CUSTOMER: REFERENCE - EquipNet · CUSTOMER: REFERENCE: GE 600 SERIES LIFE SCIENCE STERILIZERS PRODUCT SPECIFICATION PRODUCT Getinge GE 600 series sterilizers are microcomputer controlled

CUSTOMER:

REFERENCE:

GE 600 SERIESLIFE SCIENCE STERILIZERS

PRODUCT SPECIFICATION

PRODUCT

Getinge GE 600 series sterilizers are microcomputer controlledautomatic steam sterilizers with operator selectable cycles.The cycles employ mechanical air removal with a series ofpressure/vacuum pulses to effectively displace air byprogressive dilution. The PACS 3000 microcomputersequences the process and monitors all cycle phases,providing both audible and visual notification in the event of adeviation from operating parameters.

APPLICATION

For general-purpose steam sterilization of equipment, instru-ments and utensils in vented containers, animal cages, feed,and bedding material (according to selected cyclecombination). Special process combinations are available forliquids in closed rigid containers, or high contaminant effluentsterilization applications. Temperature range is from 105°-135°C. The liquid exhaust is microcomputer controlled forlinear and consistent liquid cool down.

KEY FEATURES

CHAMBER SIZES

DOOR SELECTIONS

Single DoorDouble Door

SERVICE SIDE

As seen from control sideRight side service (standard)Left side service (optional)

INSTALLATION SELECTION

Recessed through one wallRecessed through two wallsInspection door mounted in extended fasciaRecessed through one wall with cabinet

VOLTAGE SUPPLY

208/220/240V, 3 phase, 60 Hz460/480V, 3 phase, 60 Hz575V, 3 phase, 60 Hz

PROCESS COMBINATIONS (APPLICATIONS)

See process charts and descriptions.Laboratory/ Animal LiquidProduction Facilities Cooling

P3100 P3220 L3200P3101 P3222 L3202P3200 L3203P3201 L3300P3202 L3302P3203P3204

Chamber

ModelOverall Size VolumeW x H x D (Nominal

Internal)

66626 1/2'' x 26 1/2'' x 26'' 58 7/8'' x 6'-6'' x 37 3/4'' 10.5 ft3

672 x 672 x 660 mm 1496 x 1980 x 960 mm 298 L

661026 1/2'' x 26 1/2'' x 39 3/8'' 46 1/4'' x 6'-6'' x 53 1/8'' 16 ft3

672 x 672 x 1000 mm 1175 x 1980 x 1350 mm 452 L

661326 1/2'' x 26 1/2'' x 51 1/4'' 46 1/4'' x 6'-6'' x 65'' 20.7 ft3

672 x 672 x 1300 mm 1175 x 1980 x 1650 mm 587 L

661726 1/2'' x 26 1/2'' x 66 7/8'' 46 1/4'' x 6'-6'' x 6'-8 3/4'' 27.1 ft3

672 x 672 x 1700 mm 1175 x 1980 x 2050 mm 768 L

Chamber Size(Nominal Internal)

W x H x D

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QUALITY STATEMENT

Confidence in the Getinge Group is the most important qualitycriterion. This must be the hallmark of all our external andinternal commitments, activities and products. Products andservices supplied by Getinge must conform to the agreedterms and expectations to ensure recommendations for furtherbusiness. The achievement of these quality goals is the basisfor a continued competitive and successful enterprise.

