FINN-AQUA® PHARMACEUTICAL GMP STEAM

STERILIZER

APPLICATION
Designed for general purpose, sterile
room supply, media preparation, or
terminal sterilization applications
performed in biotech, pharmaceutical
pilot production, and research and
development facilities.

DESCRIPTION
The Finn-Aqua Pharmaceutical GMP
Steam Sterilizer provides shortened
validation, increased reliability, and
flexibility. The sterilizer is available with
all the standard sterilization processes
that utilize steam as the sterilizing
agent, including saturated steam,
steam-air mix, and water-air mix.
Customized cycles can also be (Typical only - some details may vary.)
developed based on customer-
specified requirements.

The Selections Checked Below Apply to This Equipment

MODEL/CHAMBER DEPTH OPTIONS (continued) OPTIONS (continued)
See chart on last page for most commonly ❏ Six-Channel Multipoint Chart Recorder ❏ Isolator Interface
available models and chamber depths ❏ Six-Channel Paperless Recorder ❏ Pure Steam Pressure Reducing Valve
❏ Ethernet Card for SLC 500 5/04 CPU ❏ Steam Pipe Insulation
DOORS
❏ Ethernet Card for Siemens ❏ Utility Shutoff Valves (Processes B, C, and CF)
❏ Single ❏ Utility Shutoff Valves (Processes, G and G∆T)
❏ HTM 2010 Compliance Accessories
❏ Double ❏ Back-Flow Preventer
❏ Extended Frame for Integral Control System
❏ Mirror Construction, Chamber Right Side ❏ Stainless-Steel Electrical Enclosure
STERILIZER VOLTAGE CONTROL VOLTAGE
❏ Two-Piece Construction ❏ Stainless-Steel Impeller for Vacuum Pump
❏ 208 V, 60 Hz ❏ 110 V, 60 Hz ❏ Stainless-Steel Vacuum Pump
❏ Stainless-Steel Sterilizer Frame
❏ 240 V, 60 Hz ❏ 220 V, 50 Hz
❏ Integral Shell-and-Tube Steam Generator
❏ 480 V, 60 Hz ❏ Vacuum Pump Recirculating/Cooling System
❏ Integral Electrical Steam Generator
❏ 600 V, 60 Hz ❏ Closed-Loop Effluent Cooling System
❏ Ground Fault Circuit Interrupt (GFI)
❏ 400 V, 50 Hz ❏ Closed-Loop Jacket Cooling System
❏ Chamber Passivation
❏ 230 V, 50 Hz ❏ Isolator Interface (66-69)
❏ Separate Plant Steam Piping for Jacket
❏ Compressed Air Back-up System for
OPTIONS Door Gasket
❏ Allen-Bradley PLC Control ACCESSORIES
Air Differential Seal
❏ Siemens PLC Control See separate product literature.
❏ Sterile Side ❏ Non-sterile Side
❏ Cycle C ❏ Trim Panel Set (Each Side)
❏ Cycle CF BioSeal (BL3/BL4 Environment) * 66- Models are not available for pit mounting.
❏ Cycle G ❏ Sterile Side ❏ Nonsterile Side
❏ Cycle G∆T ❏ Trim Panel
❏ Cycle AC ❏ Pit Mounting*
❏ Cycle RP ❏ Seismic Anchorage Restraints and Calculations
❏ Low Temperature Heat Treatment Exposure ❏ Enclosure Side Panels
Cycle ❏ Right ❏ Left
❏ Heat Pressurized Pulsed Air Drying ❏ Side Service Access Doors, Service Side
❏ Automatic Sterilization of Air Filter ❏ Right ❏ Left
❏ Decontamination Cycle ❏ 36-Thermocouple Feed-Through Assembly
❏ Automatic Integrity Test of Air Filter ❏ Process Contact Surface Finish
(Water Intrusion) <0.6 µ meters Ra
❏ Operator Interface Control Function ❏ Extended Documentation
Item
(Sterile Side) ❏ Pressure Vessel
❏ Additional Temperature Probes (Total 4) ❏ Piping Location(s)
❏ Three-Channel Pen Chart Recorder ❏ Control System Validation
❏ FAT Procedures and Results
SD632 (05/01/04)
The Finn-Aqua GMP Steam Sterilizer is
designed, manufactured, tested, and
documented according to the latest
global practices and standards to
facilitate customers' compliance with
current Good Manufacturing Practices
(cGMP) and Good Automated Manu-
facturing Practices (GAMP). Tempera-
ture distribution within the chamber,
including drain temperature, is guaran-
teed to be within ±0.5°C (±0.9°F) of the
process sterilization temperature
(exposure setpoint). This exact
temperature distribution verifies the
repeatability that is needed for vali-
dated cycles.
The sterilizer is fully tested and
prevalidated during factory qualifica-
tion. Prevalidation report of the installa-
tion, operational, and performance
qualifications are provided, along with
complete documentation on machine
design, construction, and control
software.
The sterilizer can be configured in a
number of chamber sizes with either a
