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FINN-AQUA® BIO PHARMA SERIES (BPS)

GMP STEAM STERILIZERS


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

DESCRIPTION
The Finn-Aqua BIO Pharma Series (BPS) GMP Steam
Sterilizers provide shortened validation time, increased
reliability and flexibility. The sterilizer uses saturated steam
for sterilization of hard goods and vented liquids. Optional
pressurized air during post-conditioning is available for
processing liquids in vented glass containers.
The Finn-Aqua BPS 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 Manufacturing Practices
(GAMP). Temperature distribution within the chamber,
including drain temperature, is guaranteed to be within
±0.5°C (±0.9°F) of the process sterilization temperature
(exposure setpoint). This exact temperature distribution
verifies the repeatability needed for validation cycles. (Typical - details may vary.)
The sterilizer is fully tested and prevalidated during factory
qualification. Prequalification reports of the installation,
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 single or double doors.

The Selections Checked Below Apply To This Equipment


MODEL/CHAMBER DEPTH OPTIONS OPTIONS (Cont’d)
See chart on last page for most commonly ❑ Heated Pressurized Pulsed Air Drying ❑ HTM 2010 Compliance Accessories
available model sizes and chamber depths ❑ Cooling Water Savings Package ❑ Probe for Load Temperature
❑ Automatic Sterilization of Air Filter ❑ VHP Ports
DOORS
❑ Operator Interface Control Function ❑ VHP Ready
❑ Single
❑ Double (Sterile Side) ❑ VHP Combination
❑ Control System, Remote Mounted ❑ Spare Parts Kit
❑ Three-Channel Pen Chart Recorder ❑ Extended Manufacturing Procedure
MOUNTING CONFIGURATION
❑ Floor ❑ Mirror Construction, Chamber Right Side Documentation
❑ Pit Air Differential Seal ❑ Extended Pressure Vessel Documentation
❑ Sterile Side ❑ Pure Steam PRV
CYCLE OPTIONS BioSeal (BL3/BL4 Environment) ❑ Air Filter Test Ports
❑ Cycle CA ❑ Sterile Side ❑ Utility Supervision and Monitoring
❑ Cycle C ❑ Seismic Anchorage Restraints and Calculations ❑ Six-Channel Paperless Recorder
❑ Cycle CX ❑ Enclosure Side Panels ❑ ValidCycle Software
❑ Right ❑xLeft ❑xBack
❑ Cycle SAMX
❑ 36-Thermocouple Feed-Through Assembly
❑ Decontamination Cycle ACCESSORIES
❑ Process Contact Chamber Surface Finish ❑ Loading Equipment
CONTROL SYSTEM <0.6 μ meters Ra
❑ Electric Steam Generator See separate product literature.
❑ Allen-Bradley PLC Control
(for units with door size 66 only)
❑ Siemens PLC Control Item ________________________
❑ Electronic Data Security - Siemens
❑ Electronic Data Security with Data Archiving and Location(s)___________________
Enhanced Batch Reporting -Siemens ____________________________

