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
JB
Pharmaceutical Machinery Industry Standard of the People's Republic of China JB20031-2004
Pharmaceutical Machinery
Pure Steam Generator
Ultra-purepyrogen-free steamgenerator2004-02 -05 Release
2004-06-01 Implementation
National Development and Reform Commission
Release
Foreword
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Scope
Normative reference document| |tt||Terms and definitions
Classification and labeling
Requirements
Test methods
Inspection rules
Marks, labels and instructions for use||tt| |Packaging, transportation and storage
Item
Times
JB20031—2004
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JB200312004| |tt||Foreword
This standard is based on the requirements of (Good Manufacturing Practice for Pharmaceutical Products (1998 revised edition)) and GB/T1.1-2000 (Standardization Work Guidelines Part 1: Structure and preparation of standards) Rules" and GB/T1.2-2002 "Standardization Work Guidelines Part 2: Methods for Determining the Content of Normative Technical Elements in Standards". This standard is proposed by the China Pharmaceutical Equipment Industry Association. This standard is standardized by the pharmaceutical equipment industry. Technical Committee. Responsible for drafting this standard: Shanghai Tianding General Equipment Co., Ltd. Main drafters of this standard: Cao Xianglong, Liu Dongwei. 26
Pharmaceutical Machinery
Pure Steam Generator
JB 20031-2004
This standard specifies the terms and definitions, classification and labeling, requirements, test methods, inspection rules and signs, labels, instructions for use and packaging of pure steam generators, Transportation and storage. This standard applies to tube-type pure steam generators that use boiler steam as the heating source. 2 Normative reference documents
The clauses in the following documents become this standard by reference. Standard Terms. 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. CB150 steel pressure vessel
GB1511999 shell and tube heat exchanger
GB/T191
Packaging, storage and transportation icon mark
Stainless steel rod
GB/ T1220 |
Stainless steel hot-rolled steel plate
GB/T4272
2 General principles of equipment and pipeline insulation technology
GB5226.1-2002 Mechanical Safety Mechanical and Electrical Equipment Part 1: General Technology Conditions GB13296 Stainless steel seamless steel pipes for boilers and heat exchangers GB/T13306 Labels
GB/T13384 General technical conditions for mechanical and electrical product packaging GB/T14976 Stainless steel seamless steel pipes for fluid transportation JB4730 Non-destructive testing of pressure vessels
Pressure Container 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 3 Terms and Definitions
The following terms and definitions apply to this standard. 3.1
Steam
A liquid substance, water, that becomes a gaseous substance after heating, boiling, and evaporation. 27
JB 20031—2004
3.2
Ultra-purepyrogen-freesteam purified water ① enters the evaporator and is heated by the boiler steam to generate secondary steam. The pure steam obtained by separating and removing impurities such as bacterial endotoxin is referred to as pure steam. 4 Classification and labeling
4.1 Specifications and parameters
See Table 1 for specifications and parameters.
Table 1 specifications and parameters
Specifications
50
100
200
300
400||tt| |500
800
Model mark
4.2
4.3 mark example
Pure steam output (condensate of pure steam),kg50||tt| |≥100
200
300www.bzxz.net
400
≥500
800
ZF
Specifications||tt| |1000
1500
2000
3000
4000
5000
Improved design sequence number (A, B-)||tt ||Pure steam output (condensate of pure steam), kg1000
1500
2000
>3000
4000
≥5000||tt| |Pure steam output (kg/h) (under the condition that the heating steam pressure is 0.3MPa and the pure steam outlet pressure is 0.13MPa) Feature code: pure Yan steam
Function code: steam generator||tt| |ZFC200 type: represents a pure steam generator with a pure steam output of 200kg/h. 5 Requirements | | tt | The body is made of stainless steel 0Cr17Ni12Mo2 or 00Cr17Ni14Mo2, or other materials consistent with the above properties. Rods should comply with the regulations of GB/T1220, pipes should comply with the regulations of CB/T13296 and CB/T14976, and plates should comply with the regulations of CB/T3280 and CB/T4237. ① The purified water referred to in this standard should comply with the various quality indicators of purified water in the Pharmacopoeia of the People's Republic of China (2000 edition), and the electrical isometry should be less than or equal to 2yS/cma