STANDARDS AND CODES

The sterilizer complies with the requirements of:• UL 61010A-1 as certified by ETL• Canadian Standard Association CAN/CSA-C22.2

N0.1010.1-92 as certified by ETL• ASME (Section VIII, Division 1), U Stamped• ASTM 795 (C) Specification for thermal insulation for use

in contact with austenitic stainless steel• IEC 60204-1 [EN 60204-1] Safety of machinery –

Electrical equipment of machines – Part 1: Generalrequirements

• IEC 61310-1 [EN 61310-1] Safety of machinery –Indication, marking and actuation – Part 1: Requirementfor visual, auditory and tactile signals

• IEC 61326-1 [EN 61326] Electrical equipment formeasurement, control and laboratory use (EMC)

• IEC 61000-3-2 [EN 61000-3-2] Harmonics, Electro-magnetic compatibility – limitations of voltage changes

• IEC 61000-6-1 [EN 61000-6-1, former EN 50082-1]Immunity, Electromagnetic compatibility – generic im-munity standard

• IEC 61000-6-3 [EN 61000-6-3, former EN 50081-1]Emissions, Electromagnetic compatibility – generic emis-sion standard

• EN 292-1 (A) Safety of machinery – Basic concepts,general principles for design – Part 1: Basic terminology,methodology

• EN 292-2 (A) Basic concepts, general principles fordesign – Part 2: Technical principles and specifications

• EN 12347 Performance criteria for steam sterilizers andautoclavesCRN (pressure vessel design registration NO. for Canada)Province: _____________________________

MECHANICAL FEATURES

CHAMBER AND DOOR CONSTRUCTION

The sterilizer chamber, jacket and door are constructed fromsolid, high quality, type SA240 316 Ti /EN10028-7 1.4571stainless steel; door reinforcements are in AISI 304/1.4301.Internal surfaces are highlypolished to facilitate cleaning(better than 0.5 ± 0.13 μm).The internal corners areradiuses to aid cleaning andthe chamber floor slopes to acentral drain. A stainless steelmesh strainer protects thedrain port from blockage bydebris. The sterilizer chamberis completely insulated withmineral wool (with a minimumthickness of 50 mm), com-piling to ASTM795 “Specifica-tion for thermal insulation for

use in contact with austenitic stainless steel” and encased inrigid removable sheet aluminum housing. The chamber ismounted on a stainless steel framework with adjustable feet.

Stainless steel door is AISI 304, bead blasted.Sanitary designed stainless steel door. (The insulationplates are tightly welded. One hole is left for nonepressurizing). The door is bead blasted.Sanitary designed stainless steel door. (The insulationplates are tightly welded. One hole is left for nonepressurizing). The door is grinded externally to a surfacefinish Ra 0.5 ± 0.13 μm.

AUTOMATIC, VERTICALLY SLIDING DOOR(S)

The door is fully automatic in operation and is raised andlowered by a pneumatic cylinder. Door operation is controlledvia push buttons on the control panel. A mechanical safetyedge stops the door if it is obstructed while closing, thusprotecting the operator and loading equipment. The door isautomatically sealed. For double door units a safety and cross-contamination interlock is provided.

The door seal is a silicon rubber “O” ring. At the beginning ofa process, the gasket is pressed against the rear face of thedoor by compressed air (standard) or steam (optional). Apressure switch monitors the gasket pressure throughout theprocess and initiates an alarm in the event of loss of pressure.Steam may not enter the chamber unless this switch isactuated. At the end of the process, the seal is withdrawn byvacuum and the door on the unloading side is opened forunloading.

Steam to door gasket

PERSONNEL SAFETY FEATURES

In addition to the door safety systems, the chamber isprovided with a pressure monitor that ensures that all chamberpressure has been relieved prior to allowing the door(s) toopen. As an “intrinsic safety” feature, when the door seal isretracted the chamber is completely vented to atmospherewhile the door is still retained in the fully closed andmechanically locked position.

MECHANICAL VACUUM PUMP

A highly efficient liquid ring vacuum pump, mounted onvibration isolators for quiet operation, is provided to effectivelyremove air from within the chamber. The vacuum pump isconnected in series with an efficient condenser to assist airremoval and protect the vacuum pump from excessivetemperatures. The pump impeller is cast bronze.

DRAIN COOLING

The drain discharge is cooled down to reduce the effluenttemperature to an average of 60°C or less. Under a limitedperiod of time (less than 30 seconds) the temperature could behigher.