SD852 (07/01/12)
STANDARDS Equipment Documentation Package includes three copies
of user manual and one copy each of manufacturing
Sterilizer is manufactured in an ISO 9001, ASME Section VIII documentation, control system documentation, and
Division 1, PED Module H/H1 and EN729-2 certified facility qualification documentation. Package contains information
and meets applicable requirements of the following listings required to assist in development of validation procedures
and standards: and final validation of the equipment.
• GMP Calibration is provided through the control panel to all system
• GAMP 5 temperature and pressure channels. Calibration is performed
• EN285 in Calibration Mode, accessible through touch-screen
• EN554 display, and accomplished using external temperature and
• Underwriters Laboratory (UL) Standard 508 pressure sources. Control system provides a printed record
• Canadian Standards Association (CSA) Standard C22.2 No. of all calibration data for verification of current readings.
125
Interface Port is provided for downloading cycle information
• ASME Code, Section VIII, Division 1 for unfired pressure vessels.
to Customer-furnished data acquisition system.
• CRN (Canada)
• European Directives (Europe) CYCLE DESCRIPTION
Pressure Equipment 97/23/EC Annex 111, Module D
Machinery Directive 2006/42/EC
Low Voltage 73/23/EEC, 93/68/EEC Standard Process Cycles
Electromagnetic Compatibility (EMC) 89/336/EC, 93/68/EEC,
Depending on cycle options selected, sterilizer is factory-
92/31/EC
programmed with following process cycles:
• FDA 21 CFR Part 11 Compliant/EU Annex 11. STERIS Finn-Aqua
develops, documents, and enforces policies and procedures that • Cycle B is a standard high vacuum cycle provided for
ensure security of electronic records and signatures according sterilization of all dry goods and porous loads at
to 21 CFR Part 11. Together with our Customers, Finn-Aqua will 110-135°C (230-275°F). Preconditioning includes air-
help implement and enforce Part 11-compliant solutions involving
removal phase using vacuum and steam pulses.
validation, audit trails, and security of our computer systems.
Alternatively, preconditioning could consist of a forced air
FEATURES removal. Forced air removal removes air from chamber by
introducing steam to force the air out through drain line
Control System can be configured with Allen-Bradley® PLC system. Vacuum pump is simultaneously operated to assist
or Siemens® PLC control. Control system monitors and in evacuating air. Forced air removal is designed for liquid
controls all sterilizer operations and functions. PLC control loads in vented containers. Exposure includes timed or
allows up to 20 sterilizing cycles to be configured to meet optional Fo based modes. Drying can be accomplished by
specific processing requirements. All control system fast exhaust, deep vacuum or vacuum pulsing. Pre-
components are mounted in an integral cabinet. Control vacuum and post-vacuum pulses are programmable.
cabinet can be equipped with a 10 m (33') interface cable for Vented Liquid cycles are also possible using slower rated
optional remote mounting. exhaust. Cycle B is primarily used for production, clean
Operator Interface consists of either a 7" (Allen-Bradley) or room supply and production support.
an 8" (Siemens) color touch-sensitive screen and integral • Cycle CA is an optional cycle designed to process liquid
impact printer located on non-sterile (operating) end of products in vented vials that require cooling after
sterilizer. All sterilizer functions, including cycle initiation and sterilization. Sterile air over-pressure prevents liquid from
cycle configuration, are performed using touch screen. boiling during cooling phase. Jacket steam is vented.
Displayed messages are complete phrases with no codes Cooling water is not circulated in jacket. Sterilization
that need to be cross-referenced. Screen also displays any process CA includes process B cycle. CA process cooling
abnormal (alarm) conditions that may exist in or out of a cycle. may precede or follow a vacuum drying or pulse drying
If sterilizer is equipped with double doors, indicator lights are phase. Cycle CA includes compressed air back-up for
provided on sterile (non-operating) end. door gasket(s).
A 42-column impact printer provides real-time process data • Cycle C is an optional cycle designed to efficiently process
and alarms in a comprehensive batch report. liquid products such as SVP’s and LVP’s packaged in
vented containers that require fast cooling during post-
Chamber and Jacket Pressure Gauges are mounted on
conditioning phase. Cooling phase is designed to cool
non-sterile end. Pressure is displayed in bar/psig and inHg
chamber by flowing cooling water through jacket with
(vacuum). If sterilizer is equipped with double doors, an
simultaneous air over-pressurization in chamber. Process
additional chamber pressure gauge is provided on sterilizer's
cools load and prevents product from boiling. Cycle C
sterile end.
sterilization process includes Process B cycle. Cycle C
Horizontal or Vertical (66 only) Sliding Door(s) are includes compressed air back-up for door gasket(s).
pneumatically operated using buttons located on control
• Process CX (Ejector-enhanced indirect water cooling) is
panel. Each door is equipped with a steam-activated, non-
designed to replace conventional fan assembly in sterilizer
lubricated gasket. When cycle is complete, gasket retracts
chamber. An air ejector cooling process provides similar
under vacuum into machined groove in sterilizer's end frame.
or higher air circulation efficacy than a conventional fan.