single or double door, and floor or pit
mounting.
STANDARDS
The sterilizer is manufactured in an
ISO 13485 facility and meets appli-
cable requirements of the following
listings and standards:
• GMP
• GAMP
• ISO 13485 Certification
• EN 729-2 Certification
• EN 285
• EN 554
• CE Compliance
• Underwriters Laboratory (UL)
Standard 508
• Canadian Standards Association
(CSA) Standard C22.2 No. 125
• ASME Code, Section VIII, Division
1 for unfired pressure vessels.
• PED (Europe)
• CRN (Canada)
• NEMA
• NEC
• 21 CFR Part II
FEATURES
Control System can be configured
with an Allen-Bradley PLC or a Si-
emens PLC. Control system monitors
and controls all sterilizer operations
and functions. The PLC control allows
up to 20 sterilizing cycles to be
configured to meet the specific
processing requirements. All control
system components are mounted
within a separate cabinet. The control
cabinet is equipped with a 10 m (33')
interface cable for remote-mounted
installations.
Operator Interface consists of a touch-
sensitive screen and 80-column dot-
matrix printer located on the non-sterile
(operating) end of the sterilizer. All
sterilizer functions, including cycle
initiation and cycle configuration, are
performed using the touch screen.
Displayed messages are complete
phases with no codes to be cross-
referenced. The screen also displays Control Panel
any abnormal (alarm) conditions that
may exist in or out of a cycle. Chamber and Jacket Pressure
Gauges are mounted on the non-sterile
The Allen-Bradley PanelView 1000
end of the sterilizer. Pressure is
Operator Interface consists of a touch-
sensitive screen. The PanelView displayed in psig and inHg (vacuum). If
screen size is 211 x 158 mm the sterilizer is equipped with double
(8-3/4 x 6-3/16"). doors, an additional chamber pressure
gauge is provided on the sterilizer's
The Siemens TP270 Operator Interface
sterile end.
utilizes an LCD color graphics touch-
screen display having a resolution of A Resistance Temperature Detector
640 x 480 pixels/256 colors. The (RTD) is installed in the chamber drain
line to sense and control temperature
screen size is 211 mm (8.3") wide x
158 mm (6.2") high. variations within the chamber. The
signals, converted into electrical
If the sterilizer is equipped with double
impulses, provide accurate control
doors, an additional display screen is
inputs and readouts throughout the
provided on the sterilizer's sterile (non-
entire cycle.
operating) end. The screen concur-
rently displays the same information as Chamber Temperature LED, located
the non-sterile-end screen; however, on the sterilizer's non-sterile end,
cycle initiation and configuration digitally displays the chamber refer-
ence temperature as measured by the
cannot be made from this display
RTD drain line probe. Temperature is
screen.
displayed in °C.
80-Column Dot-Matrix Printer is a full-
Horizontal Sliding Door(s) is pneu-
size printer providing an easy-to-read,
color record of all pertinent cycle data. matically operated using push buttons
Data is automatically printed through- located on the same end of the
out the cycle according to operator- sterilizer as the door. The door is
selectable print intervals. The printer equipped with a steam-activated
gasket. When the cycle is complete,
also generates a record whenever an
alarm occurs, when the alarm is the gasket retracts under vacuum into
acknowledged, and when the situation a machined groove in the sterilizer's
is corrected. end frame. Horizontally sliding door(s)
2
is used with sizes 69 and larger and
vertically sliding door(s) is for 66 size
sterilizers.
Steam Bleeds provide an even
chamber temperature distribution by
creating a more homogeneous
chamber atmosphere.
Equipment Documentation Package
includes three copies of the user
manual, and one copy each of the
manufacturing documentation, control
system documentation, and qualifica-
tion documentation. The package
contains information required to assist
in the development of validation
procedures and final validation of the
equipment.
Calibration is provided through the
control panel to all control system