28|| tt | | JB20031--2004 | | tt | Materials with consistent performance. 5.1.1.3 The thermal insulation materials used in pure steam generators should be heat-resistant and humidity-resistant not less than 180°C, non-polluting, and comply with the relevant regulations of GB/T4272
5.1.2 Mainly pressure-resistant. Components:
The design and manufacture of the main pressure components in pure steam generators should comply with the relevant provisions of GB150, CB151 and "Pressure Vessel Safety Technical Supervision Regulations" (1999 Edition) 5.1.3 Pickling and Passivation. :
In the pure steam generator, all components, pipelines and welds in contact with raw water and secondary steam should be pickled and passivated. 5.2 Safety and control components
5.2. 1 Safety valves and pressure gauges:
The safety valves and pressure gauges of pure steam generators should comply with the relevant provisions of the "Safety Technical Supervision Regulations for Pressure Vessels" (1999 Edition). All safety valves and pressure gauges in contact with pure steam. The pressure gauge should be of sanitary grade. 5.2.2 On-site monitoring (control) and display instruments: All types of on-site monitoring (control) and display instruments for pure steam generators should be reliable and accurate. 5.2.3 Control valves: | |tt||The control valve of the pure steam generator should be flexible and reliable 5.3 Working conditions
5.3.1. The boiler steam of pure steam generator Jiaren should be saturated steam. 5.3.2 The feed water of pure steam generator should be purified water. 5.3.3 The working pressure of the steam heated by the pure steam generator should be greater than or equal to 0.3MPa. 5.3.4 The pure steam outlet pressure of the pure steam generator should be greater than or equal to 0.13MPa. 5.4 Performance requirements
5.4.1 Heat exchange tubes:
The tubes in the pure steam generator should be seamless steel pipes, and a hydrostatic test should be carried out on the heat exchange tubes after docking. 5.4.2 Test of the whole machine:
5.4.2.1 Before the pure steam generator is introduced into the heating boiler steam, the whole machine should be tested for hydraulic pressure. The connections should be firm and there should be no leakage at the seal.
5.4.2.2 After the pure steam generator is connected to heat the boiler steam, the hydraulic pressure test of the whole machine should be carried out again. The connections should be firm and there should be no leakage at the seal.
5.4.3 Pure steam condensate;
The condensed water after cooling the pure steam produced by the pure steam generator should comply with the "Injection" in the "Pharmacopoeia of the People's Republic of China" (2000 edition) "Water" quality indicators. 5.4.4 Pure steam output, boiler steam consumption and raw material water consumption: The pure steam output measured by the pure steam generator at a steam pressure of 0.3MPa should comply with the provisions of Table 1, and the steam consumption and raw water consumption should be Comply with the requirements of Table 2.
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JB 20031—2004
Ratio
Q/Q
Q/Q
Note:
Table 2 Steam consumption and raw water consumption
Indicator
1.26
1.20
Q: Pure steam condensate water production measured per unit time, kg/h: Qa: The amount of boiler steam consumed to produce a certain amount of pure steam per unit time, kg/h: Q: The amount of raw water consumed to produce a certain amount of pure steam per unit time, kg/h. 5.4.5 Noise:
The operating noise of a pure steam generator should not be greater than 85dB(A). 5.4.6 Safety performance requirements:
5.4.6.1 The connection and wiring of the electrical system and the identification of wires shall be in accordance with the provisions of 14.1 and 14.2 in GB5226.1-2002. 5.4.6.2 The buttons, indicator lights and displays of the electrical system shall comply with the provisions of 10.2, 10.3 and 10.9 in GB5226.12002. 5.4.6.3 The operation panel of the electrical system should be protected by FELV (security extra low voltage) and should be in accordance with the provisions of 6.4 in CB5226.1-2002.
5.4.6.4 The continuity of the protective grounding circuit of the electrical system shall be in accordance with the provisions of 8.2.3 in GB5226.1-2002. 5.4.6.5 The insulation resistance between all power circuit conductors and protective grounding circuits in the electrical system should be greater than 1M under 500V DC voltage.
