %e30
6.1.1 Visually inspect the appearance quality of the granulator, as well as the surface quality of operating parts and exposed fasteners. 6.1.2 Visually and manually inspect the sealing and opening and closing conditions of the granulator cylinder and cylinder head, as well as the structural condition of the cylinder head. 6.1.3 Inspect the surface quality of the inner wall of the cylinder, mixing slurry and granulating knife according to the procedures specified in GB/T10610. 6.1.4 Manually check the disassembly and assembly status of the mixing paddle and granulating knife, and use a feeler gauge or a self-made plug that has passed the inspection to measure the gap between the bottom plane of the mixing blade and the bottom surface of the granulating tank. 6.1.5 Inject clean water into the cylinder of the granulator until there is no discharge port, open the discharge port, and visually inspect the discharge of clean water and whether there is water accumulation in the cylinder.
6.1.6 Check the raw material certificate or chemical analysis report of parts that are in direct contact with drugs. 6.2 Operation control safety inspection
6.2.1 Visual and manual inspection of the warning status when the cylinder head of the fixed cylinder granulator is opened and closed, and the locking status of the cylinder head after it is opened.
6.2.2 Visually check the power outage status of the stirring paddle and granulating knife motors of the fixed-cylinder granulator when the cylinder cover is opened. 6.2.3 Visually and manually inspect the warning status of the mobile cylinder granulator cylinder when it moves vertically, and the locking 19
JB 20015—2004
condition after the cylinder stops moving.
6.2.4 Visually inspect the power outage of the motors of the mixing and granulating knife when the cylinder of the mobile cylinder granulator is in the high-open working position. 6.3 Electrical system safety inspection
6.3.1 The protective grounding continuity, insulation resistance, and withstand voltage tests of the electrical system shall be tested in accordance with the provisions of 19.2, 19.3, and 19.4 in GB5226.12002 respectively.
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 test
6.4.1 No-load test:
6.4.1.1 Test conditions:
a) The mixing speed of the granulator and the speed of the granulating knife are adjusted from low speed to high speed. ;b) Run at rated maximum speed for 1 hour.
6.4.1.2 Inspection items:
a) Visually check the operation of each moving part: b) Visually and manually check the speed adjustment of the mixing paddle and granulating knife: test the mixing with a thermometer The surface temperature of the bearing shell of the paddle and granulating knife rotating shaft is calculated according to equation (1) to obtain the surface temperature e
liters.
At=t-to'
where:
——temperature rise, ℃;
t——measured part temperature, ℃;
to--actually measured ambient temperature, ℃.
d) Visually check the oil seepage at the supporting body of the mixing paddle and granulating knife rotating shaft in the cylinder. e) Inject clean water so that the water level submerges the discharge port, and check the sealing condition of the cylinder discharge port when it is closed. (1)
f) Input cooling water with a pressure of no less than 0.2MPa into the water cooling pipe of the granulator, plug the other end, and check the sealing condition of the water cooling system.
6.4.2 Load test:
6.4.2.1 Test conditions:
a) Only conducted during type test. It can also be conducted at the user's site; b) After no-load test Carry out;
c) The test materials are mainly medicinal starch, dextrin, water, etc.: d) The test time is limited to one-time preparation of materials.
6.4.2.2 Inspection items:
a) Start the granulator, adjust the stirring slurry and granulating knife speed to the maximum, and use a sound level meter to test the noise according to GB/T16769. b) Add medicinal starch and auxiliary materials according to the effective volume of the granulator, and conduct tests according to the granulation process. The wet granules are dried in an oven and the finished product indicators are checked. || tt | Spread them evenly in the baking tray, put them in the oven, and dry them at 70°C (the moisture content of the particles after drying is not more than 2%). Then sieve it with a No. 6 drug sieve (sieve hole diameter 0.15mm) and measure it with a scale. Use equation (2) to calculate the percentage of fine powder content in each group, and then use equation (3) to calculate the average percentage of fine powder content in the five groups. X
G
||H.
