Some standard content:
ICS11.120.30
C92
JB
Pharmaceutical Machinery Industry Standard of the People's Republic of China JB20013—2004
replaces YY/T0134—1993
double cone rotary type Vacuum drying machine
Double-conerevolvingvacuumdryingmachine2004-02-05 release
2004-06-01 implementation
National Development and Reform Commission release
Foreword
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range| |tt||Normative reference documents
Terms and definitions
Classification and labeling
Basic parameterswww.bzxz.net
Requirements
Test methods
Inspection Rules
Since
Logo, instructions for use, packaging, transportation and storage
Appendix A (Informative Appendix) Double Cone Rotary Vacuum Dryer Quality Classification Appendix B (Informative Appendix ) Classification of explosion and fire hazardous locations JB20013-2004
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JB 20013~2004| |tt||Foreword
This standard is based on the requirements of the "Good Manufacturing Practice for Pharmaceuticals" and the CB/T1.1-2000, GB/T1.22002 standardization work guidelines, and is based on YY/T0134-1993 Revision. This standard replaces YY/T0134-1993 from the date of implementation. Compared with YY/T0134-1993, the main technical content changes of this standard are as follows: the main chapters and clauses of YY/T0134-1993 have been deleted: a)
requirements (5.1.2, 5.6.2, 5.9, 5.10 ), revised the main chapters and clauses of YY/T0134-1993 b)
Table 1, Table 2, Table 3;
Requirements (5.1.1.2.5.2.1.5.2.2,5.5,5.8) ; Noise measurement was changed from CB3768 to CB/T16769; radiographic flaw detection was changed from GB3323 to JB4730. c) Chapters and clauses added to this standard:
- requirements for materials (see 6.1.1):
- requirements for structures (see 6.2.1);
Requirements for covering the machine (see 6.2.6); - Requirements for the appearance quality of the glass layer (see 6.2.7); - Requirements for the anti-static performance of explosion-proof equipment (see 6.4.1.10); - Electrical safety Performance requirements (see 6.4.1.2, 6.4.1.5~6.4.1.9); requirements for product instructions for use (see 9.2). 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: Baoji Pharmaceutical Machinery Factory. Drafter of this standard: Zhang Nailing.
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1 range
Double cone rotary vacuum dryer
JB20013—2004
This standard specifies the double cone rotary vacuum dryer (hereinafter referred to as the rotary dry shower machine) terms and definitions, classification and marking, basic parameters, requirements, test methods, inspection rules and signs, instructions for use, packaging, transportation and storage. This standard applies to a series of rotary dryers that use steam or hot water as the heating source. 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 acknowledgments) 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. CB150-1998 Steel pressure vessels
GB/T191 Packaging, storage and transportation pictorial mark
GB3836.1-2000 Electrical equipment for explosive gas environments Part 1: General requirements GB/T4237 stainless steel hot-rolled steel plate
GB5226.1-2002 Machinery Safety Mechanical and Electrical Equipment Part 1: General Technical Conditions GB/T6060.4 Surface Roughness Comparison Sample Polishing Surface GB/T6388 Transportation Packaging Receipt and Delivery Marks||tt| |GB/T 7991
GB/T 7993
Electromagnetic method for measuring thickness of glass layer
High voltage test method for glass equipment used under corrosive conditions GB/T9969. 1 General instructions for use of industrial products Metal cutting machine tool noise sound pressure level measurement method GB/T16769
GB/T10111-1988 Random sampling method using random numbers GB/T13306 Signage
JB/T4711 Pressure vessel coating and transportation packaging JB4730 Non-destructive testing of pressure vessels
HG2432-2001 Glass Equipment Technical Conditions Formerly State Administration of Quality and Technical Supervision
Pressure Vessel Safety Technology Supervision Regulations (1999 Edition) 3 Terms and Definitions
The following terms apply to this standard.
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JB20013—2004
3.1
Double-cone double-cone
A rotary body composed of a circular dimension connected to each end. 3.2
Body body
The inner double conical container in contact with the material. 3.3
Body container
A double-layer container composed of body and jacket.
