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									SYSTEM DESCRIPTION

A USP Purified Water System is provided for general pharmaceutical uses such as cleaning and pre-
treatment to distillation. The USP Purified Water System is designed as a skid mounted system, in a fully
validated, cGMP compliant fashion. The USP Purified Water System consists of the following fully
integrated major components:

       Multi-Media Filter
       Duplex Water Softeners and Brine Tank
       Carbon Loop Break Tank
       Hot Water Carbon Tank
       Cartridge Pre-Filters
       Carbon Loop Circulation Heater
       RO/EDI Loop Break Tank
       Reverse Osmosis System
       EDI System
       Ultraviolet Lamp
       Final Filtration System
       RO/EDI Loop Circulation Heater
       RO/EDI Loop Cooler
       Control System with HMI including all related instrumentation

The system is designed to produce 16-18 gpm (~25,000 gpd) of water meeting USP-28 – NF 23 guidelines
for Purified Water. The system is sized for continuous operation with peak consumption during a daily
12 hour shift.
PROJECT: USP PURIFIED WATER SYSTEM                                                        Page 2 of 16


PROCESS OVERVIEW




Cold city water is supplied at 21 gpm through a multi-media filter for the removal of large micron
particulates. Filtered city water passes to duplex alternating softening tanks for removal of calcium,
magnesium and other cations from the city water. Water softeners are sized for 1-1/2 days of softening
capacity per tank (2.4 mil grains) at peak consumption. The multi-media filter backwashes based on
time. The water softeners regenerate and alternate automatically based on total throughput.

Softened water passes into a hot water sanitizable carbon filtration system for the removal of chlorine,
reduction of TOCs / chloramines and particulates to 1 micron in size. The carbon loop uses a circulation
pump to transfer water continuously through a 5 micron pre-filter, carbon tank, 1 micron pre-filter,
circulation heater, and break tank. The carbon loop is designed for periodic sanitization using hot 80-85
°C water. During the sanitization process, contaminates will be released from the carbon filter. Flush
valves are provided at the inlet of the downstream break tank to prevent these contaminates from
fouling the RO/EDI loop and associated components. The carbon tank backwashes based on time.

Treated water from the pretreatment and carbon filtration system fills a RO/EDI Loop Break Tank. The
break tank is sanitary in design and equipped with a sterile vent filter, level controls, and return line
spray ball. Water that fills the break tank is blended with unused purified water. The break tank is
incorporated as part of the purified water generation loop.

Water from the break tank supplies water to the reverse osmosis system. A boost pump generates flow
and pressure through high temperature RO membranes. To increase system recovery, a portion of the
concentrate water is recycled back to the RO pump. Design recovery is 75%. The membranes will reject
PROJECT: USP PURIFIED WATER SYSTEM                                                          Page 3 of 16


95-98% of ionic contaminates. In addition, organics will be reduced to specifications based on molecular
weight. The RO will operate continuously and reject 3-4 gpm of concentrate water.

Permeate water from the RO feeds a single high temperature EDI module. The EDI module uses a
combination of membrane and resin technologies to reduce the ionic content in the water to desired
levels (0.5-0.06 µS/cm). A 600V electrical source from the control panel is used to regenerate the resin
resulting in a continuous deionization process. To conserve water, the concentrate from the EDI module
is returned back to the break tank.

Pure water from the EDI module passes through a UV lamp and final filtration system. The UV lamp will
deactivate microbes using 254-nm UV light. The absolute rated final filters capture the deactivated
microbes. Water that passes the final filters meets the specifications for USP Purified Water.

USP Purified Water is supplied through an owner supplied piping system to a USP Purified Water Storage
Tank. A series of divert valves mounted on the storage tank are interfaced to the water skid control
system. Water fills the tank based on a level signal from the owner supplied tank level transmitter.
Unused USP Purified Water is returned back to the break tank through an electric circulation heater and
chilled water cooling exchanger. On-line conductivity and TOC monitor will verify water quality.

The RO/EDI loop is design to be sanitized using hot 80-85 °C water circulated at low pressure and flow
rate through each of the components. During the sanitization process, contaminates will be released
from the RO membranes. Flush valves are provided at the inlet of the EDI module to prevent these
contaminates from fouling downstream components.

The system has a fault/alarm indicator and automatic shutdown based on operator programming for the
severity and type of fault. The system is operated by an independent PLC and normally operates
automatically. A "ladder-logic" program, runs through an Allen-Bradley SLC 5/05 programmable-logic
controller (PLC), controls the operation of the equipment. An Allen-Bradley Panel View 1000 operator-
interface terminal (OIT) is provided for the system monitoring and configuration. Set points, delay times,
and PID loop parameters can be changed via the OIT (access to configuration screens is limited with
security measures).

