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 JB20010—2004
Three-dimensional Mixer
Threedimensionalmotionsmixer2004-02-05 Released
2004- 06-01 Implementation
Released by the National Development and Reform Commission
Foreword
1 Scope
2 Normative Reference Documents
3 Terms and Definitions·|| tt||4 Classification and labeling
5 Requirements
6 Test methods·
7 Inspection rules
8 Marks, instructions for use, packaging, transportation and storage items|| tt||times
Appendix A (normative appendix)
Test method for determining mixing uniformity M using benzoic acid content determination method Appendix B (normative appendix)
Clean after cleaning Degree test
JB20010—2004
10
12
JB20010—2004
Foreword
Appendix A and Appendix B of this standard are Normative appendix. 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: Wenzhou Pharmaceutical Equipment Factory. The main drafters of this standard: Wang Xiaolun, Huang Xinen, Su Changhua, Mei Qingsheng, Yang Jun. 1 Scope
Three-dimensional mixer
JB20010-2004
This standard specifies the terms and definitions, classification and labeling, requirements, test methods, Inspection rules and markings, instructions for use, packaging, transportation and storage. This standard is applicable to mixers in which the driving shaft and the driven shaft are parallel, driven by the universal joint and Y-shaped rocker arm, so that the running trajectory of the mixing barrel is in a three-dimensional space.
2 Normative reference documents
The clauses in the following documents become the clauses of this standard through the reference of 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 the latest versions of these documents can be used. For undated referenced documents, the latest edition applies to this standard. CB/T191 packaging, storage and transportation pictorial mark
GB/T1220 stainless steel rod
GB/T3280 stainless steel cold-rolled steel plate
GB/T3323-1987 steel fusion welding butt joint radiography and quality Classification GB/T4237 Stainless Steel Hot Rolled Steel Plate
GB5226.1-2002 Mechanical Safety Mechanical and Electrical Equipment Part 1: General Technical Conditions GB/T9969.1 Industrial Product Instructions General Method of Random Sampling Using Random Numbers GB/T10111
Signs
CB/T13306
GB/T13384
GB/T16769
General technical conditions for packaging of mechanical and electrical products
Metal Method for measuring the sound pressure level of cutting machine tool calls YY/T0216 Pharmaceutical Machinery Product Model Preparation Good Manufacturing Practice (1998 revised edition) State Food and Drug Administration Pharmacopoeia of the People's Republic of China (2000 edition) State Pharmacopoeia Commission 3 Terms and Definitions || tt ||3.1 ||tt | Materials are mixed into a continuous, loose and uniform mixture. n | | tt | , using mathematical statistics methods, conduct variance analysis on a set of data, and calculate the degree of deviation between the characteristic index X and the theoretical value of the labeled quantity. Commonly used to express mixing uniformity (M). 3.3
Fillingcoefficient
The ratio of the material volume to the mixing barrel volume during the mixing process. 4 Classification and marking
4.1 Model
The model should comply with the provisions of YY/T0216.
H
Marking example:
s
Improved design sequence number (A, B)
Specification code: Mixing barrel capacity (L)| |tt||Feature code: indicates three-dimensional mixing
Function code: indicates mixing machinery
Type HS600A: indicates a three-dimensional mixer with a mixing barrel volume of 600L after the first design improvement. 4.2 Specifications and basic parameters
Specifications and basic parameters should comply with the provisions of Table 1. Table 1
Specifications and basic parameters
Model
HS5
HS20
HS50
HSI00
HS200||tt ||H5400
HS600
HS800
HS1000
HS1500
Mixing barrel volume
L
5|| tt||20
50
100
200
400
600
800
1000||tt| |1500
Note: The maximum density of filling material is 0.625g/cmr. 6
Maximum charging volume
4
16
40
80
160
320||tt| |480
640
800
1200
Drive shaft speed
rfmin
20
20||tt| |s17
14
14
≤12
≤12
12
≤12
≤12|| tt | .
