Pharmaceutical machinery industry standard of the People's Republic of China JB20039, 200402004
JB7T20041~20043-2004
Hammer mill
Knife type granulating mill
Reciprocating medicine cutting machine
Medicine washing machine
Rotary medicine cutting machine
2004-02-05 issued
2004-06-01 implementation
National Development and Reform Commission issued
ICS 11.120.30
Standard of the People's Republic of China JB/T20041:-2004
Recommended Y0022-1990
Reciprocating medicine cutting machine
To-and-fro type hcrhal medicine cutting miachine2004-02-05 issued
2004-06-01 implementation
National Development and Reform Commission issued
Normative reference documents
Terms and definitions
Classification and marking
Testing methods
Testing rules
Marking packaging, transportation and storage
JB/T 20041—2004
JB/T 20041—2004
This standard is based on the requirements of <Pharmaceutical Production Quality Management Specification 3 and (R/T1.1—2000GB/T1.2—2(X2 Standardization Work Guideline), and is revised to YY0022—1990 <Previous Female Medicine Cutting Machine 3>. This standard is implemented and will replace YY0022—1990. Compared with YYD022-1990, the main technical content of this standard has changed as follows: The main chapters and miscellaneous items are as follows: The main chapters and miscellaneous items in the standard (B5083:
5.1.5.7,6.7 and other items.
) The main chapters and clauses revised are as follows:
Noise limit measurement method;
-Product model reduction method.
\) The main group chapters and clauses added:
Chapter 5 China Electric The content of the gas system safety requirements; the content of the instruction manual and the label,
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: Henan Yongmen Pharmaceutical Machinery Factory Co., Ltd. The main drafters of this standard: Zhao Jiezhu, Li Tie III, Ma Shiyu. 20
1 Scope
Reciprocating pill cutting machine
J/T20041—2004
This standard specifies the language and definition, classification and marking, requirements, test methods, inspection rules, marking, packaging, transportation and maintenance of reciprocating pill cutting machines.
This standard applies to reciprocating pill cutting machines
2 Normative reference documents
The clauses in the referenced documents become the clauses of this standard through reference in this standard. For any referenced document with a date, all its accompanying amendments (excluding errata) or revisions are not applicable to this standard. However, the parties that have reached an agreement on the necessary changes to this standard should study whether the latest versions of these documents can be used. For any referenced document without a date, the latest version is applicable to this standard. GB/T191 Packaging and storage enclosure marking
(Yu 5226.1-2002 Mechanical safety and electrical equipment Part 1: General technical requirements CB/T6060.4 Surface roughness comparison sample polishing surface CB/T6388 Long-distance transport packaging delivery and receipt marking
Japan Product Instructions 5: General
GB/T 0069,1—1998
GHT1330 Label
G/T133B1 Mechanical and electrical product packaging Tongke Technology Polyester Parts GRT16769 Jinzhan Cutting Machine Tool Disc City Pressure Level Measurement Topic YYT0216 Pharmaceutical Machinery Product Type Guide Packaging 3 Terms and Definitions
Blade Effective Use Length bladeusalangtheficienty Force Blade Economic Fire, Paint Carbon or Compensation etc. Direct Length of the medicine cutting part: 4 Classification and marking
4.1 The model of the medicine cutting machine is compiled according to YY/10216
4.2 Model
The model marking consists of product function code, type feature code, specification code, etc. 21
JR/T20041—204
4.3 Standard condition example
Design month: A, B, C in order
Specification code: Width of medicine outlet, mm| |tt||Type characteristic code: conventional
Product type code: medicine cutting machine
(W24UA type: indicates that after the first improvement test, the width of the medicine outlet is 240mm. 5 Requirements
5.1 Material requirements
5.1.1 The parts that first connect the medicine should be non-toxic, corrosion-resistant, and not chemically react with the medicine or attach to the medicine. 5.2 Working performance requirements||t t||5.2.1 The transmission of the operating mechanism should be stable, and the noise should be less than 75dB when loading (4) 5.2.2 The reverse and unloading devices are easy to operate and easy to control 5.2.3 The bearings and brakes of the operating position should be stable, and the humidity should be less than 45 when loading. 5.2.4
The slice pressure should be accurate, and the effect after cutting should meet the requirements of Table 1. Table 1 Allowable error of slice thickness
Thickness range
>10~18
18 ~ 30
>30~50
Total qualified rate>%
5.2.5 The lubricating oil (grease) in the lubricating parts of the equipment should not be leaked. 5.3 Mechanism parts should be smooth and the cutting mechanism should be light. The gap between the blade and the lower edge of the medicine mouth should be less than (1.15mm. The contact time between the cutter and the lower edge should be greater than 80% of the medicine width.