EQUIPMENT

Multi-Media Filter

One Ecodyne 16” x 65” fiberglass multi-media tank containing layers of increasing fine media over a bed
of gravel is provided at the inlet of the system. A Fleck multi-port control valve is installed on top of the
tank. The control valve has a self contained timer. The filter backwashes based on time. During
backwash, water will bypass the control valve. Filter backwash is interfaced to the control system.
Typical filtration level is 5 to 15 microns.

Duplex Alternating Water Softeners

Two Ecodyne 24” x 72” fiberglass water softener tanks contain 8 ft3 of strong acid cation resin in the
sodium form over a bed of gravel is installed after the media filter. Each tank has a Fleck multi-port
control valve installed on top of the tanks. A water meter is installed downstream of the softeners. The
control valves are interfaced to the water meter. The meter will totalize water throughput and initiate a
regeneration of the online softener tank when the tank is exhausted. When one tank is exhausted, the
PROJECT: USP PURIFIED WATER SYSTEM                                                         Page 4 of 16


other fully regenerated tank will be placed in service for continuous operation. Water softener
regeneration is interfaced to the control system.

A single 30” x 48” brine maker will make brine for the regeneration of each water softener. Total salt
capacity is 1200 #. The tank is made of high density polyethylene with a grid plate to prevent salt
bridging.

Carbon Filter Break Tank

One custom stainless steel atmospheric vessel shall be provided with level float/switch. The tank is
completely self drainable. The tank is equipped with a heat traced vent filter and u-bend vent line. The
vessel will have a minimum working volume of 100 gallons. The vessel will be fabricated out of 304
stainless steel with welds ground smooth. The external surface finish shall be 2B with welds ground
smooth. The tank is incorporated within the carbon filtration loop and is hot water sanitized during
carbon filter sanitizations.

Carbon Filter Boost Pump

The boost pump is centrifugal design, sized to circulate 5 to 21 gpm of water through the pre-filters,
carbon tank, and circulation heater. Discharge pressure to be at least 40 psi. Pump is variable speed
and operates at different flow rates depending upon system demand. During demand periods, pump
will supply adequate flow for make-up to RO/EDI loop. During non-demand periods pump provides
continuous circulation through the carbon filter.

The pump is complete with electric motor and casing drain. The pump has a VFD controller. The pump
controls and VFD are operated through the control system.

Duplex 5 Micron Pre-Filters

Duplex filtration system is located upstream of the carbon filter. System consists of two GE Osmonics 3
round by 2 high filter housings with integral stands. Housings are 316L stainless steel with silicone o-ring
seal. Housings are fabricated by ASME certified welders. Housings have satin outside finish and mill
finish interior. Filter connections are Code 8 (222) with internal post and supports. A v-band clamp
holds the housing head to the base.

Each housing is installed with individual isolation valves, bleed valve, and drain valve. NIST calibrated
inlet and outlet pressure gauges are mounted on front of each housing.

Filters are nominal rated 20” - 5 micron cartridges with Code 8 (222) ends and a fin top. Cartridges are
constructed with multiple layers of asymmetric melt blow polypropylene media contained within a
polyester core, end caps, and cage. Gaskets are silicone. Media meets USP 24 Class VI requirements.
Efficiency is 95%.

Carbon Tank

One custom 24” by 60” steel tank with high temperature lining contains 8 ft3 of activated carbon over a
bed of gravel. Tank is configured with high temperature Aquamatic valves interfaced to the control
system. The control system backwashes the filter based on time to remove trapped particulates. During
PROJECT: USP PURIFIED WATER SYSTEM                                                          Page 5 of 16


backwash, water is not permitted to pass the tank. Filter is sized for an empty bed contact time (EBCT)
of 3 minutes resulting in removal of Free Chlorine and Odors and a reduction in Organics and
Chloramines.

Duplex 1 Micron Pre-Filter

Duplex filtration system is located downstream of the carbon filter. System consists of two GE Osmonics
3 round by 2 high filter housings with integral stands. Housings are 316L stainless steel with silicone o-
ring seal. Housings are fabricated by ASME certified welders. Housings have satin outside finish and mill
finish interior. Filter connections are Code 8 (222) with internal post and supports. A v-band clamp
holds the housing head to the base.

Each housing is installed with individual isolation valves, bleed valve, and drain valve. NIST calibrated
inlet and outlet pressure gauges are mounted on front of each housing.

