Some standard content:
JB | -02-05 released
Pure steam generator
Implemented on 2004-06-01
National Development and Reform Commission released
ICS11.120.30
C92 | |tt | ||Released on 2004-02-05
Implemented on 2004-06-01
National Development and Reform Commission
Released
Foreword
Scope||tt ||2 Normative reference documents
3 Classification and labeling
4 Requirements
5 Test methods
6 Inspection rules
Logo, instructions for use, packaging , transportation and storage purpose
times
JB20030—2004
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15
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16
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JB20030—2004
Foreword
This standard is based on GB/T1. 1-2000 "Standardization Work Guidelines Part 1: Standard Structure and Abbreviation Rules" and GB/T1.2-2002 "Standardization Work Guidelines Part 2: Methods for Determining the Content of Normative Technical Elements in Standards", for YY0229 -Revision of the 1995 "Multi-effect Distilled Water Machine". This standard replaces YY0229-1995 from the date of implementation. Compared with YY0229-1995, the main technical content changes of this standard are as follows: a) The cited standards have been modified and the latest standards have been adopted. b) Considering the needs of production, the transitional specification of "1500\" in Table 1 is retained. c) This distilled water machine must use purified water as raw water. This standard is based on the requirements of the distilled water machine for raw water, and the system is treated before the test conditions d) This standard comprehensively and reasonably implements the relevant provisions of GB5226.1--2002 in terms of electrical safety performance to ensure the normal operation of the equipment and the personal safety of the operators. The standard is proposed by the China Pharmaceutical Equipment Industry Association. This standard is under the jurisdiction of the Pharmaceutical Equipment Industry Standardization Technical Committee. The drafting unit of this standard is: Shanghai Far East Pharmaceutical Machinery General Factory. The main drafters of this standard: GB10643- 1989, YY0229-1995. 14
1 Scope
Multi-effect distilled water machine
JB20030--2004
This standard specifies the classification and marking of multi-effect water steamers , requirements, test methods, inspection rules and signs, instructions for use, packaging, transportation and storage
This standard applies to tube-type and coil-type multi-effect distilled water machines using steam as the heat source (hereinafter referred to as distilled water machines). ). 2 Normative reference documents
The provisions in the following documents become provisions of this standard through reference. For dated documents, all subsequent amendments (excluding corrigenda or revisions) The latest versions of these documents are not applicable 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. For undated references, the latest versions are applicable to CB150-1998 Steel. Manufacture of pressure vessels
GB151-1999 shell and tube heat exchanger
GB/T191 packaging, storage and transportation pictorial mark
GB/T1220 stainless steel pants
GB/T3280 stainless steel Cold-rolled steel plate
GB/T4237 stainless steel hot-rolled steel plate
GB/T4272—1992 General principles for equipment and pipeline insulation technology GB5226.1—2002 Mechanical safety mechanical and electrical equipment Part 1: General technical conditions|| tt | Conditions | |tt | Testing
HG20584--1998 Technical Requirements for Manufacturing Steel Chemical Containers YY/T0216 Pharmaceutical Machinery Product Model Preparation Method Pressure Vessel Safety Technical Supervision Regulations (1999 Edition) State Administration of Quality and Technical Supervision Pharmacopoeia of the People's Republic of China (2000 Edition) National Pharmacopoeia Commission 15
JB20030—2004
3 Classification and Labeling
3.1 Type
This machine consists of a distillation tower, a preheater and a condenser, as well as raw material water pipes and steam pipes , condensation water pipes and cooling water pipes. 3.2 Model
3.2.1 The model of the water steamer should comply with the regulations of YY/T0216. 3.2.2 Model mark:
OOOHOO
Improved design sequence number (A, B)
Effect number
Productionwww.bzxz.net
Secondary steam separation method ( S—Wire mesh height: N—Inner spiral separation: W External spiral separation may not be marked)
Product function code (LD, a tube-type multi-effect distilled water machine: PD, a coil-type multi-effect steaming and stuffing water machine ) 3.2.3 Marking example:
LD
N
3.3 Specification series of steaming stuffing water machine (see Table 1) Specification
grid
200
300
500
1000
(1500)
Note: Values ??in brackets are not recommended. 4 requirements
4.1 Water quality requirements for water for injection
Production
300-
Improvement design sequence number
4 effects
Water for injection production, 500L/h
Internal spiral separation
Tubular multi-effect distilled water machine
Table 1
Specification series
Quantity, Lh
≥200
300
a.500
≥1000
1500
Specification
Specification
2000||tt ||3000
4000
5000
Production
Quantity, Lh
2000
3000
4000||tt ||5000
The water for injection produced by the distilled water machine should comply with the various quality indicators of "water for injection" in the Pharmacopoeia of the People's Republic of China (2000 edition).