5.4.6.6 All power circuit conductors and protective grounding circuits in the electrical system should withstand a voltage impact of at least 1s, 50Hz, and 1000V without breakdown, except for circuits intended to operate at or below PELV voltage. . 5.4.6.7 Clear, eye-catching, and durable safety warning signs should be installed at dangerous locations. 5.4.6.8 Pure steam generators should have interlocking, emergency stop, safety alarm functions, and be able to work reliably. 5.5 Appearance
The appearance of the pure steam generator should be smooth and smooth, without obvious scratches, bulges and dents. 6 Test methods
6.1 Main materials
6.1.1 The raw materials should be accompanied by a quality certificate from the production unit, and the materials should be accepted according to the quality certificate. If there are any objections, they should be re-inspected.
6.1.2 The seal shall be accompanied by a certificate of conformity.
6.1.3 The insulation materials should be accompanied by a certificate of conformity.
6.2 Pressure components
The manufacturing of main pressure components in pure steam generators shall be inspected and accepted in accordance with the relevant provisions of GB150, GB151 and "Pressure Vessel Safety Technical Supervision Regulations" (1999 Edition) . 6.3 Pickling passivation
Pickling passivation components, pipelines and welds are tested by the blue dot method, and if no blue color appears within 30s, it is qualified. 6.4 Main instruments
30
6.4.1 Safety valves and pressure gauges:
Safety readings and pressure gauges must be inspected by the technical supervision department before they can be used. 6.4.2 On-site monitoring (control) and display instruments: On-site monitoring (control) and display instruments shall be inspected according to the parameters on the factory inspection certificate. 6.4.3 Control valve:
The control valve is tested according to its movement form to see whether the opening and closing is flexible and reliable. 6.5 Test conditions
Pure steam generator debugging or testing shall be based on the requirements of working conditions. 6.6 Performance indicators
6.6.1 Heat exchange tubes:
The heat exchange tubes after docking should be subjected to a hydrostatic test in accordance with the provisions of 6.3.3g in GB151-1999. 6.6.2 Test of the complete machine:
JB20031—2004
6.6.2.1 Before passing the pure steam generator to the boiler to heat the steam, and after passing in water, the whole machine should be maintained at pressure for 30 minutes for visual inspection. Each There must be no leakage at the joint.
6.6.2.2 After the pure Yan steam generator is heated by boiler steam and water is introduced, the whole machine is maintained at pressure for 30 minutes for visual inspection. There must be no leakage at any connection.
6.6.3 Pure steam condensate:
The pH value of pure steam condensate should be tested in accordance with the provisions of the "Pharmacopoeia of the People's Republic of China" (2000 edition); the bacterial content of pure steam condensate Toxins were tested in accordance with the provisions of the Bacterial Endotoxins Test Method in the Pharmacopoeia of the People's Republic of China (2000 Edition). The chemical composition test of pure steam condensate water should be tested in accordance with the relevant provisions of "Water for Injection" in the "Pharmacopoeia of the People's Republic of China" (2000 edition). 6.6.4 Pure steam output, boiler steam consumption and raw water consumption: After the pure steam generator is in normal operation, use a standard measuring cylinder and a timing clock to test the pure steam condensate water, boiler steam consumption and raw water consumption at the same time. Each measurement is 6 minutes, and a total of three measurements are taken. The arithmetic average is taken, and then converted into the output per unit time. The calculation is based on formulas (1) and (2):
10
Wa=||tt ||508
W=
Where:
(j=1,2,3)
(j=1,2,3)||tt| |W - the arithmetic mean of the ratio of boiler steam consumption to pure steam condensate production; WB - the arithmetic mean of the ratio of raw water consumption to pure steam condensate production: Q - measured per unit time Pure steam condensate production, kg/h; Qa—the amount of boiler steam consumed to produce a certain amount of pure steam per unit time, kg/h; Q—the raw materials consumed to produce a certain amount of pure steam per unit time. Water volume, kg/h. +(1)
(2)
6.6.4.1 Pure steam production test: Use the pure steam condensed water weighing method, that is, introduce the pure steam into a condenser, and all the pure steam will be cooled into water. Weigh directly after being introduced into the container.
6.6.4.2 Boiler steam consumption test: Use the steam condensate weighing method, that is, the boiler steam condensate outlet of the machine is connected to a condenser, 31
The pure steam output measured at 3MPa steam pressure should comply with the requirements in Table 1, and the steam consumption and raw water consumption should comply with the requirements in Table 2.