temperature and pressure channels.
Calibration is performed in the Calibra-
tion Mode, accessible through the
touch-screen displays, and accom-
plished using external temperature and
pressure sources. The control system
provides a printed record of all
calibration data for verification to
current readings.
Interface Port is provided for down-
loading cycle information to
customer-furnished data acquisition
system.
CYCLE DESCRIPTION
Standard Process Cycles
Depending on the cycle options
selected, the sterilizer is factory-
programmed with the following process
cycles:
• Cycle B is a standard cycle
provided for sterilization of all dry
goods and porous loads at 110°-
135°C (230°-275°F). Preconditioning
includes an air-removal phase using
vacuum and steam pulses. Exposure
includes time or Fo based modes.
Drying can be accomplished by fast
exhaust, deep vacuum, or vacuum
pulsing. Pre-vacuum and post-
vacuum pulses are programmable.
Vented Liquid cycles are also
possible using slower rated exhaust.
Cycle B is primarily used for produc-
tion, clean room supply, and
production support.
• Cycle C is an optional cycle for
sterilization of liquid products or
items in vented or sealed glass
containers at 110°-135°C (230°-
275°F). The cycle includes all
features of Cycle B, and utilizes
forced air removal and in-direct
cooling by circulating cooling water
in the sterilizer jacket. Sterile air
overpressure is maintained during
the cooling phase to prevent liquid
from boiling. Final cooling tempera-
ture and vacuum drying are pro-
grammable. Cycle C is primarily
used for production, media prepara-
tion, and research and development
purposes when liquids are in open
containers or cooling time is less
critical.
• Cycle CF is an optional cycle
provided for sterilization of liquid
products or items in vented or sealed
glass containers at 110°-135°C
(230°-275°F). Cycle CF usage and
performance are the same as Cycle
C except a fan(s) is provided to
shorten the cooling time. The number
of fans is dependent on the sterilizer
chamber depth.
• Cycle G is an optional cycle
provided for sterilization of all liquid
products or items in sealed glass
containers at 110°-135°C (230°-
275°F). Cycle G uses direct spray
cooling during the cooling phase.
Sterile air over pressure is main-
tained during the cooling phase to
prevent boiling. Optional Cycle C is
included.
• Cycle G∆ ∆T is an optional cycle
provided for sterilization of all liquid
products or items in sealed glass
containers at 110°-135°C (230°-
275°F). The cycle utilizes forced air
removal and ∆T-controlled rapid
cooling by spraying cooling water
over the load. Overpressure is
maintained during the cooling
phase, and vacuum ampoule testing
is available. Cycle G∆T is recom-
mended for terminal sterilization in
production environments requiring
high efficiency. Optional Cycle C is
included.
3
• Cycle AC is an optional cycle
provided for terminal sterilization of
liquids in plastic or glass containers
(at 110°-134°C [230°-273°F]) that are
dry at the end of the cycle. The cycle
utilizes an overpressurized air/steam
mixture to sterilize. Counterpressure
is maintained based on the product
temperature throughout entire cycle.
Cooling is accomplished by circulat-
ing air, cooled by the jacket,
throughout the chamber. Cycle AC
allows the immediate labeling of
sterilized products.
• Cycle RP is an optional cycle
provided for terminal sterilization of
liquid products in glass or plastic
sealed containers at 110°-125°C
(230°-257°F). The cycle utilizes a
superheated air/water mixture to
sterilize (pure steam is not required).
Heating and cooling are performed
by circulating water through external
heat exchangers and spraying it
over the load. Counterpressure is
maintained based on product
temperature through entire cycle.
Cycle RP is recommended for
terminal sterilization in environments
requiring high efficiency, and not
recommended for labelled products.
• Leak Test Cycle is a standard cycle
provided for verification of the
chamber's integrity. Cycle param-
eters are user-configurable. Default
values for the leak rate test may be