4.2 Material requirements
16
JB20030—2004
4.2.1 All parts in the distilled water machine that come into contact with water for injection (secondary steam) should be made of Austrian Made of stenitic stainless steel 0Cr17Ni12Mo2 or 00Cr17Ni4Mo2, or other raw materials that have been proven to be equally applicable. Rods should comply with the regulations of GB/T1220: pipes should comply with the regulations of CB/T14976; plates should comply with the regulations of GB/T3280 and GB/T4237. 4.2.2 The seals selected for each component in the distilled water machine should be non-toxic, odorless, particle-free and corrosion-resistant silicone rubber, polytetrafluoroethylene or materials with similar properties.
4.2.3 The insulation materials used in distilled water machines should comply with the provisions of 5.2 in CB/T4272-1992. 4.3 Manufacturing quality
4.3.1 The design and manufacture of the main pressure components in the distilled water machine shall comply with the relevant provisions of CB150, CB151 and the "Pressure Vessel Safety Technical Supervision Regulations": welding shall comply with GB150-1998 10.3 Provisions. 4.3.2 Welding flaw detection should comply with the provisions of 10.8.4 in GB150-1998, and the ear level is considered qualified. 4.3.3 After the main pressure-bearing parts of the steaming hall water machine are manufactured, a hydraulic pressure test should be carried out. 4.3.4 The heat exchange tubes after docking should be subjected to a hydrostatic test. 4.3.5. All connections in the steamer water machine should be firm, and there should be no leakage in the seals. 4.3.6 The cylinder body, pipelines and welds in the water retort machine that come into contact with water for injection, including secondary steam, should be pickled, passivated or electropolished.
4.4 The output of water for injection produced by the distilled water machine should comply with the regulations in Table 1. 4.5 Performance requirements
The steam consumption, cooling water consumption and raw material water consumption of the distilled water machine measured at 0.3MPa steam pressure should comply with the provisions of Table 2. Table 2 Performance parameters
type
efficiency
ratio
formula
number
Qa/Q
Qs/Q
Qc/Q
3
≤0.45
≤1.97
51.15
tubular type
4|| tt||s0.34
#1.11
#1.15
5
w0.27
≤0.58
≤1.15|| tt||6
0.23
0.2)
≤1.15
3
≤0.45
≤1.50
≤ 1.50
Note: Q. The amount of steam consumed to produce a certain amount of water for injection in one unit of time, L/h; Q8 The amount of cold water consumed to produce a certain amount of water for injection in one unit of time , L/hQc The amount of raw water consumed to produce a certain amount of water for injection in one unit of time, L/h; 0 The measured output of water for injection in one unit of time, L/h. 4.6 Functional requirements
4.6.1 The distilled water machine should have a conductivity meter that displays the quality of outlet water for injection. Coiled
4
0.32
51.00
51.45
5
E0.27
0.40||tt ||31.45
4.6.2 The distilled water machine should be equipped with an automatic temperature controller, a steam pressure alarm device and a cooling water flow regulating device. 4.6.3 The distilled water machine uses microcomputer or human-machine interface control equipment, and must provide reliable manual and automatic switching devices. 6
s0.24
Address 1.45
4.7 The safety valve and pressure gauge selected in the distilled water machine should comply with Chapter 7 of the "Pressure Vessel Safety Technical Supervision Regulations" 1999 Edition) (Safety Attachment) regulations.
