GB/T 36386-2018Specification of hygienic housing for microfiltration membrane elements (English PDF)
微孔膜滤芯用卫生级过滤器外壳技术要求
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Issued by
SAMR; SAC
Level / Type
National · Recommended
Issue date
June 7, 2018
Implementation date
January 1, 2019
Scope
GB/T 36386-2018 is the English-translated version of 微孔膜滤芯用卫生级过滤器外壳技术要求.
GB/T 36386-2018 specifies the technical requirements for hygienic filter housings that hold microporous membrane filter cartridges. It sets general requirements for compatibility with the filtered medium, biosafety, steam sterilization at not less than 130 °C, cleanability, drainage, surface finish and traceability.
It lists the austenitic and duplex stainless steels and filler metals allowed, their corrosion resistance, and the polymer sealing and coating materials such as EPDM, FKM, PTFE and PFA.
The design part covers housing category codes, hygienic gasket, O-ring and ellipsoidal seals, and components from cylinder and head to filter holder. Further clauses deal with manufacturing, welding, surface treatment, non-destructive testing, pressure and air tightness tests, marking, cleaning and packaging.
It applies to stainless steel housings. It was issued on 7 June 2018 and has applied since 1 January 2019.
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Document preview — GB/T 36386-2018
National Standard of the People's Republic of China
- ICS
- 23.100.60
- Classification
- J 77
Issued by: State Administration for Market Regulation; Standardization Administration of the PRC
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms, definitions and abbreviations
- 3.1 Terms and Definitions
- 3.2 Abbreviations
- 4 General requirements
- 4.1 Compatibility with filter media
- 4.2 Biosafety
- 4.3 Steam sterilizability
- 4.4 Washability
- 4.5 Liquidity
- 4.6 Exhaustion
- 4.7 Surface finish
- 4.8 Surface cleanliness
- 4.9 Sealing
- 4.10 Traceability
- 5 Material Requirements
- 5.1 Body material and filler metal
- 5.2 Polymer Materials
- 6 Design Requirements
- 6.1 Design parameters
- 6.2 Shell Category Mark
- 6.3 Seal design
- 6.4 Part Design
- 7 Manufacturing requirements
- 7.1 Manufacturing Control Program
- 7.2 Forming and assembly
- 7.3 Welding
- 7.4 Post-weld heat treatment
- 7.5 Surface treatment
- 8 Inspection requirements
- 8.1 Nondestructive testing
- 8.2 Withstand voltage test
- 8.3 Air tightness test
- 9 Marking, cleaning, packaging, random file requirements
- 9.1 Mark
- 9.2 Cleaning
- 9.3 Packaging
- 9.4 Random File
- Appendix A (informative) Stainless steel corrosion resistance test and evaluation method and material reliability identification method
- Appendix B (Normative) Shell Category
- Appendix C (informative) Sanitary take-over and joint reference standard
- Appendix D (Normative) Non-hygienic connection example
- Appendix E (Normative) Clamp Design Requirements
- Reference
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
1 Scope
This standard specifies the materials, design, manufacture, inspection, and standard of sanitary filter housings (hereinafter referred to as "outer casings") for microporous membrane filters. Technical requirements for ambition, cleaning, packaging, and random documents.
This standard applies to sanitary filter housings for stainless steel microporous membrane cartridges.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this document. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 150.3-2011 Pressure Vessels Part 3. Design
GB/T 150.4-2011 Pressure vessels - Part 4. Manufacture, inspection and acceptance
GB/T 983 stainless steel welding rod
GB/T 1031 Product Geometric Specifications (GPS) Surface structure profiling surface roughness parameters and their values
GB/T 1220 stainless steel rod
GB/T 1954 chrome-nickel austenitic stainless steel weld ferrite content measurement method
GB/T 3280 stainless steel cold rolled steel plate and strip
GB/T 3452.1-2005 O-ring seals for hydraulics - Part 1. Dimension series and tolerances (ISO 3601-1. 2002, MOD)
GB/T 3452.2 O-ring seals for hydraulic and pneumatic applications - Part 2
GB/T 4237 stainless steel hot rolled steel sheet and strip
GB/T 11170 Determination of multi-element content of stainless steels
GB/T 11446.1-2013 electronic grade water
GB/T 14976 stainless steel seamless pipe for fluid transportation
GB/T 16886.11 Biological evaluation of medical devices - Part 11. Systemic toxicity test
GB/T 17854 stainless steel welding wire and flux for submerged arc welding
GB/T 20878-2007 Stainless steel and heat resistant steel grades and chemical composition
GB/T 21833 Austenitic-ferritic duplex stainless steel seamless steel pipe
GB/T 29713 stainless steel welding wire and welding tape
JB/T 7901 metal material laboratory uniform corrosion full immersion test method
NB/T 47010 Stainless steel and heat resistant steel forgings for pressure equipment
NB/T 47013.8-2012 Non-destructive testing of pressure equipment - Part 8. Leak detection
NB/T 47018.2 Specification for welding materials for pressure equipment - Part 2. Steel welding rod
NB/T 47018.4 Specification for welding materials for pressure equipment - Part 4. Submerged arc welding steel wire and flux
SJ20893 Stainless Steel Pickling and Passivation Specification
Electrolytic polishing method for YB/T 4377 metal sample
YB/T 5092 stainless steel wire for welding
ISO 3601-1:2012 Hydraulic power system O-rings - Part 1. Internal diameter, section, tolerances and identification code
People's Republic of China Pharmacopoeia.2015 Edition
3 Terms, definitions and abbreviations
3.1 Terms and definitions
The following terms and definitions apply to this document.