used, or specific leak rate test
parameters may be configured in
accordance with the customer's
standard operating procedure.
SAFETY FEATURES
Emergency Stop Button, located on
non-sterile end (and sterile end if
double door unit) of sterilizer, returns
valves to failsafe condition and halts
cycle processing when pressed. Once
pressed, the operator chooses to either
abort or continue cycle operation.
Security Access Codes provide
restricted access of unauthorized
users to critical operational modes.
Five access levels are available:
1) Operator Level (level 1) allows the
operator to select the cycle, start
the cycle, view the cycle param-
eters, and print reports.
2) Supervisor Level (level 2) allows
the operator to select the cycle,
start the cycle, view the cycle
parameters, print reports, and edit
the cycle and proportional-integral-
derivative control (PID) parameters.
3) Calibrator (level 3) allows the
operator to select the cycle, start
the cycle, view the cycle param-
eters, print reports, edit the cycle
and PID parameters, and calibrate
Pressure Vessel
instruments.
4) Service Level (level 4) allows the
operator to select the cycle, start Pressure Interlock prevents user from 63 mm (2-1/2") chamber penetrations
the cycle, view the cycle param- opening door when unit is above with tri-clamp connections are pro-
eters, print reports, calibrate atmospheric pressure. vided for validation purposes.
instruments, activate/deactivate
Chamber Level Switch activates Chamber Door(s)
inputs and outputs, edit common
alarm, aborts cycle, and safely vents
settings, change date/time, and The door is constructed of AISI 316L
chamber with a controlled exhaust if
view service diagnostics. stainless steel and insulated with
excessive condensate is detected in
mineral wool to reduce surface
5) Administrator Level (level 5) the vessel chamber.
temperature of the stainless-steel door
allows the operator to select the
cover. The door is equipped with a
cycle, start the cycle, view the
CONSTRUCTION one-piece, silicone sealing gasket. The
cycle parameters, print reports,
gasket is activated by pure steam
calibrate instruments, activate/ Pressure Vessel pressure, and retracted by pulling a
deactivate inputs and outputs, edit
The standard chamber pressure vessel vacuum.
common settings, change date/
time, view service diagnostics, and is a full-dimple, jacket-type vessel
Facia Panel(s)
edit passwords. designed in accordance with ASME
applicable pressure vessel code. The The sterilizer's framework is enclosed
Door Sensing Device automatically pressure vessel inner shell (chamber) by a front facia panel, located on the
reverses direction and opens chamber and outer shell (jacket) are designed to non-sterile end. If the sterilizer is
door if an obstruction is detected while withstand operating pressures from full equipped with double doors, a back
door is closing. vacuum to 3.1 bar (45 psig). The facia panel encloses the sterile end.
Door Interlock (Double Door Units chamber and jacket are constructed of Facia panel(s) is constructed of AISI
Only) allows only one door to be AISI 316L stainless steel with the 304 stainless steel with No. 3 brush
opened at a time, and during process- chamber interior polished to ≤15 µ" finish.
ing, prevents both doors from being (0.4 µm) Ra-value surface finish or Vacuum System
opened until the sterilization cycle is better.
A two-stage, water ring seal-type pump
complete. The door logic is The jacket is insulated with mineral is used for evacuating the sterilizer
configurable. wool that meets ASTM 795 for contact chamber. Pump is sized to pull a 3 psia
Pressure Relief Devices on the with Austentic stainless steel. The vacuum in five minutes utilizing 20°C
chamber and jacket limit the amount of insulation sheathing is aluminum. (68°F) sealing water.
pressure buildup so that the rated The steam-supply openings, inside the
pressure of the vessel is not exceeded. chamber, are shielded by full-length
Steam Valve Interlock prevents steam baffles to evenly distribute the pure
valve from opening when door is open. steam as it enters the chamber. Two

