This standard specifies the terms and definitions, classification and labeling, requirements, test methods, inspection rules, marking, packaging and storage of knife-type granulators. This standard applies to the series of knife-type particle crushers. JB 20040-2004 Knife type particle crusher JB20040-2004 Standard download and decompression password: www.bzxz.net

JB
Pharmaceutical Machinery Industry Standard of the People's Republic of China JB20039.20040—2004
JB/T20041~20043—2004
Hammer Crusher
Knife Type Granulator
Reciprocating Medicine Cutter
Medicine Washer
Rotary Medicine Cutter
Published on 2004-02-05||tt| |2004-06-01 implementation
National Development and Reform Commission
issued
ICS11.120.30
C93
JB
Pharmaceutical Machinery Industry Standard of the People's Republic of China JB200402004
Replace YY0228—1995
Knife shape of separating powder shape of grinder2004-02-05 Issued
2004-06-01 Implementation
National Development and Reform Commission
Issued
Foreword
Scope
2 Normative references
3 Terms and definitions
Classification and marking
4
5
Requirements
6 Test methods| |tt||Inspection rules
7
Marking, packaging, transportation and storage
8
Item
No.
JB20040—2004
12
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3
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1
JB200402004
Foreword
This standard is a revision of YY0228-1995 "Graining Type Pulverizer" based on the requirements of (Good Manufacturing Practice for Pharmaceuticals) and GB/T1.1-2000, GB/T1.2-2002 Standardization Work Guidelines. This standard replaces YY0228-1995 from the date of implementation. This standard and YY0228-199 5, the main technical content changes are as follows: a) The main chapters and articles in YY0228--1995 have been deleted: - Product classification (3.1abc, d):
Technical requirements (4.2.1, 4.4.2, 4.4.3, 4.4.7); Test methods (5.4, 5.4.1, 5.4.2, 5.4.3) Inspection rules (6.2.2.1);
Packaging (7.2.2).
Revised the main chapters and articles in YY0228-1995: b)
Scope (Chapter 1):
Referenced documents (Chapter 2):
Product classification (Chapter 3);
Technical requirements (4.1.1, 4.2.3, 4.3);
Test methods (5.4.4, 5.4.5);
Inspection rules (6.2.2.3);
Marking (7.1.2).
e) The main chapters and clauses added to this standard are:
References (see Chapter 2)
Terms and definitions (see Chapter 3);
Classification and marking (see 4.2.2);
Requirements (see 5.1.1, 5.3.3, 5.4.1, 5.5.4~5.5.8); Test methods (see 6.1.1, 6.3, 6.4.2); -Inspection rules (see 7.2.3);
Marking (see 8.1.3.8.2.3).
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: Tianjin Traditional Chinese Medicine Machinery Factory. The main drafters of this standard: Tang Hengguang and Wei Lihua. 12
1 Scope
Knife-type granulating mill
JB20040—2004
This standard specifies the terms and definitions, classification and marking, requirements, test methods, inspection rules, marking, packaging, transportation and storage of knife-type granulating mills.
This standard applies to the series of force-type granulating mills, hereinafter referred to as mills. 2 Normative references
The clauses in the following documents become the clauses of this standard through reference in this standard. For any referenced document with a date, all subsequent amendments (excluding errata) or revisions are not applicable to this standard. However, the parties to an 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. GB/T191 Pictorial signs for packaging, storage and transportation
CB5226.1-2002 Mechanical safety Mechanical and electrical equipment Part 1: General technical conditions GB/T6388 Transport and delivery signs
GB/T9969.1 General provisions for instructions for use of industrial products GB/T13306 Signs
General technical conditions for packaging of electromechanical products
GR/T13384
GB/T16769
Method for measuring the sound pressure level of noise from metal cutting machines YY/T0216
Method for compiling product models of pharmaceutical machinery
3 Terms and definitions
The following terms and definitions apply to this standard. 3.1
Separating
The function of discharging powder without passing the sieve. 4 Classification and marking
4.1 Classification
Grinding mills are divided into two types according to their structure: ordinary type and water-cooled type. 4.2 Model
Grinding mill model compilation shall comply with the provisions of YY/T0216. 4.2.1 Model marking
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JB 200402004
DL
4.2.2 Marking example
Improved design sequence number: A, B, C in sequence Specification code: Indicated by crushing case diameter (mm) Structural feature code: Water-cooled type is indicated by S, and ordinary type is not indicated Type code: Graining
Product function code: Knife crusher
DLS700A type: indicates a granulating water-cooled knife crusher with a crushing chamber diameter of 700mm after the first improved design. 5 Requirements
5.1 Materials
5.1.1 All parts of the pulverizer that come into contact with the drug should be made of non-toxic, corrosion-resistant materials that do not undergo chemical changes with the material or absorb the material.
