Some standard content:
JB | |tt | Machine
reciprocating medicine cutting machine
medicine washing machine
rotary medicine cutting machine
released on 2004-02-05
2004-06-01 Implementation
National Development and Reform Commission
Release
ICS11.120.30
C93
JB
Pharmaceutical Machinery Industry Standard of the People's Republic of China JB20039 —2004
Replacing YY02271995
Hammer Mill
Hammermill
Released on 2004-02-05
Implemented on 2004-06-01||tt| |Published by the National Development and Reform Commission
Foreword
Scope
1
Normative reference documents
2
3 Classifications and tags.
4 requirements·
5 test methods
6 inspection rules
7 marking, packaging and storage
item
times||tt ||JB20039—2004
JB20039—2004
Foreword
This standard is based on the "Good Manufacturing Practice for Drugs" and GB/T1.1-2000, GB/T1.2- The requirements of the 2002 Standardization Work Guidelines are revised to YY0227-1995 "Chain Crusher". This standard replaces YY0227-1995 from the date of implementation. Compared with YY0227-1995, the main technical content changes of this standard are as follows: a) The main chapters and clauses of YY0227-1995 are deleted; technical requirements (4.1.4.3.4.4).
Test methods (5.1,5.4,5.5,5.8,5.9). —Transportation (7.4).
b) Revised the main chapter of YY0227-1995, Article: Scope (Chapter 1).
A reference to a standard (Chapter 2).
- Product Classification (Chapter 3).
Technical requirements (4.2,4.6,4.8,4.9).
Test methods (5.2,5.3,5.6,5.7).
Testing rules (Chapter 6).
Logo, packaging, transportation and required storage (7.1~7.3). c) The main chapters and clauses added to this standard are:
performance requirements (see 4.1.1, 4.1.2).
—Material and structural requirements (see 4.2.2.4.2.3). Safety requirements (see 4.3.1~4.3.6).
Test of performance requirements (see 5.1.1, 5.1.2). Tests required for materials and construction (see 5.2.2.5.2.3). - Testing of safety requirements (see 5.3.1, 5.3.2, 5.3.3). Test of appearance quality (see 5.4).
This standard is proposed by China Pharmaceutical Equipment Industry Association. This standard is under the jurisdiction of the Pharmaceutical Equipment Industry Standardization Technical Committee. This standard was drafted by: Shanghai Medicinal Materials Co., Ltd. Traditional Chinese Medicine Machinery Factory. The main drafters of this standard are Shuai Xiaohua and Sun Deping. 4
1 Scope
Hammer crusher
JB20039—2004
This standard specifies the classification and marking, requirements, test methods, inspection rules, Marking, packaging and storage. This standard applies to pharmaceutical hammer mills (hereinafter referred to as mills) whose hammer rotation diameter is not greater than 300mm. 2 Normative reference documents
The provisions in the following documents become provisions of this standard through reference in this standard. For dated reference documents, all subsequent amendments (excluding corrigenda) or revisions do not apply to this standard. However, parties that reach an agreement based on this standard are encouraged to study whether the latest versions of these documents can be used. Version. For undated referenced documents, the latest edition applies to this standard. GB/T191 Pictorial marks for packaging, storage and transportation
GB5226.1-2002 Mechanical safety mechanical and electrical equipment Part 1: General technical documents GB/T6388 Transport, packaging, receipt and delivery marks
GB/T9969.1 General instructions for industrial products GB/T10111 Random sampling method using random numbers GB/T 13306
5 signs
General technical conditions for packaging of mechanical and electrical products
GB/T13384 format| |tt||GB/T16769-1997 Metal cutting machine tool noise sound pressure level measurement method YY/T0216 Pharmaceutical machinery product model compilation method 3 classification and labeling
3.1 classification
Divided into water-cooled type according to cooling method And the ordinary type, the water-cooled type is represented by "S\, and the ordinary type is not represented. According to the installation direction of the spindle, it is divided into vertical shaft type and horizontal shaft type. The vertical shaft type is represented by "L\, and the horizontal shaft type is represented by "W\. 3.2 Model and Marking
The crusher model is marked according to the requirements of YY/T0216 and the following method. C port stamp number
Improved design sequence (A, B, C..)