4
Air Filter
An air inlet filter, used for chamber
pressure equalization, is a 0.2 µm
hydrophobic bacteria-retentive filter.
Air filter is housed in a AISI 316L
stainless-steel housing.
Piping
The process piping for pure steam,
process air to chamber, and water
supplies is constructed of AISI 316L
stainless steel. All piping connections
terminate within the confines of the
sterilizer and are accessible from the
right side of the sterilizer, when facing
non-sterile (operating) end. The pure
steam piping connections are tri-clamp
fittings; water and air piping connec-
tions are either threaded or compres-
sion fittings.
MOUNTING ARRANGEMENT
The sterilizer is arranged for either floor
or pit-mounted installations, as speci-
fied. All sterilizer components are
integrally mounted within the sterilizer
framework. Each sterilizer is equipped
with adjustable leveling legs.
The sterilizer is shipped in one piece,
ready for installation, utility connec-
tions, and start-up.
OPTIONAL FEATURES
Automatic Air Filter Sterilization
cycle is used for sterilization of the
0.2 µm sterile air filter, filter housing,
and piping (from filter housing to
chamber air shut-off valve) either prior
to or after cycle processing.
Automatic Integrity Test of Air Filter
(Water Intrusion) with WFI or purified
water is designed for applications
where the customer requires that the
0.2 µm sterile filter assembly is integrity
tested in place (in-situ). This option is
typically used when the filter assembly
is routinely sterilized in place (SIP) and
verification of the filter's integrity is
required.
Decontamination Cycle is used in
situations where the chamber conden-
sate is contaminated and cannot be
drained prior to processing a steriliza-
tion cycle. During this cycle, steam is
introduced into the chamber through
the drain line, and all effluents dis-
charged from the unit are sterilized.
Low Temperature Heat Treatment
Exposure Cycle is provided for
sterilization of heat-sensitive products
at 60°-110°C (140°-230°F). The cycle is
designed to function in saturated
steam conditions under a vacuum. The
chamber temperature variation is
typically at ±1°C (±1.8°F).
Heat Pressurized Pulsed Air Drying
is incorporated into the sterilization
cycle as an additional drying phase
that reduces the overall drying time by
approximately 50%. The drying
temperature is programmable from 50-
120°C (122-248°F). Pulse air drying is
typically used to dry rubber stoppers
and articles packaged in pouches.
Sterile Side Operator Interface
Control Function (Double Door Units
Only) permits operator to select and
initiate cycles from the operator
interface panel located on the
sterilizer's sterile (non-operating) end.
Additional Temperature Probes are
installed to allow positioning of up to
four temperature probes within the
load. Four temperature probes are
included with this option.
Three-Channel Pen Chart Recorder
graphs chamber pressure and tem-
perature for each channel in a different
color. Additional RTD is added in the
chamber and drain for independent
recording. Depending on location of
control cabinet, the recorder is
integrally mounted into the cabinet or
remotely mounted at customer speci-
fied location.
Six-Channel Multi-point Chart
Recorder graphs chamber pressure,
chamber temperature, and tempera-
ture readings from up to four product
temperature probes. Up to four
additional RTDs are added in the
chamber and one RTD in the drain line
for independent recording. Other
temperatures such as filter exposure
and jacket temperature may also be
recorded. Depending on location of
control cabinet, the recorder is
integrally mounted into the cabinet or
* Optional Compressed Air Backup System
for Door Gasket is recommended for use
with this option.
5
remotely mounted at customer speci-
fied location.
Six-Channel Paperless Recorder is
21 CFR Part II compatible. The
acquired process information can be
stored onto a MegaZip disk or trans-
ferred online to the client's network for
further analysis. Typically, these six
channels are used for recording
chamber temperature, chamber
pressure, jacket temperature, filter
temperature, and/or load temperatures.
Ethernet Card for SLC 500 5/04 CPU
is a separate Ethernet card that can be
connected to a SLC 5/04 processor
Ch0 port. The card allows the user to
monitor all real-time process data via
an Ethernet connection.
Upgrade Allen-Bradley SLC 500 5/05
CPU replaces SLC 500 5/04 CPU
(standard). The CPU SLC 500 5/05
allows the user to monitor all real-time
process data via an Ethernet connec-
tion.
Ethernet Card for Siemens CPU
provides an Ethernet card for external
connections. This option does not
include the configuration of the data
transfer communication, which has to
be agreed upon separately.
HTM 2010 Compliance Accessories
are designed to meet the European
requirements for a porous load
sterilizer. The system includes the
addition of ports to take samples in
order to perform non-condensable
gases, superheat, and dryness fraction
tests. The option also provides an air
detection system based on an addi-
tional temperature probe located in the
drain line.
Extended Frame for Integral Control
System increases the sterilizer's width
by 330 mm (13"), and the control
system is installed within the sterilizer's
framework.
Mirror Construction reverses the
standard positioning of the sterilizer
chamber and service area. As viewed
from the non-sterile end, the sterilizer
chamber is relocated to the right side
and service area is relocated to the left
side. The standard configuration is
chamber on left and service on the
right side (as viewed from the non-
sterile side).