4.8 The working noise sound pressure level of the distilled water machine should not be greater than 85dB(A). 4.9 Electrical safety performance requirements
4.9.1 The continuity of the protective grounding circuit of the electrical system shall comply with the provisions of 19.2 in CB5226.1-2002. 17
JB200302004
4.9.2 The insulation resistance of the electrical system should comply with the provisions of 19.3 in GB5226.1-2002. 4.9.3 The withstand voltage of the electrical system shall comply with the provisions of 19.4 in GB5226.1-2002. 4.9.4 The protective grounding circuit of the electrical system should comply with the provisions of 8.2 in GB5226.1-2002. 4.9.5 The buttons of the electrical system should comply with the provisions of 10.2 in CB5226.1-2002. 4.9.6 The indicator lights and displays of the electrical system should comply with the provisions of 10.3 in CB5226.1-2002. 4.9.7 The wiring of the electrical system should comply with the provisions of Chapter 14 of GB5226.1-2002. 4.9.8 The markings, warning signs and project codes of the electrical system shall comply with the provisions of Chapter 17 of GB5226.12002. 4.10 Appearance
4.10.1 The appearance quality of the evaporator should be smooth and smooth, without obvious scratches, bulges and dents. 4.10.2 The connecting pipes of the water steamer should be arranged neatly. 5 Test methods
5.1 The test conditions of the water evaporator should comply with the provisions of Table 3. Table 3 Test conditions
Steam pressure, MP
Raw water quality, conductivity, ss/em
Initial temperature of raw water, ℃
Oxides in raw water|| tt||Cooling water hardness (calcium carbonate content), mg/L cooling water initial temperature, ℃
5.2 Water quality test for water for injection
0.3 (saturated, dry)
<2| |tt||15 ~20
0
90
20
5.2.1 The pH value of water for injection should be measured according to the "Pharmacopoeia of the People's Republic of China" (2000 edition) ) in accordance with the provisions of Appendix VIH. 5.2.2 The determination of bacterial endotoxins in water for injection should be carried out in accordance with the provisions of Appendix XIE in the "Pharmacopoeia of the People's Republic of China" (2000 edition). 5.2.3 The chemical composition inspection of water for injection should be carried out in accordance with the provisions of "Water for Injection" in the "Pharmacopoeia of the People's Republic of China" (2000 edition).
5.2.4 The water for injection temperature of the water steamer should be 92℃~99℃. 5.3 Material quality
For all parts in the water evaporation machine that come into contact with water for injection (including secondary steam), the rods, plates, and pipes used should provide material certificates.
5.4 Manufacturing quality
5.4.1 The design, manufacture and welding of the main pressure components in the distilled water machine shall be in accordance with the provisions of 4.3.1. 5.4.2 Weld flaw detection shall be carried out according to the relevant provisions in JB4730. 5.4.3 The hydraulic test shall be carried out in accordance with Article 98 of the "Safety Technical Supervision Regulations for Pressure Vessels" (1999 Edition). 5.4.4 The hydrostatic test of heat exchange tubes shall be in accordance with the provisions of 3.17 of CB151-1999. 5.4.5 Conduct a leakage test on the complete machine by visual inspection under specified working conditions. 5.4.6 All boilers and pipelines that should be pickled and purified should be tested by the blue point method in accordance with the provisions of HG20584-1998 10.1. If no blue color appears in 18
within 30s, it is qualified.
5.5 Performance requirements test
JB20030—2004
After the distilled water machine is in normal operation, use a standard measuring instrument, a rotor flowmeter and a clock to measure the water for injection production, steam consumption, and cooling water consumption. The amount and raw material water consumption are tested at the same time, each measurement is 6 minutes, and a total of three measurements are taken. The arithmetic average value should be calculated according to formula (1): where:
W, = point Q||tt| |1Q
(i=A,BC;j=1, 23)
The ratio of W steam consumption to water for injection production; W - the ratio of cooling water consumption to water for injection production: Wc - the ratio of raw material water consumption to water for injection production. a) Water for injection production test: introduce qualified water for injection into a container and weigh it. b) Steam consumption test: Direct the condensed water of the heating steam into a container and weigh it. .(1)
Raw material water consumption test: Put the raw water into a container first, and calculate the raw water consumption according to the reduced volume of the raw water in the container.
d) Cooling water consumption test: Direct the cooling water after heat exchange into a container and weigh it. 5.6 Functional requirements test
5.6.1 The instruments and meters selected on the evaporator must be regularly calibrated or approved to control the error within the allowable range and meet the functional requirements of 4.6.1 and 4.6.2.
