Some standard content:
JB | Cone rotary vacuum dryer
Released on 2004-02-05
Implemented on 2004-06-01
Released by the National Development and Reform Commission
ICS11.120.30||tt ||C92
JB
Pharmaceutical Machinery Industry Standard of the People's Republic of China JB200122004
Replaces YY0219—1995
Trough type mixer
Box typemixer||tt ||Released on 2004-02-05
Implemented on 2004-06-01
Released by the National Development and Reform Commission
Foreword
Scope
1|| tt||2 Normative reference documents
3 Classification and labeling
4 Requirements
Test methods
5
6 Inspection rules
7 Logo, instructions for use, packaging, transportation and storage Item
times
JB20012—2004
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JB20012—2004
Foreword
This standard is a revision of YY0219-1995 based on the requirements of "Good Manufacturing Practice for Pharmaceutical Products" and GB/T1.1-2000, GB/T1.2-2002 Standardization. Work Guidelines. This standard replaces YY0219-1995 from the date of implementation. Compared with the YY0219-1995 standard, the main changes in this standard are as follows: a) The main chapters and clauses of YY0219-1995 are deleted: the maximum inclination column in Table 1;
requirements (4.1, 4.7, 4.15, 4.16).
b)
Revised the main chapters and articles of YY0219-1995: Table 1. Table 2;
requirements (4.2, 4.4, 4.8).
c) Main chapters and clauses added to this standard:
Requirements for covering the entire machine (see 4.7); Requirements for exposed welds (see 4.8);
Requirements for electrical safety performance (see 4.9.1~4.9.8): The noise measurement standard GB/T16769 is added to the test method: a pair of requirements for instructions for use (see 7.2). This standard is proposed by the China Pharmaceutical Machinery and Equipment Industry Association. This standard is under the jurisdiction of the Pharmaceutical Machinery and Equipment Industry Standardization Technical Committee. This standard was drafted by: Baoji Pharmaceutical Machinery Factory. The main drafters of this standard: Zhang Baoshun and Zhang Nailing. Previous releases of this standard: ZBC92002-1986, YY0219-1995. 42
1 Scope
Trough mixer
JB 20012-2004
This standard specifies the box Type mixer product classification, requirements, test methods, inspection rules and signs, instructions for use, packaging, transportation and storage.
This standard applies to trough mixers (hereinafter referred to as mixers). 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 to an agreement based on this standard are encouraged to study whether to use the latest versions of these documents. For undated referenced documents, the latest edition applies to this standard. GB/T191 Packaging, storage and transportation pictorial mark
CB/T3280 stainless steel cold-rolled steel plate
GB5226.1-2002 Mechanical safety mechanical and electrical equipment Part 1: General technical conditions CB/T6060.4 Surface roughness Comparison of the polished surface of the sample GBT9969.1 General instructions for use of industrial products GB/T10111 Method of random sampling using random numbers of strands GB/T13306 Label
GB/T13384
GB/T16769||tt ||3 Classification and Marking
3.1 Model
Marking Example
General Technical Conditions for Mechanical and Electrical Product Packaging
Metal Cutting Machine Tool Operation Sound Pressure Level Measurement Method CH Port|| tt||Improved design number (A, B)
Main parameters: working volume (L)
Type and feature code: Indicated mixing machine CH100 type: Indicates a trough mixing with a working volume of 100L machine. 3.2 The specifications and basic parameters of the mixer are shown in Table 1. 43
JB20012—2004
Model
CH100
CH150
CH200
4 requirements
Mixing tank
Working volume, L
100
150
200
Table 1 Specifications and basic parameters| |tt||Paddle speed
Inclination speed, rad/s
<0.6
/mmin
25
24
20
Power, w
Stirring motor
3
W4
Pouring motor
0.75
w1.1| |tt||4.1 All parts in contact with drugs should be made of non-toxic, corrosion-resistant materials that do not chemically change with or absorb drugs. The austenitic stainless steel material used should comply with the requirements of GB/T3280. 4.2 The stainless steel welds of the stirring paddle should be smooth and smooth, and the shuttle angles of the blades and rods should be rounded. 4.3 The roughness Ra value of the inner surface in contact with the material shall not be greater than 0.8um. 4.4 The clearances between the mixing slurry and various parts of the mixing tank are shown in Table 2. There is no collision during rotation. Table 2 Spacing between various parts of the mixing paddle and the mixing tank Radial clearance between the mixing paddle and the inner wall of the mixing tank 1~3
Paddle shaft part
2.5
Mixing paddle and tank side plate The axial clearance
Chain head part
m5
mm
4.5 The side plate of the mixing tank and the stainless steel lining plate should be smooth and firm, and the stainless steel side plate should not have any Scratches and obvious bumps and other phenomena. 4.6 The non-machined surfaces of castings and carbon steel parts should be coated with anti-rust paint. The interface between the painted surface and the non-coated surface should be clear, and there should be no scars, pores, etc.
