Some standard content:
JB | Published
Pure steam generator
Implemented on 2004-06-01
National Development and Reform Commission releasedwwW.bzxz.Net
ICS11.120.30
C92||tt| |JB | ||Implemented on 2004-06-01
Released by the National Development and Reform Commission
Foreword
1 Scope
2 Normative Reference Documents
3 Classification and Marking
4 Requirements
5 Test methods
++
6 Inspection rules·
7 Marks, instructions for use, packaging, transportation and storage items| | tt | , GB/T1.2-2002 standardization work guide requirements, revision of YY0230-1995 "Hot Pressed Distilled Water Machine". This standard replaces YY0230-1995 from the date of implementation. Compared with YY0230-1995, the main technical content changes of this standard are as follows: a) Some chapters and clauses in YY0230-1995 have been deleted: Normative reference documents: HGJ18-1989 Technical Requirements for the Manufacturing of Steel Chemical Vessels, JB2880-1981 Steel Technical conditions for welding atmospheric pressure vessels, YY0076-1992 Technical conditions for metal parts coating classification; requirements (4.5.4);
test methods (5.8).
b) Revised some chapters and articles in YY0230-1995: Preface:
Normative reference document GB5226.1;
-Models and specifications and basic parameters (3,3.1 ,3.3); requirements (4,4.1,4.5,4.6~4.10);
Test method (5.5.1.1,5.1.3d,5.2.3.5.4.2.5.8~5.10,5.10.1~5.10.2 ); Inspection rules (6, 6.2.1.2, 6.2.2.1, 6.2.2.2); Marking, instructions for use, packaging, transportation, storage (7). e) Main chapters and clauses added to this standard:
Normative reference documents: CB151, CB/T3280, GB/T4237, CGB13296, CB/T14976, Good Manufacturing Practice for Pharmaceuticals (1998 revised edition);| |tt|| Distilled water machine performance requirements (see 4.2): Electrical system safety performance requirements (see 4.9.1~4.9.7); - Electrical system safety performance test (see 5.8.1, 5.8.2); - Instructions for use (See 7.2).
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. The main drafters of this standard: Zhang Baoshun, Zhang Nailing, and Li Ping. The previous releases of the standards replaced by this standard are: GB11752-1989, YY0230--1995. 4
1 scope
Hot-pressure distilled water machine
JB20029-2004||tt| |This standard specifies the classification and labeling, requirements, test methods, inspection rules and signs, instructions for use, packaging, transportation and storage of hot-pressed distilled water machines.
This standard applies to hot-pressure distilled water machines that use heat pumps to compress secondary steam to achieve cyclic evaporation (hereinafter referred to as Yanguan water machines).
2 Normative reference documents
The clauses in the following documents are quoted in this standard and become the clauses of this standard. For referenced documents with a reference period, all subsequent amendments (excluding errata content) or revisions do not apply 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 referenced documents, the latest edition applies to this standard. GB151 shell and tube heat exchanger
Packaging, storage and transportation icon mark
GR/T191
GB/T1220 stainless steel rod
GB/T3280 stainless steel cold-rolled steel plate|| tt | Polished surface of sample block GB/T9969.1 General instructions for industrial products GB/T10111 Random sampling method using random numbers 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 CB/T14976 Stainless steel seamless steel pipes for fluid transportation GB/T16769 Method for measuring noise and sound pressure level of metal cutting machine tools JB4735-1997 Steel welded atmospheric pressure vessels YY/T0216 Pharmaceutical machinery product model compilation method Pharmacopoeia of the People's Republic of China (2000 Edition) National Pharmacopoeia Commission Good Manufacturing Practice for Drugs (1998 Edition) State Drug Administration JB 200292004
3 Classification and Labeling
3.1 Model
Model preparation should comply with YY/ Provisions of T0216. RY | | tt | ：Hot-pressure steaming water machine RY500A type: represents the first improved design of the hot-pressure steaming water machine with a steaming water output of 500k/h. 3.3 See Table 1 for specifications and basic parameters.
Table 1 US
Specifications and basic parameters
Specifications
Rated output of water addition, kg/h
4 requirements
100| |tt||100
200
200
500
500
1000
1000
2000||tt ||2000
3000
3000
5000
5000
4.1 The distilled water produced by the distilled water machine should comply with the "Pharmacopoeia of the People's Republic of China" (2000 The various quality indicators of "Water for Injection\" in the version). The raw water should be purified water, and the allowable conductivity is less than 2uS/cme4.2 The distilled water machine should be safe to use, stable in operation, easy to clean, easy to operate and maintain. 4.3 Steaming When the water adding machine leaves the factory, the steaming water output should not be less than 105% of the rated output. 4.4 The design and manufacturing of the normal pressure vessels and heat exchange vessels in the distilled water machine should comply with the relevant regulations of JB4735 and CB151. 4.5 Main material requirements | |tt||4.5.1 All parts in the distilled water machine that come into contact with raw water, secondary steam and steaming water should be made of austenitic 0Cr17Ni12Ma2 and 00Cr17Ni14Mo2 stainless steel. The steel plates should comply with the regulations of GB/T3280 and GBT4237: the steel pipes should be made. Comply with the regulations of GB13296 and GB/T14976; the stainless steel rods should comply with the regulations of GB/T1220. 4.5.2 The seals at the joints of each component of the distilled water machine should be made of non-toxic, odorless, non-falling high-temperature silicone rubber, polytetrafluoroethylene or Made of materials with similar performance.