5.6.2 The manual and automatic switching devices provided on the distilled water machine should be sensitive and accurate. 5.7 The safety valve and pressure gauge selected in the water evaporator should comply with the requirements of 4.7. 5.8 Working noise test
Use a sound level meter to test the working noise of the water steamer in accordance with the relevant provisions of GB/T16769. 5.9 Electrical safety performance test
5.9.1 The continuity, insulation resistance and withstand voltage tests of the protective grounding circuit of the electrical system shall be carried out in accordance with the provisions of 19.2, 19.3 and 19.4 of CB5226.1-2002 respectively. 5.9.2 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 Chapter 17 of GB5226.1-2002 respectively. Provision is made. 5.10 Appearance quality
Inspect the appearance quality of the evaporating water machine by visual method. 6 Inspection Rules
6.1 Each distilled water machine must pass the inspection by the inspection department of the manufacturing unit before it can leave the factory. 6.2 Water distillers are subject to factory inspection and type inspection. 6.2.1 Factory inspection
6.2.1.1 Factory products must be inspected one by one according to the provisions of Table 4, and qualified products will be issued with product certificates and quality certificates. 6.2.1.2 If the distilled water machine is found to be unqualified during the inspection process, it is allowed to be returned for repair and re-inspection. If it is still unqualified, the product will be judged to be unqualified.
19
6. The cylinder body, pipelines and welds in the water evaporator that come into contact with water for injection, including secondary steam, should be pickled, passivated or electropolished.
4.4 The output of water for injection produced by the distilled water machine should comply with the regulations in Table 1. 4.5 Performance requirements
The steam consumption, cooling water consumption and raw material water consumption of the distilled water machine measured at 0.3MPa steam pressure should comply with the provisions of Table 2. Table 2 Performance parameters
type
efficiency
ratio
formula
number
Qa/Q
Qs/Q
Qc/Q
3
≤0.45
≤1.97
51.15
tubular type
4|| tt||s0.34
#1.11
#1.15
5
w0.27
≤0.58
≤1.15|| tt||6
0.23
0.2)
≤1.15
3
≤0.45
≤1.50
≤ 1.50
Note: Q. The amount of steam required to produce a certain amount of water for injection in one unit of time, L/h; Q8 The amount of cold water required to produce a certain amount of water for injection in one unit of time , L/hQc The amount of raw water consumed to produce a certain amount of water for injection in one unit of time, L/h; 0 The measured output of water for injection in one unit of time, L/h. 4.6 Functional requirements
4.6.1 The distilled water machine should have a conductivity meter that displays the quality of outlet water for injection. Coiled
4
0.32
51.00
51.45
5
E0.27
0.40||tt ||31.45
4.6.2 The distilled water machine should be equipped with an automatic temperature controller, a steam pressure alarm device and a cooling water flow regulating device. 4.6.3 The distilled water machine uses microcomputer or human-machine interface control equipment, and must provide reliable manual and automatic switching devices. 6
s0.24
Address 1.45
4.7 The safety valve and pressure gauge selected in the distilled water machine should comply with Chapter 7 of the "Pressure Vessel Safety Technical Supervision Regulations" 1999 Edition) (Safety Attachment) regulations.