5.2 Working conditions
5.2.1 Working voltage: The fluctuation range of the power supply voltage to which the pulverizer is exposed should be within ±5% of the rated voltage. 5.2.2 Working environment: The temperature is -5℃~40℃. 5.3 Appearance quality
5.3.1 After the non-processed surface of the pulverizer is painted, the coating should be solid, bright, and uniform in color. There should be no defects such as pores, wrinkles, scratches, etc. that affect the appearance, and the boundary with the non-painted surface should be clear. 5.3.2 The surface of the sheet metal should not have obvious hammer marks and uneven defects. 5.3.3 The surface of the stainless steel should not have defects such as scratches and strains. All welds should be polished and passivated. 5.4 Structural requirements
5.4.1 The water jacket of the water-cooled pulverizer shall not have water seepage or leakage. 5.5 Safety requirements
5.5.1 The continuity of the protective grounding circuit of the electrical system shall comply with the provisions of 19.2 of CB5226.1-2002. 5.5.2 The insulation resistance of the electrical system shall comply with the provisions of 19.3 of GB5226.1-2002. 5.5.3 The withstand voltage of the electrical system shall comply with the provisions of 19.4 of CB5226.1-2002. 5.5.4 The protective grounding circuit of the electrical system shall comply with the provisions of 8.2 of CB5226.12002. 5.5.5 The buttons of the electrical system shall comply with the provisions of 10.2 of GB5226.1-2002. 5.5.6 The indicator lights and displays of the electrical system shall comply with the provisions of 10.3 of GB5226.1-2002. 5.5.7 The wiring of the electrical system shall comply with the provisions of Chapter 14 of GB5226.1-2002. 5.5.8 The markings, warning signs and project codes of the electrical system shall comply with the provisions of Chapter 17 of GB5226.1-2002. 5.6 Performance requirements
5.6.1 The idling current of the grinder shall not exceed 55% of the rated current. 5.6.2 The temperature rise of the grinder membrane shall not exceed 40℃. 5.6.3 The noise pressure level of the grinder under load operation shall not exceed 85dB(A). 5.6.4 All parts in the grinder shall be securely fastened. All adjusting parts and rotating parts shall operate flexibly. 6 Test methods
6.1 Material inspection
6.1.1. The materials used in the crusher shall be inspected according to the supplier's qualified material inspection report. 6.2 Appearance inspection
6.2.1 The appearance quality of the crusher shall be inspected by daily testing, hand feeling and other methods. 6.3 Pressure test
Use a manual pressure pump to fill the water jacket of the pulverizer with water, pressurize it to 0.2MPa (gauge pressure), and maintain the pressure for 1 hour. 6.4 Safety performance test
JB 200402004
6.4.1 The continuity, insulation resistance and withstand voltage tests of the protective grounding circuit of the electrical system shall be tested according to the provisions of 19.2, 19.3 and 19.4 in GB5226.1-2002 respectively. .