5.3.2 The structure of the blade tightening mechanism should be stable and there should be no movement caused by pregnancy, etc. 5.3.3 The finished products of each mechanism should be replaced and cleaned
5.3.4 The quality of the blade should be guaranteed ：
5.3.4.1 Blade hardness HRC52-HR156°, blade width should be greater than the width of the medicine mouth, effective use time of the blade should be greater than 22
50%~80% of the total length,
5.3.4.2 Blade surface grain size is 3.2m5.3.4.3 Angle 20-27°, small piece line 9 level, 5.4 Safety performance requirements
5.4.1 Electrical system safety requirements:
5.4.1.1 The continuity of the protective grounding circuit should comply with the provisions of 19.2 in 5226.1-2002. 5.4.7.2 The insulation resistance should comply with the provisions of 19.3 in B5226.1--77. 5.4.1.3 The resistance shall comply with the provisions of 9.4 in 5226.1-2002. 5.4.1.4 The protective earth line shall comply with the provisions of 8.2 in CB5226.1-2002. 5.4.1.5 The button shall comply with the provisions of R57%6.12002. 5.4.1.6 The indicator light screen shall comply with the provisions of 103 in GB5226.1-200. 5.4.1.7 The electrical wiring shall comply with the provisions of Chapter 14 in GB5226.1-2002. 5.4.1.B Marking and warning signs The code for use shall comply with the provisions of Chapter 17 of CB5226.1-22. 5.4.2. Safety protection requirements:
JB/T 20041—2004
6.4.2.1 The manual material feeding and automatic feeding parts shall be equipped with obvious safety warning signs. The material inlet is the "general stop button". 5.4.2.2 All machine board transmission external expansion parts are increased by the protection rate of the network 6 Test method
6.1 Material
Check the quality of the material in advance, and conduct pump inspection if there is any abnormality. 6.2 Working performance test
6.2.1 Operation reduction test: negative operation, check and GB16769 regulations, user-level meter measurement of noise value. 2.2 Return material test: piece when the door. Daily grass or substitute material test judgment, 2.3 Temperature safety test: negative operation is greater than 0m, use a point thermometer to measure the shaft temperature, and the sleeve temperature 6.2.4 Thickness Degree adjustment test: compare the sequence degree value and the actual thickness with the requirements. 8.2.5 Commercial slide pool (fat rate) test: sensory inspection 6.3 Mechanical performance test
6.3.1 Ten thousand motion test: after turning off the power, use a feeler gauge to measure the gap at the bottom of the series blade: cut the contact point with red lead powder, and then measure it on the dynamic disc.
6.3.2 Light knife locking test: microscopic state, confirm the installation performance, 6.3.3 Each mechanism is easy to disassemble and replace, easy to recycle or clean: actual operation confirmation: 6.3.4 Tool quality test:
6.3.4.1. Hardness test: Use Rockwell hardness tester to measure the hardness of the blade. The blade width is measured by using a ruler. B.3.4.2. Roughness measurement: Use the blade width tester to measure the roughness of the blade. (B/T6060.4 stipulates that the blade width is measured by using the companion block comparison method. B.3.4.5. The blade angle and blade width are measured by using a ruler and a dial indicator on a Class II flat plate. 73 JB/T 20041—2004 8.4 Safety performance test 6.4.1. Electrical system safety test (greater than 1 width) Figure 1 Blade
Small piece measurement points (6 evenly distributed) 3.1.1.1 The protective earthing continuity, insulation resistance and endurance test of the electrical system shall be tested in accordance with the provisions of 19.2.19.3.19.4 of GB5226.1-2002. 6.4.1.2 The protective earthing pedal, connection button, indicator lamp, display, loading, marking, warning sign and project code of the electrical system shall be checked in accordance with the provisions of 8.2, 10.2..3, Chapter 14 and Chapter 17 of GB5226.1-2002. Full inspection and protection test:
6.4.2.1 Daily inspection of the safety warning sign position, power-on test of the emergency stop function. 8.4.2.2 Monthly inspection, feel the solidity of the protective cover net 7 Inspection rules
7.1 Inspection division
Product inspection is divided into factory inspection and type inspection: 7.2 Factory inspection
72.1 Products are inspected according to the requirements of Table 2. After passing the inspection, they are allowed to be tested together with the product certificate. Table 2 Factory inspection items
Monthly category
One energy
Seven energy
5.1.1, 5.2.1, 5.2.3, 5.4.1.4.- 5.4.1.8, 5.4.2.25.2.4, 5.3.1, 5.3.4.1. 5.4.1.1 ~ 5.4.1.37.2.2 During the inspection process, if a product fails a certain test, it is allowed to be repaired and re-inspected. If it still passes, it shall be judged as a defective product:
7.3 Type inspection
7.3.1 Type inspection shall be carried out in the following circumstances: a) When a new product or an old product is transferred to trial production; b) When the product design, process or materials used involve major changes or major improvements; c) When production is resumed after an interval of more than 1 year; d) When the factory inspection result is significantly different from that of the last type inspection; e) When the national quality supervision agency makes a request for type inspection. 7.3.2 Fiber bundling: The sample for type inspection shall be randomly selected from the qualified products for inspection. 7.9.3 State regulations: TB/T 20041-2004 During type inspection, if the protective grounding circuit connection sample, insulation distribution, and time termination of the electrical safety performance are unqualified, it shall be judged as unqualified for the type inspection: If there are unqualified items in other performance items, the unqualified items shall be doubled and retested. If they are still unqualified, it shall be judged as unqualified for the product type inspection.