4.8 The working noise sound pressure level of the distilled water machine should not be greater than 85dB(A). 4.9 Electrical safety performance requirements
4.9.1 The continuity of the protective grounding circuit of the electrical system shall comply with the provisions of 19.2 in CB5226.1-2002. 17
JB200302004
4.9.2 The insulation resistance of the electrical system should comply with the provisions of 19.3 in GB5226.1-2002. 4.9.3 The withstand voltage of the electrical system shall comply with the provisions of 19.4 in GB5226.1-2002. 4.9.4 The protective grounding circuit of the electrical system should comply with the provisions of 8.2 in GB5226.1-2002. 4.9.5 The buttons of the electrical system should comply with the provisions of 10.2 in CB5226.1-2002. 4.9.6 The indicator lights and displays of the electrical system should comply with the provisions of 10.3 in CB5226.1-2002. 4.9.7 The wiring of the electrical system should comply with the provisions of Chapter 14 of GB5226.1-2002. 4.9.8 The markings, warning signs and project codes of the electrical system shall comply with the provisions of Chapter 17 of GB5226.12002. 4.10 Appearance
4.10.1 The appearance quality of the evaporator should be smooth and smooth, without obvious scratches, bulges and dents. 4.10.2 The connecting pipes of the water steamer should be arranged neatly. 5 Test methods
5.1 The test conditions of the water evaporator should comply with the provisions of Table 3. Table 3 Test conditions
Steam pressure, MP
Raw water quality, conductivity, ss/em
Initial temperature of raw water, ℃
Oxides in raw water|| tt||Cooling water hardness (calcium carbonate content), mg/L cooling water initial temperature, ℃
5.2 Water quality test for water for injection
0.3 (saturated, dry)
<2| |tt||15 ~20
0
90
20
5.2.1 The pH value of water for injection should be measured according to the "Pharmacopoeia of the People's Republic of China" (2000 edition) ) in accordance with the provisions of Appendix VIH. 5.2.2 The determination of bacterial endotoxins in water for injection should be carried out in accordance with the provisions of Appendix XIE in the "Pharmacopoeia of the People's Republic of China" (2000 edition). 5.2.3 The chemical composition inspection of water for injection should be carried out in accordance with the provisions of "Water for Injection" in the "Pharmacopoeia of the People's Republic of China" (2000 edition).
5.2.4 The water for injection temperature of the water steamer should be 92℃~99℃. 5.3 Material quality
For all parts in the water evaporation machine that come into contact with water for injection (including secondary steam), the rods, plates, and pipes used should provide material certificates.
5.4 Manufacturing quality
5.4.1 The design, manufacture and welding of the main pressure components in the distilled water machine shall be in accordance with 4.3.1. 5.4.2 Weld flaw detection shall be carried out according to the relevant provisions in JB4730. 5.4.3 The hydraulic test shall be carried out in accordance with Article 98 of the "Safety Technical Supervision Regulations for Pressure Vessels" (1999 Edition). 5.4.4 The hydrostatic test of heat exchange tubes shall be in accordance with the provisions of 3.17 of CB151-1999. 5.4.5 Conduct a leakage test on the complete machine by visual inspection under specified working conditions. 5.4.6 All boilers and pipelines that should be pickled and purified should be tested by the blue point method in accordance with the provisions of 10.1 in HG20584-1998. If no blue color appears in 18
within 30s, it is qualified.
5.5 Performance requirements test
JB20030—2004
After the distilled water machine is in normal operation, use a standard measuring instrument, a rotor flowmeter and a clock to measure the water for injection production, steam consumption, and cooling water consumption. The amount and raw material water consumption are tested at the same time, each measurement is 6 minutes, and a total of three measurements are taken. The arithmetic average value should be calculated according to formula (1): where:
W, = point Q||tt| |1Q
(i=A,BC;j=1, 23)
The ratio of W steam consumption to water for injection production; W - the ratio of cooling water consumption to water for injection production: Wc - the ratio of raw material water consumption to water for injection production. a) Water for injection production test: introduce qualified water for injection into a container and weigh it. b) Steam consumption test: Direct the condensed water of the heating steam into a container and weigh it. .(1)
Raw material water consumption test: Put the raw water into a container first, and calculate the raw water consumption according to the reduced volume of the raw water in the container.
d) Cooling water consumption test: Direct the cooling water after heat exchange into a container and weigh it. 5.6 Functional requirements test
5.6.1 The instruments and meters selected on the evaporator must be regularly calibrated or approved to control the error within the allowable range and meet the functional requirements of 4.6.1 and 4.6.2.
5.6.2 The manual and automatic switching devices provided on the distilled water machine should be sensitive and accurate. 5.7 The safety valve and pressure gauge selected in the water evaporator should comply with the requirements of 4.7. 5.8 Working noise test
Use a sound level meter to test the working noise of the water steamer in accordance with the relevant provisions of GB/T16769. 5.9 Electrical safety performance test
5.9.1 The continuity, insulation resistance and withstand voltage tests of the protective grounding circuit of the electrical system shall be carried out in accordance with the provisions of 19.2, 19.3 and 19.4 of CB5226.1-2002 respectively. 5.9.2 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 Chapter 17 of GB5226.1-2002 respectively. Provision is made. 5.10 Appearance quality
Inspect the appearance quality of the evaporating water machine by visual method. 6 Inspection Rules
6.1 Each distilled water machine must pass the inspection by the inspection department of the manufacturing unit before it can leave the factory. 6.2 Water distillers are subject to factory inspection and type inspection. 6.2.1 Factory inspection
6.2.1.1 Factory products must be inspected one by one according to the provisions of Table 4, and qualified products will be issued with product certificates and quality certificates. 6.2.1.2 If the distilled water machine is found to be unqualified during the inspection process, it is allowed to be returned for repair and re-inspection. If it is still unqualified, the product will be judged to be unqualified.