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Ejector process is designed to speed up cooling process Door Interlock (Double Door Units Only) allows only one
by generating symmetrical air flow pattern for transferring door to be opened at a time, and during processing, prevents
heat from load to water-cooled chamber walls. Chamber either door from being opened until sterilization cycle is
pressure is controlled automatically by bleeding excess complete. Door opening/closing sequencing logic is
air out. There are no moving parts or penetration seals configurable. Double door not available on 666 (660 x 660 x
through the chamber to wear. Additional air is required for 660 mm [26 x 26 x 26"]) model.
this option. Air consumption is based on size of vessel. Pressure Relief Devices on chamber and jacket limit the
See equipment drawing. amount of pressure buildup so rated pressure of vessel is not
• Steam-Air-Mix (SAMX) Cycle is designed for moist heat exceeded.
sterilization of various types of non-vented liquid products Steam Valve Interlock prevents steam valve from opening
such as ampoules, vials, bottles, backs, etc. The SAMX when door is open.
process uses one or multiple air ejectors to provide
Pressure Interlock prevents user from opening door when
required differential pressure in chamber and to circulate
unit is above/below atmospheric pressure.
steam and air mix within chamber. Air ejector(s) occupy
only 4 inches (102 mm) of space in top of chamber. There CONSTRUCTION
are no moving parts or penetration seals through the
chamber to wear. Additional air is required for this option. Pressure Vessel
Air consumption is based on size of vessel. See equipment
The standard chamber pressure vessel is a fully jacketed-
drawing.
type vessel that meets ASME and PED pressure vessel codes.
• Leak Test Cycle is a standard cycle provided for Pressure vessel inner shell (chamber) and outer shell (jacket)
verification of chamber integrity. Cycle parameters are are designed to withstand operating pressures from full
user-configurable. Default values for the leak rate test may vacuum to 3.1 bar (45 psig). Chamber and jacket are
be used, or specific leak rate test parameters may be constructed of stainless steel. Chamber interior is glass-
configured in accordance with Customer's Standard beaded to a fine finish.
Operating Procedure (SOP).
Jacket is insulated with 13 mm (1") black foam insulation with
SAFETY FEATURES aluminum backing.
Steam-supply openings, inside chamber, are shielded by a
Emergency Stop Button, located on operating end (and
full-length baffle to evenly distribute clean steam as it enters
non-operating end if double door unit) of sterilizer, returns
chamber. A 63 mm (2-1/2") chamber penetration with tri-
valves to safe condition and halts cycle processing when
clamp connections is provided for validation purposes.
pressed. Once pressed, operator chooses to either abort or
continue cycle operation. Chamber Door(s)
Security Access Codes provide restricted access of Door is constructed of AISI 316L stainless steel and insulated
unauthorized users to critical operational modes. Five access with mineral wool to reduce surface temperature of stainless-
levels are available: steel door cover. Door is equipped with a one-piece, silicone
1. Operator level password (level 1) permits the user to select sealing gasket. Gasket is activated by pure steam or
a cycle, start a cycle, acknowledge alarms, view cycle compressed air pressure, and retracted by pulling a vacuum.
parameters and manually print reports; Facia Panel(s)
2. Supervisor level password (level 2), in addition to level 1,
permits the user to edit cycle parameters, edit the Sterilizer's framework is enclosed by a front facia panel,
Proportional Integral Derivative (PID) parameters, skip the located on operating end. If sterilizer is equipped with double
current step of the running cycle and stop the doors, a back facia panel encloses sterile end. Facia panel(s)
Programmable Logic Controller (PLC) from accumulating is constructed of stainless steel with No. 3 brush finish.
exposure time;
Vacuum System
3. Calibrator level password (level 3), in addition to level 2,
permits the user to calibrate instruments; Two-stage, water ring seal-type pump is used for evacuating
4. Service level password (level 4), in addition to level 3, sterilizer chamber. Pump is sized to create a 0.2 bar (3 psia)
permits the user to view inputs, view system diagnosis, vacuum in five minutes utilizing 20°C (68°F) sealing water.
activate/deactivate outputs, edit common settings and Air Filter
change date/time;
Air filter, used for chamber pressure equalization, is 0.2 µm
5. Administrator level password (level 5), in addition to level
4, permits the user to configure user names and edit hydrophobic bacteria-retentive filter. Filter is steam
passwords. sterilizable up to fifty times.
Compressed Air Back-up for door gasket(s) is provided on Piping
all double door sterilizers and with C cycle, CA cycle,
Process piping for clean steam and sterile air to chamber,
decontamination cycle, and bioseal installations.
and drain piping up to first valve is constructed of AISI 316L
Door Sensing Device automatically stops if an obstruction stainless steel. All piping connections terminate within
is detected while the door is closing. confines of sterilizer and are accessible from right side of