VALVES & COMPONENTS

Process valves are pneumatically operated piston valves andappropriately HEPA filtered, providing long service life, limitedmaintenance and containment breech. Process piping isdesigned and constructed to minimize dead legs. All standardcomponents are non-proprietary and commonly availableworldwide. T/C-flanges are (if used) secured with highpressure clamps.

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SAFETY VALVES

Safety valves are, if required, provided on the chamber andjacket. (Piped to discharge to floor. Program 3302/3 requiresspecial venting).

PRESSURE INDICATORS

Fascia mounted diaphragm gauges on control side areprovided for• Chamber pressure/vacuum• Jacket pressure/vacuum• Process steam supply pressure

Fascia mounted diaphragm gauges on non-control side areprovided for• Chamber pressure/vacuum

PRESSURE INDICATORS IN SERVICE AREA

• Chamber pressure gauge (Standard)• Steam pressure gauge (Optional)• Air pressure gauge(Optional)• Water pressure gauge (Optional)

TEMPERATURE AND PRESSURE SENSORS

The PACS 3000 control system has a built-in linearization, tocorrect the individual characteristics of each type of sensorconnected to the system. Each sensor is calibrated withindividual constants to correct the deviation in manufacturingand aging. The following sensors are provided and are used inthe automatic control of the sterilizer:• Chamber drain temperature sensor (control)• Jacket temperature sensor• Chamber pressure sensor• Chamber load temperature probe (for liquid process

control)The temperature sensors are Pt100, according to IEC 60751,accurate to ± 0.1°C.The pressure sensor is equipped with software basedtemperature compensation. Accuracy is 1% over the range 0to 5 bar (a).

Additional load temperature probe(s) Qty:______

VALIDATION CONNECTIONS

The chamber is provided with one 2" T/C connection foroptional vacuum/pressure gauge as a standard. Optionalports can be provided if it is requested.

Additional validation port(s) Qty:______

AIR ADMISSION FILTER

A disposable filter is provided for air admission to chamberduring vacuum break at the end of a cycle. The filter separationefficiency is higher than 99.998% for particle size 0.3 μm. Filterreplacement intervals can be monitored by the PACS 3000.• Stainless steel filter housing with 0.2 μm absolute sterile

filter, for air support pressure. (This filter only applies tounits with L-program combinations.)

cGMP FEATURES

Getinge features to meet or exceed current GoodManufacturing Practices (cGMP).Temperature distribution with a maximum variation of plusor minus (±) 0.5°C from the average chamber temperatureonce stabilization is achieved.

Secondary temperature verification including additionaltemperature sensor located in close proximity to the drainsensor. Digital read-out of the secondary temperaturesensor.

CROSS CONTAMINATION SEAL (CCB)

The CCB is designed to prevent cross contamination betweenthe work space and mechanical space of the sterilizer. A solidstainless steel flange is welded at one end of the sterilizer.Stainless steel panels are provided to extend the welded flangeto adjacent walls, ceiling and floor. Panels are anchored and allseams are filled with silicone sealant to form the barrier. TheCCB is an air differential barrier and not a gas tight barrier. Thisbarrier will not pass a helium leak rate detection test.

Cross contamination seal, non-control sideCross contamination seal, control sideDual cross contamination seal (n/a on 666/6610)

BIOLOGICAL SEALING FLANGE (BIOSEAL)

The Getinge GE Sterilizers can be configured with a stainlesssteel flange, welded around the chamber periphery. A stainlesssteel wall frame is appropriately designed to be installed in thefacility wall (see NOTE). Studs are located and welded aroundthe flange plate and the wall frame. The seal is then maintainedwith a thick Nitril rubber (i.e. Buna-N) gasket material usingstainless steel clamping bars, nuts and lock washers. Thecomplete sealing assembly and wall frame provides an airtightseal, capable of preventing passage of airborne micro-organisms from a “hot” to “cold” side. Any necessary penetra-tions in the flange plate for wiring or plumbing shall be throughpotted condulet fittings. Gas tightness tests show no crosscontamination leakage through the sealing flange withpressure differential of 0.22 psig (6" WC). The barrier gasket isclamped from “hot” side. A factory leak test is performed foreach individual design cross-section under third partysupervision. A test report is issued from a notified body.

