WELCOME

PT.STAINLESSSTEELPRIMAVALVE
MAJUBERSAMASeminar

How EGMO implement ASME BPE

standard .
PresentedBy:
Mr. Alon Bousso, Regional Sales Manager
10.2014
 The
NEUMOEhrenberg
Group
 TheNEUMOEhrenbergGroup

Multinational organization of 26 companies

Over 1 billion $US in sales per year
1500 workers
Major
divisions:

StainlessSteel Metal Industrial

FlowEquipment CuttingTools StainlessSteel
 TheNEUMOEhrenbergGroup
StainlessSteelFlowDivision

EGMO VNE NEUMO HERRLI AWH RIEGER

Major industries served:

Food&Dairy Bio-Pharm Semiconductors Solar

 TheNEUMOEhrenbergGroup
StainlessSteelFlowDivision

EGMO VNE NEUMO HERRLI AWH RIEGER

Active distribution network in more than 30 countries

Depot network supply
NeumoEhrenbergCompanies: Partners:
Germany Israel Korea
Spain Turkey India
USA Scandinavia Singapore
UK China Philippines
Hungary Indonesia
Poland Malaysia
Switzerland Vietnam

Technical, Engineering & Educational Support Centers

 TheNEUMOEhrenbergGroup
StainlessSteelFlowDivision

EGMO VNE NEUMO HERRLI AWH RIEGER

International standards organizations participation:

SEMI IAFIS
ASME BPE EHDEG
ISPE 3A
DIN
 MaxPure
Bio-PharmFittings
(ASME-BPE)
 ASME BPE is a worldwide standard for the
Biopharmaceutical, Personal Care and API
industries
International standard established in 1997
Recognized in more than 30 countries
Support bio-processing, pharmaceutical, and
personal care product industries as well as
other applications with relatively high levels
of hygienic requirements,
covering the subjects:
Materials
Design & fabrication
Inspections, testing and certifications
 ?What Does it Provide
Clear acceptance/ rejection criterias
Easy to specify hygienic fittings, tubes & process
components for:
Components in contact with the product
Critical systems in product manufacturing: WFI,
steam, filtration & intermediate product storage
 ASME BPE std. comparison
Subject Standard
ASMEBPE DIN ISO 3A IDF SMS
11865
Materials 316L Sulfur content 0.005-0.017% - - - - -

Dimensions ASME BPE DT + - - - -

Tolerances ASME BPE DT + - - - -

Surface finish- RaMax ASME BPE SF-3 (0.5 m-M.P./0.38 - - - - -

m-E.P.)
Cleaning ASTM A 380 6.1 - - - - -

Marking Permanent Heat #, Size Mat., Std., + - - - -

Surface finish, Brand (Job#-MaxPure)

Packaging ASME BPE capped & bagged with label + - - - -

Documentations Material Test Report (MTR) + - - - -

Acceptance criteria for ASME BPE SF-1 + - - - -

interior surface finish
Acceptance criteria for ASME BPE MJ-3 - - - - -
weld profiles
 Using ASME BPE makes
Installation, validation & maintenance:

Easier to manage
Minimize overall project & maintenance costs
Guarantee quality & same tolerances
Faster start ups
Ease contractors by using quality tubes,
fittings & equipment
ASME BPE
Awards the end user & project
partners
REPEATABILITY