5.2 The materials in the mixer that come into contact with the drugs should be corrosion-resistant and should not chemically change with or absorb the drugs. 5.3 The maximum allowable value of surface roughness Ra at the contact point between the mixing barrel and the drug is 0.4um, and the upper limit of the outer surface roughness Ra is 0.8pamo
5.4 The mixing barrel should be easy to clean. After final cleaning, the mixing There should be no visible stains left on the inner wall of the barrel, and its cleanliness after cleaning should be such that the chemical residue content is no more than 10g/g
5.5 The welding quality of the main stress-bearing components of the mixer (Y-shaped sowing arm, mixing barrel) must not be Lower than the Level II requirements in GB/T3323-1987.
5.6 Complete machine requirements
5.6.1 All purple firmware of the mixer should be connected reliably and should not be loose. 5.6.2 The running direction of the mixer's driving shaft should be consistent with the running direction mark of the driving shaft. 5.6.3 The mixer should operate smoothly, without crawling when the machine base is tightened. 5.6.4 The mixer should be flexible and reliable in operation; no lubricating parts are allowed to pollute the working environment; when shutting down, the discharge valve should be in the lowest position.
When the 5.6.5 mixer is running dry, its noise sound pressure level shall not be greater than 75dB(A). 5.6.6 The mixing barrel shall not leak powder during operation. 5.7 Electrical system safety requirements
5.7.1 The continuity of the protective grounding circuit of the electrical system shall comply with the provisions of 19.2 in GB5226.1-2002. 5.7.2 The insulation resistance of the electrical system shall comply with the provisions of 19.3 in CB5226.1-2002. 5.7.3 The withstand voltage of the electrical system shall comply with the provisions of 19.4 in CB5226.1-2002. 5.7.4. The protective grounding circuit of the electrical system should comply with the provisions of 8.2 in GB5226.1-2002. 5.7.5 The buttons of the electrical system shall comply with the provisions of 10.2 in GB5226.1-2002. 5.7.6 The indicator lights of the electrical system should comply with the provisions of 10.3 in GB5226.1-2002. 5.7.7 The wiring of the electrical system should comply with the provisions of Chapter 14 of CB5226.1-2002. 5.7.8 The markings, warning signs and project codes of the electrical system shall comply with the provisions of Chapter 17 of GB5226.1-2002. 5.8 Mixing uniformity M
Under the determined process parameters, after the materials are fully mixed, the mixing uniformity M should reach 99%. 6 Test methods
6.1 The surface of the mixer is inspected by sensory method
6.2 Inspection of materials in contact with drugs in the mixer should be checked against the material certification data, and if necessary, a qualified third party should be entrusted with relevant inspections Standard inspection. bzxZ.net
6.3 The roughness of the mixing barrel surface is tested using the sample comparison method. 6.4 See Appendix B for the inspection of cleanliness after cleaning. 7
JB20010-2004
6.5 The welds of the main stress-bearing components shall be inspected by radiography according to the regulations of GB/T3323-1987. 6.6 Load test of the complete machine
6.6.1 The volume of the mixing barrel and the maximum loading quality shall be inspected by the weighing method. 6.6.2 The running direction of the mixer's driving shaft is inspected by visual inspection. 6.6.3 The mixer's driving shaft speed is inspected with a tachometer. 6.6.4 The operation and operation of the mixed batch shall be subject to official inspection. 6.6.5 The noise of the mixer shall be tested with a sound level meter in accordance with the provisions of GB/T16769. 6.6.6 The sealing performance of the mixing barrel shall be inspected by visual inspection. Use no less than 10% of the volume of the mixing barrel of fine powder with a size of 0.18mm ~ 0.15mm (80 ~ 100 mesh), pour it into the mixing barrel, and start the mixer to run for 10 minutes. 6.7 Electrical system safety test
6.7.1 The continuity, insulation resistance and withstand voltage tests 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 in GB5226.1-2002 respectively.