Filters are nominal rated 20” - 1 micron cartridges with Code 8 (222) ends and a fin top. Cartridges are
constructed with multiple layers of asymmetric melt blow polypropylene media contained within a
polyester core, end caps, and cage. Gaskets are silicone. Media meets USP 24 Class VI requirements.
Efficiency is 95%.

Carbon Filter Circulation Heater

One Indeeco packaged circulation heater rated at 20KW-480V-3P is provided. Unit has 304 stainless wet
components with flange elements and 1.5"-150# flanged inlet / outlet ports. Unit has 50WIN2 watt
density. Electrical interface is through a NEMA 4 enclosure. Unit is assembled in accordance with ASME
section VIII, Division 1, Code Stamp U. One process thermocouple attached to element bundle and one
pilot duty thermostat is provided as a hardwired safety. Unit is vertical with an upward flow mounting
configuration. Unit is 57"H x 7.5"D. Heater is designed to heat water flowing @ 5 gpm with an inlet
temp of 17°C and an outlet temp of 30°C. The design temp and pressure is 87°C @ 100 psig.

One 16"H x 14"W x 8"D NEMA 4X fiberglass contactor control panel operates the heater. Panel is
supplied with 480V-3P and incorporates a remote thermostat process control, one 50A contactor, one
120 VAC control transformer, interface to the main control panel, a type K limit control, a 60A
disconnect switch, no fusing, and 150W enclosure heater for freeze protection

RO/EDI Loop Break Tank

One custom stainless steel insulated atmospheric vessel shall be provided with level control. The tank is
a vertical cylindrical tank of sanitary design. All pure water contact surfaces are 316L stainless steel with
welds ground smooth and with an internal electropolish finish. The tank is designed to be free draining.
The tank is equipped with a heat traced vent filter and u-bend vent line. The tank is incorporated within
the RO/EDI loop and is hot water sanitized during the RO/EDI sanitizations. Tank has a removable spray
ball assembly at USP return line.

RO Boost Pump

The Grundfos RO boost pump shall be multi-stage vertical design, sized to circulate at ~41 gpm of water
through the RO membranes and 16-18 gpm through the EDI module, UV, final filters, circulation heater,
PROJECT: USP PURIFIED WATER SYSTEM                                                        Page 6 of 16


and cooling heat exchanger. Discharge pressure to be ~260 psi. Pump is variable speed and operates at
different flow rates depending upon system demand. During sanitization, the pump will operate at
lower speeds and pressures per RO membrane and EDI manufacturer specifications.

The pump is complete with electric motor and casing drain. The pump has a VFD controller. The pump
controls and VFD are operated through the control system.

RO Membranes

The RO Membranes are configured in a 5:3 array with membranes contained in eight GE Osmonics 4” x
80” housings. Housings are 316L stainless steel with stainless steel end caps. Housings have side entry
tri-clamp ports eliminating the need for high pressure piping. Permeate plugs are stainless steel.
Permeate and concentrate connections are tri-clamp.

Membranes are FILMTEC™ HSRO heat sanitizable reverse osmosis membrane elements. Membranes
are Polyamide Thin-Film Composite. Membranes are full-fit configuration minimizing stagnant areas.
Each element has an active area 90 ft2.

RO is configured with concentrate and recycle lines, roto-meters, and pressure gauges. All permeate
contact surfaces are sanitary in design using tri-clamp connections. Inlet and outlet conductivity sensors
are provided to monitor RO performance.

EDI Module

One Ionpure EDI hot water sanitizable module with tri-clamp connections is provided. Module is piped
to RO permeate line using 316L stainless steel. Module is powered by 600V power supply in high
voltage panel. Output is adjusted using the module interface on the door of the panel. Module has
double o-ring seals for leak-free operation, electrical isolation, and suitable up to 100 psi continuous
operation. Module is 26.19” long by 20.92” wide. Module is suitable for sanitization at 85 °C up to 30
psig pressure. Sanitization can be instant without ramping. Recovery through module is 93% or better.

Inlet and outlet conductivity sensors are provided to monitor EDI performance. Concentrate flow switch
is provided as a safety. EDI is grounded per manufacturer’s recommendation.

UV Lamp

One Aquafine SL Series UV lamp is provided. Connections are tri-clamp. Internal parts are 316L stainless
steel. Unit has a running time meter, ballast, and UV intensity meter. Two double ended 254-nm lamps
and quartz sleeves are provided. Unit is UL and CE listed.