29
JB 20031—2004
Ratio
Q/Q
Q/Q
Note:
Table 2 Steam consumption and raw water consumption
Indicator
1.26
1.20
Q: Pure steam condensate water production measured per unit time, kg/h: Qa: The amount of boiler steam consumed to produce a certain amount of pure steam per unit time, kg/h: Q: The amount of raw water consumed to produce a certain amount of pure steam per unit time, kg/h. 5.4.5 Noise:
The operating noise of a pure steam generator should not be greater than 85dB(A). 5.4.6 Safety performance requirements:
5.4.6.1 The connection and wiring of the electrical system and the identification of wires shall be in accordance with the provisions of 14.1 and 14.2 in GB5226.1-2002. 5.4.6.2 The buttons, indicator lights and displays of the electrical system shall comply with the provisions of 10.2, 10.3 and 10.9 in GB5226.12002. 5.4.6.3 The operation panel of the electrical system should be protected by FELV (security extra low voltage) and should be in accordance with the provisions of 6.4 in CB5226.1-2002.
5.4.6.4 The continuity of the protective grounding circuit of the electrical system shall be in accordance with the provisions of 8.2.3 in GB5226.1-2002. 5.4.6.5 The insulation resistance between all power circuit conductors and protective grounding circuits in the electrical system should be greater than 1M under 500V DC voltage.
5.4.6.6 All power circuit conductors and protective grounding circuits in the electrical system should withstand a voltage impact of at least 1s, 50Hz, and 1000V without breakdown, except for circuits intended to operate at or below PELV voltage. . 5.4.6.7 Clear, eye-catching, and durable safety warning signs should be installed at dangerous locations. 5.4.6.8 Pure steam generators should have interlocking, emergency stop, safety alarm functions, and be able to work reliably. 5.5 Appearance
The appearance of the pure steam generator should be smooth and smooth, without obvious scratches, bulges and dents. 6 Test methods
6.1 Main materials
6.1.1 The raw materials should be accompanied by a quality certificate from the production unit, and the materials should be accepted according to the quality certificate. If there are any objections, they should be re-inspected.
6.1.2 The seal shall be accompanied by a certificate of conformity.
6.1.3 The insulation materials should be accompanied by a certificate of conformity.
6.2 Pressure components
The manufacturing of main pressure components in pure steam generators shall be inspected and accepted in accordance with the relevant provisions of GB150, GB151 and "Pressure Vessel Safety Technical Supervision Regulations" (1999 Edition) . 6.3 Pickling passivation
Pickling passivation components, pipelines and welds are tested by the blue dot method, and if no blue color appears within 30s, it is qualified. 6.4 Main instruments
30
6.4.1 Safety valves and pressure gauges:
Safety readings and pressure gauges must be inspected by the technical supervision department before they can be used. 6.4.2 On-site monitoring (control) and display instruments: On-site monitoring (control) and display instruments shall be inspected according to the parameters on the factory inspection certificate. 6.4.3 Control valve:
The control valve is tested according to its movement form to see whether the opening and closing is flexible and reliable. 6.5 Test conditions
Pure steam generator debugging or testing shall be based on the requirements of working conditions. 6.6 Performance indicators
6.6.1 Heat exchange tubes:
The heat exchange tubes after docking should be subjected to a hydrostatic test in accordance with the provisions of 6.3.3g in GB151-1999. 6.6.2 Test of the complete machine:
JB20031—2004
6.6.2.1 Before passing the pure steam generator to the boiler to heat the steam, and after passing in water, the whole machine should be maintained at pressure for 30 minutes for visual inspection. Each There must be no leakage at the joint.
6.6.2.2 After the pure Yan steam generator is heated by boiler steam and water is introduced, the whole machine is maintained at pressure for 30 minutes for visual inspection. There must be no leakage at any connection.