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sterilizer, when facing non-sterile (operating) end. All sanitary
stainless-steel piping utilizes sanitary tri-clamp fittings. Other
piping connections are screwed or compression fittings.

MOUNTING ARRANGEMENT
Sterilizer is designed for freestanding or recessed mounting
through one or two walls. All sterilizer components are
integrally mounted within sterilizer confines of footprints. Each
sterilizer is equipped with adjustable leveling legs.

OPTIONAL FEATURES
Automatic Air Filter Sterilization cycle used for sterilization
of the 0.2 mm sterile air filter, filter housing and piping (from
filter housing to chamber air shut-off valve) either prior to or
after cycle processing.
Air Filter Test Ports add valves and ports to perform integrity
test in-place.
ValidCycle™ software provides automated/documented
verification of compliance for each cycle by comparing
parameters of cycle in process to pre-validated cycle. Full Jacket Chamber
Decontamination Cycle is used in situations where chamber Seismic Restraints provided, along with an anchoring report
condensate may be contaminated and cannot be drained in conformance with latest seismic Zone 4 requirements.
before sterilization. During this cycle, steam is introduced into
Integral Electrical Steam Generator is designed to produce
chamber through drain line, and all effluent is sterilized before
steam of a quality equal to the feed water. Integral Electrical
discharge. Decontamination cycle includes process B cycle.
Steam Generator does not include any entrainment device to
Decontamination cycle includes compressed air back-up.
remove pyrogens. Feed water for the Integral Electrical Steam
Operator Interface Control Function (Double Door Units Generator system should be either Deionized (DI), Reverse
Only) permits operator to select and initiate cycles from Osmosis (RO) or Water for Injection (WFI) quality water. GMP
operator interface panel located on sterilizer's sterile (non- requirements dictate that steam must not contain any boiler
operating) end. additives. System is built into the sterilizer service area and
Three-Channel Pen Chart Recorder records chamber includes feed water pump, steam generator and associated
pressure and temperature for each channel in a different color. controls. This option increases height or width (depending on
An additional RTD is added in drain for independent recording. installation) of unit by 800 mm (31"). Electrical steam generator
Recorder is integrally mounted in the cabinet. is available for sterilizers with door size 66. For specific
Six-Channel Paperless Recorder records chamber pressure capacities, connections and utility consumption values, please
and temperature in electronic format. Data is stored in 21 CFR refer to dimensional drawing.
Part II system. An additional RTD is installed for load HTM 2010 Compliance Accessories are designed to meet
temperature recording. requirements for a porous load sterilizer. System includes
Mirror Construction reverses standard positioning of addition of ports to take samples in order to perform non-
sterilizer chamber and service area. In mirror construction, as condensable gases, superheat and dryness fraction tests. The
viewed from operating end, sterilizer chamber is relocated to option also provides an air detection system based on an
right side and service side is relocated to left side. Standard additional temperature probe located in drain line.
configuration is chamber on left and service on right side (as Probe for Load Temperature. One product load is provided.
viewed from operating side). Load probe can be placed in product during a sterilization cycle
Air Differential Seal (Non-Operating Side) is fabricated from for controlling and monitoring purposes. This option is typically
stainless steel, and is affixed to sterile end. Adjustable used to monitor load by Customers who are processing liquid
interface panels are provided at top, bottom, and sides, with loads.
a silicone gasket to seal unit system to facility structure. This Extended Documents. In addition to standard validation
seal is used to help maintain room air pressure. document package, extended document packages are
BioSeal (BL3/BL4 Environment) is located on sterilizer's available to assist IQ/OQ and validation. Packages include:
sterile end to prevent passage of airborne microorganisms • Extended pressure vessel
from one classified area to another. The seal is used most • Extended piping
often in Biolevel 3 (BL3) and Biolevel 4 (BL4) applications. • Extended control system
Bioseal includes compressed air back-up on the door seal. • FAT procedures and results
• Manufacturing procedures
Side/Back Enclosure Panels are installed on the right and/or
• Surface finish reports chamber and piping
left side or back of sterilizer framework as specified. Side • Loop diagrams
panels are constructed of stainless steel. • Component data sheets