4.7 When covering the entire machine shape, the covering plate should be made of stainless steel. After coating, the surface should be flat, smooth and beautiful, without obvious convexity and other appearance defects, and should be easy to clean.
4.8 The exposed welds should be polished to be flush with the base body and polished. 4.9 Electrical safety requirementsbzxZ.net
4.9.1 The continuity of the protective grounding circuit of the electrical system shall comply with the provisions of 19.2 in GB5226.12002. The insulation resistance of the electrical system should comply with the provisions of 19.3 in GB5226.1-2002. 4.9.2
4.9.3
4.9.4
4.9.5
4.9.6
4.9.7
4.9. 8
4.10
4.11
4.12
4.13
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The withstand voltage of the electrical system should comply with the provisions of 19.4 in GB5226.12002 . The protective grounding circuit of the electrical system shall comply with the provisions of 8.2 in GB5226.1-2002. The buttons of the electrical system should comply with the provisions of 10.2 in GB5226.12002. The indicators and displays of the electrical system should comply with the provisions of 10.3 in GB5226.1-2002. The wiring of the electrical system should comply with the provisions of Chapter 14 of GB5226.1-2002. The markings, warning signs and project codes of electrical systems should comply with the provisions of Chapter 17 of GB5226.1-2002. There should be no oil in the seal of the reducer. The transmission system operates flexibly, lightly and without any blockage. The material-preventing device operates smoothly and reliably.
The sound pressure level of the whole machine load should not be greater than 75dB(A). 4.14 The sealing devices at both shaft ends of the mixing tank are in good condition, and there must be no leakage or contamination of materials. 4.15 The temperature rise of the shell wall of the worm gear reducer shall not exceed 35℃. 5 Test methods
5.1 Materials and appearance
5.1.1 Check the material certificate of the materials used. In case of objection, the inspection should be carried out according to relevant standards. 5.1.2. The surface roughness is tested according to GB/T6060.4 using a comparison sample. 5.1.3 The dimensional accuracy is measured with measuring tools and the machine appearance is visually inspected. 5.2 Electrical safety performance
JB20012-2004
5.2.1 The continuity, insulation resistance and withstand voltage tests of the protective grounding circuit of the electrical system shall be in accordance with the provisions of 19.2, 19.3 and 19.4 in GB5226.1-2002 respectively. conduct.
5.2.2. The protective grounding circuit, buttons, indicator lights and displays, wiring, markings, warning signs and project codes of the electrical system shall be in accordance with 8.2, 10.2, 10.3 and Chapter 14 of GB5226.1-2002 respectively. and Chapter 17. 5.3 The sealing performance of the reducer
shall be run continuously for no less than 1 hour, and the sealing performance shall be detected by sensory method. 5.4 Assembly quality
Continuous dry operation for not less than 1h. Check the assembly quality. 5.5 Noise
Noise sound pressure level measurement shall be carried out in accordance with the provisions of CB/T16769. 5.6 Load test
5.6.1 The load test shall be carried out after passing the dry running test. 5.6.2 The load must be operated continuously for no less than 2 hours.