19
6. The cylinder body, pipelines and welds in the water evaporator that come into contact with water for injection, including secondary steam, should be pickled, passivated or electropolished.
4.4 The output of water for injection produced by the distilled water machine should comply with the regulations in Table 1. 4.5 Performance requirements
The steam consumption, cooling water consumption and raw material water consumption of the distilled water machine measured at 0.3MPa steam pressure should comply with the provisions of Table 2. Table 2 Performance parameters
type
efficiency
ratio
formula
number
Qa/Q
Qs/Q
Qc/Q
3
≤0.45
≤1.97
51.15
tubular type
4|| tt||s0.34
#1.11
#1.15
5
w0.27
≤0.58
≤1.15|| tt||6
0.23
0.2)
≤1.15
3
≤0.45
≤1.50
≤ 1.50
Note: Q. The amount of steam consumed to produce a certain amount of water for injection in one unit of time, L/h; Q8 The amount of cold water consumed to produce a certain amount of water for injection in one unit of time , L/hQc The amount of raw water consumed to produce a certain amount of water for injection in one unit of time, L/h; 0 The measured output of water for injection in one unit of time, L/h. 4.6 Functional requirements
4.6.1 The distilled water machine should have a conductivity meter that displays the quality of outlet water for injection. Coiled
4
0.32
51.00
51.45
5
E0.27
0.40||tt ||31.45
4.6.2 The distilled water machine should be equipped with an automatic temperature controller, a steam pressure alarm device and a cooling water flow regulating device. 4.6.3 The distilled water machine uses microcomputer or human-machine interface control equipment, and must provide reliable manual and automatic switching devices. 6
s0.24
Address 1.45
4.7 The safety valve and pressure gauge selected in the distilled water machine should comply with Chapter 7 of the "Pressure Vessel Safety Technical Supervision Regulations" 1999 Edition) (Safety Attachment) regulations.
4.8 The working noise sound pressure level of the distilled water machine should not be greater than 85dB(A). 4.9 Electrical safety performance requirements
4.9.1 The continuity of the protective grounding circuit of the electrical system shall comply with the provisions of 19.2 in CB5226.1-2002. 17
JB200302004
4.9.2 The insulation resistance of the electrical system should comply with the provisions of 19.3 in GB5226.1-2002. 4.9.3 The withstand voltage of the electrical system shall comply with the provisions of 19.4 in GB5226.1-2002. 4.9.4 The protective grounding circuit of the electrical system should comply with the provisions of 8.2 in GB5226.1-2002. 4.9.5 The buttons of the electrical system should comply with the provisions of 10.2 of CB5226.1-2002. 4.9.6 The indicator lights and displays of the electrical system should comply with the provisions of 10.3 of CB5226.1-2002. 4.9.7 The wiring of the electrical system should comply with the provisions of Chapter 14 of GB5226.1-2002. 4.9.8 The markings, warning signs and project codes of the electrical system shall comply with the provisions of Chapter 17 of GB5226.12002. 4.10 Appearance
4.10.1 The appearance quality of the evaporator should be smooth and smooth, without obvious scratches, bulges and dents. 4.10.2 The connecting pipes of the water steamer should be arranged neatly. 5 Test methods
5.1 The test conditions of the water evaporator should comply with the provisions of Table 3. Table 3 Test conditions
Steam pressure, MP
Raw water quality, conductivity, ss/em
Initial temperature of raw water, ℃
Oxides in raw water|| tt||Cooling water hardness (calcium carbonate content), mg/L cooling water initial temperature, ℃
5.2 Water quality test for water for injection
0.3 (saturated, dry)
<2| |tt||15 ~20
0
90
20
5.2.1 The pH value of water for injection should be measured according to the "Pharmacopoeia of the People's Republic of China" (2000 edition) ) in accordance with the provisions of Appendix VIH. 5.2.2 The determination of bacterial endotoxins in water for injection should be carried out in accordance with the provisions of Appendix XIE in the "Pharmacopoeia of the People's Republic of China" (2000 edition). 5.2.3 The chemical composition inspection of water for injection should be carried out in accordance with the provisions of "Water for Injection" in the "Pharmacopoeia of the People's Republic of China" (2000 edition).