Two-Piece Construction configures
the service frame and chamber frame
in two sections for easy separation
during installation. Piping, rigging, and
electrical lines are fabricated to
minimize field reassembly.
Stainless-Steel Sterilizer Frame and
all piping supports are constructed of
AISI 304 stainless steel. This option is
recommended for corrosive environ-
ments.
Closed Loop Recirculation for
Vacuum Pump minimizes consump-
tion of the building-supply cold water
used in the operating/cooling of the
vacuum pump. A 40-L (10-gal)
recirculation tank and plate heater are
included.
Closed Loop Recirculation for
Effluent Cooling eliminates the use of
the building-supply cold water when
cooling drain effluents. Drain effluents
are circulated through a plate heat
exchanger, and cooled to < 60°C
(140°F) before discharging.
Compressed Air Backup System for
Door Gasket acts as a redundant
safety system to maintain integrity of
the door seal in the event of pure
steam pressure loss. Backup system is
recommended for liquid and terminal
sterilization processes to prevent
contamination of a load, or a sterile
area.
Air Differential Seal (Sterile or Non-
sterile Side) is fabricated from AISI
304 stainless steel, and is affixed to the
sterile or non-sterile end. Adjustable
interface panels are provided at the
top, bottom, and sides, with a silicone
gasket to seal the unit system to facility
structure. This seal is used to maintain
room air pressure.
BioSeal (BL3/BL4 Environment) is
located on the sterilizer's sterile end to
prevent passage of airborne microor-
ganisms to a non-classified area. The
seal is used in Biolevel 3 (BL-3) and
Biolevel 4 (BL-4) applications. This
option may also be selected with bio-
seal on non-sterile side.
Trim Panel Set (Each Side) is pro-
vided with a spring-loaded sealing
frame assembly to seal the gap
between the sterilizer panels and the
wall opening in one-wall and two-wall
recessed installations.
Side Enclosure Panel(s) is installed
on the right and/or left side of sterilizer
framework as specified. The side panel
is constructed of AISI 304 stainless
steel.
Side Service Access Door (Service
Side Only) is installed on either the
right or left side of the sterilizer
framework to conceal and provide
access to internal piping, mechanical,
and electrical components from the
side of the unit.
Seismic Restraints are provided,
along with an achoring report conform-
ance with the latest seismic Zone 4
requirements per California building
codes.
Feed-Through Assembly for 36
Thermocouples is provided for use
with one of two 63.5 mm (2-1/2") tri-
clamp chamber penetrations to simplify
the validation process. Maximum of two
assemblies can be used per sterilizer.
Process Contact Surface Finish Ra
<0.6 µm (25 µ") provides enhanced
polish for all internal chamber surfaces
and penetrations, main pure steam and
sterile air lines, condensate line (up to
the first drain line valve), and system
components to a Ra ≤ 0.6 µm (25 µ")
Ra-value surface finish or better.
Extended Documentation options are
designed to meet customer demands
when more specific and comprehen-
sive information is required. The
following extended documentation
packages are available:
• Extended Pressure Vessel Documen-
tation
• Extended Piping Documentation
• Extended Control System Validation
Documentation
• FAT Procedures and Results
6
Isolator Interface
The isolator interface option connects
the sterilizer with either a rigid or
flexible wall isolator. The isolator and
the isolator interface area can be
sterilized by utilizing a VHP Generator.
The proper type and size isolator must
be acquired to verify compatibility.
Pure Steam Pressure Reducing
Valve
With this option, the pure steam line is
fitted with a sanitary PRV that is
fabricated of AISI 316 stainless steel. It
is designed to limit the incoming steam
pressure to meet pressure vessel
design requirements.
Steam Pipe Insulation
With this option, the steam line seg-
ments are insulated to protect service
personnel from potentially hot surfaces.
The insulation covers the steam lines
(components are not covered). The
material used is HT/ARMAFLEX.
Utility Shutoff Valves (Process B, C,
and CF)
As standard, the unit is provided with
single point utility connections for easy
installation. This option provides
manual shutoff ball valves on the
domestic water, pure steam, air, and
cooling water lines (excluding the
drain) to isolate the utility lines. If no
utility shutoff valves are located near
the equipment, this option can be
used.
Utility Shutoff Valves (Process G and
∆T)
G∆
As standard, the unit is provided with
single point utility connections for easy
installation. This option provides
manual shutoff ball valves on the
domestic water, pure steam, air, and
cooling water lines as required
(excluding the drain) to isolate the
utility lines. The WFI or purified water
line is provided with a diaphragm
shutoff valve. If no utility shutoff valves
are located near the equipment, this
option can be used.
Back-Flow Preventer
As standard, two check valves are
provided on the domestic water line to
prevent back-flow. This option re-
places the check valves with a back-
flow preventer.
Stainless-Steel Electrical Enclo-
sures
As standard, the enclosures located in
the service area are fabricated from
painted carbon steel. With this option,
the enclosures are made from AISI 304
stainless steel. The separate main
control cabinet is manufactured from
AISI 304 stainless steel as standard. If
the facility standard is stainless steel,
or if the cabinet is placed in a corro-
sive environment, this option can be
used.
Stainless-Steel Impeller for Vacuum