6.4.2 The protective grounding circuit, buttons, indicators and displays, wiring, markings, warning signs and project codes of the electrical system shall be in accordance with 8.2, 10.2, 10.3, Chapter 14 and Chapter 14 of GB5226.1-2002 respectively. Check the provisions of Chapter 17. 6.5 Performance test
6.5.1 Run the pulverizer idling for 1 hour. Use an ammeter to detect the current. 6.5.2 Test of the temperature rise of the pulverizer wall: Use TDA thermometer to measure the temperature throughout the process and calculate it. 6.5.3 Test of pulverizer noise: Use a sound level meter to test according to the regulations in GB16769 when the pulverizer is running under load. 6.5.4 Fastening and operation test of various parts of the pulverizer: use special tools and manual and visual inspection. 7 Inspection rules
7.1 Inspection classification
The crusher is divided into factory inspection and type inspection. 7.2 Factory inspection
7.2.1 Each pulverizer must pass the factory inspection by the inspection department of the manufacturing unit in accordance with this standard and be accompanied by a certificate of conformity before leaving the factory. 7.2.2 Factory inspection should be conducted one by one according to the items in Table 1. Table 1 Crusher Factory Inspection Items
Item Category
Appearance
Safety
Performance
7.2.3 Judgment Rules:
Inspection Items
5.3.1,5.3.2,5.3.3,5.4.1
5.5.1,5.5.2,5.5.3Www.bzxZ.net
5.6.1,5.6.2,5.6 .3,5.6.4
If a product is found to be unqualified during the inspection process, it is allowed to be returned for repair and re-inspection. If it is still unqualified, the product will be determined to be unqualified.
7.3 Type inspection
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JB 20040—2004
7.3.1 Type inspection is required when one of the following situations occurs: a) New product trial design or When the old product is transferred to the factory for production; b) After formal production, if there are major changes in structure, materials, and processes: c) The product resumes production after 2 years of discontinuation;
d) The factory inspection results are consistent with the last type inspection Big difference: e) The national quality supervision agency proposes type inspection requirements. 7.3.2 Type inspection shall be carried out on a random sample of products that have passed the factory inspection. 7.3.3 Type inspection shall comply with all requirements of Chapter 5. During the inspection, if any one of the electrical safety system's protective grounding circuit continuity, insulation resistance, and withstand voltage performance fails, it will be deemed to have failed the type inspection. If one of the other items is unqualified, double re-inspection of the unqualified item is allowed. If the unqualified item is still unqualified, the type inspection will be deemed unqualified. 8 Marking, packaging, transportation and storage
8.1 Marking
8.1.1 The sign of each crusher should be fixed at a prominent position on the machine. The size and technical requirements of the sign should comply with the provisions of GB/T13306 . The content of the sign is as follows:
a) product name and trademark;
b) product model;
c) main parameters;
d) product factory number and factory number Date:
e) Product standard number:
f)) Manufacturer’s name.
8.1.2 Storage and transportation indication signs shall be carried out in accordance with the provisions of GB/T191. 8.1.3 The marking of transportation packaging for receipt and delivery shall be carried out in accordance with the provisions of GB/T6388. 8.2 Packaging
8.2.1 The packaging of crusher products should comply with the regulations of CB/T13384. 8.2.2 The following documents should be included in the packaging box: a) Product certificate:
b) Product instruction manual:
e) Packing list;
d) Foundation installation drawing.
8.2.3 Instructions for use shall be prepared in accordance with CB/T9969.1. 8.3 Transportation
should be firmly attached to the transportation vehicle during transportation, and rolling and collision are strictly prohibited. 8.4 Storage
After packing the crusher, it should be stored in a dry and ventilated room or under a shed without corrosive gas. It should not be stored in the open air. 16
3. The instructions for use should be prepared in accordance with CB/T9969.1. 8.3 Transportation
should be firmly attached to the transportation vehicle during transportation, and rolling and collision are strictly prohibited. 8.4 Storage
After packing the crusher, it should be stored in a dry and ventilated room or under a shed without corrosive gas. It should not be stored in the open air. 16
3. The instructions for use should be prepared in accordance with CB/T9969.1. 8.3 Transportation
should be firmly attached to the transportation vehicle during transportation, and rolling and collision are strictly prohibited. 8.4 Storage
After packing the crusher, it should be stored in a dry and ventilated room or under a shed without corrosive gas. It should not be stored in the open air. 16
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