5.2.4 The water for injection temperature of the water steamer should be 92℃~99℃. 5.3 Material quality
For all parts in the water evaporation machine that come into contact with water for injection (including secondary steam), the rods, plates, and pipes used should provide material certificates.
5.4 Manufacturing quality
5.4.1 The design, manufacture and welding of the main pressure components in the distilled water machine shall be in accordance with 4.3.1. 5.4.2 Weld flaw detection shall be carried out according to the relevant provisions in JB4730. 5.4.3 The hydraulic test shall be carried out in accordance with Article 98 of the "Safety Technical Supervision Regulations for Pressure Vessels" (1999 Edition). 5.4.4 The hydrostatic test of heat exchange tubes shall be in accordance with the provisions of 3.17 of CB151-1999. 5.4.5 Conduct a leakage test on the entire machine by visual inspection under specified working conditions. 5.4.6 All boilers and pipelines that should be pickled and purified should be tested by the blue point method in accordance with the provisions of HG20584-1998 10.1. If no blue color appears in 18
within 30s, it is qualified.
5.5 Performance requirements test
JB20030—2004
After the distilled water machine is in normal operation, use a standard measuring instrument, a rotor flowmeter and a clock to measure the water for injection production, steam consumption, and cooling water consumption. The amount and raw material water consumption are tested at the same time, each measurement is 6 minutes, and a total of three measurements are taken. The arithmetic average value should be calculated according to formula (1): where:
W, = point Q||tt| |1Q
(i=A,BC;j=1, 23)
The ratio of W steam consumption to water for injection production; W - the ratio of cooling water consumption to water for injection production: Wc - the ratio of raw material water consumption to water for injection production. a) Water for injection production test: introduce qualified water for injection into a container and weigh it. b) Steam consumption test: Direct the condensed water of the heating steam into a container and weigh it. .(1)
Raw material water consumption test: Put the raw water into a container first, and calculate the raw water consumption according to the reduced volume of the raw water in the container.
d) Cooling water consumption test: Direct the cooling water after heat exchange into a container and weigh it. 5.6 Functional requirements test
5.6.1 The instruments and meters selected on the evaporator must be calibrated or approved regularly to control the error within the allowable range and meet the functional requirements of 4.6.1 and 4.6.2.
5.6.2 The manual and automatic switching devices provided on the distilled water machine should be sensitive and accurate. 5.7 The safety valve and pressure gauge selected in the water evaporator should comply with the requirements of 4.7. 5.8 Working noise test
Use a sound level meter to test the working noise of the water steamer in accordance with the relevant provisions of GB/T16769. 5.9 Electrical safety performance test
5.9.1 The continuity, insulation resistance and withstand voltage tests of the protective grounding circuit of the electrical system shall be carried out in accordance with the provisions of 19.2, 19.3 and 19.4 of CB5226.1-2002 respectively. 5.9.2 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 Chapter 17 of GB5226.1-2002 respectively. Provision is made. 5.10 Appearance quality
Inspect the appearance quality of the evaporating water machine by visual method. 6 Inspection Rules
6.1 Each distilled water machine must pass the inspection by the inspection department of the manufacturing unit before it can leave the factory. 6.2 Water distillers are subject to factory inspection and type inspection. 6.2.1 Factory inspection
6.2.1.1 Factory products must be inspected one by one according to the provisions of Table 4, and qualified products will be issued with product certificates and quality certificates. 6.2.1.2 If the distilled water machine is found to be unqualified during the inspection process, it is allowed to be returned for repair and re-inspection. If it is still unqualified, the product will be judged to be unqualified.
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2. If the distilled water machine is found to be unqualified during the inspection process, it is allowed to be returned for repair and re-inspection. If it is still unqualified, the product will be judged as unqualified.
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