Pump
As standard, the vacuum pump
impellers are fabricated from bronze.
With this option, the vacuum pump
impeller is constructed of AISI 316
stainless steel. If the pump is sub-
jected to aggressive or corrosive
media, this option can be used.
Stainless-Steel Vacuum Pump
As standard, the vacuum pump
housing is fabricated from carbon
steel. With this option, all wetted parts,
including the vacuum pump housing,
are constructed of AISI 316 stainless
steel. If the pump is subjected to
aggressive or corrosive media, this
option can be used.
Integral Shell-and-Tube Steam
Generator
An Integral Shell-and-Tube Steam
Generator is designed to produce
steam of a quality equal to the feed
water that is introduced into the
system. The integral steam generators
are available for a maximum chamber
volume of 3.33 m3 (117.6 ft3). The
integral steam generator does not
include any entrainment device to
remove pyrogens. Plant steam is
supplied to the shell while process
quality water is fed to the inner tubes
by the feed water pump. Plant steam
vaporizes the feed water to produce
the process steam. Finn-Aqua recom-
mends the use of a Finn-Aqua Pure
Steam Generator for the production of
the sterilizing medium in GMP applica-
tions.
The feed water for the Integral Electri-
cal Steam Generator system should be
either deionized, RO, or WFI quality
water. GMP requirements dictate that
steam must not contain any boiler
additives.
The system is built into the sterilizer
service area or on top of chamber and
includes the feed water system, steam
generation system, and the controls.
An additional 800 mm (32") width or
height is required with this option. All
piping and components in contact with
the feed water or pure steam are
constructed of AISI 316 or 316L
stainless steel. The heating element
contains stainless-steel AISI 316L
tubular elements. The unit can be
fused for 208, 240, or 480 volt, 60 Hz,
or 400 volt, 50 Hz three-phase
operation. For specific capacities,
connections, and utility consumption
values, please refer to the dimensional
drawing.
Ground Fault Circuit Interrupt (GFI)
A Ground Fault Circuit Interrupt (GFI)
is installed to sense low level (arcing)
ground faults that are below the fuse
or circuit breaker rating, and therefore
go undetected. The GFI is intended for
equipment protection only. The GFI
system consists of two parts; a relay
and a sensor. The operation of the
ground fault detection system is
indicated with an indicator light.
Chamber Passivation
The chamber is passivated with a
solution that is composed of hydrofluo-
ric acid, nitric acid, and deionized
water after fabrication. The process
(solution concentration and exposure
time and temperature) is controlled by
specific Quality Assurance Procedures
to verify proper processing. The
assembly is rinsed with deionized
water and cleaned with pure steam
after exposure. A chamber passivation
certificate is included.
7
Separate Plant Steam Piping for
Jacket
In a standard configuration, the
sterilizer jacket is heated by pure
steam (pressure range 2.5 bar/
36-44.9 psig). With this option, the
jacket is fitted with a plant steam line
for heading purposes. Customers who
are using large volume sterilizers or
have limited quanties of pure steam
available can utilize this option. The
option consists of a Y-strainer,
pressure reducing valve, associated
piping, on/off control valve, and
condensate trap and connection to
return the condensate back to the
boiler (only with Process B).
NOTES
1. The sterilizer is not supplied with a
backflow preventer and, where
required by local codes, installa-
tion of such a device in water line
is by others. The drain line should
have a two inch air-gap to prevent
backflow.
2. The pipe sizes shown indicate
terminal outlets only. Building
service lines, provided by others,
must supply the specified pres-
sures and flow rates.
3. A nonfused, pad-lockable discon-
nect switch is provided with the
sterilizer.
4. The clearances shown are minimal
for installing and servicing the
equipment.
5. The floor drain is provided as
specified on STERIS equipment
drawings.
UTILITY REQUIREMENTS*
Pure Steam
Tri-Clamp; 2.8 ±0.3 bar (40 ±4 psig).
Drain
2-1/2" ODT gravity discharge.
Domestic Feed Water
NPT male; 3-5 bar (44-73 psig); 20°C
(68°F) max; 7 dH (125 ppm CaCO3)
max. hardness. Water is used for
vacuum pump sealing, drain cooling,
and jacket cooling.
Process Water (Cycle RP, G, and G∆ ∆T
option only)
Tri-Clamp, 44 psig min. DI or WFI
water quality recommended.
Chilled or tower water (optional).
NPT male; 1.4-3.5 bar (20-50 psig);
20°C (68°F) max. water is used for
optional closed loop systems.
Compressed Air CUSTOMER IS RESPONSIBLE FOR
NPT male; 5-8 bar (73-120 psig). COMPLIANCE WITH APPLICABLE
LOCAL AND NATIONAL CODES AND
Process Air (Optional)
REGULATIONS.
Tri-Clamp; 5-8 bar (73-120 psig).
Chamber Safety Relief * Utility connection sizes and flow rates are
Tri-Clamp; 3.1 bar (45 psig) max. dependent on the chamber size selected.
Jacket Safety Relief Refer to STERIS equipment drawing for
NPT male; 3.1 bar (45 psig) max. details.
Electricity - Sterilizer
208 V, 60 Hz, 3-Phase;
240 V, 60 Hz, 3-Phase;
480 V, 60 Hz, 3-Phase;
600 V, 60 Hz, 3-Phase;
400 V, 50 Hz, 3-Phase; or
230 V, 50 Hz, 3-Phase
Electricity - Control
110 V, 60 Hz, 1-Phase; or
220 V, 50 Hz, 1-Phase.
8
Dimensions shown here are typical, and subject to change without notice.
REFER TO STERIS EQUIPMENT DRAWINGS FOR
COMPLETE AND DETAILED INSTALLATION SPECIFICATIONS.
Compressed Air, 600 mm
Process Air, (23-5/8")
Sterilizer Feed Water,
Jacket Safety Relief Pure Steam
Electricity -
Chamber Safety Relief Electricity - Sterilizer Control