CONSISTENCY

QUALITY
COST REDUCTION

PRODUCTS UPGRADE
ASME BPE fittings save money
!!!
Less time spending on income
inspection
Shorter installation time
Decrease Validation time and cost
Geometric & Surface finish save time,
cleaning agents and waste treatment
cost
BPE Standards Committee Members
Committee established with Volunteers from
the following Industry Segments:
Industry Users (Biopharmaceutical Manufacturers)
Designer/Constructors (Engineering Firms)
Manufacturers (Equipment Vendors)
Material Manufacturers (Tubing & Fitting Mfrs.)
General Interest (Consultants, Inspectors, etc.)
Insurance/Regulatory
Company Commitment
EGMOisthefirst
fittingsmanufacture
tobeapprovedby
ASME.
Implementation of ASME BPE
2014 in EGMO
Production
Polishing
Welding
Cleaning
Q.A
FullTraceability
 Advanced Polishing Technology
Inner surface Guaranteed Ra
ing Technologyinbendingarea.
ur
e as
d M
a n
ing
lish
Po
AdvancedPolishingTechnology
Autopolishing:Repeatability
AdvancedPolishingTechnology-
Repeatability
competitor
 ASME BPE Standard
Requirements

Controlled Sulfur content of 0.005-0.017% for optimal

Automatic Orbital Welding process (Table DT-3, ASME BPE)
Automated orbital welding
Butt Welding: heat-to-heat variation

ELECTRODE ARC SHIFT

 ASME BPE Standard
Requirements
EGMO Implementation

Controlled Sulfur content of 0.005-0.017% for optimal

Automatic Orbital Welding process (Table DT-3, ASME BPE)
Automated orbital welding
Weld bead shifting

(A) (B)
Symmetrical weld puddle Symmetrical weld puddle
with deep penetration. shallower & smoother bead.
Cleaning Process Set-Up

Degreasing Pickling Passivating Drying

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15

.E.P
Process
R W W D.I. Wash
Finest Cleanability
FinalRinsing:
In-LinePassivation
acc. To ASTM A967 with Citric Acid.
Cleaning process with multi-step active cleaning:
1st Stage: anti-stained Alkali degreasing
2nd Stage: cascade water washing.
3rd Stage: Citric acid passivation.
4th Stage: DI washing.
5th Stage: with circulated DI water.
Final Stage drying with heated dry air units.
 Unconditional Quality
In-processcontrol
Special care for handling is taken to maximum
protection of component quality and traceability.
 Quality
Assurance
Egmo Quality Process

Rawmaterial
Raw materialInspection
Inspection

InProcess
In ProcessInspection
Inspection

FinalQA
Final QAInspection
Inspection
 Raw
Material
Inspection
Incoming Inspection of Raw Materials
Tube
Round Bar
Hollow Bar
Sheet
Coil
Production materials
 Incoming Inspection Process

General:
Each and every batch of raw material, arrives to the factory, is being
specimen inspected and recorded by Q.C Inspectors to comply with the
P.O requirements, while paying attention to the specified standards and to
the following examinations step by step:
.Incoming Inspection cont
StepNo.1Identification
Matching between suppliers C.O.T / C.O.A details and tube marking
for the parameters: Heat Number, Chemical Composition, Diameter,
Wall Thickness, Grade, etc.
.Incoming Inspection cont
StepNo.2PositiveMaterialIdentification(PMI)

Checking for material grade and composition using NITON XRF

Alloy Analyzer.
.Incoming Inspection cont
StepNo.3-Dimensionalmeasurements
O.D Measuring at 4 sections, as described at the following sketch,
with Caliber:

Section 1

Section 2 Section 3

Section 4 Section 4

Section 3 Section 2

Section 1
.Incoming Inspection cont
StepNo.4-Dimensionalmeasurements(Cont.)
Wall Thickness measuring at 6 points as described in the following
sketch, with Micrometer and Ultra Sonic W.T Instrument at the
edge of the tubes, and in addition at the middle of the tubes:

