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 | -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, labels and instructions for use
9 Packaging, Transportation and storage
Appendix A (Normative Appendix)
No-load and full-load tests
Appendix B (Normative Appendix)
Appendix C (Normative Appendix)| | tt |
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JB20011—2004
Foreword
This standard Appendix A, Appendix B, and Appendix C are normative appendices. 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: Zhejiang Canaan Pharmaceutical Equipment Co., Ltd. The main drafters of this standard: Zhang Zhaosheng, Fang Hengzhi, Zhou Jindao. 18
1 Scope
Turnover hopper mixer
JB20011—2004
This standard specifies the terms, definitions, and classification of turnover hopper mixers (hereinafter referred to as mixers) With markings, requirements, test methods, inspection rules and signs, labels, instructions for use and packaging, transportation and storage. This standard applies to mixers that can remove the hopper from the machine and transfer it to the next process after completing the mixing process of different powder materials.
2 Normative reference documents
The clauses in the following documents become the clauses 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 the latest versions of these documents can be used. Version. For undated referenced documents, the latest edition applies to this standard. GB/T191 Packaging, storage and transportation pictorial mark (eqvIS0780: 1997) GB/T1220 stainless steel rod
GB2894 safety mark (negIS03864: 1984) GB/T3280 stainless steel cold-rolled steel plate
GB/T3358.1 1993 Statistical Terminology Part 1 General Statistical Terminology GB/T4237 Stainless Steel Hot Rolled Steel Plate
GB5226.12002 Mechanical Safety Mechanical and Electrical Equipment Part 1: General Technical Conditions (IEC60204-1:2000, IDT)
GB/T6388 Transportation, packaging, receipt and delivery marks
GB/T9969.1 Industrial product instruction manual, general product geometry and technical specifications, rules and methods for surface structure assessment by surface structure profile method (eqvISO GB/T10610
4288 ) Method for measuring noise and sound pressure level of metal cutting machine tools (negISO/DIS230-5-2) YY/T0216 Pharmaceutical Machinery Product Model Preparation Method Good Manufacturing Practice (1998 revised edition) State Food and Drug Administration Pharmacopoeia of the People's Republic of China (2000 edition) National Pharmacopoeia Commission 19
JB20011-2004
IS07000 List of graphic symbols used for equipment EC417 Graphical symbols used for equipment - Compilation of index, list and leaflet IEC445 Identification and unification of electrical terminals using alphanumeric symbols General rules for terminal marking 3 Terms and definitions bzxZ.net
The terms and definitions established by CB/T3358.1-1993, GB/T13732-1992, and the following apply to this standard. 3.1
Intermediatebulkcontainerblender is a turnover hopper mixer controlled by a PLC program. After completing the mixing process of different powder materials, the mixing container (hopper) can be unloaded from the machine and the crop flow transport container can be transferred to the next mixing process. equipment. 3.2
Filing coefficient filingcoefficient
The ratio of the material volume to the net volume of the hopper during the mixing process. 3.3
Mixture
mixture
refers to continuous loose materials that are difficult to distinguish between individuals or sampling units, such as materials that mix raw materials and excipients to a certain uniform state.
3.4
Homogeneousmixturewithevengrain is a mixture with uniform particle size, small coefficient of variation, and meets the requirements. [Derived from GB/T13732-1992 3.1.2] 3.5 | Sampling for a given sample size. [5.8 of GB/T3358.1-1993]
3.6
Sampling unit samplingunit
For the purpose of sampling, the population is divided into a limited number of parts composed of individuals, and each part is called is a sampling unit. [5.2 of GB/T3358.1-1993]
3.7
sample
A group (one or more) individuals (or sampling units) selected from the population according to a certain procedure ). [GB/T3358.1—1993 3.5]
3.8
Sample size nsamplesizen
The number of individuals (or sampling units) included in the sample. [3.7 of GB/T3358.1—1993]
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3.9
Sample mean×samplemean×
Sample X.,.*,arithmetic mean of X .
[CB/T3358.1-1993 3.23]
3.10
variance variance
The variance of random variable X is defined as:
3.11|| tt||Standard deviation (also called SD)
The positive square root of the variance.
3.12
X
standarddeviationg
12x
n信
g=. 2
The coefficient of variation VcoefficientofvariationV is the ratio of the absolute value of the standard deviation to the mean.
V
3.13
Mixing uniformity MmixingprecisionM
The definition of mixing uniformity M can be described by formula (5): M=(1-
Formula Medium:
00—the standard deviation at the beginning of mixing, calculated from equation (6): ×100%
1X100%
=VP(1-P)||tt| |In the formula:
P
- The theoretical content of key components (tracers) in the mixture 4 Classification and labeling
4.1Basic parameters
The basic parameters of the mixer are shown in Table 1.