6.7.2 The protective grounding circuit, buttons, indicators, 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 17 of CB5226.12002 respectively. Inspections are required. 6.8 Inspection of mixing uniformity M
Inspection of mixing uniformity M shall be carried out according to Appendix A. 7 Inspection Rules
7.1 Inspection Categories
Mixer inspection is divided into factory inspection and type inspection. 7.2 Factory inspection
7.2.1 The mixers shall be inspected one by one according to the provisions of Article 2. Only those that pass the test shall be allowed to leave the factory, and shall be accompanied by a product certificate. Table 2 Factory inspection items
Item category
General performance
Main performance
Inspection items
5.1, 5.2, 5.3,5.4, 5.6.1 , 5.6.25.6.3,5.6.4, 5.6.5, 5.6.6,5.7.2,5.7.4,5.7.5,5.7.6,5.7.7,5.7.87.2.2 The mixer is in the process of inspection If a substandard product is found, it is allowed to be returned for repair and re-inspection. If it is still unqualified, the mixer will be judged as a substandard product. || tt | , when there are major changes in the process that may affect product performance; b)
When production is resumed after 1 year of suspension:
e
There is a difference between the factory inspection results and the last type inspection When there is a big difference; d)
During normal production, type inspection should be carried out every 3 years: e
f)
When the national quality supervision agency proposes type inspection requirements. 8 | | tt | 7.3.3 Judgment rules:
During the type inspection, if any of the electrical safety performance protective grounding circuit continuity, insulation resistance, and withstand voltage tests 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 retested twice. If it is still unqualified, the product will be judged to have failed the type inspection.
8 Logo, instructions for use, packaging, transportation and storage 8.1 Logo
The mixer should have a product label. The label should comply with the regulations of CB/T13306 and be fixed in an obvious position on the machine. The sign should include the following content:
a) Product name:
b) Product model and specification:
c) Main parameters;
d) Manufacturer name: | |tt||e) Product number and manufacturing date;
f) Implementation standard number.
8.2 Instructions for use
Product instructions for use shall comply with the relevant provisions of GB/T9969.1. 8.3 Packaging
Product packaging should be in accordance with the provisions of GB/T13384 and include the following contents: a) Packing list and list of accompanying documents:
b) Technical documents: product instruction manual, equipment installation instructions and Installation drawings, etc.: c) Product guarantee documents: product factory inspection report, product certificate (book), warranty letter, warranty certificate, quality analysis report of materials in direct contact with drugs, measurement certificate and validity certificate of supporting measuring instruments, etc. . 8.4 Transportation
The transportation of the mixer should comply with the relevant national land and water transportation regulations. 8.5 Storage
After the mixer is packed, it should be stored in a dry, ventilated, corrosive-gas-free indoor or sheltered place. It should not be stored in the open air. o
1 Mixers shall be inspected one by one according to the provisions of Article 2. Only qualified ones can be allowed to leave the factory and be accompanied by a product certificate. Table 2 Factory inspection items
Item day category
General performance
Main performance
Inspection items
5.1, 5.2, 5.3,5.4, 5.6.1, 5.6.2 5.6.3,5.6.4, 5.6.5, 5.6.6,5.7.2,5.7.4,5.7.5,5.7.6,5.7.7,5.7.8 7.2.2 If unqualified products are found in the mixer during the inspection process, they are allowed to be returned for repair and re-inspection. If they are still unqualified, the mixer is judged to be unqualified.
7.3 Type inspection
7.3.1 Type inspection shall be conducted in any of the following cases:a) Trial design and identification of new products or old products after formal production, if there are major changes in structure, materials and process, which may affect product performance;b) When production is resumed after one year of suspension:
e
When there is a major difference between the factory inspection result and the last type inspection;d) During normal production, type inspection shall be conducted every three years:e
f) When the national quality supervision agency proposes a requirement for type inspection. 8
7.3.2 Sampling:
JB20010-2004
The prototype for type inspection shall be selected from the products that have passed the factory inspection according to the method specified in GB/T10111. 7.3.3 Judgment rules:
During the type inspection, if one of the continuity of the protective grounding circuit, insulation resistance, and withstand voltage test of the electrical safety performance fails, the product is judged to have failed the type inspection. If one of the other items fails, the unqualified item should be doubled and retested. If it still fails, the product is judged to have failed the type inspection.