5.6.3 Use medicinal lake to add materials according to the working volume of the mixing tank, and add 10% (mass) of water. 5.6.4 Load testing items:
a) Visually inspect the reducer and mixing tank shaft seal leakage and operation conditions; b) Use a thermometer to detect the temperature rise of the reducer shell wall: Use a tachometer to detect the rotation speed; || tt | =3UIcosp
Where:
p—three-phase electric power, W
U—line voltage, V
I one-line current, A;
$—The phase difference between phase voltage and phase current. (1)
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JB 20012—2004
6 Inspection Rules
6.1 Inspection types include factory inspection and type inspection. 6.2 Factory inspection
6.2.1 Mixer products must be inspected by the quality inspection department of the manufacturer, and only those that pass the test can leave the factory. 6.2.2 All products leaving the factory must be inspected one by one according to Table 3. Only those that pass the factory will be allowed to leave the factory, and a product certificate will be attached. Table 3 Factory inspection items
item category
appearance
size
performance
performance
inspection items
4.2, 4.3,4.5,4.6,4.7,4.8
4.4
4.9, 4.10, 4.11, 4.12., 4.13,4.14, 4.156.2.3 If any substandard product is found during the acceptance process, it should be returned for inspection. Trim it and then submit it for acceptance. If it still fails, it will be judged as a non-conforming product.
6.3 Type inspection
6.3.1 Type inspection shall be carried out in one of the following situations: a) Trial making or transfer to factory for production;
b) Design and process are relatively different. When there are major changes:
c) When the product resumes production after a long-term suspension; d) When the national quality supervision agency requests type inspection. 6.3.2 For type inspection prototypes, 10% of the products that have passed the factory inspection shall be selected according to the method specified in GB/T10111, and one unit shall be tested.
6.3.3 Inspection items:
Type inspection items are all the requirements of this standard. 6.3.4 Judgment rules:
During the type inspection, if any of the electrical safety performance of protective grounding circuit continuity, insulation resistance, and withstand voltage fails, the product will be judged to have failed the type inspection. If one of the other items is unqualified, the unqualified item should be re-inspected twice. If it is still unqualified, the product will be judged to have failed the type inspection.
7 Logo, Instructions for Use, Packaging, Transportation and Storage 7.1 Logo
Each mixer has a product label fixed at the position specified on the drawing, and the label should comply with the regulations of GB/T13306. The content of the sign is as follows:
a) product name and model;
b) manufacturer name:
c) factory number and date;
d) main technical parameters ;
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e) product standard number.
7.2 Product instructions for use shall comply with the relevant provisions of GB/T9969.1. The content should include: a) product name, production unit, address, postal code and contact number; b) implemented product standards;
JB20012—2004
c) main structure, performance, specifications, Product purpose, usage scope, precautions, warnings and reminder instructions, safety measures;
d) Explanation of logo graphics, symbols, abbreviations, etc.; e) Installation instructions and illustrations||tt| |f) Correct product lifting methods, product care and maintenance methods, and special storage methods. 7.3 Packaging
7.3.1 The packaging of the product should comply with the regulations of GB/T13384, and the following documents should be included in the packaging box: a) Product certificate:
b) Product manual;
c )Packing List.
The words and logos on the outer wall of the packaging box should be clear, comply with the regulations of GB/T191, and have the following content: 7.3.2
a) Product name and model;
b) Shipping date;
c) Shipping and receiving station names:
d) Shipping and receiving unit and address;
e) Gross weight and overall dimensions.
7.4 Transportation
Transportation According to the provisions of the order contract, the packaging equipment should be firmly fixed on the transportation vehicle during transportation, and rolling and collision are strictly prohibited. 7.5 Storage
After the mixer is packed, it should be stored in a dry and well-ventilated indoor or sheltered place without corrosive gas. 47
3. If unqualified products are found during the acceptance process, they should be returned for repair and then submitted for inspection. If they are still unqualified, they will be judged as unqualified products.
6.3 Type inspection
6.3.1 Type inspection shall be carried out in one of the following situations: a) Trial making or transfer to factory for production;
b) There are differences in design and process When there are major changes:
c) When the product resumes production after a long-term suspension; d) When the national quality supervision agency requests type inspection. 6.3.2 For type inspection prototypes, 10% of the products that have passed the factory inspection shall be selected according to the method specified in GB/T10111, and one unit shall be tested.
6.3.3 Inspection items:
Type inspection items are all the requirements of this standard. 6.3.4 Judgment rules:
During the type inspection, if any of the electrical safety performance of protective grounding circuit continuity, insulation resistance, and withstand voltage fails, the product will be judged to have failed the type inspection. If one of the other items is unqualified, the unqualified item should be re-inspected twice. If it is still unqualified, the product will be judged to have failed the type inspection.