3.1.1 Hygienic filter housing
A container-like housing for mounting filter cartridges that meets clean and bio-safe requirements.
Note: mainly by cylinder, head, barrel connection, filter seat, tie rod, pressure plate, filter medium inlet, filter medium outlet, pressure gauge interface, exhaust port, sewage Port, sampling port, temperature sensor interface, fasteners, legs and so on.
3.1.2 Host material
Stainless steel material in direct contact with the filter media.
3.1.3 Filler metal
In the welding process, participate in the general term for the formation of weld metal welding materials.
Note: such as welding rod, welding wire, filler wire, flux, preset filler metal, metal powder, fuser, etc. are all filler metals.
3.1.4 Retention volume
The volume of liquid remaining in the filter housing after the drain opening is opened.
3.1.5 Dead end
An area that can retain fluid, cannot be drained, or cannot be cleaned.
3.1.6 Hygienic gasket
Flat annular gasket for sanitary joints.
3.1.7 O-ring
An annular seal with a circular cross section.
3.1.8 Nondestructive testing
Under the premise of not damaging the object to be inspected, physical or chemical means, with the aid of the corresponding equipment and equipment, in accordance with the prescribed technology To test and test the structure, properties or state of the interior and surface of the object, and analyze and evaluate the results. [NB/T 47013.1-2015, Definition 3.1]
3.1.9 Incomplete penetration
The root of the joint is not completely penetrated during welding. For butt welds, it also refers to the phenomenon that the welding depth does not meet the design requirements. [NB/T 47013.1-2015, Definition 3.2]
3.1.10 Lack of fusion
The unbonded portion between the weld metal and the base metal or weld metal weld layers.
Note: Unfused may be in one of the following forms.
a) the side walls are not fused;
b) the layers are not fused;
c) The roots are not fused.
3.1.11 Slag
Slag remaining in the weld metal.
Note: Depending on the formation, these slag inclusions may be.
a) linear;
b) isolated;
c) Clustered.
3.1.12 Burn through
During the welding process, the molten metal flows out of the perforations formed from the back of the groove. [NB/T 47013.1-2015, Definition 3.5]
3.1.13 Overlap
During the welding process, the molten metal flows to the metal tumor formed on the unmelted base metal or weld. [NB/T 47013.1-2015, definition 3.6]
3.1.14 Undercut
An irregular gap in the base metal (or the previous deposited metal) due to welding at the weld toe. [NB/T 47013.1-2015, Definition 3.7]
3.1.15 Porosity
When the molten metal solidifies, the gas therein does not escape and the formed void remains. [NB/T 47013.1-2015, definition 3.8]
3.1.16 Crack
A gap created by a new interface formed by the destruction of the bond of metal atoms. [NB/T 47013.1-2015, definition 3.9]
3.1.17 Corrosion
Physical-chemical interactions between metals and the environment (usually electrochemical properties), which result in changes in the properties of the metal and often The function of the technical system that leads to metals, the environment or by which they are part is compromised. [NB/T 47013.1-2015, Definition 3.10]
3.1.18 Shrinkage
Holes in the casting during the solidification process due to poor shrinkage. Very irregular shape, rough wall and dendritic crystals, often appearing The part where the casting is finally solidified. [NB/T 47013.1-2015, definition 3.11]
3.1.19 Loose
The inside of the casting or forging is defective in the distribution of fine pores. [NB/T 47013.1-2015, definition 3.12]
3.1.20 Inclusion
Defects formed by mixing non-metallic slag or refractory materials in castings or forgings. [NB/T 47013.1-2015, definition 3.13]
3.2 Abbreviations
The following abbreviations apply to this document.
GMAW. gas metal arc welding (gas metal arc welding)
GTAW. Tungsten inert gas shielded welding (gas tungsten arc welding)
PAW. plasma welding (plasma arc welding)
PMI. Material Reliability Identification (positive material identification)
SAW. submerged arc welding (submerged arc welding)
SMAW. automatic protection metal arc welding (shielded metal arc welding)
4 General requirements
4.1 Compatibility with filter media
The main body material and filler metal of the outer casing should be able to withstand the corrosion of the filter medium at the use temperature, reach the design life, seal The material should maintain a reliable seal in the filter media and the polymer coating should not be easily peeled off.
