Pure-Flo®

COMPLIANCE, APPROVALS AND VALIDATION DOCUMENTATION 77
The ITT Philosophy: We at Pure-Flo Solutions Group
believe in customer satisfaction through a total quality
approach in meeting our business objectives. Our strategy is
continuous improvement through the empowerment of our
people to satisfy our customers.
Quality of Design: Quality begins at the first stages of the
product design. Engineering, Manufacturing, and Marketing
work together to assure a functional design capable of meeting
our customers’ system requirements. All new products are
prototype and tested in our Engineering Lab prior to the new
product release. Design Reviews are conducted throughout
the product development process in accordance with ISO-
9000. This process ensures a high-quality functional and
manufacturable product.
100% Interior Surface Finish Inspection:
All Pure-Flo Valve bodies are 100% visually inspected for
adherence to the customer specified surface roughness. In
addition, a surface profilometer is also used as a check and
balance system to assure consistency between inspectors.
100% Visual Weld Inspection: All Pure-Flo Valve fabrication
welds are 100% visually inspected to assure defect-free
welds. All welds are performed by ASME Section IX certified
welders.
100% Leak and Shell Test: All Diaphragm Valve assemblies,
manufactured at Pure-Flo Solutions Group, are leak and
shell tested in accordance with MSS SP-88. The valve is pressurized
pneumatically and submerged in a noncorrosive liquid
and visually examined for leakage. The valve is tested in the
open and closed position.
100% Final Assembly Inspection: All completed valve
assemblies are 100% visually inspected prior to shipment to
assure proper assembly.
Certified Mill Tests Reports: All Pure-Flo Valve bodies
contain a heat number identifiable on the bottom surface of
the valve body. This heat number is traceable to the material
properties which can be provided on request in the form of a
Certified Mill Test Report (CMTR). If specified at order placement,
CMTRs can also be furnished for weld wire and tubing
used in Pure-Flo Valve fabrications. This report has become a
popular request to aid in facilitating the validation process.
Non-Destructive Testing: Alloy Identity Testing, Liquid
Penetration Inspection and Radiographic Inspection are Non-
Destructive Tests (NDT) performed upon request. Alloy Identity
Testing provides the exact chemical composition of the material
and is performed using a Texas Nuclear Alloy Analyzer.
Liquid Penetrant Inspection is a surface inspection capable of
identifying subsurface porosity and weld defects.
Radiographic Inspection is a volumetric test capable of locating
voids or inclusions within the material.
VALIDATION DOCUMENTATION
Pure-Flo Solutions Group can provide the following validation
documentation on request
• Certified Mill Test Reports on the valve body
• Interior Surface Characterization documentation
• Certification of compliance to specifications
• Certification of compliance to CFR Title #21 section 177
• Certification to USP XXIII Class VI compliance and/or physical
testing document
• Quality assurance manual
• ISO 9001 certification
• Certification of testing to MSS-SP-88
In addition, to assist you in compliance to IQs, OQs and PQs,
a preventative maintenance program can be established for
the change out of diaphragms based on your passivation,
cleaning, sterilization and process protocols. Pure-Flo
Solutions Group has a field sales force of 44 individuals
worldwide, backed up by local distribution to assist in your
start-up efforts, the training of your personnel, as well as
maintaining a local inventory to supply your component
needs.
SERVICE
Pure-Flo Diaphragm Valves are available to meet the requirements
of 3A sanitary standards. Strict in-house procedures
outlined in Engineering Specification ES-A-0007, assure a top
quality 3A product. Just look for the 3A tag.
Selection from the following configurations is necessary to
assure 3A conformance:
Body: 316L stainless steel investment casting or forging,
for superior quality and finish, 1/2"–6" (DN 15–150).
Interior Polishes: 35 μin (,89 μm, 150 grit) through 11μin
(,28 μm, 320 grit) interior polishes are available, as well as
electropolish exterior.
End Connections: Five (5) different quick disconnect end
connections for 16 gauge tubing, as well as buttweld for
16 gauge tubing.
Diaphragms: For Class I Applications, Grade R-2 PTFE is
utilized. For Class III Applications, Grade P Buna N or Grade
H EPDM may be used.
Bonnet/Actuator: Stainless steel, cast or ductile iron bonnet
shells ground smooth to meet ACI surface indicator scale
SIS-3. All non-stainless surfaces to be coated with PVDF.
Bonnet shells have four 3/32" (2,4 mm) diameter holes 90°
apart to assure a drain hole at the lowest point of installation.
Bonnet bolts or studs are stainless steel; cap nuts are
designed to eliminate exposed threads and are also stainless
steel. Only food grade lubricants shall be used.
Bonnet internals consist of the following:
• Stainless Steel Bushing
• Stainless Steel Stem
• Stainless Steel Fingerplate where applicable
• PVDF Coated Compressor
Note: PVDF complies with the requirements of 3A Spec. #2000.
USDA ACCEPTED
The Pure-Flo Diaphragm Valve is accepted by the USDA for
use in federally inspected meat and poultry plants.
Selection from the following configurations is necessary to
assure USDA acceptance.
Body: 316L stainless steel investment casting, or forging for
superior quality and finish, 1/2"–6" (DN 15–150).
Interior Polishes: 35 μin (89 μm, 150 grit) through 11μin
(28 μm, 320 grit) interior polishes are available, as well as
electropolish exterior.
End Connections: Five (5) different quick disconnect end
connections, including Tri-Clover Tri-Clamp, Cherry Burrell “S”,
“Q”, and “I” line, male sanitary thread or any combination of
the above, to match your process piping requirements.
Diaphragms: Five (5) different diaphragms including Soft
Gum Rubber, Black Butyl, Buna N, EPDM and PTFE are available.
Bonnets: A variety of bonnet options including atmospheric
white epoxy, Nylon 11 and PVDF coatings, as well as stainless
steel may be selected.
VALIDATION & APPROVALS