4.5.3 The insulation materials used in the distilled water machine should comply with the relevant regulations of GB/T4272. 4.6 Manufacturing quality requirements
4.6.1 Each connecting piece of the steamed water machine. It should be firm and there should be no leakage in the seal. 4.6.2 The parts containing the heat medium should be insulated. 4.6.3 All stainless steel cylinders and steamers in the steaming water machine that are in contact with the steaming water (including secondary steam). The pipeline should have no dead ends, blind pipes, or structures that are difficult to drain away residual water, and the inner surface should be mechanically polished or electropolished 4.6.4 When the distilled water machine is working, the noise sound pressure generated by the main unit should not exceed 85dB (A). 6
4.6.5 When the distilled water machine is working, the compressor should run smoothly and the horizontal amplitude of the shell should not exceed 0.1mm. JB20029-2004
4.6.6 After the distilled water machine is installed, it should be subjected to a water pressure test in accordance with the relevant provisions of 15.2.5 of JB/T4735-1997. 4.7 The distilled water machine should be equipped with a temperature meter that displays the outlet distilled water temperature and a conductivity meter that displays the quality of distilled water, and has an automatic alarm and discharge function for unqualified steamed filling water. 4.8 The control system of the distilled water machine should be flexible and reliable in operation, and be able to display and alarm in time for faults that occur during the operation of the machine. 4.9 Safety performance requirements for electrical systems
4.9.1 The continuity of the protective grounding circuit of the electrical system should comply with the provisions of 19.2 of GB5226.1-2002. 4.9.2 The insulation resistance of the electrical system shall comply with the provisions of 19.3 of GB5226.1-2002. 4.9.3 The withstand voltage of the electrical system shall comply with the provisions of 19.4 of GB5226.1-2002. 4.9.4 The protective grounding circuit of the electrical system shall comply with the provisions of 8.2 of GB5226.1-2002. 4.9.5 The buttons of the electrical system shall comply with the provisions of 10.2 of GB5226.1-2002. 4.9.6 The indicator lights and displays of the electrical system shall comply with the provisions of 10.3 of GB5226.1-2002. 4.9.7 The wiring of the electrical system shall comply with the provisions of Chapter 14 of GB5226.1-2002. The markings, warning signs and project codes of the electrical system shall comply with the provisions of Chapter 17 of GB5226.1-2002. 4.10 The energy consumption index of distilled water production shall be calculated and determined for every 1000kg of distilled water produced, as shown in Table 2. Table 2 Energy consumption index of distilled water production
Specification
Item
Steam.kg
(When the outlet water temperature is 40℃)
Electricity, kw-h
100kg/h ~ 200kg/h
Electricity auxiliary heating
40
4.11 The distilled water machine shall be equipped with a drainage trough and exhaust steam collection device. 4.12 Appearance quality
Electricity auxiliary heating
≤35
Specification
≥500kg/h
Steam auxiliary heating
25
ng 20
4.12.1 The various pipes of the steamed water machine shall be arranged neatly, and the discharge outlet of the horizontal pipe shall not be higher than the discharge inlet. 4.12.2 The outer surface of the distilled water machine should be smooth and flat, without obvious scratches, protrusions or depressions. 5 Test methods
5.1 Determination of distilled water quality
5.1.1 Test conditions: The raw water used to prepare distilled water is purified water, and the conductivity is less than 2μS/cm at 20℃. 5.1.2 Sampling: After the distilled water machine has been producing water normally for 1 hour, sampling is performed at the rated output. The water samples taken should be measured within 8 hours. 5.1.3 Test items and methods:
The chemical composition of distilled water shall be tested according to the test items and a)
methods specified in the "Water for Injection" in the "Pharmacopoeia of the People's Republic of China" (2000 edition).
