ISPE CCChUSPH2OSuccess

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
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
USP H2O Success
Water Science & Technology
USP H2O Success
Water is the worlds most ubiquitous

solvent
Water is able to absorb and carry some
of most of the known elements
With todays ability to measure down to
parts per trillion if you look for it - you
can find it!
USP H2O Success
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.
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
USP H2O Success
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
USP H2O Success
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
USP H2O Success
Most scaling is controlled by one of;

softening, lowering pH, anti scalants, or nano
filtration
Fouling is controlled with a multi-media filter

and / or cartridge filtration
pH to remove dissolved gas, particularly

carbon dioxide
USP H2O Success
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
USP H2O Success
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.
USP H2O Success
Project Management
USP H2O Success


USP H2O Success
Start with a high level definition of the

requirements a draft URS
The supply of USP - PW appears very
complicated.
The reality follow the many steps of

simple chemistry and logical process
engineering from start to finish
USP H2O Success
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
USP H2O Success
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
USP H2O Success
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
USP H2O Success
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
USP H2O Success
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
USP H2O Success
What does a typical system look like?
USP H2O Success
Full USP system diagram here
USP H2O Success
USP H2O Success
WFIRO is a patented RO system that meets

or exceeds USP guidelines for WFI, but not
currently accepted in Europe
WFIRO technology does not require a tank

& is self sanitizing
USP H2O Success
USP H2O Success
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
USP H2O Success
USP H2O Success
Supplied by a 10 GPM system
30,000 gallon tank flat bottom - poor

turn over outdoor micro issues
Ozone system solution

USP H2O Success
USP H2O Success
2 floors each @ 25 K Sq Ft
International vaccines supplier
Equipment 18 months in outdoor

unsheltered storage prior to installation
- problems
USP H2O Success
USP H2O Success
2 Pass RO system with multi media

filtration and EDI
25 GPM capability
Silica issues with rainy season

USP H2O Success
USP H2O Success
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
USP H2O Success
Account for inbound and outbound

water use for cost credits from supply
source
USP H2O Success
Project management continues;
Document all the usage criteria
Review all criteria with the end users
USP H2O Success
Update and expand the preliminary URS into

the completed URS
Sign off the user acceptance
Reconfirm the budget and the schedule
Black box P & ID
USP H2O Success
10 Minute Networking Break
USP H2O Success
System Design
USP H2O Success

Evolve the initial detail design for;
Generation equipment
Storage requirements (buffer & quality
balance)
Distribution needs
Points of use
USP H2O Success
Continue to evolve the initial detail design;
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
USP H2O Success
Create the final P & ID
Create the schematic flow diagram &

preliminary layout
USP H2O Success
Prepare a FRS (Functional Requirement

Specification)
This is a detailed description of the

functionality of the total system
Along with the URS it provides important

overview documentation for the later
validation stage
USP H2O Success
Pre-qualify vendors and suppliers
Prepare all detail arrangement drawings
Draft and finalize tender packages for all key

supply items
Pre-order long lead time items
USP H2O Success
Specification package includes;

URS, FRS, Water Analysis,
Design Detail (surface finishes,
materials specs for product contact)
Instrumentation & Controls
Layout, orientation, sizes & access needs
USP H2O Success
Evaluate all submitted tender packages for

content and scope coverage
USP H2O Success
Review systems design in the context of

tender packages and vendor / supplier input
detail
USP H2O Success
Reconfirm the budget and time line
Confirm vendor and suppliers
Issue purchase orders (long leads pre

ordered)
USP H2O Success
Prepare detail work packages for;

Mechanical
Piping
Electrical
Civil / structural if required
USP H2O Success
Verification & Validation
USP H2O Success
Develop FAT and SAT protocols
Develop the commissioning protocol and

check sheets
Execute the FAT on all key equipment
USP H2O Success
Develop validation documentation;

IQ
(installation)
(operation)
OQ
(performance)
PQ
SOPs (required for training)
The above are all based on the URS,

FRS and operations manuals from the
suppliers and vendors
USP H2O Success
Install all equipment
Connect all piping
Connect all control requirements
USP H2O Success
Execute the SAT from the developed SAT

protocol
USP H2O Success
Commission the system based on the

commissioning protocol developed
USP H2O Success
Update all as built drawings for the system

turn-over package
USP H2O Success
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
USP H2O Success
PQ requires the SOPs 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
USP H2O Success
System ready for turnover to users
Questions Please

ISPE CCChUSPH2OSuccess

Diunggah oleh

Informasi Dokumen

Judul Asli

Hak Cipta

Format Tersedia

Bagikan dokumen Ini

Bagikan atau Tanam Dokumen

Opsi Berbagi

Apakah menurut Anda dokumen ini bermanfaat?

Apakah konten ini tidak pantas?

Hak Cipta:

Format Tersedia

ISPE CCChUSPH2OSuccess

Diunggah oleh

Hak Cipta:

Format Tersedia

USP H2O Success

USP H2O Success

OBK Technology Ltd. 2008

USP H2O Success

This is a review of all the key steps required

OBK Technology Ltd. 2008

USP H2O Success

Water Science & Technology

OBK Technology Ltd. 2008

USP H2O Success

Water is the worlds most ubiquitous

USP H2O Success

Basic criteria: Purified water must

USP H2O Success

OBK Technology Ltd. 2008

USP H2O Success

Water source is critical:

OBK Technology Ltd. 2008

USP H2O Success

With characteristics defined - pretreatment

OBK Technology Ltd. 2008

USP H2O Success

Most scaling is controlled by one of;

Fouling is controlled with a multi-media filter

pH to remove dissolved gas, particularly

USP H2O Success

For organic & inorganic reduction - ultrafiltration, ultraviolet light, organic

OBK Technology Ltd. 2008

USP H2O Success

With pre-treatment defined select the main

OBK Technology Ltd. 2008

USP H2O Success

OBK Technology Ltd. 2008

USP H2O Success

OBK Technology Ltd. 2008

USP H2O Success

Define it, Design it, Deliver it

Start with a high level definition of the

The reality follow the many steps of

USP H2O Success

Finalize the technical content of URS

USP H2O Success

Draft an outline schedule

USP H2O Success

Define the detail of the water source(s)

OBK Technology Ltd. 2008

USP H2O Success

Reconfirm the consumption usage matrix

OBK Technology Ltd. 2008

USP H2O Success

Make system capacity decisions from the

OBK Technology Ltd. 2008

USP H2O Success

What does a typical system look like?

OBK Technology Ltd. 2008

USP H2O Success

Full USP system diagram here

OBK Technology Ltd. 2008

USP H2O Success

OBK Technology Ltd. 2008

USP H2O Success

WFIRO is a patented RO system that meets

WFIRO technology does not require a tank