Bioseal, non-control sideBioseal, control sideDual bioseal

NOTE: The wall frame is shipped prior to the sterilizer forbuilding integration. It shall be the responsibility of the coatingcontractor to provide final containment seal between wallframe and contiguous laboratory wall, specific to “hot side.”

Embedded wall frameLagged wall frame

MECHANICAL OPTIONS

PIPES & VALVES

PROCESS PIPING

Standard steam to chamber piping systems includingchamber components are constructed of copper, bronze orbrass. Pipe connections are threaded, flanged, brazed orsoldered as applicable. Valves and major components arearranged to be easily accessible or removable for servicing andreplacement.

NON-PROCESS PIPING

Non-process piping systems are constructed of copper,bronze or brass. Pipe connections are threaded, flanged,brazed or soldered as applicable. Valves and majorcomponents are arranged to be easily accessible or removablefor servicing and replacement.

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STAINLESS STEEL PROCESS PIPING

Steam to chamber piping, components and other pipework connected to the chamber, up to and including thefirst drain isolating valve of stainless steel. Thread fittingsand/or compression couplings. Valves and majorcomponents are arranged to be easily accessible orremovable for servicing and replacement.

STAINLESS STEEL SANITARY PROCESS PIPING

Steam to chamber piping, components and other pipework connected to the chamber, up to and including thefirst drain isolating valve of stainless steel. Stainless steelpiping in contact with clean steam and sterile air areorbital welded pipe with tri clamp connectors. Otherstainless steel piping is welded with flanged or threadedconnections. Valves and major components are arrangedto be easily accessible or removable for servicing andreplacement.

STAINLESS STEEL JACKET PIPING

Stainless steel non-sanitary jacket piping. Threaded andcompressed fittings.

MODULATING VALVE

For regulation of incoming modulated media.Incoming steamIncoming airIncoming water

RUPTURE DISC

A rupture disc is provided as an addition in series with thesafety valve to maintain sanitary piping standards for thesteam to chamber piping. A pressure switch mountedbetween the disc and the chamber safety valve ismonitored to ensure the integrity of the rupture disc. Avisible and audible alarm is generated upon failure of thedisc.

SELF CLEANING DRAIN STRAINER

The external maintenance drain strainer is equipped withan automatic cleaning system. Water is back flushedthrough the strainer to increase the service period beforemanual cleaning. This is particularly necessary inautoclaves that are used to sterilize animal feed andbedding. NOTE: Compressed air demand increases withthis option. See utility data for further information.

STEAM SUPPLY

Central Steam Supply (units are supplied as standard to beconnected to a building steam supply)

An automatic, integral, electrically heated steam generator60 kW, mounted under the sterilizer chamber. The integralsteam generator pressure vessel is made of stainlesssteel, W.Nr. 1.4571, insulated with 50 mm chloride freemineral wool enclosed in a rigid removable aluminumsheet housing. A water level glass for inspection of thepressure vessel is visible from the service area. Theheating elements are made of stainless steel ASTMS31254.Pressure vessel volume: 52 l. Water volume: 31 l.The unit is automatically controlled and comes completewith a feed water unit. All parts in contact with the feedwater are made of stainless steel.

The unit is equipped with a fully automatic blow downsystem to guarantee that the outlet to drain does notexceed 60°C.

An automatic, integral steam heated steam generator. Thegenerator pressure vessel is made of stainless steel, W.Nr.1.4571, insulated with 50 mm chloride free mineral woolenclosed in a rigid removable aluminum sheet housing. Awater level glass for inspection of the pressure vessel isvisible from the service area. The heating coils are madeof stainless steel ASTM S31254.Pressure vessel volume: 52 l. Water-volume: 31 l.The unit is automatically controlled and comes completewith a feed water unit. All parts in contact with the feedwater are made of stainless steel.