Distilled water bacterial endotoxin test, according to the "Bacterial endotoxin test method\test" in the "Pharmacopoeia of the People's Republic of China" (2000 edition). b)
The pH value of steamed water shall be tested according to the provisions of the "Pharmacopoeia of the People's Republic of China" (2000 edition). e
The conductivity of distilled water shall be tested with a conductivity meter. The conductivity of steamed stuffing water measured at 20℃ shall be less than 1.0uS/cm. d)
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JB20029—2004
5.2 Determination of distilled water output
5.2.1 Measuring instruments: standard measuring tube, rotor flowmeter and timer. 5.2.2 Measurement: Measure the water output of the 6-minute distillation machine once every hour, measure three times in total, and calculate the arithmetic mean. 5.2.3 The output is calculated according to formula (1):
Ci + C2 + C3
C=10×S
3
Wherein:
C——calculated value of distilled water output per hour, kg. Cl, C2, Cs——water output three times, kg. 5.3 Noise measurement
Measure the noise of the machine under load according to the method specified in GB/T16769. 5.4 Determination of amplitude
5.4.1 The machine should be placed on a solid foundation and run under full load. 5.4.2 Use a dial gauge to measure the steam compressor using a foundation separated from the machine. Vibration amplitude of the shell. 5.5 Leakage test of the whole machine
The test shall be carried out in accordance with the relevant provisions of 15.2.5.4 of JB4735-1997. (1)
5.6 The body, pipelines and welds of the distilled water machine that need to be mechanically polished or electrochemically polished shall be visually inspected for uniform gloss. Use GB/T6060.4 comparison sample blocks for comparative determination. 5.7 The water pressure test of the distilled water machine shall be carried out in accordance with the method specified in 15.2.5.5 of JB4735-1997. 5.8 Safety performance test of electrical system
5.8.1 The continuity, insulation resistance and withstand voltage test of the protective grounding circuit of the electrical system shall be tested in accordance with the provisions of 19.2, 19.3 and 19.4 of GB5226.1-2002.
5.8.2 The protective grounding circuit, buttons, indicator lights and displays, wiring, markings, warning signs and project codes of the electrical system shall be checked in accordance with the provisions of 8.2, 10.2, 10.3, Chapter 14 and Chapter 17 of GB5226.1-2002. 5.9 Determination of energy consumption
5.9.1 Determination of heating steam consumption Definition: Use a standard measuring tube to measure the amount of heating steam condensate generated and use a timer to measure the generation time. The amount generated per hour is the heating steam consumption. 5.9.2 Determination of power consumption: Connect an electric meter to the dedicated power supply line of the distillation and water increasing machine. Measure the distilled water output and power consumption for 1 hour, and calculate the power consumed for each production of 1000kg of distilled water. The measurement can be continuous for three times, and the arithmetic average of the three power consumptions is taken. 6 Inspection rules
6.1 The hot filling water machine must be inspected by the quality inspection department of the manufacturer. It can only be shipped after passing the inspection and attached with a product certificate. 6.2 The inspection of the distillation and water increasing machine is divided into factory inspection and type inspection. 6.2.1 Factory inspection
6.2.1.1 The distilled water machine must be inspected one by one according to the provisions of Table 3. 8
Item category
Appearance
General performance
Main performance
Table 3 Factory inspection items
Inspection items
4.12
4.3,4.5,4.6,4.7,4.8,4.10
4.1,4.9
JB200292004
6.2.1.2 If any unqualified product is found in the inspection process of each steam and water adding machine, it shall be returned for repair. If it still fails the re-inspection, it shall be judged that the product fails the factory inspection.
6.2.2 Type inspection
6.2.2.1 Type inspection shall be conducted in any of the following cases: a) When the product is trial-formed or transferred to another factory for production; b) When there are major improvements in product design, materials or processes; c) When the product is resumed after being discontinued for 2 years; d) When there is a significant difference between the factory inspection result and the last type inspection result; e) When the national quality supervision and inspection agency proposes a type inspection requirement. 6.2.2.2 Type inspection items include all requirements and basic parameters of this standard. 6.2.2.3 Judgment rules:
The prototype for type inspection shall be sampled from the qualified products according to GB/T10111. During the inspection, if the continuity of the protective grounding circuit, insulation resistance and withstand voltage of the main performance are unqualified, the product shall be judged as unqualified in the type inspection. If one general performance is unqualified, the unqualified item shall be retested twice. If the item is still found to be unqualified, the product shall be judged as unqualified in the type inspection. 7 Marking, instruction manual, packaging, transportation and storage 7.1 Marking
7.1.1 The nameplate of each steaming machine should be fixed in a conspicuous position on the machine. The size and technical requirements of the nameplate should comply with the provisions of CB/T13306. The content of the nameplate includes:
a) manufacturer's name;
b) product model and name;
c) main parameters of the product;
d) product standard code;
e) product trademark;
f) product factory number and date.
7.1.2 Packaging mark:
The mark on the outer wall of the packaging box should comply with the provisions of GB/T191 and have the following contents: a) Transport number;
b) Product model and name;
c) Shipping date;
d) Name of the shipping station and the receiving station;
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