Specification code : Use the chain rotation diameter (mm) to indicate the cooling method code: S means water-cooled type
Type code: L means vertical shaft type, W means horizontal shaft type Product function code: means hammer mill JB20039-2004|| tt||Marking example
Example 1: CW160 type: indicates a horizontal shaft hammer mill with a hammer rotation diameter of 160mm. Example 2: CL.S250A type: indicates the first improved design. Water-cooled vertical shaft hammer mill with a body rotation diameter of 250mm.
4 Requirements
4.1 Performance Requirements
4.1.1 The rotating parts of the pulverizer should rotate flexibly and without jamming. 4.1.2 The pulverizer should operate smoothly, without looseness or abnormal vibration. 4.1.3 The temperature rise on the outer surface of the pulverizer main shaft bearing seat should not exceed 40°C. 4.1.4 When the pulverizer is operating under load, the noise sound pressure level should not be greater than 40°C. Greater than 85dB(A). 4.2 Material and structural requirements
4.2.1 Parts in direct contact with drugs should be made of corrosion-resistant stainless steel or other materials that have been proven to be equally suitable.
4.2. 2. The surface of the parts in direct contact with the medicine should be smooth and clean, and should be easy to clean, disinfect and sterilize. 4.2.3 The lubrication system of the pulverizer should be sealed and leak-free. 4.2.4 For pulverizers with a water cooling structure, There should be no leakage in cooling components or pipelines. 4.3 Safety requirements
4.3.1 The exposed rotating parts of the pulverizer should be equipped with safety shields or protective nets. 4.3.2 The one-way rotating motor in the pulverizer should be installed. Arrow signs and warning signs should be set at dangerous locations. The signs should be clear, visible and durable.
4.3.3 The protective grounding circuit of the electrical system should comply with the provisions of 8.2 in GB5226.1-2002. 4.3.4 The buttons, indicators and displays of the electrical system shall comply with the provisions of 10.2 and 10.3 in GB5226.1--2002 respectively. 4.3.5 The wiring of the electrical system should comply with the provisions of Chapter 14 of CB5226.1-2002. 4.3.6 The markings, warning signs and project codes of the electrical system should comply with the provisions of Chapter 17 of GB5226.1-2002. 4.3.7 The continuity of the protective grounding circuit of the electrical system shall comply with the provisions of 19.2 of CB5226.1-2002. 4.3.8 The insulation resistance of the electrical system should comply with the provisions of 19.3 in GB5226.1-2002. 4.3.9 The withstand voltage of the electrical system should comply with the provisions of 19.4 in GB5226.1-2002. 4.4 Appearance quality
4.4.1 The outer surface of the powder alcohol machine should be flat and smooth, and there should be no protruding sharp corners or sharp edges. 4.4.2 The exposed parts of the pulverizer should be corrosion-resistant, non-falling, and easy to clean. 5 Test Method
5.1 Mechanical Performance TestWww.bzxZ.net
5.1.1 Cut off the power supply, open the grinding chamber, and turn the rotating parts of the grinder by hand to check whether there is any jamming. 5.1.2 Turn on the power, start the grinder, and observe its operation. 5.1.3 Turn on the power and run the pulverizer for no less than 1 hour. Use a thermometer to measure and calculate the temperature rise on the outer surface of the main shaft bearing seat. 6
JB 20039---2004
5.1.4 Under load operation, use a sound level meter to measure the load operation noise according to the method specified in GB/T16769-1997. 5.2 Material and structural testing
5.2.1. Visually inspect the material certificate of the parts used in the parts where the crusher is in direct contact with the drug. 5.2.2 Visually inspect the surfaces of parts of the crusher that are in direct contact with the medicine. 5.2.3 Visually inspect the sealing condition of the lubrication system of the crusher. 5.2.4 Use a manual pressure pump to fill the cooling system with water, pressurize it to 0.2MPa (gauge pressure), keep the pressure for 1 hour, and check whether there is any leakage in the cooling system.