6.6.3 Pure steam condensate:
The pH value of pure steam condensate should be tested in accordance with the provisions of the "Pharmacopoeia of the People's Republic of China" (2000 edition); the bacterial content of pure steam condensate Toxins were tested according to the provisions of the bacterial endotoxin examination method in the "Pharmacopoeia of the People's Republic of China" (2000 edition). The chemical composition test of pure steam condensate water should be tested in accordance with the relevant provisions of "Water for Injection" in the "Pharmacopoeia of the People's Republic of China" (2000 edition). 6.6.4 Pure steam output, boiler steam consumption and raw water consumption: After the pure steam generator is in normal operation, use a standard measuring cylinder and a timing clock to test the pure steam condensate water, boiler steam consumption and raw water consumption at the same time. Each measurement is 6 minutes, and a total of three measurements are taken. The arithmetic average is taken, and then converted into the output per unit time. The calculation is based on formulas (1) and (2):
10
Wa=||tt ||508
W=
Where:
(j=1,2,3)
(j=1,2,3)||tt| |W - the arithmetic mean of the ratio of boiler steam consumption to pure steam condensate production; WB - the arithmetic mean of the ratio of raw water consumption to pure steam condensate production: Q - measured per unit time Pure steam condensate production, kg/h; Qa—the amount of boiler steam consumed to produce a certain amount of pure steam per unit time, kg/h; Q—the raw materials consumed to produce a certain amount of pure steam per unit time. Water volume, kg/h. +(1)
(2)
6.6.4.1 Pure steam production test: Use the pure steam condensed water weighing method, that is, introduce the pure steam into a condenser, and all the pure steam will be cooled into water. Weigh directly after being introduced into the container.
6.6.4.2 Boiler steam consumption test: Use the steam condensate weighing method, that is, the boiler steam condensate outlet of the machine is connected to a condenser, 31
The output of pure steam measured under 3MPa steam pressure shall comply with the provisions of Table 1, and the steam consumption and raw water consumption shall comply with the provisions of Table 2.
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JB 20031—2004
Ratio
Q/Q
Q/Q
Note:
Table 2 Steam consumption and raw water consumption
Indicators
1.26
1.20
Q: The output of pure steam condensate measured per unit time, kg/h: Qa: The amount of boiler steam consumed per unit time to produce a certain amount of pure steam, kg/h: Q: The amount of raw water consumed per unit time to produce a certain amount of pure steam, kg/h. 5.4.5 Noise:
The working noise of the pure steam generator shall not exceed 85dB(A). 5.4.6 Safety performance requirements:
5.4.6.1 The connection and wiring of the electrical system and the marking of the wires shall comply with the provisions of 14.1 and 14.2 of GB5226.1-2002. 5.4.6.2 The buttons, indicator lights and displays of the electrical system shall comply with the provisions of 10.2, 10.3 and 10.9 of GB5226.1-2002. 5.4.6.3 The operation panel of the electrical system shall adopt FELV (security extra low voltage) protection and shall comply with the provisions of 6.4 of CB5226.1-2002.
5.4.6.4 The continuity of the protective grounding circuit of the electrical system shall comply with the provisions of 8.2.3 of GB5226.1-2002. 5.4.6.5 The insulation resistance between all power circuit conductors and protective grounding circuits in the electrical system shall be greater than 1M at a DC voltage of 500V.
5.4.6.6 All power circuit conductors and protective grounding circuits in the electrical system shall withstand a voltage shock of at least 1s, 50Hz, and 1000V without breakdown, except for circuits intended to operate at or below PELV voltage. 5.4.6.7 Clear, eye-catching, and durable safety warning signs shall be provided at dangerous locations. 5.4.6.8 Pure steam generators shall have interlocking, emergency stop, and safety alarm functions, and shall be able to operate reliably. 5.5 Appearance
The appearance of pure steam generators shall be smooth and flat, without obvious scratches, protrusions, and depressions. 6 Test methods
6.1 Main materials
6.1.1 The raw materials shall be accompanied by the quality certificate of the production unit, and the materials shall be accepted according to the quality certificate. If there is any objection, re-inspection shall be carried out.
6.1.2 The seals shall be accompanied by a certificate of conformity.
6.1.3 The insulation materials shall be accompanied by a certificate of conformity.
6.2 Pressure-bearing components
The manufacture of the main pressure-bearing components in the pure steam generator shall be inspected and accepted in accordance with the relevant requirements of GB150, GB151 and the "Regulations on Safety Technical Supervision of Pressure Vessels" (1999 Edition). 6.3 Pickling and passivation
The pickled and passivated cylinders, pipelines and welds are tested by the blue dot method, and they are qualified if no blue appears within 30 seconds. 6.4 Main instruments
30
6.4.1 Safety valves and pressure gauges:
Safety valves and pressure gauges must be tested by the technical supervision department before they can be used. 6.4.2 On-site monitoring (control) and display instruments: On-site monitoring (control) and display instruments shall be inspected according to the parameters on the factory inspection certificate. 6.4.3 Control valves:
Control valves shall be inspected according to their movement forms to see if the opening and closing properties are flexible and reliable. 6.5 Test conditions
The commissioning or test of the pure steam generator shall be in accordance with the requirements of working conditions. 6.6 Performance indicators
6.6.1 Heat exchange tubes:
The heat exchange tubes after docking shall be subjected to water pressure test in accordance with the provisions of 6.3.3g of GB151-1999. 6.6.2 Test of the whole machine:
JB20031-2004
6.6.2.1 Before the pure steam generator is fed with steam from the heating boiler, after water is fed in, the whole machine shall be kept under pressure for 30 minutes for visual inspection, and no leakage shall be found at any joint.