8 Marking, instruction manual, packaging, transportation and storage 8.1 Marking
The mixer should have a product label, which should comply with the provisions of CB/T13306 and be fixed in a conspicuous position on the machine. The label should include the following contents:
a) Product name:
b) Product model and specifications:
c) Main parameters;
d) Manufacturer's name:
e) Product number and manufacturing date;
f) Implementation standard number.
8.2 Instructions for use
The product instructions for use shall comply with the relevant provisions of GB/T9969.1. 8.3 Packaging
The product packaging shall comply with the provisions of GB/T13384 and include the following contents: a) Packing list and random document list:
b) Technical documents: product instructions for use, equipment installation instructions and installation drawings, etc.: c) Product guarantee documents: product factory inspection report, product certificate (book), quality assurance book, warranty card, quality analysis report of materials in direct contact with drugs, measurement certificate and validity certificate of supporting measuring instruments, etc. 8.4 Transportation
The transportation of the mixer shall comply with the relevant national regulations on land and water transportation. 8.5 Storage
After the mixer is packed, it should be stored in a dry, ventilated, corrosive gas-free room or a sheltered place. It must not be stored in the open air. o
1. The mixers shall be inspected one by one according to the provisions of Article 2. Only those that are qualified can be allowed to leave the factory, and a product certificate shall be attached. Table 2 Factory inspection items
Item category
General performance
Main performance
Inspection items
5.1, 5.2, 5.3,5.4, 5.6.1 , 5.6.25.6.3,5.6.4, 5.6.5, 5.6.6,5.7.2,5.7.4,5.7.5,5.7.6,5.7.7,5.7.87.2.2 The mixer is in the process of inspection If a substandard product is found, it is allowed to be returned for repair and re-inspection. If it is still unqualified, the mixer will be judged as a substandard product. || tt | , when there are major changes in the process that may affect product performance; b)
When production is resumed after 1 year of suspension:
e
There is a difference between the factory inspection results and the last type inspection When there is a big difference; d)
During normal production, type inspection should be carried out every 3 years: e
f)
When the national quality supervision agency proposes type inspection requirements. 8 | | tt | 7.3.3 Judgment rules:
During the type inspection, if any of the electrical safety performance protective grounding circuit continuity, insulation resistance, and withstand voltage tests 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 retested twice. If it is still unqualified, the product will be judged to have failed the type inspection.
8 Logo, instructions for use, packaging, transportation and storage 8.1 Logo
The mixer should have a product label. The label should comply with the regulations of CB/T13306 and be fixed in an obvious position on the machine. The sign should include the following content:
a) Product name:
b) Product model and specification:
c) Main parameters;
d) Manufacturer name: | |tt||e) Product number and manufacturing date;
f) Implementation standard number.
8.2 Instructions for use
Product instructions for use shall comply with the relevant provisions of GB/T9969.1. 8.3 Packaging
Product packaging should be in accordance with the provisions of GB/T13384 and include the following contents: a) Packing list and list of accompanying documents:
b) Technical documents: product instruction manual, equipment installation instructions and Installation drawings, etc.: c) Product guarantee documents: product factory inspection report, product certificate (book), warranty letter, warranty certificate, quality analysis report of materials in direct contact with drugs, measurement certificate and validity certificate of supporting measuring instruments, etc. . 8.4 Transportation
The transportation of the mixer should comply with the relevant national land and water transportation regulations. 8.5 Storage
After packing the mixer, it should be stored in a dry, ventilated, corrosive gas-free indoor or sheltered place, and should not be stored in the open air. o
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