5.3 Safety performance test
5.3.1 Visually inspect the protective devices of the exposed rotating parts of the crusher. 5.3.2 Visually inspect the arrow signs of the crusher and the safety warning signs of dangerous parts. 5.3.3 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 17 of GB5226.1--2002 respectively. Check the regulations of the chapter. 5.3.4 The continuity, insulation resistance and withstand voltage of the protective grounding circuit of the electrical system shall be tested in accordance with the provisions of 19.2, 19.3 and 19.4 of GB5226.1-2002 respectively.
5.4 Appearance Test
Use visual inspection method for inspection.
6 Inspection Rules
6.1 Inspection Categories
The inspection of crusher is divided into factory inspection and type inspection. 6.2 Factory inspection
6.2.1 The crusher shall be inspected one by one according to the provisions of Table 1. Only those that pass the inspection shall be allowed to leave the factory, and shall be accompanied by a product certificate. 6.2.2 If the product is found to be unqualified during the inspection, it is allowed to be returned for repair and re-inspection. If the product is still unqualified, the product will be judged to be unqualified. Table 1 Factory inspection items
Item category
General performance
Main performance
6.3 Type inspection
Inspection items
4.1.1. 4.1.2. 4.3.3, 4.3.4. 4.3.5. 4.3.6, 4.4.14.1.3,4.2,4.3.7,4.3.8,4.3.9
6.3.1 In the following situations Type inspection should be carried out when: a) During trial production and appraisal of new products;
b) After formal production, when there are major improvements in design, process and materials that may affect product performance: production has been suspended for more than 2 years and production is resumed when;
c)
d) when the national quality supervision agency proposes type inspection requirements. 6.3.2 Type inspection shall be carried out according to the sampling method specified in GB/T10111, and one unit shall be randomly selected from the products that have passed the factory inspection. 6.3.3 Judgment rules: During the inspection, if any of the continuity of the protective grounding circuit, insulation resistance, and withstand voltage of the main electrical safety performance is unqualified, the type inspection will be judged to be unqualified. If other items are unqualified, the unqualified items should be re-tested. If they are still unqualified, the 7
JB20039-2004
product will be deemed to have failed the type inspection.
7 Marks, Packaging and Storage
7.1 Marks
7.1.1 The crusher should have a sign at an obvious position on the machine as specified in the drawing. The sign should comply with the provisions of GB/T13306. The sign The content should include:
a) Product model and name;
b) Main technical parameters:
c) Product standard number:
d)||tt| |Rated voltage, number of phases, frequency and rated power: e) Manufacturer’s name and address;
f) Manufacturing date.
2 The packaging box should be marked according to the requirements specified in GB/T6388 and GB/T191, and should include the following content: 7.1.2
a) Receiving location and receiving unit; ||tt| |Shipping unit;
b)
c) Product model and name;
d) Manufacturer name;
e) Manufacturing date:
f) Weight (gross weight and net weight);
g) Volume (length × width × height);
h) signs such as "Afraid of Rain", "Upward" and "No Rolling". 7.2 Packaging
The packaging box of the crusher should comply with the regulations of CB/T13384, and measures should be taken to prevent moisture and rain. The following technical documents should be attached in the packaging box:
a) Product instruction manual;
b) Product qualification certificate;
c) Packing list.
Product instructions for use should be prepared in accordance with the requirements specified in GB/T9969.1. 7.3 Storage
The grinder should be stored in a sheltered and well-ventilated environment with a relative humidity of no more than 85%.2 Packaging
The packaging box of the crusher should comply with the regulations of CB/T13384, and measures should be taken to prevent moisture and rain. The following technical documents should be attached in the packaging box:
a) Product instruction manual;
b) Product qualification certificate;
c) Packing list.
Product instructions for use should be prepared in accordance with the requirements specified in GB/T9969.1. 7.3 Storage
The grinder should be stored in a sheltered and well-ventilated environment with a relative humidity of no more than 85%.2 Packaging
The packaging box of the crusher should comply with the regulations of CB/T13384, and measures should be taken to prevent moisture and rain. The following technical documents should be attached in the packaging box:
a) Product instruction manual;
b) Product qualification certificate;
c) Packing list.
Product instructions for use should be prepared in accordance with the requirements specified in GB/T9969.1. 7.3 Storage
The crusher should be stored in a sheltered and well-ventilated environment with a relative humidity of no more than 85%.
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