Seam

Point No.4 Point No.3

Point No.6 Point No.5

Ironing
.Incoming Inspection cont
StepNo.5-Dimensionalmeasurements(Cont.)
Welding and Ironing convexity / concavity is being inspected by
cutting a piece from the tube seam and ironing and detect them
with surface texture and form profile measuring machine.
.Incoming Inspection cont
StepNo.6-VisualInspection
Outer Diameter the O.D surface and seam line is being
inspected very carefully for defects and imperfections by
inspectors human eye.
Internal Diameter the I.D surface and seam line is being
inspected very carefully for defects and imperfections using
Video Borescope.
 In
Process
Inspectio
n
In-process control
Dimensional measurements in compliance
with specifications
Ra measuring
Visual inspection
Roughness measurements
with full CNC Tester and double Tip
.(top/down)
 Maximum Cleanability
EPProcessControlledParameters:
Temperature
Time
Concentration
Conductivity
Acidity
Iron content
Humidity level
Specific gravity
EP Process Validation Certificate
 Unconditional Quality
WeldingRequirements
According to ASME BPE part MJ (Material Joining)

WeldingProcedures
According to ASME IX
WPS Welding Procedure Specifications

WPQ Welder Performance Qualification

PQR Procedure Qualification Records

WeldingRequirementsDiscolorationMJ-8.4-2/3
ElectropolishedTubing MechanicallyPolished
 Product
Final QA
Inspection
Every Fitting Quality Inspected
FinalInspection
Surface Roughness (Ra) measurements acc.
to ASME BPE SF-2.4-1
100% Visual Inspection acc. to ASME BPE
SF-2.2-1,2.2-2 & SF-2.6-1
Dimensional measurements
acc. to ASME BPE DT-3-1
Parameters

Roundness Wall Thickness Squareness face to

tangent

Off plane Height Off angle

ASME BPE DT-5 Table
FinalTolerancesforM.PFittings
Every fitting quality inspected
FinalInspection
Dimensional measurements
acc. to ASME BPE DT-3-1

Off Angle
Off Plane
Squareness Face to Tangent
Every fitting quality inspected
FinalInspection
Dimensional measurements
acc. to ASME BPE DT-3-1

Outer diameter
Wall thickness
Height
Traceability
Traceability

Positive Material Identification (PMI)

Process routing (Job No.)
Final inspection (MTR On Line)
Permanent marking

Vendor
Warehouse
Production
Customers
Testing
Marking
Traceability Procedure - Vendor
Traceability starts at raw material suppliers, as all are
approved by EGMO Q.A acc. To ASME BPE
definitions.

Prior to approval of raw material and services suppliers, a

survey performed by EGMO Q.A at the suppliers site to
meet the requirements.
After approval there are two more audits during 5 years period.
Product Traceability Procedure

Incoming Raw Material Inspection

Incoming inspection with trace numbers contains the
following analysis:
Comparing P.O details to vendor's documents
Visual and dimensional inspection
Marking comparison to vendor's MTR, with special
notice to the Heat Number, chemical analysis and
mechanical properties
PMI Test Positive Material Identification
Product Traceability Procedure
Warehouse
Documenting the raw material records into EGMO'S system
using the Heat Number as the vendor's raw material trace
number
Product Traceability Procedure
Warehousing
Product Traceability Procedure

Production
Job numbers and Routing cards
opened with raw material allocations.
Each authorized employee signs his
operation of responsibility
Product Traceability Procedure
Testing
Q.C. inspection according Q.A. procedures
Product Traceability Procedure

Marking
Job number
Heat number
Material grade
ASME BPE SF code
Brand name
Product Traceability
Procedure
Labeling
Job number
Item description
Ra Finish ID & OD
Barcode for traceability
ASME BPE logo
Product Traceability
Procedure
Packaging
Each and every product is
caped and packed in a
plastic bag with label
MTR's are issued for each
item and Job number
Products are packed in a
card board box with
external labeling.
The external labeling
includes Job number,
material grade, item
Product Traceability Procedure
Customer
The MTR is the customer's
information certificate and
reference for the entire
traceability process.
The MTR document can be
generated on line via
MaxPure web site according
to the job number.
 Product Traceability Procedure
MTR On Line

.Click on the Job No

To get the material
.cert. online
No login required
Free of Charge

Unique QR Code
For smart phones
Getting the MTR
online
. No Login required
Thank
!You