Final Filters

Two Allegheny Bradford 3 round by 2 high filter housings with stands are provided. Housings are 316L
stainless steel with silicone o-ring seal. Housings are fabricated by ASME certified welders. Housings
have 25 Ra internal surface finish with no wetted threaded connections. Internal and external finishes
are electropolished. Filter connections are Code (226) with locking tabs. Swing bolts hold the housing
head to the base.
PROJECT: USP PURIFIED WATER SYSTEM                                                        Page 7 of 16


Each housing is installed with individual isolation diaphragm valves, bleed valve, and drain valve. NIST
calibrated inlet and outlet pressure gauges are mounted on top and discharge of each housing.

Filters are Graver absolute rated 20” – 0.2 micron cartridges with Code 7 (226) ends and a fin top.
Cartridges are constructed with double layers of polyester membrane media contained within a
polyester core, end caps, and cage. Gaskets are silicone. Media meets USP 24 Class VI requirements.
Each cartridge is supplied with a validation support guide.

Filters are arranged to be integrity tested in place using either a manual bubble point or automated
pressure hold / water intrusion method.

RO/EDI Circulation Heater

One Indeeco packaged circulation heater rated at 37kW -480V-3P is provided. Unit has 316L stainless
wet components with flange elements and 1.5"-150# flanged inlet / outlet ports. Unit has 50WIN2 watt
density. Electrical interface is through a NEMA 4 enclosure. Unit is assembled in accordance with ASME
section VIII, Division 1, Code Stamp U. One process thermocouple attached to element bundle and one
pilot duty thermostat is provided as a hardwired safety. Unit is vertical with an upward flow mounting
configuration. Unit is 38"H x 11"D. Heater is designed to heat water flowing @ 21 gpm with an inlet
temp of 17°C and an outlet temp of 23°C. The design temp and pressure is 83°C @ 100 psig.

One 20"H x 16"W x 8"D NEMA 4/12 painted steel SCR control panel operates the heater. Panel is
supplied with 480V-3P and incorporates a remote thermostat process control, one 50A contactor, one
120 VAC control transformer, interface to the main control panel, a type K limit control, a 60A
disconnect switch, no fusing, and 150W enclosure heater for freeze protection

RO/EDI Chilled Water Heat Exchanger

One Allegheny Bradford heat exchanger is provided to cool the RO/EDI loop. The heat exchanger has
10.5 ft2 of surface area and designed to maintain temperatures of the RO/EDI loop at 20°C. The
exchanger is designed in accordance with ASME Section VIII Div. 1 and TEMA guidelines. The heat
exchanger is double tubesheet type with 316L stainless steel product contact surfaces. Process contact
surfaces are cleanable with no pockets or crevices. Unit is designed to be drainable in the designated
mounting orientation. Tri-clamp style fittings are used on all product connections. Process fluids will
circulate on the tube side of the exchanger. The cooling medium shall be on the shell side of the
exchanger.

All welding procedures shall be in accordance with section IX of the ASME Boiler and Pressure Vessel
Code. All welding shall be of GTAW (tig) or GMAW (mig) types. All product contact tube to tubesheet
joints shall be seal welded. All grinding tools shall not have been used previously on carbon steel
materials. The unit shall be manufactured in an area separated from any area where carbon steel is
being ground. Testing shall be done accordance with Section VIII Div 1 of the ASME code.

Product contact surfaces are 316L stainless steel. Non-product contact surfaces are 304L stainless steel.
Bolting is stainless steel all-thread-monel with hex nuts & washers. Elastomers are Viton USP Class VI.
Product contact finish is <25 Ra. Non-product finish is mill, glass beaded blasted. Design pressure is 150
psig @ 177 °C.
PROJECT: USP PURIFIED WATER SYSTEM                                                       Page 8 of 16


MECHANICAL DETAILS

General

All exposed moving parts are enclosed with OSHA approved guards.

Equipment complies with the Current Good Manufacturing Practices of the Department of Health,
Education and Welfare; Food and Drug Administration and the Department of Health and Social
Services.

Design includes provisions for ease of maintenance of all components. A 3D model will be generated for
approval prior to fabrication for access verification.

All pressure rated vessels shall be designed, fabricated, inspected and tested in accordance with ASME
Code Section VIII, Division 1. National Board (NB) registration and U stamp.

Relief valves are provided for the process and utility sides of heat exchangers as required by codes.
As a minimum, the valves shall be sized for conditions of thermal expansion, failed open regulators /
control valves, blocked outlet with continued heating, and fire scenario.

Field NIST calibration of all instrumentation is provided.

All engineered wiring systems and their components are assembled in accordance with UL 508A
standards.