IN LINE FILTER STERILIZATION

This additional factory pre-set program is used to sterilizethe chamber air admission filter in place. The program willautomatically sterilize and “dry” the filter with no userintervention.

IN LINE FILTER WATER INTRUSION TEST

This optional factory pre-set program is used to test thechamber air admission filter in place. The program willautomatically test and dry the filter with no user inter-vention. A visible and audible alarm sounds in case of afilter failure. (Delivered with SATORIUS™ filter house andfilter cartridge.)

CONDENSATE RETURN

The equipment can be furnished with a condensate returnutility connection. Only condensate that has not come incontact with the product will be returned to the user plantsteam generator. This utility may be connected to thecustomer’s condensate return system while installing theequipment. (Maximum lift is 15 ft.)

WATER CONSERVATION SYSTEM

The Sterilizer is provided with a water conservation system(standard) for reduced consumption of potable water andmaximum vacuum pump efficiency.

Chilled water with a maximum temperature of *°C re-circulation connection for external cooling (re-circulation)which may reduce the potable water consumption by upto 75%. This option may only be combined with waterconservation system. This option may be connected tothe customer’s chilled water return system while installingthe equipment.

* See Utility Data Sheet, note 4

UTILITY GAUGES (SERVICE AREA) & UTILITY ALARMS

Chamber pressure gauge will be provided in the service area.Additional incoming media gauges are available in the servicearea. (Gauges are for information only.)

Incoming Steam Pressure GaugeIncoming Air Pressure GaugeIncoming Water Pressure GaugeIncoming Utility Alarm/SteamIncoming Utility Alarm/AirIncoming Utility Alarm/Water

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PIPE INSULATION

All pipes that average greater than 60º C.Cold water pipes are insulated.

PASSIVATION

Passivation for the interior surfaces of the chamber,chamber doors, process piping and process valves. Seefurther technical information.

CONTROL SYSTEM FEATURES

CONTROL SYSTEM PACS 3000

The PACS 3000 modular PLC control system dedicated tocontrolling of Getinge sterilizers, including:• CPU processor with battery backup• Digital in- and outputs for sterilizer control• Analogue measuring inputs• COM ports for printer & PC communicationThe PACS 3000 controls all system functions, monitors systemoperations, both visually and audibly alerts the operator ofcycle malfunctions and, on demand, provides visual indicationof the chamber temperature and pressure.

OPERATOR PANELS

The PACS 3000 control system is operated via an easy-to-use“menu system.” As default, the operator has access to thecycle selection, cycle start and door control. Operators canonly run “validated” cycles. Access to other functions, such asrunning test cycles, setting parameters, calibration, serviceand maintenance is controlled using pre-defined access levelspreventing unauthorized access.

“MULTIFLOW” – DUAL STERILIZER CONTROLS

The unit may be provided with dual control capabilitiesallowing for pass-through sterilization of materialsentering into containment areas, decontamination ofused items and waste leaving the area, and single doorsterilization applications from either side of the unit.

OPERATOR PANEL CONTROL SIDE

OP 30

• 5.7" color display• Door open/close buttons• Cycle & Phase• Temperature(s)• Graphical Process• Plot graph, bar graph,

parameter settings, maintenance & service menus• System configuration

OP30 OPERATOR INTERFACE FEATURES

The OP30 color screen is divided into specific sections todisplay selection and performance information in a consistentmanner. The top section identifies the time and temperatureselected for the cycle. Below that is the type of cycle selected.The middle portion provides a choice of three screens to viewactual, real time cycle information. “Pop-up” dialog boxes tochange values appear within parameter selection screens toimplement changes. Parameters are password protected. Thescreens are:

SETUPSELECT

CYCLE

PARA-

METER

Exposure Time Exposure Temp Drying Time

P1 vac PREVAC1

01 STANDBY

00:03:00 135.0 C 00:20:00

00:00:00

01:12:44

UNSEAL

Chamber Temp

Cham Press/PSIG

Jacket Temp

Atmosphere PSIA

Chamber PSIA

Steam Table Diff

Exp. Temp Max

29.1 C

0.00 PSI

129.9 C

14.25 PSI

14.25 PSI

-13.82 PSI

135.6 C

• Detail. Displays real time process information in text form.