6.6.2.2 After the pure steam generator is fed with steam from the heating boiler, after water is fed in, the whole machine shall be kept under pressure for 30 minutes for visual inspection, and no leakage shall be found at any joint.
6.6.3 Pure steam condensate:
The pH value of pure steam condensate shall be tested in accordance with the provisions of the Pharmacopoeia of the People's Republic of China (2000 Edition); the bacterial endotoxin of pure steam condensate shall be tested in accordance with the provisions of the bacterial endotoxin test method in the Pharmacopoeia of the People's Republic of China (2000 Edition). The chemical composition of pure steam condensate shall be tested in accordance with the relevant provisions of the "Water for Injection" in the Pharmacopoeia of the People's Republic of China (2000 Edition). 6.6.4 Pure steam production, boiler steam consumption and raw water consumption: After the pure steam generator is operating normally, the pure steam condensate, boiler steam consumption and raw water consumption are tested simultaneously with a standard measuring cylinder and a stopwatch. Each measurement lasts for 6 minutes, and a total of three measurements are taken. The arithmetic mean is taken and then converted into the production per unit time. The calculation is based on formula (1) and formula (2):
10
Wa=
508
W= ... 1,2,3)
(j=1,2,3)
W——arithmetic mean of the ratio of boiler steam consumption to pure steam condensate production; WB——arithmetic mean of the ratio of raw water consumption to pure steam condensate production: Q——pure steam condensate production measured per unit time, kg/h; Qa—the amount of boiler steam consumed to produce a certain amount of pure steam per unit time, kg/h; Q—the amount of raw water consumed to produce a certain amount of pure steam per unit time, kg/h. +(1)
(2)
6.6.4.1 Pure steam production test: Use the pure steam condensate weighing method, that is, the pure steam is introduced into a condenser, the pure steam is completely cooled into water, and then introduced into a container and weighed directly.
6.6.4.2 Boiler steam consumption test: Use the steam condensate weighing method, that is, the boiler steam condensate outlet of the machine is connected to a condenser, 31
1 Safety valve and pressure gauge:
Safety valve and pressure gauge must be inspected by the technical supervision department before use. 6.4.2 On-site monitoring (control) and display instruments: On-site monitoring (control) and display instruments shall be inspected according to the parameters on the factory inspection certificate. 6.4.3 Control valve:
Control valve shall be inspected according to its movement form to see whether the opening and closing performance is flexible and reliable. 6.5 Test conditions
Pure steam generator commissioning or testing shall be carried out according to the requirements of working conditions. 6.6 Performance indicators
6.6.1 Heat exchange tube:
The heat exchange tube after docking shall be subjected to water pressure test according to the provisions of 6.3.3g of GB151-1999. 6.6.2 Test of the whole machine:
JB20031—2004
6.6.2.1 Before the pure steam generator is fed with steam from the heating boiler, after water is introduced, the whole machine is kept under pressure for 30 minutes for visual inspection, and no leakage is allowed at any connection.
6.6.2.2 After the pure steam generator is fed with steam from the heating boiler, after water is introduced, the whole machine is kept under pressure for 30 minutes for visual inspection, and no leakage is allowed at any connection.