Materials and Finishes

RO/EDI Loop

Tubing will be manufactured of Type 316L stainless steel using TIG (Tungsten Inert Gas) welding
methods without the addition of filler metal to produce pharmaceutical grade tubing conforming to
ASTM A269 and A270. Tubing will be fully annealed after welding. Tubing wall thickness will be as
follows: 1/4" OD 0.035"; 3/8" OD 0.035"; 1/2" through 3" OD 0.065"; 4" 0.083". Tubing is 20 µ inch Ra
internal and 30 µ inch Ra external surface finishes.

Tube fittings will be suitable for fabrication into the system by automatic welding or sanitary clamped
connections. Fittings will be of material, wall thickness, and finish specified for tubing.

Automatic machine butt-welded and tri-clamp type joints will be provided. Tri-clamp type joints will be
used when connecting to equipment and accessories with tri-clamp type ends; ANSI Flange / Victaulic
type joints will be used when connecting to equipment accessories with ANSI Flange / Victaulic type
ends; otherwise, joints will be automatic machine butt-welded.

Pretreatment / Carbon Filter Loop

Materials will be Schedule 80 PVC or Type-L copper installed for the intended services and operating
temperature. Valves and fittings will be installed in a manner to prevent standing water. Unions will be
provided in locations to facilitate service or component replacement.
PROJECT: USP PURIFIED WATER SYSTEM                                                           Page 9 of 16


Support Frame

Support frame fabricated using epoxy painted steel or 304 stainless steel square tubing. All welds
ground and polished suitable for washdown cleaning.

Valves

Sanitary piping will have diaphragm valves with tri-clamp or butt weld endings to match ferrules to
which they are attached and Teflon faced EPDM gaskets. Interior finish will be electro-polish over multi-
pass mechanical polish to 32 micro-inch Ra. Exterior finish will be standard mill finish. All elastomers
shall be either PTFE or EPDM and be CFR 21 Part 177 compliant.

Non-sanitary piping will have ball or gate valves with threaded endings to match components they are
attached to. Gaskets will be silicone or EDPM. Finishes will be compatible with softened water.

Pneumatic diaphragm and ball valves will be supplied with limit switches tied to the control system to
indicate status of the valve. Aquamatic valves are not available with limit switches.

Assembly

All sanitary pipe work is seamless and designed and constructed to be adequately sloped (target of 1/8”
per foot) to allow free self-drainage to a common drain. Size reductions in horizontal pipe will be made
with eccentric reducers only and be positioned to allow for self-drainage. Branch valves, gauges, and
control devices will be located within six pipe diameters of branch pipe measured from axis of piping
main.

Non-sanitary pipe work will be threaded and arranged to allow for drainage. Piping will be arranged to
minimize standing water and dead-legs.

Painting and Insulation

All non-insulated, non-stainless steel metal components shall be painted with epoxy paint that is
resistant to water, ethanol, acetone and isopropyl alcohol.

All potentially hot piping will be insulated with chloride free insulation. All insulated surfaces will be
cleaned to remove dirt, grease, or other foreign matter prior to application of insulation materials. Tank
heads will not be insulated.

All openings for nozzles, nameplates, etc., will be cut as close as possible to achieve a tight fit without
interfering with make up connections.

Nameplates and Code stamps will be left uncovered and readable.

Certification

Stainless steel valve, tube and fitting certification will indicate mill heat number from which they were
manufactured. Chemical analysis will be furnished for each mill heat number.
PROJECT: USP PURIFIED WATER SYSTEM                                                         Page 10 of 16


Weld and Passivation certificates shall be provided for all sanitary piping and tubing including the
following as a minimum:

       Weld Log
       Weld Map
       Material Certifications including Heat Numbers
       Welding Procedures
       Welder Qualifications
       Boroscope of all welds (where boroscope access is possible), with 10% of those welds being
        videotaped

CONTROL SYSTEM

Description

The control system includes a main control panel and separate high voltage distribution panel. Main
power will be provided to the high voltage distribution panel. High voltage will be routed to the
equipment where required. A step down transformer will provide the necessary voltage to 110V field
equipment and the main control panel.

The main control panel is a NEMA 4 panel mounted on the skid frame. The panel will have an operator
interface mounted to the front of the control panel. The operator interface is an Allen Bradley
Panelview 1000 screen with an Ethernet communication port. The OIT will communicate with the PLC
via the Ethernet port using an Ethernet protocol. The OIT will allow the users to view process data,
enter setpoints and change control states. The main control panel door will also contain conductivity
meters displaying system information.