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Cooling Water Savings Package utilizes the facility’s closed • VHP ready system allows the use of a portable VHP
loop water supply and heat exchanger system (not provided Biodecontamination System such as VHP 1000ED or VHP
by STERIS) to cool the vacuum pump and effluent. ARD Biodecontamination Systems* (sold separately). The
Heated Pressurized Pulsed Air Drying uses steam heated unit is used for biodecontamination of heat sensitive
heat exchanger to provide hot pressurized air during post products when the sterilizer chamber is not being used for
conditioning phase. This method is recommended for porous steam sterilization. Ports are welded into sterilizer. Hoses
rubber loads, e.g., stoppers. are extended to front fascia of sterilizer and fitted with
automated valves. The portable unit is manually connected
Pure Steam PRV includes stainless steel PRV to reduce
to the sterilizer automated valves and a cable to sterilizer
steam pressure coming into the unit that is > 3 bar (45 psig).
control. Operator selects the VHP cycle from the portable
Utility Supervision and Monitoring includes pressure VHP Biodecontamination System and the steam sterilizer
gauges and switches to monitor incoming steam, air and water operator interface.
pressure. Alarm is included to indicate if pressure is below
• VHP steam combination system utilizes integrated VHP
requirements.
M100-X Biodecontamination System* (sold separately).
Spare Parts Kit. A spare parts kit containing selected The bidecontamination process is used in the sterilizer
mechanical and electrical components is provided. The kit when a steam sterilization cycle is not being run. The unit
includes a two year supply (with normal maintenance and is attached in the service access area and all piping and
operation of the sterilizer) of these selected items. controls are integral to the steam sterilizer. Both steam
36-Thermocouple Feed-Through Assembly is provided for sterilizer and VHP M100-X Biodecontamination System*
use with 38 mm (1-1/2") Tri-clamp chamber penetration to are controlled through steam sterilizer’s operator interface
simplify the validation process. panel.
Electronic Data Security. Upgraded Siemens control * See tech data SD840, SD716 and SD776 for information on these systems

package provides 21 CFR Part 11 and EU Annex 11 capability.


System includes Electronic Batch Report Data, Audit trail and
batch cycle data that is viewable from the HMI screen via
appropriate password setting, E-signature for final batch
verification/acceptance, local removable memory for
temporary data storage of audit trail and batch cycle data, and
data export capability.
Electronic Data Security with Data Archiving and
Enhanced Batch Reporting. Upgraded Siemens control
package provides 21 CFR Part 11 and EU Annex 11 capability.
System includes Electronic Batch Report Data, Audit trail and
batch cycle data (formatted into a PDF file) that is viewable
from the PC screen via appropriate password setting, E-
signature for final batch verification/acceptance, local hard
drive for data storage of audit trail and batch cycle data, and
Data export capabilities.
Process Contact Surface Finish Ra <0.6 mm (25 m")
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. NOTES
VHP® Biodecontamination System (options), choose from
1. The drain line should have a 51 mm (2") air-gap to prevent
the following (see note 5 below): backflow.
• VHP Ports are welded into the steam sterilizer during 2. The pipe sizes shown indicate terminal outlets only. Building
service lines, provided by others, must supply the specified
manufacturing. The ports allow the use of a portable VHP dynamic pressures and flow rates.
Biodecontamination System such as the VHP ARD or VHP 3. A non-fused, pad-lockable disconnect switch is provided with the
1000ED Biodecontamination Systems* (sold separately) at sterilizer.
some time in the future. The ports are accessible from the 4. The clearances shown are the minimum clearances for installing
and servicing the equipment.
service area. Manual ball valves are installed on the ports
5. The VHP options are to be used by trained and certified Applicators
and can be padlocked. Door logic allows the operator to who have successfully completed both the STERIS Training and
open and close the door before and after the cycle. A key Certification Course for applicators of Vaprox Hydrogen Peroxide
switch is provided so door can be locked closed while cycle Sterilant and the VHP pertinent Biodecontamination System
Operator Course. Certification must be active and in force for all
is in operation. Interface with VHP Biodecontam-ination Applicators of Vaprox Hydrogen Peroxide Sterilant.
System is not included.