Mass, many;
G
H——Average fine powder content percentage of five groups: -Number of particle groups, n=5;
i
Particle group number ,i=12,3.4.5.
7 Inspection Rules
Granulators are divided into factory inspection and type inspection. Only products that pass the factory inspection can be delivered as qualified products. 7.1 Factory inspection
7.1.1 Before leaving the factory, the granulator should be inspected one by one according to the regulations in Table 2. Table 2 Inspection items
Project category
General performance
Main performance
Inspection items
5.1,5.2.2,5.2.4,5.3.4 ,5.3.5,5.3.6,5.3.7,5.3.8,5.4.1,5.4.2,5.4.3, 5.4.4, 5.4.6, 5.4.7
5.2.1,5.2 .3,5.3.1,5.3.2,5.3.3,5.4.5(2)
(3)
7.1.2 During the inspection process of each granulator, if a If the item fails to pass, it will be returned for repair. If it still fails, the product will be judged to be unqualified and will not leave the factory.
7.2 Type Inspection
7.2.1 When the granulator is in one of the following situations, it should undergo type inspection together with the machine user, and conduct quality assessment and evaluation on all requirements of this standard.
a) Trial design and identification of new products or old products for conversion to production: b) After formal production, if there are major changes in structure, materials, and processes, product performance may be affected; c) After the product has been discontinued for a long time, the Production; d) The factory inspection results are significantly different from the last type inspection: e) The national quality supervision agency proposes a requirement for type inspection. 7.2.2 Judgment and re-inspection rules:
One prototype for type inspection shall be randomly selected from the products that have passed the factory inspection. During the inspection, if the operation control safety requirements specified in 5.2.121
1 Visually and manually check the warning status of the fixed cylinder granulator cylinder cover when it is opened and closed, as well as the locking status of the cylinder cover after it is opened.
6.2.2 Visually check the power outage status of the stirring paddle and granulating knife motors of the fixed-cylinder granulator when the cylinder cover is opened. 6.2.3 Visually and manually inspect the warning status of the mobile cylinder granulator cylinder when it moves vertically, and the locking 19
JB 20015—2004
condition after the cylinder stops moving.
6.2.4 Visually inspect the power outage of the motors of the mixing and granulating knife when the cylinder of the mobile cylinder granulator is in the high-open working position. 6.3 Electrical system safety inspection
6.3.1 The protective grounding continuity, insulation resistance, and withstand voltage tests of the electrical system shall be tested in accordance with the provisions of 19.2, 19.3, and 19.4 in GB5226.12002 respectively.
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 test
6.4.1 No-load test:
6.4.1.1 Test conditions:
a) The mixing speed of the granulator and the speed of the granulating knife are adjusted from low speed to high speed. ;b) Run at rated maximum speed for 1 hour.
6.4.1.2 Inspection items:
a) Visually check the operation of each moving part: b) Visually and manually check the speed adjustment of the mixing paddle and granulating knife: test the mixing with a thermometer The surface temperature of the bearing shell of the paddle and granulating knife rotating shaft is calculated according to equation (1) to obtain the surface temperature e
liters.
At=t-to'
where:
——temperature rise, ℃;
t——measured part temperature, ℃;
to--actually measured ambient temperature, ℃.
d) Visually check the oil seepage at the supporting body of the mixing paddle and granulating knife rotating shaft in the cylinder. e) Inject clean water so that the water level submerges the discharge port, and check the sealing condition of the cylinder discharge port when it is closed. (1)
f) Input cooling water with a pressure of no less than 0.2MPa into the water cooling pipe of the granulator, plug the other end, and check the sealing condition of the water cooling system.
6.4.2 Load test:
6.4.2.1 Test conditions:
a) Only conducted during type test. It can also be conducted at the user's site; b) After no-load test Carry out;
c) The test materials are mainly medicinal starch, dextrin, water, etc.: d) The test time is limited to one-time preparation of materials.