The control system will automatically control the pumps and automatic valves on the system for a
seamless continuous operation of the system. The control system will also control the operation of the
two purified water supply and divert valves (owner installed - as depicted in the overall system
schematic). Connection of pneumatic lines from the valve is provided.

The OIT will use a series of screens to navigate the system controls. The OIT screens will provide for
operations monitoring, operator interface, alarm monitoring and alarm summary, and system
diagnostics. The operations screens will indicate the operating parameters and status of the equipment.
Operators will have the ability to set timers, change timers, control and change flow rates and controller
set points, and select sanitization recipes from the main control panel. Operator interface screens will
enable the operator to operate the equipment via programmable function keys and input selected
numeric data. The diagnostics screen(s) shall provide status of critical inputs and outputs.

The system will include continuous alarm monitoring. Critical alarms will result in a safety interlock
requiring operator action. The operator will be required to acknowledge the alarm before the alarm can
be reset and the system restarted. All alarms will be displayed on the alarm summary page. When any
alarm is reported, the PLC will generate a signal to an audible device on the control panel. Audible
alarms will be silenced on the OIT. The operator interface will be provided with a restart button to
restart the equipment for operation after alarm clearance. Sanitization sequences will restart from the
point of alarm.
PROJECT: USP PURIFIED WATER SYSTEM                                                        Page 11 of 16


The control system will be fully 21 CFR Part 11 compliant. Software automation shall be deployed to
achieve Part 11 compliance wherever practical. Compliance validation is a customer responsibility.

The equipment will be provided with an Emergency Stop button. The Emergency Stop button will be
highly visible and readily accessed without obstruction. When activated, the hard-wired Emergency Stop
button disables all mechanical operations immediately.

Security

Access to certain screens will require entry of a numeric password. If a password-protected screen is
accessed, a pop up will appear requesting log in. If the correct password is entered, access will be
granted. If an incorrect password is entered, access will be denied and the OIT will return to the
previous screen. Log out is automatic when the screen saver activates on the OIT. Screen saver
activation is user adjustable. Password protection is provided at three (3) levels: Operator, Supervisor,
and Maintenance. These passwords can be modified on the Supervisor screen.

OIT Screens

The following are proposed Control Panel OIT Screens. Final screens may vary.

 Screen Number     Description                    Comment
 NA                Alarm Banner                   Pop up display when an alarm occurs
 1                 Main                           Main Screen
 2                 Navigator                      System Navigation Screen
 3                 System Overview                System Overview Screen
 4                 Pretreatment Status            Displays detailed information about the pretreatment
                                                  Displays detailed information about the carbon filter, pre-
                   Carbon Filter Status
 5                                                filters, carbon circulation heater, and carbon break tank
                   RO Break Tank and              Displays detailed information about the RO break tank, RO
 6                 Exchangers Status              circulation heater, and RO chilled water exchanger
 7                 Reverse Osmosis Status         Displays detailed information about the RO.
 8                 EDI Status                     Displays detailed information about the EDI
 9                 UV and Final Filter Status     Displays detailed information on the UV and Final Filters
 10                Active Alarm                   Displays active alarms
 11                Alarm History                  Displays alarm history
 12                Operator                       Operator control screen
 13                Admin                          Administrator control screen
 14                Control Setpoint               Control setpoint adjustment screen
 15                Alarm Setup                    Alarm setup adjustment screen
 15                Output Override                Output override screen
 16                PID Loop Tuning                PID Loop tuning screen
 17                Alarm Delay                    Alarm delay adjustment screen.
PROJECT: USP PURIFIED WATER SYSTEM                                                        Page 12 of 16


Analog Inputs

The Control System will interface with field-mounted sensors that are connected to the PLC analog
inputs through terminal blocks in the main control panel. This data will be scaled and used for control
within the PLC and indicated on the OIT. 10% additional capacity will be provided.

Analog Outputs

The Control System will interface with field-mounted controls that are connected to the PLC analog
outputs through terminal blocks in the main control panel. This output will be used for control and
indicated on the OIT. 10% additional capacity will be provided.

Discrete Inputs

The Control System will interface with field-mounted sensors that are connected to the PLC discrete
inputs through terminal blocks in the main control panel. This data will be used for control within the
PLC and indicated on the OIT. 10% additional capacity will be provided.

Discrete Outputs

The Control System will interface with field-mounted controls that are connected to the PLC discrete
outputs through terminal blocks in the main control panel. This output will be used for control and
indicated on the OIT. 10% additional capacity will be provided.