4.2 Biosafety
The extractor or leachate released from the main body material, filler metal, sealing material and polymer coating of the outer casing to the filter medium shall not be visible. The biosafety of the filter media.
4.3 Steam sterilizability
All parts of the casing and sealing material should be able to withstand saturated steam not less than 130 °C (gauge pressure not less than 0.165 MPa) online Sterilize.
4.4 Washability
All parts of the enclosure should be clean.
4.5 Liquidity
The casing must not have dead spots due to gaps or dents, and the filter media should be able to flow sufficiently in the casing.
4.6 Exhaustion
The sewage outlet should be placed at the lowest point of the outer casing. After opening the sewage outlet valve, the filter medium in the outer casing should be able to be discharged by its own gravity.
Out, reduce the retention volume, the surface residual liquid height of any part should be no more than 2mm.
4.7 Surface finish
All surfaces of the parts in direct contact with the filter media should be finely polished or coated, resulting from sealing, nozzles, surface treatment, etc.
Defects such as pits and gaps shall comply with the provisions of this standard; and threads shall be avoided. When threaded fasteners are required, the threads shall be used. The ring is isolated.
4.8 Surface cleanliness
The inner and outer surfaces of the outer casing shall be free of impurities such as welding slag, polishing paste, oil stains, scale and dust.
4.9 Sealing
The sealing surfaces of the outer casing, including the cylinder, the filter interface, the nozzle, etc., should have good sealing.
4.10 Traceability
The manufacturer of the enclosure should have strict quality control procedures in place to ensure that the source of the material and its processing can be traced back to ensure the process The material will not be confused.
5 Material requirements
5.1 Body material and filler metal
5.1.1 Selection of main materials
The main body material of the outer casing should be austenitic stainless steel or austenitic-ferritic (duplex) stainless steel in Table 1, the main body materials of each part Types and applicable standards should be in accordance with Table 2.
5.1.2 Selection of filler metal
5.1.2.1 Grades of metal filling
The filler metal grades corresponding to different host materials shall comply with the requirements of Table 3.
5.1.2.2 Ferrite content of filler metal
The ferrite content in the filler metal can be determined by both the supplier and the buyer, and sealed according to the provisions of GB/T 1954. Ferrite content Increase or decrease should not affect the corrosion resistance of the outer casing.
5.1.3 Corrosion resistance of bulk materials and filler metals
The corrosion resistance of the main body material and filler metal of the outer casing shall meet the following requirements.
a) The body material and filler metal of the enclosure shall be resistant to pitting, crevice corrosion, stress corrosion and intergranular corrosion of the filter media, For the corrosion resistance test of stainless steel, see A.1 in Appendix A;
b) Corrosion of the filter media to the material shall not affect the sealability of the filter element interface, the cleanability of the outer casing and the pressure resistance, due to stainless steel The release of substances caused by corrosion shall not affect the quality of the filter media;
c) The general design life of the outer casing shall be not less than 10 years, unless the supply and demand sides confirm the reduction of the design service life;
d) When the corrosion parameters of the filter medium to the material cannot be confirmed during design, the corrosion rate shall be measured according to the method specified in JB/T 7901;
Or choose stainless steel with high pitting corrosion equivalent (NPRE) value. For the calculation of NPRE, see A.2.
5.1.4 Inspection of chemical composition of host materials and filler metals
The manufacturer of the enclosure shall provide at least one of the following chemical composition test documents for the host material and filler metal.
a) proof of source of material containing chemical composition analysis;
b) re-examine the chemical composition of the material in accordance with the method specified in GB/T 11170;
c) Material Reliability Identification (PMI), see A.3.
5.2 Polymer materials
5.2.1 Selection of polymer materials
The outer casing sealing material should be coated with fluoropolymer with thermosetting rubber or thermosetting rubber without asbestos. The commonly used materials are shown in Table 4. outer The shell coating material should be a thermoplastic polymer without asbestos composition. The commonly used materials are shown in Table 5.
5.2.2 Biosafety of polymeric materials
The polymer material shall have no acute systemic toxicity according to GB/T 16886.11, and the extraction conditions are as follows. mass concentration is 9g/L The sodium chloride injection and the freshly refined vegetable oil were leached at 70 °C ± 2 °C for 24 h ± 2 h, and the ratio of the surface area of the sample to the extract was 6 cm²/mL ± 0.6 cm²/mL.
5.2.3 Quality documentation for polymer materials
At least the following quality documents should be provided for all polymer materials.
a) raw material manufacturer, brand, batch number;
b) additive components;
c) finished product number, batch number;
d) Date of manufacture.