SETUPSELECT

CYCLE

PARA-

METER

Exposure Time Exposure Temp

P13 liq LIQUIDS1

03 LIQ EXHAUST

00:30:00 121.1 C

00:47:30

00:13:00

ABORT

Chamber Temp 103.6 C

Chamber PSIA 17.45 PSI

TIME00:50

• Plot Graph. Displays cycle temperature and pressure in acolored graph during a cycle.

SETUPSELECT

CYCLE

PARA-

METER

Exposure Time Exposure Temp Drying Time

P7 grv GRAVITY1

02 EXPOSURE

00:30:00 250.0 F 00:30:00

00:36:15

00:25:00

MORE

Chamber Temp Chamber PSIA

REMAINING TIME

36

250.5 F 30.25 PSI

• Bar Graph. Displays the temperature and pressure in abar graph, with a large, easy to read, time remaining to theend of the cycle (averages the last three cycles for eachcycle type).

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OP30

The lower portion of the screen provides text alarm messagesand non-critical system messages, both using color displays,and shift key identifications. Navigating the various screens isaccomplished by use of soft keys, directional arrows to movethe cursor and change values and the Enter key. Time andtemperature can be changed using a quick edit feature. Eachchange prompts operator acceptance and a “Save” soft key.

For Supervisor access, an alpha-numeric display provideslevels of access for individual operators and service. Using thesoft key labelled “Setup” provides the ability to:• Adjust system menu for setting the calendar• Establish user’s passwords for each operator• Choose language, date format, and temperature and

pressure measurement• Adjust parameters through password access

OPERATOR PANEL NON CONTROL SIDE

OP10

• For unloading side only• Door open/close

buttons• Status LEDs

OP 30 (See specifications under section Operator PanelsControl Side).

SELF DIAGNOSTIC PROGRAM

PACS 3000 features a comprehensive alarm/alert system, withautomatic triggering of pre-programmable information alerts(service intervals, maintenance, etc.).

PACS 3000 CYCLE DOCUMENTATION

Cycle performance data is printed during the cycle and atcycle complete. The printed cycle information includestransition points, pressure and temperatures, cycle start time,date, both sterilizer and cycle number, and any cycle alarmthat occurred during the cycle. In case of printer failure duringthe cycle, the PACS 3000 stores the cycle data and can, ondemand, reprint the last cycle.• Daily cycle # – total cycle count• Summary verification of time at selected temperature

(min/max values)• Cycle verification and signature line• Fo Control. The control system allows control of liquid

sterilization by Fo value rather than time and temperature.This mode of control may optionally be used for heatsensitive liquids.

The PACS 3000 supports the following printing modes:• Data printout – numerical data

PRINTER TO PACS

• Cobex 32 column thermo printer (standard)Color printer, remote mounted. Printer is configured byGetinge.Printer stand (shelf for printer)

LEAK TEST

The sterilization process is sensitive to residual air in thechamber. If the chamber is not leak-tight, sterilization

efficiency may be impaired. Getinge vacuum sterilizers areequipped with a fully automatic leak test process to confirmleak tightness of the chamber.

