1、Tubes & Fittings 丁祿軍丁祿軍成都辦事處成都辦事處A healthy injection for your businessAgendaProduct rangeComparision ISO 2037 vs. ASME BPEMarking and packagingDocumentation packagePricingCA healthy injection for your businessTri-Clover UltraPure Tube and Fitting portfolioLaunch During 2010NEWMaterial A healthy

2、injection for your businessDifference of Normal ISO and ASME BPEISO 2037ASME BPESurface finish Ramax (m)ID0,5-0,4 EP0,5-0,4 EPOD1,00,8Material1.4404, (316L)ASTM A270 S2Chemical CompositionNormalStrictWall thickness (mm)1.0, 1.2, 1.6, 2.00.89, 1.65, 2.11QA inspectionSamplingAllTraceabilityOptionSA he

3、althy injection for your businessASME BPE & ISO 2037 UPTri-Clover UltraPure SpecificationsDimension standardASME BPE ISO 2037Surface finishDesignationStandardInternal, RaExternal, RaPL /SF1ASME BPE0,5m0,8mPM/SF4ASME BPE0,4 EP0,8mH4oDIN 118660,4m0,8mHE40DIN 118660,4 EP0,8mMaterial316L(ASTM A270-S

4、2)1.4404(EN 10088-1)GasketsEPDM, FPM, Silicone, PTFE, Nitrile, White Nitrile, White FPMEPDM, FPM & PTFEA healthy injection for your businessDifferences - DimensionsASME BPEISO 2037DNInchOD/ID x tOD/ID x t8103/81512,7 x 1,65*2019,05 x 1,65*25125,4 x 1,6525 x 1,232140138,1 x 1,6538 x 1,250250,8 x

5、1,6551 x 1,265263,5 x 1,6563,5 x 1,680376,2 x 1,6576,1 x 1,61004101,6 x 2,11101,6 x 2,0 Difference in wall thickness. Same clamp rings are used for ASME BPE and ISO 2037-UP. * Will be available during 2010 A healthy injection for your businessDifferences - Surface finishSurface FinishASME BPEISO 203

6、7ASME BPEISO 2037SF1H4/H4oSF4HE4/HE4oInternalRa0,5mRa0,4mRa0,4EPRa0,4EPExternalRa0,8mRa0,8mRa0,8mRa0,8m SF1 and SF4 are in accordance to ASME BPE. H4/H4o and HE4/HE4o are in accordance to DIN 11866 Differences and acceptance criteria follows on the coming A healthy injection for your businessSurface

7、 texture acc. ASME BPEA healthy injection for your businessSurface texture acc. to DIN 11866Tubular fittings (bends and Tees): H4o and HE4oMachined fittings (reducers): H4 and HEA healthy injection for your businessAcceptance criteria for ASME BPEA healthy injection for your businessAcceptance crite

8、ria for ASME BPEA healthy injection for your businessAcceptance criteria for DIN A healthy injection for your businessSurface finish difference- Very little difference between the two standards !A healthy injection for your businessDifferences - MaterialSteel designationChemical Composition in % by

9、massNumberStandardCSiMnPSNCrMoNi1.4404EN 10088-1 0,030 1,00 2,00,045 0,015 0,1116,50 - 18,502,00 - 2,5010,00 - 13,00316L1) UNS S31603 0,035 0,75 2,000,04 0,030 16,00 - 18,002,00 - 3,0010,00 - 15,00316L 2)ASME BPE DT-3/ ASTM A270 S2 0,035 0,075 2,000,040,005 - 0,017 16,00 - 18,002,00 - 3,0010,00 - 15

10、,001) Clamp ferrule2) Weld ends and tubular material ISO 2037 tubes are TIG welded. ASME BPE tubes are laser welded. Both tubes are annealed. A healthy injection for your businessStainless steel material for weldingLow sulphurHigh sulphur L steel (ex. 316L) with low carbon level C 0,035 wt. %,compar

11、ed to “non L” steel (ex 316) C 0,080 wt. % Minimise the risk of carbide precipitation during the welding process. (Carbide precipitation weakens the weld and leads to premature corrosion) Controlled sulphur content, 0,005-0,017 wt.%, according to ASTM A270 S2. A low sulphur content gives a wide weld

12、 zone A high sulphur content develops manganese sulphide inclusions which gives micron-size pits after polishing and can cause pitting A healthy injection for your businessSulphur ContentA low sulphur content (0,0% - 0,005%) gives a wide weld pool and it is difficult to get a full penetration of the

13、 base material.A high sulphur content (0,020% - 0,030%) gives micron-size pits after electropolishing and can cause pitting corrosion (Sulphur and Manganese form manganese sulphide inclusions)A healthy injection for your businessSulphur ContentFor these orbital welds on 316L tubing, the electrode is

14、 centred on the weld joint. The weld on the left is 0.008 percent to 0.008 percent sulphur with a symmetrical weld puddle. The weld on the right is 0.002 percent sulphur (top) to 0.014 percent sulphur. The weld pool is shifted toward the low-sulphur heat, resulting in an asymmetrical weld bead. A he

15、althy injection for your businessASME BPE Product A healthy injection for your businessISO 2037 Product rangePhase 1 1”- 4” Bends 90 and 45 with weld ends Tees with weld ends Ferrules Clamp rings Clamp gaskets in EPDM, FPM and PTFEA healthy injection for your business Fittings in ” and ” Reducers Re