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UTILITY REQUIREMENTS* CUSTOMER IS RESPONSIBLE FOR COMPLIANCE WITH
APPLICABLE LOCAL AND NATIONAL CODES AND
* See drawings for specific quantities and additional notes. Utility connection sizes REGULATIONS.
and flow rates are dependent on the chamber size selected. Refer to STERIS
equipment drawing for details.

Refer to the Following Equipment Drawing for Installation Details

Equipment Drawing Number Equipment Drawing Title

329343 Finn-Aqua BPS GMP Steam Sterilizer 66X

Views Shown With Typical Piping Modules


All Process Components Not Shown
Dimensions are typical –
Sterilizer Width
1320 mm (52") drawings are not to scale.

View Shown without Optional Air

(25-5/8")
650 mm
Differential Seal or BioSeal

1960 mm
(77-1/8")

Chamber Width
775 mm (30-1/2")
Loading Height

Front View

View Shown with Separate Control Cabinet Option

Panel Removable for Service Access

Chamber and Jacket Pressure Gauges


Validation Port

Four Leveling Legs

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Refer to the Following Equipment Drawing for Installation Details

Equipment Drawing Number Equipment Drawing Title

329341 Finn-Aqua BPS GMP Steam Sterilizer Pit Mounting

Sterilizer Width*
View Shown without Optional Air
Differential Seal or BioSeal Load
Width*
Sterilizer Height*

Load Height*

Chamber*

(Typical only – some details may vary.)

*Refer to table on page 8 for common models and sizes


Panels Removable for
Service Access

Chamber and Jacket Pressure


Gauges

Integrated Controls

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Common Finn-Aqua BIO Pharma Series (BPS) Sterilizer Models

Nominal Chamberb Internal Chamber


Typical Sizesa
Size - W x H mm (inches) Depth - mm (inches)

666a, 669, 6612, 6615 650 x 650 (26 x 26) 650, 950, 1250, 1550 (26, 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 650 x 650 (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)

a. Additional sizes are available; please consult your STERIS sales representative for further details.
b. See detailed drawing for external dimensions. Actual load dimensions may differ.

Chamber Size Key to Model


Numbers
Sample Model Number
Number Size: mm (inches)
Finn-Aqua Model #
6 650 (26)
Internal Chamber Width = 26"
9 950 (37) Internal Chamber Height = 37"
12 1250 (49) Internal Chamber Depth = 49"
Double Door
15 1550 (61) Pit Mounted
Cycle Type
18 1850 (73)
cGMP Version
21 2150 (85) Control System Type

24 2450 (96)

30 3050 (120)

For Further Information, contact:

STERIS Corporation
5960 Heisley Road
Mentor, OH 44060-1834 • USA
440-354-2600 • 800-548-4873
www.STERISLifeSciences.com

This document is intended for the exclusive use of STERIS Customers, including
architects or designers. Reproduction in whole or in part by any party other than
SD852 ©2012, STERIS Corporation. All rights reserved. (07/01/12) a Customer is prohibited.

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