7 Logo, Instructions for Use, Packaging, Transportation and Storage 7.1 Logo
Each mixer has a product label fixed at the position specified on the drawing, and the label should comply with the regulations of GB/T13306. The content of the sign is as follows:
a) product name and model;
b) manufacturer name:
c) factory number and date;
d) main technical parameters ;
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e) product standard number.
7.2 Product instructions for use shall comply with the relevant provisions of GB/T9969.1. The content should include: a) product name, production unit, address, postal code and contact number; b) implemented product standards;
JB20012—2004
c) main structure, performance, specifications, Product purpose, usage scope, precautions, warnings and reminder instructions, safety measures;
d) Explanation of logo graphics, symbols, abbreviations, etc.; e) Installation instructions and illustrations||tt| |f) Correct product lifting methods, product care and maintenance methods, and special storage methods. 7.3 Packaging
7.3.1 The packaging of the product should comply with the regulations of GB/T13384, and the following documents should be included in the packaging box: a) Product certificate:
b) Product manual;
c )Packing List.
The words and logos on the outer wall of the packaging box should be clear, comply with the regulations of GB/T191, and have the following content: 7.3.2
a) Product name and model;
b) Shipping date;
c) Shipping and receiving station names:
d) Shipping and receiving unit and address;
e) Gross weight and overall dimensions.
7.4 Transportation
Transportation According to the provisions of the order contract, the packaging equipment should be firmly fixed on the transportation vehicle during transportation, and rolling and collision are strictly prohibited. 7.5 Storage
After packing the mixer, it should be stored in a dry and well-ventilated indoor or sheltered place without corrosive gas. 47
3. If unqualified products are found during the acceptance process, they should be returned for repair and then submitted for inspection. If they are still unqualified, they will be judged as unqualified products.
6.3 Type inspection
6.3.1 Type inspection shall be carried out in one of the following situations: a) Trial making or transfer to factory for production;
b) There are differences in design and process When there are major changes:
c) When the product resumes production after a long-term suspension; d) When the national quality supervision agency requests type inspection. 6.3.2 For type inspection prototypes, 10% of the products that have passed the factory inspection shall be selected according to the method specified in GB/T10111, and one unit shall be tested.
6.3.3 Inspection items:
Type inspection items are all the requirements of this standard. 6.3.4 Judgment rules:
During the type inspection, if any of the electrical safety performance of protective grounding circuit continuity, insulation resistance, and withstand voltage fails, the product will be judged to have failed the type inspection. If one of the other items is unqualified, the unqualified item should be re-inspected twice. If it is still unqualified, the product will be judged to have failed the type inspection.
7 Logo, Instructions for Use, Packaging, Transportation and Storage 7.1 Logo
Each mixer has a product label fixed at the position specified on the drawing, and the label should comply with the regulations of GB/T13306. The content of the sign is as follows:
a) product name and model;
b) manufacturer name:
c) factory number and date;
d) main technical parameters ;
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e) product standard number.
7.2 Product instructions for use shall comply with the relevant provisions of GB/T9969.1. The content should include: a) product name, production unit, address, postal code and contact number; b) implemented product standards;
JB20012—2004
c) main structure, performance, specifications, Product purpose, usage scope, precautions, warnings and reminder instructions, safety measures;
d) Explanation of logo graphics, symbols, abbreviations, etc.; e) Installation instructions and illustrations||tt| |f) Correct product lifting methods, product maintenance and upkeep methods, and special storage methods. 7.3 Packaging
7.3.1 The packaging of the product should comply with the regulations of GB/T13384, and the following documents should be included in the packaging box: a) Product certificate:
b) Product manual;
c )Packing List.
The words and logos on the outer wall of the packaging box should be clear, comply with the regulations of GB/T191, and have the following content: 7.3.2
a) Product name and model;
b) Shipping date;
c) Shipping and receiving station names:
d) Shipping and receiving unit and address;
e) Gross weight and overall dimensions.
7.4 Transportation
Transportation According to the provisions of the order contract, the packaging equipment should be firmly fixed on the transportation vehicle during transportation, and rolling and collision are strictly prohibited. 7.5 Storage
After packing the mixer, it should be stored in a dry and well-ventilated indoor or sheltered place without corrosive gas. 47
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