6.4.2.2 Inspection items:
a) Start the granulator, adjust the stirring slurry and granulating knife speed to the maximum, and use a sound level meter to test the noise according to GB/T16769. b) Add medicinal starch and auxiliary materials according to the effective volume of the granulator, and conduct tests according to the granulation process. The wet granules are dried in an oven and the finished product indicators are checked. || tt | Spread them evenly in the baking tray, put them in the oven, and dry them at 70°C (the moisture content of the particles after drying is not more than 2%). Then sieve it with a No. 6 drug sieve (sieve hole diameter 0.15mm) and measure it with a scale. Use equation (2) to calculate the percentage of fine powder content in each group, and then use equation (3) to calculate the average percentage of fine powder content in the five groups. X
G
||H.
Mass, more;
G
H——Average fine powder content percentage of five groups: -Number of particle groups, n=5;
i
Particle group number ,i=12,3.4.5.
7 Inspection Rules
Granulators are divided into factory inspection and type inspection. Only products that pass the factory inspection can be delivered as qualified products. 7.1 Factory inspection
7.1.1 Before leaving the factory, the granulator should be inspected one by one according to the regulations in Table 2. Table 2 Inspection items
Project category
General performance
Main performance
Inspection items
5.1,5.2.2,5.2.4,5.3.4 ,5.3.5,5.3.6,5.3.7,5.3.8,5.4.1,5.4.2,5.4.3, 5.4.4, 5.4.6, 5.4.7
5.2.1,5.2 .3,5.3.1,5.3.2,5.3.3,5.4.5(2)
(3)
7.1.2 During the inspection process of each granulator, if a If the item fails to pass, it will be returned for repair. If it still fails, the product will be judged to be unqualified and will not leave the factory.
7.2 Type Inspection
7.2.1 When the granulator is in one of the following situations, it should undergo type inspection together with the machine user, and conduct quality assessment and evaluation on all requirements of this standard.
a) Trial prototype identification of new products or old products for conversion to production: b) After formal production, if there are major changes in structure, materials, and processes, product performance may be affected; c) After the product has been discontinued for a long time, the Production; d) The factory inspection results are significantly different from the last type inspection: e) The national quality supervision agency proposes a requirement for type inspection. 7.2.2 Judgment and re-inspection rules:
One prototype for type inspection shall be randomly selected from the products that have passed the factory inspection. During the inspection, if the operation control safety requirements specified in 5.2.121
1 Visually and manually check the warning status when the cylinder cover of the fixed cylinder pellet mill is opened and closed, and the locking status after the cylinder cover is opened.
6.2.2 Visually check the power-off status of the motors of the stirring paddle and pelletizing knife when the cylinder cover of the fixed cylinder pellet mill is opened. 6.2.3 Visually and manually check the warning status when the cylinder body of the mobile cylinder pellet mill moves vertically, and the locking status after the cylinder body stops moving.
6.2.4 Visually check the power-off status of the motors of the stirring paddle and pelletizing knife when the cylinder body of the mobile cylinder pellet mill is in the high-open working position. 6.3 Electrical system safety inspection
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 GB5226.12002 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 test
6.4.1 No-load test:
6.4.1.1 Test conditions:
a) The speed adjustment of the mixing slurry and pelletizing knife of the granulator is carried out from low speed to high speed in sequence; b) Run at the rated maximum speed for 1h.
6.4.1.2 Inspection items:
a) Visually check the operating conditions of each moving part: b) Visually and manually check the speed adjustment conditions of the stirring paddle and pelletizing knife: Use a thermometer to test the surface temperature of the bearing housing shell of the stirring paddle and pelletizing knife shaft, and calculate the surface temperature e
according to formula (1).