JB20011-2004
(1)
(2)
(3)
(4)
(5)|| tt||(6)
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JB20011—2004
Basic parameters
Nominal volume of hopper, L
Maximum volume of materials allowed to be loaded, L| |tt||hopper size, mm
working speed,/min
400
400
320
600
600|| tt||480
Table 1 basic parameters
Specification series
800
800
640
1000x1450
800x1200
1000×1550
3 ~ 20
1000
1000
800
1200
1200||tt| |960
1500
1500
1200
2000
2000
1600
1200×15001200×16001200×175g1200 ×21503 ~ 15
Note: The maximum capacity of materials allowed to be loaded is determined based on the loading coefficient of 80% and the material density of 0.8gcm2. 4.2 Model
4.2.1 Model preparation:
The model preparation method is in accordance with YY/T0216. HZD
Improved design sequence number A, B, C.
Hopper lifting method code: Self-lifting without standard, forklift lifting - C Specification code: Hopper nominal volume, L
Structure Feature code: single support -D, double support is not marked. Type code: turnover hopper
function code: mixer
4.2.2 Marking example:
HZD1000: indicates double support It is a turnover hopper mixer with a self-lifting function and a hopper capacity of 1000L. HZDD800C: Indicates a single-support, forklift-lifted, turnover hopper mixer with a hopper volume of 800L. 5 Requirements
5.1 Environmental adaptability
5.1.1 Working environment
The mixer should be able to operate normally in the following climate environment: a) Ambient temperature: The normal operating ambient air temperature is 5℃~40℃; b)
Humidity: When the maximum temperature is 40℃ and the relative humidity does not exceed 50%, it should be able to work normally. Low temperature allows high relative mixing (e.g. 90% at 20°C);
c) Atmospheric pressure: 86kPa~106kPaz
d) Adapt to cleanliness level: It should be able to clean at level 100,000 The area is functioning normally. 5.1.2 Special conditions and special contracts
Under the following special conditions, according to customer requirements, a special contract shall be concluded after review by both parties of supply and demand for design, manufacturing and delivery. a) Working environment that does not meet the requirements of 5.1.1; b) Special products that do not meet the basic parameters listed in Table 1; 22
e) Others (such as power supply conditions, explosion-proof, hopper materials, special function settings, etc. ). 5.2 Performance
5.2.1 Charging coefficient
The charging coefficient of the mixer is 50%~80%.
5.2.2 Working speed
The working speed should comply with the requirements in Table 1, and the allowable error is ±2%. 5.2.3 Working time
The allowable error of setting working time is 1%.
5.2.4 Functions that the operation control system should have The control system should have the following functions:
a) Intelligent function;
b) Display function;
c) Adjustment function;
d) monitoring function;
e) warning function;
f) chain function;
JB20011—2004
linkage matching function: The mixer with the hopper self-lifting function should be equipped with a displacement sensor and a pressure sensor or an electrical trigger device to ensure that there is no lifting movement when there is no hopper and no rotation movement when the hopper is not locked. Among them, the locking sensing (or triggering) of the hopper should adopt margin design technology. 5.3 Physical and chemical properties
5.3.1 Mixing uniformity M
After the optimized combination of process parameters is confirmed and fully mixed, the mixing uniformity M should be greater than 99%. 5.3.2 Cleaning requirements after cleaning
After thorough cleaning and visual inspection, there should be no visible stains remaining on the inner wall of the hopper. Take a sample from the final flushing liquid and the chemical residue content should not be greater than 10g/g.
5.4 Stability
5.4.1 Clamping device and clamping force
The clamping device should be adjusted consistently and the action should be flexible and reliable; the hopper should be lifted smoothly without crawling; the hopper should be lifted After it is in place, it should be locked reliably and there should be no looseness during work; the clamping force should be even after the hopper is lifted into place. 5.4.2 Main bearing temperature rise
When fully loaded and rotating at the highest operating speed, the main bearing temperature rise shall not exceed 30°C. 5.4.3 No-load and full-load tests
The mixer should pass the prescribed no-load and full-load tests (see Appendix A). During the test, it should work normally without collision when lifting, compressing, rotating, and descending movements. There is no friction and abnormal noise, and no dust is blown out. After the test, the fasteners should still be reliably tightened, and the hopper and rotary body are not allowed to have permanent deformation visible to the naked eye.
5.5 Health, Safety and Environmental Protection
5.5.1 Electrical System
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2 Special conditions and special contracts
Under the following special conditions, according to customer requirements, a special contract shall be concluded after review by both parties of supply and demand for design, manufacturing and delivery. a) Working environment that does not meet the requirements of 5.1.1; b) Special products that do not meet the basic parameters listed in Table 1; 22
e) Others (such as power supply conditions, explosion-proof, hopper materials, special function settings, etc. ). 5.2 Performance
5.2.1 Charging coefficient
The charging coefficient of the mixer is 50%~80%.