“ALARMS” (IF APPLICABLE)

Automatic process check-up and failure corrections areprovided with the PACS 3000 control system. In the situationof a disturbance during the sterilization cycle, the processenters an alarm phase, which safely will end the processautomatically. The range of alarms includes:• Temperature & pressure sensor failure• Service failure alarms

Alarms:• Power Failure Alarm• Door Failure Alarm• Gasket Failure Alarm• Phase Timeout Failure Alarm• Analogue Input Failure Alarm• Safety Interlock Failure Alarm• PACS Fault Alarm• Vacuum Pump Failure Alarm• Fan Failure Alarm• Pump Failure Alarm• Motor Failure Alarm

ABORT

In case of a failure alarm, the sterilizer goes into an alarmphase. The sterilizer waits for the operator technician to decidehow to proceed. There are 2 alternatives of action:1. Abort cycle, through pressing the start button.2. Use stepping key. (This makes it possible to step phases

by pressing the alarm button or re-start the cycle.) Notthrough safety set points.

EMERGENCY STOP

A cycle can be shutdown by pushing the emergencyshutdown button. The “shutdown” facility enables the user tostop any cycle. It can then be taken into a safe ending unlessthe cycle is already at or beyond that stage. If this facility isused, then an “Emergency Shutdown” alarm will be activated.

The main purpose of the emergency shutdown is animmediate shutdown of all media and processing. There aretwo different ways to end the process after a shutdown. Whenthe E-stop has been reset, the program can either:• Be taken to safe ending via the start button or• Re-started by authorized person (requires key)

OPTIONS FOR CONTROL SYSTEM

OPERATOR PANEL LOCATION(S)

Above chamber doorSide mounted (will in-crease the total width) Left sideSide mounted (will in-crease the total width) Right side

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INDEPENDENT CYCLE DOCUMENTATION

The independent cycle documentation for redundant moni-toring is using independent sensors, connected directly to theindependent recorder.

PACS Supervisor is a completely independent monitoringand documentation system that constantly receivesreadings from PACS 3000 and compares them with itsown independent sensors. PACS Supervisor prints allprocess data on one printout, eliminating the need for aseparate recorder.Printer selection (connection located in service area):

Color printer for the supervisor. Printer is configuredby Getinge.80 column dot matrix printer for the supervisor.

2 channel line recorder on control side for independentmonitoring of chamber temperature and chamber drain.3 channel line recorder on control side for independentmonitoring of chamber temperature and chamber drain.

CS1000

The optional CS1000 software runs on Windows ’95-’98,NT, 2000 & XP operating systems. The software offerscomplete control over all aspects of the PACS 3000control system. Operator, calibration, validation,maintenance and programming functions can beaccomplished using the CS1000 software. The softwareis presented in classic Windows folder format with pointand click commands and has online help to assist theuser.

Remote mounted desktop PC is provided to runCS1000 software.A free standing PC enclosure is provided to house adesktop PC, slide out keyboard, monitor and printer.

Step key in front fasciaPC connection in front fasciaLight in electrical enclosureAuxiliary electrical outlets in service areaStainless steel electrical cabinet, NEMA 4X rated

OPTIONAL ALLEN BRADLEY CONTROL SYSTEM

An Allen Bradley SLC 500 series control system may besupplied as an alternate to the standard PACS 3000system. All software for our Allen Bradley control systemoption is created in RSLogix and panel builder software,respectively. Our Allen Bradley control system optionfunctions similarly to the PACS 3000. Display screens andcycle functions are identical, with the exception of ourapplication specific PACS boolean programminglanguage.

PV600Control sidePV600Non-control sidePV1000, color touch screenControl sidePV1000, color touch screenNon-control sideEthernet communication port

CYCLE TYPES

LABORATORY/PRODUCTION APPLICATIONS

See the program combination chart in the appendix of thisdocument for an overview of the cycles provided.

LABORATORY/PRODUCTION

P3100 – The P3100 program combination has been designedfor the sterilization of items such as utensils, textiles, rubberstoppers and filters. Parameters for each process may beadjusted and saved for each respective program. See theprogram combination chart in the appendix of this documentfor an overview of the cycles provided.

P3101 – Similar to program P3100, but with P1 program. Aneconomical alternative for specific process applications.