At=t-to'
Where:
——temperature rise, ℃;
t——measured part temperature, ℃;
to--measured ambient temperature, ℃.
d) Visually inspect the oil seepage condition of the stirring paddle and the granulating knife shaft support in the cylinder. e) Pour clean water to make the water level submerge the discharge port, and check the sealing condition of the cylinder discharge port when it is closed. (1)
f) Inject cooling water with a pressure of not less than 0.2MPa into the water cooling pipe of the granulator, block the other end, and check the sealing condition of the water cooling system.
6.4.2 Load test:
6.4.2.1 Test conditions:
a) Only carried out during type test. It can also be carried out at the user's place; b) Carried out after no-load test;
c) The test materials are mainly medicinal starch, dextrin, water, etc.; d) The test time is limited to one material preparation.
6.4.2.2 Inspection items:
a) Start the granulator, adjust the stirring slurry and granulating knife speed to the maximum, and test the noise with a sound level meter according to GB/T16769. b) Add medicinal starch and auxiliary materials according to the effective volume of the granulator, and test according to the granulation process. The wet granules produced are dried in an oven and the finished product indicators are checked.
6.4.2.3 Inspection method for fine powder content:
20
JB20015—2004
Randomly select five groups, each group of 100g wet granules without lumps. Spread them evenly on a baking tray, put them in an oven, and dry them at 70℃ (the moisture content of the granules after drying is not more than 2%). Then sieve them with a No. 6 medicine sieve (sieve hole diameter 0.15mm) and measure them with a scale. Use formula (2) to calculate the percentage of fine powder content in each group, and then use formula (3) to calculate the average percentage of fine powder content in the five groups. X
G
X100%
H;
艺
H
n
Wherein:
H.
X,
percentage of fine powder content of a group of dry granules:
mass of group powder of a group of dry granules, more:
—mass of a group of dry granules, more;
G
H——average percentage of fine powder content of five groups: -number of granule groups, n=5;
i
granule group number, i=12,3.4.5.
7 Inspection rules
The granulator is divided into factory inspection and type inspection. The product can be delivered as a qualified product only after passing the factory inspection. 7.1 Factory inspection
7.1.1 Before leaving the factory, the granulator shall be inspected one by one according to the provisions in Table 2. Table 2 Inspection items
Item category
General performance
Main performance
Inspection items
5.1,5.2.2,5.2.4,5.3.4,5.3.5,5.3.6,5.3.7,5.3.8,5.4.1,5.4.2，5.4.3, 5.4.4, 5.4.6, 5.4.7
5.2.1,5.2.3,5.3.1,5.3.2,5.3.3,5.4.5(2)
(3)
7.1.2 During the inspection process, if one item of each pellet mill is found to be unqualified, it will be returned for refurbishment. If it is still unqualified, the product will be judged as unqualified and will not be shipped out.
7.2 Type inspection
7.2.1 In any of the following situations, the pellet mill shall be subject to type inspection together with the machine user unit, and quality assessment and evaluation shall be conducted on all requirements of this standard.
a) Trial production and identification of new products or old products for production conversion: b) After formal production, if there are major changes in structure, materials, and processes, it may affect product performance; c) Resuming production after a long period of suspension of production; d) There is a significant difference between the factory inspection results and the last type inspection results: e) The national quality supervision agency proposes a requirement for type inspection. 7.2.2 Judgment and re-inspection rules:
The type inspection prototype shall be sampled from the products that have passed the factory inspection. During the inspection, if 5.2.121 in the operation control safety requirements
3. Inspection method of fine powder content:
20
JB20015-2004
Take five groups at random, each group has 100g of wet particles without lump particles. Spread them evenly in the baking tray, put them in the oven, and dry them at 70°C (the moisture content of the particles after drying is not more than 2%). Then sieve it with a No. 6 drug sieve (sieve hole diameter 0.15mm) and measure it with a scale. Use equation (2) to calculate the percentage of fine powder content in each group, and then use equation (3) to calculate the average percentage of fine powder content in the five groups. X
G
||H.