Interface with Other Systems

The Control System will be interfaced to the USP Storage tank level sensor. When required, the control
system will open and close the storage tank fill and divert valves. A set of common dry contacts is
provided as a general remote alarm interface.

System Architecture

The Control System will consist of (1) Allen Bradley SLC 5/05 PLC and (1) PanelView 1000 Operator
Interface Terminal.

The PLC and PanelView will communicate over an Ethernet cable internal to the main Control System
cabinet.

The PLC and PanelView will be programmed and communicate using Panelbuilder 32 Rev 3.82,
RSLogix500 Rev #7.00.00, and RSLinx #2.50.00 or newer versions.

Power Loss

In the event of a power loss the system will return to the state prior to power loss. The Panelview will
return to the Main screen.
PROJECT: USP PURIFIED WATER SYSTEM                                                      Page 13 of 16


Power Up

The Process PLC is operational upon the application of power. The program will execute, based on
inputs and operator interface settings, on the application of power.

The PanelView terminals are operational upon the application of power. The main screen is the start up
screen.

Power Down

The PanelView consoles and PLC processor have battery-backed memory which will maintain the
programming when power is removed.

Redundancy

The PLC’s processors and OIT’s have battery backed RAM which will retain the contents of user memory
through extended power outages. Should a hardware failure result in a loss of program software the PLC
& Panel View software must be restored from backup into the repaired hardware. There is a 10%
hardware redundancy in the PLC control system. A hardware failure may cause the system to become
inoperable or may cause unexpected results.

Manual Control Operations

Manual operations can only be initiated from the password protected PLC Output Override and PID
Loop Tuning Screen. A PLC output can be turned off or turned on. In the case of analog outputs, these
can be turned off (0%) or turned on. When an analog output is turned on, it will be set to the analog
override % set from the override screen. Only PLC outputs controlled by the Local PLC rack are available
for override.

The normal operating mode of all PLC outputs is Automatic. All outputs will be set to Auto from the PLC
Output Override Screen and PID Loop Tuning Screen. If any of the outputs are not in automatic, the
Override Indicator will appear on all screens.

Automatic Operator Control Functions

Operator control functions are initiated from the password protected Operator screen. When selected,
these functions will enable the automatic control sequence associated with that function. The operator-
initiated functions will have associated prerequisites and permissives.

The control system uses multiple sequence steps. Each step will have a unique indentifying initiating
condition, any action conditions and setpoints, step number, and the state of the system outputs and
valves

ELECTRICAL

The system shall be provided complete, with all necessary motor starters, step-up and step-down
transformers, and transfer switches premounted in the control enclosures.
PROJECT: USP PURIFIED WATER SYSTEM                                                       Page 14 of 16


All motor starting equipment and transfer switches shall be separated from the control panel devices in
a manner to prevent interference with these devices. A separate motor starting panel may be provided
if necessary.

Stop switches shall be provided and shall be mounted adjacent to each motor.

Analog and digital wiring will be insulated and shielded and connected to devices and routed directly
through bulkheads in the panel.

High voltage wiring will be contained in suitable conduit.

PHYSICAL CONSTRAINTS

The USP Purified Water System is designed for 14’L x 8.5’W x 12’H of space. Final dimensions including
elevations will be submitted upon receipt of purchase order.

UTILITIES

Power: 480 Volt / 3 Phase / 60 Hertz; Necessary step down transformers will provide 110V / 1 Phase / 60
Hertz power to the skid equipment. Skid requires one fused 200 amp (includes 50% overage factor,
peak draw is 135 amps) electrical feed to distribute power at system voltage/phase as required.

Compressed Air: Available at 80 psig, 8-10 scfm

Chilled Water: Available at 40 psig @ 40°F, 11-12 gpm

City Water: Available at 40 psig, 1.5” connection, 20-25 gpm

Drain: Single 4” drain, maximum flow of 40 gpm. No temperature or chemical treatment is provided.
Customer may need to temper effluent from the equipment prior to introducing it to a PVC drain.

DOCUMENTATION

Project will be managed in accordance with GAMP. At the necessary intervals documentation will be
transmitted to the customer for approval. QPS will follow good documentation practices and maintain
revision history for submitted documents.

Installation, operation, and maintenance instruction documentation for the system will be developed to
a level that is comprehensible to a high school graduate. The documentation reflecting “as-built”
condition will be generated with final delivery. All documents will be in English and may be delivered in
Electronic Format as detailed below.