Classification and labeling
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4.1 Classification
is divided into ordinary type and explosion-proof type according to electrical type. According to the body material, it is divided into channel glass type and stainless steel type. 4.2 Specification series
specifications are determined according to the nominal volume (L) of the body, see Table 1. Table 1
400
4.3 mark
800
1000
1500
Specification series
2000||tt| |3000
4000
5000
4.3.1 Model consists of product function code, type code, specification code, feature code and design improvement number, and is marked as follows: G||tt ||SZ
Design improvement number (A, B-))
Feature code: structure and energy body material (see Table 2) specification code: body nominal volume (L)
Type code: Double cone return type vacuum coal dryer Product function code: Dry combustion machinery
Identification symbols of table 2 characteristic codes
Structural type code
Common type||tt| |Explosion-proof type
B
When there are new materials and new layers, continue according to Roman numerals. 4.3.2 Marking examples:
Body material and lining code\
Cuo glass
I (generally omitted marking)
Stainless steel
GSZ800Ⅱ/A : Indicates an ordinary rotary dryer with a nominal volume of 800L and a stainless steel body that has been improved for the first time. GSZ1500B: Indicates an explosion-proof rotary dryer with a nominal volume of 1500L and a sugar glass tank. 54
5Basic parameters
The basic parameters of the double-cone rotary vacuum dry explosion machine are shown in Table 3. Table 3 basic parameters
item
item
using Yan steam as heating medium
maximum charging volume, L
drying strength, kg/(m ·h))
Ultimate vacuum degree, MPa (gauge pressure)
Maximum allowable gas leakage rate, Pa-L/s
Jacket working pressure, MPa
Working temperature, ℃
Rotation speed, m/s
6 requirements
6.1 Material requirements
0.3
:143
Parameter value
JB20013—2004
Using hot water as heating medium
nominal volume (50%±10%)
2.5
0.098||tt| |1.33×10
0.2
100
The rotation linear speed of the maximum rotation diameter of the relay is 0.3-1.26.1.1 Parts that are in direct contact with drugs should be made of materials that are non-toxic, corrosion-resistant, do not react with drugs, and do not absorb drugs. 6.1.2 The steel plate used for Czech glass should comply with the requirements of 5.2.1 in HG2432-2001. The quality of the glass shaft used in the glass should comply with the relevant provisions of 5.2.4 in HG2432-2001. The thickness of the glass layer is 0.6mm~2.0mm, and no pinholes are allowed. According to the glass layer high voltage test of 5kV, the equipment can withstand rapid temperature difference, cold shock of 110°C, and thermal shock of 120°C. 6.1.3 Stainless steel plates should comply with the requirements of GB/T4237. 6.2 Structural and appearance requirements
6.2.1 The internal surfaces of equipment and working parts that are in direct contact with drugs should be flat, smooth, without dead corners, and easy to clean and disinfect. 6.2.2 Asbestos, rubber fillers and lubricants must not be used in the rotary shaft seal of the vacuum pumping part of the body. The sealing performance must be stable and reliable. The maximum allowable gas leakage rate is shown in Table 3.
6.2.3 The lubricating seals of transmission components should have no oil leakage. 6.2.4 The roughness Ra value of the inner surface of the body shall not be greater than 0.8um. ??The inflection points of the inner wall of the body must be connected by arc transitions, and the minimum radius of the circle shall not be less than 25mmg
6.2.5 The equipment should be easy to carry out on-site operations Cleaning and sterilization in place. 6.2.6 The outer surface of machine transmission parts and terminals should be covered with stainless steel plates. The coated surface should be flat and smooth, without obvious convex and concave appearance defects.
6.2.7 The appearance quality of the glass layer shall comply with the provisions of 7.1 in HG2432-2001: 6.3 Performance requirements
6.3.1 The action of the machine operating system shall be flexible and reliable: the mechanical transmission system shall be free of In case of blockage and abnormal noise, the rotation of the tank should be stable; the vacuum suction tube and the tank should be coaxial, and there should be no coronal motion. 6.3.2 Dry strength should comply with the requirements of Table 3. 55
JB20013—2004
6.3.3 The sound pressure of operating noise should not be greater than 85dB(A). 6.4 Safety requirements
6.4.1 Electrical safety:
6.4.1.1 The electrical device of the rotary dryer should comply with the corresponding explosion-proof level requirements for the category and level of explosive locations, and the electrical performance should comply with GB3836.1- 2000 relevant provisions. When the operating environment belongs to the Q-3 or G-2 hazardous location level (see Appendix B), the electrical control device can be a non-explosion-proof structure, but it must be isolated from the machine. 6.4.1.2 The continuity of the protective grounding circuit of the electrical system shall comply with the provisions of 19.2 in GB5226.12002. 6.4.1.3 The insulation resistance of the electrical system shall comply with the provisions of 19.3 in GB5226.1-2002. 6.4.1.4 The withstand voltage of the electrical system shall comply with the provisions of 19.4 in GB5226.1-2002. 5. The protective grounding circuit of the electrical system shall comply with the provisions of 8.2 in CB5226.1-2002. 6.4.1.5
3 The buttons of the electrical system shall comply with the provisions of 10.2 in GB5226.1-2002. 6.4.1.6
The indicator lights and displays of the electrical system shall comply with the provisions of 10.3 in CB5226.1-2002. 6.4.1.7
6.4.1.8
The wiring of the electrical system shall comply with the provisions of Chapter 14 of GB5226.12002. 9. The markings, warning signs and project codes of the electrical system shall comply with the provisions of Chapter 17 of CGB5226.1-2002. 6.4.1.9
6.4.1.10 Explosion-proof dryers should be equipped with static elimination devices, and their grounding resistance should be greater than 1000. 6.4.2 Safety of tanks and mechanical transmission devices: 6.4.2.1 Design and manufacturing of tanks , inspection and container classification shall be carried out in accordance with the relevant provisions of GB1501998 and (Safety Technical Supervision Regulations for Pressure Vessels (1999 Edition).
6.4.2.2 Mechanical transmission parts should have sufficient strength and stiffness, and necessary measures should be taken for the transmission device. Protective measures to ensure the safety of operators.