Mass, many;
G
H——Average fine powder content percentage of five groups: -Number of particle groups, n=5;
i
Particle group number ,i=12,3.4.5.
7 Inspection Rules
Granulators are divided into factory inspection and type inspection. Only products that pass the factory inspection can be delivered as qualified products. 7.1 Factory inspection
7.1.1 Before leaving the factory, the granulator should be inspected one by one according to the regulations in Table 2. Table 2 Inspection items
Project category
General performance
Main performance
Inspection items
5.1,5.2.2,5.2.4,5.3.4 ,5.3.5,5.3.6,5.3.7,5.3.8,5.4.1,5.4.2,5.4.3, 5.4.4, 5.4.6, 5.4.7
5.2.1,5.2 .3,5.3.1,5.3.2,5.3.3,5.4.5(2)
(3)
7.1.2 During the inspection process of each granulator, if a If the item fails to pass, it will be returned for repair. If it still fails, the product will be judged to be unqualified and will not leave the factory.
7.2 Type Inspection
7.2.1 When the granulator is in one of the following situations, it should undergo type inspection together with the machine user, and conduct quality assessment and evaluation on all requirements of this standard.
a) Trial design and identification of new products or old products for conversion to production: b) After formal production, if there are major changes in structure, materials, and processes, product performance may be affected; c) After the product has been discontinued for a long time, the Production; d) The factory inspection results are significantly different from the last type inspection: e) The national quality supervision agency proposes a requirement for type inspection. 7.2.2 Judgment and re-inspection rules:
One prototype for type inspection shall be selected from the products that have passed the factory inspection. During the inspection, if the operation control safety requirements specified in 5.2.121
3. Inspection method of fine powder content:
20
JB20015-2004
Take five groups at random, each group has 100g of wet particles without lump particles. Spread them evenly in the baking tray, put them in the oven, and dry them at 70°C (the moisture content of the particles after drying is not more than 2%). Then sieve it with a No. 6 drug sieve (sieve hole diameter 0.15mm) and measure it with a scale. Use equation (2) to calculate the percentage of fine powder content in each group, and then use equation (3) to calculate the average percentage of fine powder content in the five groups. X
G
||H.
Mass, many;
G
H——Average fine powder content percentage of five groups: -Number of particle groups, n=5;
i
Particle group number ,i=12,3.4.5.
7 Inspection Rules
Granulators are divided into factory inspection and type inspection. Only products that pass the factory inspection can be delivered as qualified products. 7.1 Factory inspection
7.1.1 Before leaving the factory, the granulator should be inspected one by one according to the regulations in Table 2. Table 2 Inspection itemsbZxz.net
Project category
General performance
Main performance
Inspection items
5.1,5.2.2,5.2.4,5.3.4 ,5.3.5,5.3.6,5.3.7,5.3.8,5.4.1,5.4.2,5.4.3, 5.4.4, 5.4.6, 5.4.7
5.2.1,5.2 .3,5.3.1,5.3.2,5.3.3,5.4.5(2)
(3)
7.1.2 During the inspection process of each granulator, if a If the item fails to pass, it will be returned for repair. If it still fails, the product will be judged to be unqualified and will not leave the factory.
7.2 Type Inspection
7.2.1 When the granulator is in one of the following situations, it should undergo type inspection together with the machine user, and conduct quality assessment and evaluation on all requirements of this standard.
a) Trial design and identification of new products or old products for conversion to production: b) After formal production, if there are major changes in structure, materials, and processes, product performance may be affected; c) After the product has been discontinued for a long time, the Production; d) The factory inspection results are significantly different from the last type inspection: e) The national quality supervision agency proposes a requirement for type inspection. 7.2.2 Judgment and re-inspection rules:
One prototype for type inspection shall be selected from the products that have passed the factory inspection. During the inspection, if the operation control safety requirements specified in 5.2.121
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