6 Design requirements
6.1 Design parameters
Both the supplier and the buyer should confirm the following design parameters when ordering.
a) the enclosure category;
b) filter media;
c) design pressure or maximum allowable working pressure (if necessary);
d) design temperature;
e) the main material;
f) component materials that are not in direct contact with the filter media;
g) sealing material;
h) surface treatment requirements;
i) filter specifications (including filter diameter, length and interface) and quantity;
j) take over the standard, size and purpose;
k) pipe joint standards and specifications;
l) Other information that needs to be confirmed.
6.2 Shell category marking
The category mark of the outer casing is composed of the filter medium import and export arrangement code, the filter seat setting mode code and the filter quantity code.
The meaning of the code is shown in Table 6. See Appendix B for a schematic of the different types of enclosures.
6.3 Seal design
6.3.1 Sealing method
The cylinder flange or pipe joint of the outer casing shall be of sanitary seal, as shown in Figures 1a) and b); or O-ring seal, as shown in Figure 1c)
An ellipsoidal gasket or O-ring seal may be used between the valve body and the valve seat of the exhaust and drain valve.
6.3.2 Hygienic seal design requirements
Hygienic gasket seal design should meet the following requirements.
a) There is no gap between the gasket and the interface card slot;
b) there is no slip when the gasket is pressed and used normally;
c) The protrusion or depression of the gasket relative to the joint after pressing shall be no more than 0.6 mm, see Figure 2.
6.3.3 O-ring seal design requirements
O-ring seal design should meet the following requirements.
a) O-ring should not slide easily in the interface groove;
b) After the O-ring is pressed, it should fill the slot as much as possible, and it should be able to fully fill the gap at the joint, as shown in Figure 3;
c) In order to ensure the reliability of the seal, when the space permits, the O-ring with a larger diameter should be used as much as possible;
d) O-rings shall not affect their physical and chemical properties after thermal expansion or chemical expansion;
e) After the O-ring is installed, it does not include the coefficient of thermal expansion and chemical expansion, and the tensile elongation shall not exceed 5%;
f) the outer diameter of the O-ring should be no larger than the outer diameter of the groove to prevent bending;
g) O-ring compression should normally be maintained at 10% to 25%, and the shrinkage rate can reach 10% due to changes in materials and pressure. 30%, but not more than 30%;
h) The O-ring should be as close as possible to the fluid side;
i) O-rings conforming to GB/T 3452.1-2005 or ISO 3601-1:2012 standards should be selected, and the appearance should conform to GB/T 3452.2 Provisions.
6.3.4 Ellipsoid seal sealing design requirements
The ellipsoidal seal can be used for sealing between the valve body and the seat and should meet the following requirements.
a) When the gasket is pressed, the end surface should be able to fit seamlessly with the valve seat and the valve body, see Figure 4;
b) When the valve is opened, the gasket should not fall off easily;
c) The surface of the gasket should be free of cracks, pits, etc., which affect the sealing performance;
d) The resilience of the gasket shall ensure that the valve maintains a good seal after at least 1000 opening and closing.
6.4 Component design
6.4.1 Housing component composition
The components of the outer casing are shown in Table 7, and the components are marked in Appendix B.
6.4.2 Cylinder
The cylinder should be cylindrical, and the design of the internal pressure cylinder should meet the requirements of Chapter 3 of GB/T 150.3-2011.
The calculation shall comply with the provisions of Chapter 4 of GB/T 150.3-2011.
6.4.3 Head
The head should adopt an elliptical head or a dish-shaped head. The design calculation of the elliptical head should meet the requirements of 5.3 of GB/T 150.3-2011.
The design calculation of the dish-shaped head should meet the requirements of 5.4 of GB/T 150.3-2011.
6.4.4 Cylinder connector
The cylinder shall be flanged with O-ring seals, and the O-ring seal design shall comply with the provisions of 6.3.3. The diameter of the cylinder is not more than 150mm
The outer casing can also be connected by a sanitary pipe joint.
6.4.5 Filter holder
6.4.5.1 General design requirements for filter cartridges
The filter holder should meet the following requirements.
a) The filter holder should be set horizontally to ensure that the filter element is installed vertically; […]
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 38 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 150.3-2011Pressure vessels - Part 3: Design
- GB/T 150.4-2011Pressure vessels - Part 4: Fabrication, inspection and testing, and acceptance
- GB/T 983Covered electrodes for manual metal arc welding of stainless and heat-resisting steels
- GB/T 1031Geometrical product specifications(GPS) - Surface texture: Profile method - Surface roughness parameters and their values
- GB/T 1220Stainless steel bars
- GB/T 1954Methods of measurement for ferrite content in austenitic Cr-Ni stainless steel weld metals
GB/T 21833 · SJ20893 · ISO 3601-1:2012
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