16、ducing Tees Use Points Tees with Clamp endsISO 2037 Product rangePhase 2 (launc Q2/Q3?)Tube Marking & PackagingISO 2037 Tri-Clover KS ODxt 1.4404(316L) ISO 2037 H?o CH xxxxxxx Tri-Clover UI LWT ODxt T316L ASME BPE SF? SA249/A249/A269/A270 S-2 NDE A 33-01 HT#xxxxxASME BPEPacked in plastic A healt

17、hy injection for your businessFitting Marking & PackagingISO 2037 & ASME BPE Laser markedTri-Clover UltraPure ISO 203738x1,2 1.4404 (316L) H3o KS AAABD Protected with Green end caps Packed in plastic bags with MTR certificate Labelled with item no, description and serial ID(ODxt, material, S

18、urface designation, Kunshan, Serial ID)A healthy injection for your businessASME BPE PackagingBox conceptBendsTeesFerrules Same heat no. Better protection Easy to store Re-use box A healthy injection for your businessSame documentationOnline access to MTR certificates https:/ FDA, USP Class VI and T

19、SE/ADI conformity declarations. Surface finish cert.Sub-titlesDocumentation packageISO 2037 & ASME BPEA healthy injection for your businessDocumentationWeldingPolishingCleaningMarkingQuality InspectionPackingApart from: MTR Elastomer conformity Surface A healthy injection for your businessWeld c

20、ost is one of the largest part of the total system costPoor welds gives many implications on the total system designUp to 90% of all product contact surfaces relates to tubes and fittingsCritical facts:Tubes & Fittings A healthy injection for your businessEquipment shall be of appropriate design

21、, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance.Equipment shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug productEquipment shall be cleaned, maintaine

22、d, and sanitized at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug productAbstracts from CFR 21 part 211 (US GMP):RA healthy injection for your businessWelding processGoal: A well documented weld with hig

23、h repeatability from weld to weldWelding SOPs for material handling, cutting and end-prepping of tubing, inert gas purging, welding, etc.Opening coupon a sample weld on the exact same material heat which is to be installed, demonstrates that the machine is set up properly, the purge is adequate, and

24、 the welding operator knows how to operate the equipmentCoupon log The opening coupon is logged and stored, incl. label, weld number, date, time, welder, heat number, argon cert., weld head, power supply, inspector signatureWeldingBench weldingField weldingWeld inspection(Re-weld)Pressure testingPA

25、healthy injection for your businessContaminationWeldabilityCostDocumentationOthers?= Customer valueCustomer key concernsTubes & FA healthy injection for your businessPolishing & CleaningNormally more that 90% of all product contact surfaces relates to tubes and fittingsLaser vs. TIG weldingC

26、orrosion and rouging + weldabilityAnnealed vs. unannelaedCorrosion and rouging + weldabilityOthers?ContaminationTubes & FA healthy injection for your businessMust not be reactive, additive or absorptiveMust be cleanableShould not corrodeBasics:Product contact surfacesRemember that tubes & fi

27、ttings stands for the majority of all product contacted A healthy injection for your businessPolishing/cleaningAcid testCorrect polishing/cleaning proceduresIncorrect polishing/cleaning A healthy injection for your businessLaser welding: Creates a deep narrow weld. Makes a smaller heat affected zone

28、. More corrosion resistant weld area. Straighter Weld Greater strength (less grain growth)Welding Laser vs TIGA healthy injection for your businessLaser Welding uses a high heat concentration: Creates a deep narrow weld. Makes a smaller heat affected zone. Result = more corrosion resistant weld area

29、.Laser vs TIGLaserTIGA healthy injection for your businessLaser vs TIGAdditional Advantages of Laser Welding: Straighter Weld Greater Strength (less grain growth) Finer Grain Structure. (good for fabrication)Disadvantage: welding edges must be preciseLaserTIGA healthy injection for your businessAnne

30、alingStress and hardness relieve caused by forming - (stress corrosion)Reduce segregations (Cr and Mo) - (prevent corrosion)Reduce ferrite content - (easier to weld.)Reduce Martensite content (magnetic) - (prevent corrosion)Dissolve carbides and other precipitates - (prevent corrosion)A healthy inje

31、ction for your businessRouge FormationStable systemWater H2OPassive Layer CrOSteelFe + A healthy injection for your businessWater H2OPassive Layer CrOSteelFe + othersFe (III) oxide (red brown)Fe2O3Fe (II) oxide (black)FeOFe (II, III) oxide(black) Fe3O4Rouge FormationClass I A healthy injection for y

32、our businessWater H2OPassive Layer CrOSteelFe + othersFe (III) oxide (red brown)Fe2O3Fe (II) oxide (black)FeOFe (II, III) oxide(black) Fe3O4Rouge FormationClass II A healthy injection for your businessAnnealing process importanceDocumentation show if a tube is annealed (heat treatment temperature is

33、 stated)Heat temperature alone does not prove good annealing process!-Too quick heating time gives a lower quality-Cooling media decides how good quality you get (Gas is best Water is worst)A healthy injection for your businessAnnealed vs unannealed tubesAnnealed tubes are: easier to weld less corro

34、sive lower risk of cracking A correct annealing gives a cost adder of around 1020% of total tube A healthy injection for your business Heat treatment- A healthy injection for your businessWeldability & CostCost per weld? US$ 200-250 (2-5 times more than the fitting cost)Incomming inspection Prepare weldingWeldInspect weldFill out welding documentationCertificate handlingCollect welding documentation A healthy injection for your businessWeldability & CostWhat affect weld cost:DocumentationWeld ends dimension continuity, packagi