6.6.3 Pure steam condensate:
The pH value of pure steam condensate shall be tested in accordance with the provisions of the "Pharmacopoeia of the People's Republic of China" (2000 edition); the bacterial endotoxin of pure steam condensate shall be tested in accordance with the provisions of the bacterial endotoxin test method in the "Pharmacopoeia of the People's Republic of China" (2000 edition). The chemical composition test of pure steam condensate shall be tested in accordance with the relevant provisions of "Water for Injection" in the "Pharmacopoeia of the People's Republic of China" (2000 edition). 6.6.4 Pure steam production, boiler steam consumption and raw water consumption: After the pure steam generator is operating normally, use a standard measuring cylinder and a stop clock to test the pure steam condensate, boiler steam consumption and raw water consumption simultaneously. Each measurement lasts for 6 minutes, and a total of three measurements are taken. The arithmetic mean is taken and then converted into the production per unit time. The calculation is based on formula (1) and formula (2):
10
Wa=
508
W= ... 1,2,3)
(j=1,2,3)
W——arithmetic mean of the ratio of boiler steam consumption to pure steam condensate production; WB——arithmetic mean of the ratio of raw water consumption to pure steam condensate production: Q——pure steam condensate production measured per unit time, kg/h; Qa—the amount of boiler steam consumed to produce a certain amount of pure steam per unit time, kg/h; Q—the amount of raw water consumed to produce a certain amount of pure steam per unit time, kg/h. +(1)
(2)
6.6.4.1 Pure steam production test: Use the pure steam condensate weighing method, that is, the pure steam is introduced into a condenser, the pure steam is completely cooled into water, and then introduced into a container and weighed directly.
6.6.4.2 Boiler steam consumption test: Use the steam condensate weighing method, that is, the boiler steam condensate outlet of the machine is connected to a condenser, 31
1 Safety valves and pressure gauges:
Safety valves and pressure gauges must be inspected by the technical supervision department before they can be used. 6.4.2 On-site monitoring (control) and display instruments: On-site monitoring (control) and display instruments shall be inspected according to the parameters on the factory inspection certificate. 6.4.3 Control valve:
The control valve is tested according to its movement form to see whether the opening and closing is flexible and reliable. 6.5 Test conditions
Pure steam generator debugging or testing shall be based on the requirements of working conditions. 6.6 Performance indicators
6.6.1 Heat exchange tubes:
The heat exchange tubes after docking should be subjected to a hydrostatic test in accordance with the provisions of 6.3.3g in GB151-1999. 6.6.2 Test of the complete machine:
JB20031—2004
6.6.2.1 Before passing the boiler steam to the pure steam generator and after passing in the water, the whole machine should be maintained at pressure for 30 minutes for visual inspection. There must be no leakage at the joint.
6.6.2.2 After the pure Yan steam generator is heated by the boiler steam and water is introduced, the whole machine is maintained at pressure for 30 minutes for visual inspection. There must be no leakage at any connection.
6.6.3 Pure steam condensate:
The pH value of pure steam condensate should be tested in accordance with the provisions of the "Pharmacopoeia of the People's Republic of China" (2000 edition); the bacterial content of pure steam condensate Toxins were tested according to the provisions of the bacterial endotoxin examination method in the "Pharmacopoeia of the People's Republic of China" (2000 edition). The chemical composition test of pure steam condensate should be tested in accordance with the relevant provisions of "Water for Injection" in the "Pharmacopoeia of the People's Republic of China" (2000 edition). 6.6.4 Pure steam output, boiler steam consumption and raw water consumption: After the pure steam generator is in normal operation, use a standard measuring cylinder and a timing clock to test the pure steam condensate water, boiler steam consumption and raw water consumption at the same time. Measure for 6 minutes, and measure three times in total. Take the arithmetic average and convert it into the output per unit time. The calculation is based on formulas (1) and (2):
10
Wa=||tt ||508
W=
Where:
(j=1,2,3)
(j=1,2,3)||tt| |W - the arithmetic mean of the ratio of boiler steam consumption to pure steam condensate production; WB - the arithmetic mean of the ratio of raw water consumption to pure steam condensate production: Q - measured per unit time Pure steam condensate production, kg/h; Qa—the amount of boiler steam consumed to produce a certain amount of pure steam per unit time, kg/h; Q—the raw materials consumed to produce a certain amount of pure steam per unit time. Water volume, kg/h. +(1)
(2)
6.6.4.1 Pure steam production test: Use the pure steam condensed water weighing method, that is, introduce the pure steam into a condenser, and all the pure steam will be cooled into water. Weigh directly after being introduced into the container.
6.6.4.2 Boiler steam consumption test: Use the steam condensate weighing method, that is, the boiler steam condensate outlet of the machine is connected to a condenser, 31
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