5.2.2 Working speed
The working speed should comply with the requirements in Table 1, and the allowable error is ±2%. 5.2.3 Working time
The allowable error of setting working time is 1%.
5.2.4 Functions that the operation control system should have The control system should have the following functions:
a) intelligent function;
b) display function;
c) Adjustment function;
d) monitoring function;
e) warning function;
f) chain function;
JB20011—2004
linkage matching function: The mixer with the hopper self-lifting function should be equipped with a displacement sensor and a pressure sensor or an electrical trigger device to ensure that there is no lifting movement when there is no hopper and no rotation movement when the hopper is not locked. Among them, the locking sensing (or triggering) of the hopper should adopt margin design technology. 5.3 Physical and chemical properties
5.3.1 Mixing uniformity M
After the optimized combination of process parameters is confirmed and fully mixed, the mixing uniformity M should be greater than 99%. 5.3.2 Cleaning requirements after cleaning
After thorough cleaning and visual inspection, there should be no visible stains remaining on the inner wall of the hopper. Take a sample from the final flushing liquid and the chemical residue content should not be greater than 10g/g.
5.4 Stability
5.4.1 Clamping device and clamping force
The clamping device should be adjusted consistently and the action should be flexible and reliable; the hopper should be lifted smoothly without crawling; the hopper should be lifted After it is in place, it should be locked reliably and there should be no looseness during work; the clamping force should be even after the hopper is lifted into place. 5.4.2 Main bearing temperature rise
When fully loaded and rotating at the highest operating speed, the main bearing temperature rise shall not exceed 30°C. 5.4.3 No-load and full-load tests
The mixer should pass the specified no-load and full-load tests (see Appendix A). During the test, it should work normally without collision when lifting, compressing, rotating, and descending movements. There is no friction and abnormal noise, and no dust is blown out. After the test, the fasteners should still be reliably tightened, and the hopper and rotary body are not allowed to have permanent deformation visible to the naked eye.
5.5 Health, Safety and Environmental Protection
5.5.1 Electrical System
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2 Special conditions and special contracts
Under the following special conditions, according to customer requirements, a special contract shall be concluded after review by both parties of supply and demand for design, manufacturing and delivery. a) Working environment that does not meet the requirements of 5.1.1; b) Special products that do not meet the basic parameters listed in Table 1; 22
e) Others (such as power supply conditions, explosion-proof, hopper materials, special function settings, etc. ). 5.2 Performance
5.2.1 Charging coefficient
The charging coefficient of the mixer is 50%~80%.
5.2.2 Working speed
The working speed should comply with the requirements in Table 1, and the allowable error is ±2%. 5.2.3 Working time
The allowable error of setting working time is 1%.
5.2.4 Functions that the operation control system should have The control system should have the following functions:
a) Intelligent function;
b) Display function;
c) Adjustment function;
d) monitoring function;
e) warning function;
f) chain function;
JB20011—2004
linkage matching function: A mixer with a hopper self-lifting function should be equipped with a displacement sensor and a pressure sensor or an electrical trigger g)
device to ensure that there is no lifting movement when there is no hopper, and no rotational movement when the hopper is not locked. Among them, the locking sensing (or triggering) of the hopper should adopt margin design technology. 5.3 Physical and chemical properties
5.3.1 Mixing uniformity M
After the optimized combination of process parameters is confirmed and fully mixed, the mixing uniformity M should be greater than 99%. 5.3.2 Cleaning requirements after cleaning
After thorough cleaning and visual inspection, there should be no visible stains remaining on the inner wall of the hopper. Take a sample from the final flushing liquid and the chemical residue content should not be greater than 10g/g.
5.4 Stability
5.4.1 Clamping device and clamping force
The clamping device should be adjusted consistently and the action should be flexible and reliable; the hopper should be lifted smoothly without crawling; the hopper should be lifted After it is in place, it should be locked reliably and there should be no looseness during work; the clamping force should be even after the hopper is lifted into place. 5.4.2 Main bearing temperature rise
When fully loaded and rotating at the highest operating speed, the main bearing temperature rise shall not exceed 30°C. 5.4.3 No-load and full-load tests
The mixer should pass the specified no-load and full-load tests (see Appendix A). During the test, it should work normally without collision when lifting, compressing, rotating, and descending movements. There is no friction and abnormal noise, and no dust is blown out. After the test, the fasteners should still be reliably tightened, and the hopper and rotary body are not allowed to have permanent deformation visible to the naked eye.
5.5 Health, Safety and Environmental Protection
5.5.1 Electrical System
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