Sterilizer 1825 mm
Height* (71-7/8")

Nominal
Chamber
Height*

Nominal Optional Recorder

Chamber Drain 80-Column Printer
Size* Control Cabinet

Optional Loading Cart Validation Ports Sliding Door Support Rail

Service Access Door

Front View

Sterilizer Width*

Chamber Safety Relief Sterilizer Feed Water Pure Steam

Exterior Depth*
(including
Chamber Service Clearance)
Depth*

499 mm
(19-5/8")

Jacket Safety Relief Drain Process Electricity - Com- Electricity -

Air Sterilizer pressed Control
Air

FLOW
Top View

* Refer to chart on following page for chamber size for the appropriate model sterilizer.
Some process configurations (e.g., G∆T or RP) may require wider clearance. See detailed drawing for external
dimensions.

9
 Common Finn-Aqua Sterilizer Models
Typical Nominal Chamber** Internal Chamber
Sizes* Size - W x H mm (inches) Depth - mm (inches)
669, 6612, 6615 650 x 650 (26 x 26) 950, 1250, 1550 (37, 49, 61)
699, 6912, 6915 650 x 950 (26 x 37) 950, 1250, 1550 (37, 49, 61)
6129, 61212, 61215 650 x 1250 (26 x 49) 950, 1250, 1550 (37, 49, 61)
999, 9912, 9915, 9918 950 x 950 (37 x 37) 950, 1250, 1550, 1854 (37, 49, 61, 73)
91212, 91215, 91218 950 x 1250 (37 x 49) 1250, 1550, 1850 (49, 61, 73)
121212, 121215, 121218, 121221 1250 x 1250 (49 x 49) 1250, 1550, 2150 (49, 61, 85)
121521, 121524 1250 x 1550 (49 x 61) 2150, 2450 (85, 96)
122121, 122124, 122130 1250 x 2150 (49 x 85) 2150, 2450, 3050 (85, 96, 120)
* Additional sizes are available; please consult your STERIS sales representative for further details.
** Load area may differ from nominal chamber size. Refer to STERIS installation drawing for load dimensions.

Chamber Size Key to Model Sample Model Number

Numbers
Finn-Aqua Model # 6 9 12 - D - P - B - GMP - AB
Number Size: mm (inches)
Internal Chamber Width = 26"
6 650 (26)
Internal Chamber Height = 37"
9 950 (37) Internal Chamber Depth = 49"
12 1250 (49) Double Door
15 1550 (61) Pit Mounted
18 1850 (73) Cycle Type
21 2150 (85) cGMP Version
24 2450 (96) Control System Type
30 3050 (120)
 i f e e s
L nc
c i e
S

11
For further information, please contact:

STERIS Corporation
5960 Heisley Road
Mentor, OH 44060-1834 • USA
440-354-2600 • 800-444-9009
www.steris.com

This data is intended for the exclusive use of STERIS customers, including architects or
SD632 ©1997-2004, STERIS Corporation All rights reserved. (05/01/04) designers. Reproduction in whole or in part by any party other than a customer is prohibited.