       Detailed Design Specifications (DDS)                                     Microsoft Word
       Functional Requirement Specification (FRS)                               Microsoft Word
       Controls Test                                                            Microsoft Word
       Hardware Installation Test                                               Microsoft Word
       Operational Test                                                         Microsoft Word
PROJECT: USP PURIFIED WATER SYSTEM                                                            Page 15 of 16


         Factory Acceptance Test (FAT)                                              Microsoft Word
         Site Acceptance Test (SAT)                                                 Microsoft Word
         Operator, Maintenance and Service Manuals                                  Microsoft Word
         Process and Instrumentation Diagram (P&ID)                                 AutoCAD
         General Arrangement Diagram                                                AutoCAD
         Isometric Drawing                                                          AutoCAD
         Instrument Listing                                                         MS Word or Excel
         Control Schematics                                                         AutoCAD
         Control Panel Assembly Drawings                                            AutoCAD
         Equipment Assembly Drawings                                                AutoCAD
         Bill of Materials                                                          MS Word or Excel
         Spare Parts List                                                           MS Word or Excel
         Component Cut Sheets                                                       PDF
         Certificates of compliance for materials, welding, and inspection.         PDF

FACTORY ACCEPTANCE TESTING (FAT)

General

In advance of the FAT, QPS shall undertake the following as a minimum:

         Verification that the equipment is mechanically and electrically complete; satisfying the User
          Requirements Specification.
         100% P&ID Verification
         100% Electrical / Wiring Diagram Verification
         100% Input / Output Verification (digital and analog)
         100% Alarms / Interlocks Verification

The intent of the FAT is for the owner to confirm specification compliance. The FAT will not be used to
trouble shoot the equipment. Troubleshooting / commissioning of the equipment will be done prior to
the owner’s witnessing of the FAT.

Factory Testing

QPS will develop Factory Acceptance Test (FAT) documents. QPS will submit the FAT documents, for
review, by the owner.

QPS will submit the testing procedures for review two weeks prior to the start of testing.

In general, the FAT is intended to confirm compliance to the equipment specification. The FAT will
provide testing of all operations that are required by the equipment. These tests shall be developed to
simulate normal operating conditions to the extent possible. The overall FAT testing will include,
functional testing, documentation confirmation, alarm, and interlock testing. As a minimum,
documentation confirmations shall include dimensional checks; alarm lists; sequence of operation;
calibration, spare parts list; material certification reviews; and welding including visual inspection of all
welds, flushing, cleaning and passivation documentation reviews.
PROJECT: USP PURIFIED WATER SYSTEM                                                         Page 16 of 16


QPS will be responsible for the development and the execution of the FAT document. The owner will be
given the opportunity to witness and/or participate in the FAT execution at their discretion. A schedule
of FAT execution activities will be developed and maintained by QPS.

During the execution of the FAT, QPS will conform to good documentation practices. This includes, but is
not limited to, using indelible ink for data recording, signing and dating all data entries at the time they
are recorded, using a single line strike out that is initialed and dated for all data entry errors, and
providing explanation for line-outs that do not have an obvious reason. It is the intent of this project
that some testing conducted and documented in the FAT may not be repeated once the system is
installed at the owner site.

A formal deviation recording process will be described in the FAT document. The deviation process will
describe what actions and sequences take place when data is recorded that does not conform to the
acceptance criteria or expected results. The process of recording deviations, informing the appropriate
personnel, determining corrective actions, determining dispositions, closing out, and final approval will
be described.

Calibrated instrumentation traceable to the National Institute of Standards and Technology (NIST) will
be used. Copies of all calibration certificates shall be turned over with the completed FAT document.
At the conclusion of the FAT, the originally approved document, the completed data sheets, and all
referenced documentation and attachments shall be submitted to the owner’s designated agent for
their acceptance.

SITE ACCEPTANCE TESTING (SAT)

At the owner’s discretion, all or some of the tests performed during the FAT will be repeated at the
jobsite. QPS will demonstrate the complete functional integration of all of the components of the
water system.

ADDITIONAL SUPPORT SERVICES

In addition to the specific services listed within this document, the following additional support services
are available and included unless noted.

       Start-up support
       Training
       Post start-up routine service, calibration and maintenance (via separate service contract)
       Execution of validation protocols (via separate service contract)

GUARANTEES/WARRANTIES

QPS guarantees the equipment, materials, and workmanship for period of twelve (12) months from date
of start-up or eighteen (18) months from date of shipment, whichever comes first. During this period,
QPS shall promptly provide travel time, labor, material, equipment, and services necessary to correct
defects that may occur all at no cost to the buyer. QPS guarantees the system will produce water
meeting USP-28 – NF 23 guidelines for Purified Water.

								
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