USP H2O Success
USP H2O Success
Successful Project Delivery of
USP PW & WFI Systems
OBK Technology Ltd. 2008
USP H2O Success
“Define it, Design it, Deliver it”©
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This is a review of all the key steps required
for a successful USP water system delivery
This review covers; Science & Technology,
Pretreatment & Generation, Distribution
System, Project Management & Validation
Concept design to a validated conclusion
OBK Technology Ltd. 2008
USP H2O Success
Water – “Science & Technology”
OBK Technology Ltd. 2008
USP H2O Success
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Water is the worlds most ubiquitous
solvent
Water is able to absorb and carry some
of most of the known elements
With today’s ability to measure down to
parts per trillion – if you look for it - you
can find it!
OBK Technology Ltd. 2008
USP H2O Success
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Basic criteria: “Purified water must
meet the requirements for ionic and
organic chemical purity and must be
protected from microbial
contamination. PW systems must be
validated to reliably and consistently
produce and distribute water of
acceptable chemical and
microbiological quality”.
OBK Technology Ltd. 2008
USP H2O Success
USP XXIX allows WFI from distillation OR
an equivalent process (equivalent
processes not yet accepted by European
Pharmacopoeia)
„ WFI for global use products must come
from distillation
„ So to produce WFI - either vapor
compression or Multi-Effect distillation
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OBK Technology Ltd. 2008
USP H2O Success
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Water source is critical:
„ Potable sources include: surface, ground
and groundwater under surface influence
„ It is critical to understand seasonal
variability since this can mean big
difference in water sources
OBK Technology Ltd. 2008
USP H2O Success
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With characteristics defined - pretreatment
equipment can be selected
Pretreatment systems manage:
„ Scaling (precipitation) of mineral salts &
silica
„ Fouling due to organic and inorganic
materials
„ Oxidation due to chlorine, chloramines
OBK Technology Ltd. 2008
USP H2O Success
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Most scaling is controlled by one of;
softening, lowering pH, anti scalants, or nano
filtration
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Fouling is controlled with a multi-media filter
and / or cartridge filtration
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pH to remove dissolved gas, particularly
carbon dioxide
OBK Technology Ltd. 2008
USP H2O Success
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For organic & inorganic reduction - ultrafiltration, ultraviolet light, organic
scavenging and regular cleaning and
sanitization
For oxidation control - sodium bi-sulphite
addition, activated carbon and ultraviolet
light
OBK Technology Ltd. 2008
USP H2O Success
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With pre-treatment defined – select the main
purification method
„ Most usual is RO (Revere Osmosis) to
remove salt and organic material
„ Deionization (polishing) - either anion and
cation resins or Electro-Deionization.
OBK Technology Ltd. 2008
USP H2O Success
Project Management
OBK Technology Ltd. 2008
USP H2O Success
“Define it, Design it, Deliver it”©
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OBK Technology Ltd. 2008
USP H2O Success
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“Define it, Design it, Deliver it”©
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Start with a high level definition of the
requirements – a draft URS
The supply of USP - PW appears very
complicated.
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The reality – follow the many steps of
simple chemistry and logical process
engineering from start to finish
OBK Technology Ltd. 2008
USP H2O Success
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Finalize the technical content of URS
„ Develop a water consumption matrix
„ Develop clearly defined end water quality
specifications from;
„ What product(s) and/or cleaning
processes will be served at the points of
use
„ Develop the process requirements
OBK Technology Ltd. 2008
USP H2O Success
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Draft an outline schedule
„ This provides a preliminary indication of
the expected end date
„ This also provides a flag for those long
lead time items that need to be ordered
early
This is also the time you can reconfirm the
budget
OBK Technology Ltd. 2008
USP H2O Success
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Define the detail of the water source(s)
Temperatures, composition variability
Arrange for source sampling analysis if
required (recommended)
Check to ensure that all seasons and all
likely sources are covered and documented
OBK Technology Ltd. 2008
USP H2O Success
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Reconfirm the consumption usage matrix
spread sheet
Verify all the process requirements –
volumes, flows, temperature & pressure
Check all the points of use and their capacity
requirements & diversification
Reconfirm the required quality parameters
OBK Technology Ltd. 2008
USP H2O Success
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Make system capacity decisions from the
usage matrix
What is the hourly, daily and weekly
consumption need?
Is usage batch or continuous?
This will drive the system capacity choice &
prospective storage tank size
OBK Technology Ltd. 2008
USP H2O Success
What does a typical system look like?