6.5 Manufacturing requirements
6.5.1 The glass type is manufactured according to the requirements of Chapter 6 of HG2432-2001. 6.5.2 The stainless steel type is manufactured according to Chapter 10 of CB1501998. Relevant manufacturing requirements. 7 Test methods
7.1 Material inspection
7.1.1 Check the material certificate
7.1.2 Glass porcelain layer test:
7.1 .2.1 The high voltage test is carried out according to the method of GB/T7993, and the test voltage is 5kV. 7.1.2.2 The thickness of the porcelain layer is measured according to the provisions of GB/T7991. 7.2 Structural test
7.2.1 Visual inspection of the inner surface of the tank. structure. 7.2.2 Sealing performance test:
7.2.2.1 Do the vacuum leak detection method, using the closed leak detection method. The test device consists of a vacuum pump, vacuum valve, pipeline, vacuum gauge, etc., see Figure 1 | |tt||56
7.2.2.2 Test steps:
Compressor
Valve
Area
Body
Figure 1 Sealing performance Simplified diagram of the test system
a)
Clean the tank and leak detection device system;
Start the tank under no-load condition:
b)
Table
JB 20013—2004
After pumping the tank to the ultimate vacuum, continue pumping for 30 minutes, close the baffle valve, stop the pump, and wait until the vacuum gauge pressure rises to e
0.09 When MPa (p:), start timing, read the gauge pressure value (pz) after 30 minutes (△t), and then calculate the gas leakage rate (Q) according to formula (1). 7.2.2.3 The calculation formula of gas leakage rate (0) is shown in equation (1): Q=VxP2-P
At
where:
Q——gas leakage rate, Pa ·L/s;
V The full volume of the chain under test, L;
△t——The time required from Pi to P2, 8:
(pz - p)| |tt||The pressure difference Pa between two adjacent measurements.
7.2.3 Lubrication seal:
Use sensory method to detect.
7.2.4 Determination of the roughness of the polished surface in stainless steel tanks, using GB/T6060.4 comparison sample for comparative measurement. 7.2.5 Cleaning test:
After cleaning with high-pressure water, observe the material accumulation on the inner surface. 7.2.6 Use sensory method to detect coating quality.
7.2.7 Visually inspect the appearance quality of the glass layer. 7.3 Performance test
7.3.1 Dry running test:
7.3.1.1 Carry out repeated starting, braking and other operations for no less than three times to confirm that the control system is sensitive, accurate and reliable. 7.3.1.2 Carry out continuous operation for no less than 30 minutes to confirm that the tank rotation and transmission system are stable and reliable. 7.3.2 Load test:
(1)
Powdered and granular organic medicines with low adhesion and moisture content (16%±4%) according to the tank filling volume, and conducted for no less than one period. For batch load vacuum drying test, calculate the drying strength when the final moisture content of the material is less than 0.4%. 7.3.3 The noise sound pressure level shall be measured in accordance with the provisions of GB/T16769. 57 | |tt | The pressure tests are carried out in accordance with the provisions of 19.2, 19.3 and 19.4 in GB5226.1-2002.
7.4.1.2 The protective grounding circuit, buttons, indicators and displays, wiring, markings, notice 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 the provisions of Chapter 17. 7.4.1.3 The test of explosion-proof electrical devices shall be carried out in accordance with the relevant provisions of CB3836.1-2000. 7.4.1.4 Static elimination device test: Use a resistance meter to measure the resistance between each component of the dryer and the ground. 7.4.2 Safety test of the tank and mechanical transmission device: 7.4.2.1 The flaw detection of the tank shall be carried out in accordance with the provisions of JB4730, and the pressure test and other inspections shall be carried out in accordance with the requirements of Chapter 10 of CB150-1998.
7.4.2.2 Visually inspect the protective measures of the mechanical transmission device. 7.5 Manufacturing inspection
Review the pressure vessel product quality certificate. 8 Inspection rules
8.1 Inspection types include factory inspection and type inspection. 8.2 Factory inspection
8.2.1 Rotary dryer products must be inspected by the quality inspection department of the manufacturer, and only those that pass the test can leave the factory. 8.2.2. All products leaving the factory must be inspected according to Table 4. Only those products that pass the factory are allowed to leave the factory and are accompanied by a product certificate. Table 4 Factory inspection items
Item category
General performance
Main performance
Inspection items
6.2.1,6.2.3,6.2.4, 6.2.6, 6.2.7, 6.3.16.1.2, 6.3.1, 6.3.3, 6.4, 6.58.2.3 If the product is found to be unqualified during the inspection process, it is allowed to be returned for repair and re-inspection. If it still fails If it is qualified, the product is judged to be unqualified.
8.3 Type inspection
8.3.1 When one of the following situations occurs, type inspection shall be carried out: a) New product trial production identification;
b) After formal production, after Or when there are major improvements in materials that may affect product performance; c) When production is resumed after a long-term suspension;
When quality certification or quality arbitration is required. | |tt | 8.3.3 Inspection items:
Type inspection items include all requirements for factory inspection and the following performance test items:) Vacuum sealing performance test;
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