8 Marking, packaging, transportation and storage
B.1 Marking
8.1.1 The label shall comply with the provisions of (B) 133D6 label. It shall include the following: 1) Name and model;
b) Trademark:
) Manufacturer: Name or address;
d) Production number, factory date:
Standard number adopted:
www.bzxz.nete) Equipment self-inspection ().
8.1.2 The transportation label shall comply with the provisions of (T/T191), including: a) Receiving unit and location:
b) Name and model:
Shipping unit and location:
"center of gravity", "beautiful", "upward"; e) Overall dimensions and weight (k).
8.2 Packaging
8.2.1 The product packaging should be in accordance with the provisions of (B/T13384. B.2.2 The following documents should be attached to the package box: a) Product certificate:
b) Packing list;
Special tool list:
c) Equipment base map:
Product instructions 5. 8.2.3 The product manual shall comply with the provisions of RT9969.1, including a) product name, model, manufacturer, address, mailing address and contact number; b) product standards implemented: main purpose, structure, performance parameters, operating precautions, warnings and prompts, instructions for protecting operators and product safety measures; d) graphic, symbol, abbreviation content of the logo: JB/T20041-2004 e) installation and commissioning methods, maintenance and maintenance methods, fault analysis and arrangement 8.3 This product should be semi-fixed on the transport vehicle [rolling, collision and squeezing are strictly prohibited] 8.4 The storage cabinet should be placed flat, and no inversion or code effect is allowed. When storing, the cloth should be protected from separation. 261. The product packaging should be in accordance with the provisions of (B/T13384. B.2.2 The following documents should be attached to the package box: a) Product certificate:
b) Packing list;
Special tool list:
iii) Equipment base map:
Product instructions 5. 8.2.3 The product manual shall comply with the provisions of RT9969.1, including a) product name, model, manufacturer, address, mailing address and contact number; b) product standards implemented: main purpose, structure, performance parameters, operating precautions, warnings and prompts, instructions for protecting operators and product safety measures; d) graphic, symbol, abbreviation content of the logo: JB/T20041-2004 e) installation and commissioning methods, maintenance and maintenance methods, troubleshooting and sorting 8.3 This product should be semi-fixed on the transport vehicle [rolling, collision and squeezing are strictly prohibited] 8.4 The storage cabinet should be placed flat, and no inversion or code effect is allowed. When storing, the cloth should be protected from separation. 261. The product packaging should be in accordance with the provisions of (B/T13384. B.2.2 The following documents should be attached to the package box: a) Product certificate:
b) Packing list;
Special tool list:
iii) Equipment base map:
Product instructions 5. 8.2.3 The product manual shall comply with the provisions of RT9969.1, including a) product name, model, manufacturer, address, mailing address and contact number; b) product standards implemented: main purpose, structure, performance parameters, operating precautions, warnings and prompts, instructions for protecting operators and product safety measures; d) graphic, symbol, abbreviation content of the logo: JB/T20041-2004 e) installation and commissioning methods, maintenance and maintenance methods, troubleshooting and sorting 8.3 This product should be semi-fixed on the transport vehicle [rolling, collision and squeezing are strictly prohibited] 8.4 The storage cabinet should be placed flat, and no inversion or code effect is allowed. When storing, the cloth should be protected from separation. 26
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