OBK Technology Ltd. 2008
USP H2O Success
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Full USP system diagram here
OBK Technology Ltd. 2008
USP H2O Success
OBK Technology Ltd. 2008
USP H2O Success
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WFIRO® is a patented RO system that meets
or exceeds USP guidelines for WFI, but not
currently accepted in Europe
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WFIRO® technology does not require a tank
& is self sanitizing
OBK Technology Ltd. 2008
USP H2O Success
OBK Technology Ltd. 2008
USP H2O Success
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45 GPM 2 x Pass WFIRO®
Self Contained & Compact (20 x 6 x 6)
Softeners not shown
5 years of Municipal water data
Drought conditions upon start up
8 Months of operation – zero micro
count & zero cleaning
OBK Technology Ltd. 2008
USP H2O Success
OBK Technology Ltd. 2008
USP H2O Success
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Supplied by a 10 GPM system
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30,000 gallon tank – flat bottom - poor
turn over – outdoor – micro issues
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Ozone system solution
OBK Technology Ltd. 2008
USP H2O Success
OBK Technology Ltd. 2008
USP H2O Success
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2 floors each @ 25 K Sq Ft
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International vaccines supplier
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Equipment 18 months in outdoor
unsheltered storage prior to installation
- problems
OBK Technology Ltd. 2008
USP H2O Success
OBK Technology Ltd. 2008
USP H2O Success
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2 Pass RO system with multi media
filtration and EDI
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25 GPM capability
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Silica issues with rainy season
OBK Technology Ltd. 2008
USP H2O Success
OBK Technology Ltd. 2008
USP H2O Success
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185 GPM RO system
Over 30 Points of Use
Serious supply water issues –
Municipality not in control – Municipal
softeners not functional at time of
commissioning
City supply not to EPA standards at
times
OBK Technology Ltd. 2008
USP H2O Success
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Account for inbound and outbound
water use for cost credits from supply
source
OBK Technology Ltd. 2008
USP H2O Success
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Project management continues;
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Document all the usage criteria
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Review all criteria with the end users
OBK Technology Ltd. 2008
USP H2O Success
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Update and expand the preliminary URS into
the completed URS
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Sign off the user acceptance
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Reconfirm the budget and the schedule
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“Black box” P & ID
OBK Technology Ltd. 2008
USP H2O Success
10 Minute Networking Break
OBK Technology Ltd. 2008
USP H2O Success
System Design
OBK Technology Ltd. 2008
USP H2O Success
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“Define it, Design it, Deliver it”©
Evolve the initial detail design for;
Generation equipment
Storage requirements (buffer & quality
balance)
Distribution needs
Points of use
OBK Technology Ltd. 2008
USP H2O Success
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Continue to evolve the initial detail design;
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Confirm piping run(s)
„ (no dead legs and no air traps & 1 Mps
return flow)
Plan for expansion needs
Hot or chemical sanitization?
„ Ozone generation system requirements
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OBK Technology Ltd. 2008
USP H2O Success
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Create the final P & ID
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Create the schematic flow diagram &
preliminary layout
OBK Technology Ltd. 2008
USP H2O Success
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Prepare a FRS (Functional Requirement
Specification)
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This is a detailed description of the
functionality of the total system
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Along with the URS – it provides important
overview documentation for the later
validation stage
OBK Technology Ltd. 2008
USP H2O Success
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Pre-qualify vendors and suppliers
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Prepare all detail arrangement drawings
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Draft and finalize tender packages for all key
supply items
Pre-order long lead time items
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OBK Technology Ltd. 2008
USP H2O Success
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Specification package includes;
URS, FRS, Water Analysis,
„ Design Detail (surface finishes,
materials specs for product contact)
„ Instrumentation & Controls
„ Layout, orientation, sizes & access needs
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OBK Technology Ltd. 2008
USP H2O Success
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Evaluate all submitted tender packages for
content and scope coverage
OBK Technology Ltd. 2008
USP H2O Success
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Review systems design in the context of
tender packages and vendor / supplier input
detail
OBK Technology Ltd. 2008
USP H2O Success
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“Define it, Design it, Deliver it”©
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Reconfirm the budget and time line
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Confirm vendor and suppliers
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Issue purchase orders (long leads – pre
ordered)
OBK Technology Ltd. 2008
USP H2O Success
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Prepare detail work packages for;
Mechanical
Piping
Electrical
Civil / structural if required
OBK Technology Ltd. 2008
USP H2O Success
Verification & Validation
OBK Technology Ltd. 2008
USP H2O Success
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Develop FAT and SAT protocols
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Develop the commissioning protocol and
check sheets
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Execute the FAT on all key equipment
OBK Technology Ltd. 2008
USP H2O Success
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Develop validation documentation;
IQ
(installation)
(operation)
„ OQ
(performance)
„ PQ
„ SOP’s (required for training)
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The above are all based on the URS,
FRS and operations manuals from the
suppliers and vendors
OBK Technology Ltd. 2008
USP H2O Success
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Install all equipment
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Connect all piping
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Connect all control requirements
OBK Technology Ltd. 2008
USP H2O Success
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Execute the SAT from the developed SAT
protocol
OBK Technology Ltd. 2008
USP H2O Success
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Commission the system based on the
commissioning protocol developed
OBK Technology Ltd. 2008
USP H2O Success
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Update all “as built” drawings for the system
turn-over package
OBK Technology Ltd. 2008
USP H2O Success
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Execute the validation protocols based on
the approved documentation
Note: IQ can overlap with final installation
and the start of commissioning
„ OQ can overlap with the execution &
completion of commissioning
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OBK Technology Ltd. 2008
USP H2O Success
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PQ requires the SOP’s approved and
operator training to be complete
PQ execution is user driven, requires
constant monitoring (usually first month) and
full documentation
System requires ongoing monitoring,
recording & maintenance
OBK Technology Ltd. 2008
USP H2O Success
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System ready for turnover to users
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Questions Please
OBK Technology Ltd. 2008