P3200 – This cycle is equipped with a self-cooling process forvented containers. A liquid loss of about 5% due toevaporation cooling is to be expected. Set at 0.75 psi/min (5kPa/min) during manufacture, the liquid exhaust rate isadjustable within the range of 0.1-1.5 psi/minute (1 to 10kPa/minute). The P3200 program combination has beendesigned for the sterilization of items such as utensils, textiles,rubber stoppers, filters and liquids in vented containers.

P3201 – Similar to program P3200, but with P1 and P2 pro-gram. An economical alternative for specific processapplications.

P3202 – The P3202 program combination has been designedfor the sterilization of items such as utensils, textiles, rubberstoppers, filters, and vented liquids when effluent sterilization isrequired. These program combinations are recommended forBSL-3 application. The Getinge effluent sterilization process isuniquely designed to entrap potentially contaminateddischarge from the sterilizer until the completion of theprocess. Air removal is through a bacteria retentive filter andsteam is injected into the bottom of the sterilizer to heatcontained condensate.

P3203 – The P3203 program combination has been designedfor the sterilization of items such as utensils, textiles, rubberstoppers, filters, and liquids. All processes in this combinationare used to entrap and deactivate the effluent exiting thesterilizer drain.

P3204 – Similar to program P3203, but with P1 program.

ANIMAL FACILITIES

P3220 – The P3220 program combination has been designedfor the sterilization of items such as: animal feed, utensils,textiles, rubber stoppers, filters, vented liquids, animal cagesand bedding.

P3222 – The P3222 program combination has been designedfor the sterilization of items such as animal feed, utensils,textiles, rubber stoppers, filters, vented liquids, animal cagesand bedding when effluent sterilization is required. Theseprogram combinations are recommended for BSL-3application. One process in this combination is used to entrapand deactivate the effluent exiting the sterilizer drain.

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LIQUID COOLING

L3200 – The L3200 program combination has been designedfor the sterilization of items such as utensils, textiles, rubberstoppers, filters and liquids in either sealed or vented rigidcontainers. The Getinge air-overpressure jacket coolingprocess is designed for slow cooling of liquids in ventedcontainers where boiling and liquid loss need to be prevented,or to prevent liquids in sealed rigid containers from rupturing.Filtered compressed air is introduced into the chamber, andcooling water into the jacket at the completion of the exposurephase. The air ballast prevents boiling of vented liquids andprovides counter pressure for sealed liquids in rigid containers.The cooling water in the jacket absorbs energy normally givenup during a slow exhaust process. This process extends theentire cycle. Time extension is dependent upon loadconfigurations.

L3202 – Similar to program L3200, but the P2 filter program isreplaced with an effluent cycle.

L3203 – Similar to program L3200, but all cycles with effluentsterilization.

FORCED AIR LIQUID COOLING

L3300 – The L3300 program combination is similar to L3200,but includes a uniquely designed fan to improve cooling andshorten the processing time.

L3302 – Similar to program L3300, but the P2 filter program isreplaced with an effluent cycle.

GEL. This is the first level of forced aeration system on asterilizer, using a magnetic fan and jacket-cooling phase. Thislow cost system gives a major time reduction of the coolingphase, speeding up the process time.

Program combination P 3100P1 Cycle type Vacuum Cycle

RAX1000 Typical load Utensils, Glassware, Textiles, Plastic & Rubber products

Parameter

1. Pre pulse vacuum2. Sterilizing temperature3. Sterilizing time4. Drying vacuum time5. Drying pulses

- - -°Cminmin- - -

Range

1 - 99105 - 1353 - (9 h)0 - (9 h)0 - 10

Delivered

3134750

Actual

_ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ _

P2 Cycle type Vacuum Cycle

RAX1001 Typical load Textiles, Plastic & Rubber products

Parameter


- - -°Cminmin- - -

Range

1 - 99105 - 1353 - (9 h)0 - (9 h)0 - 10

Delivered

31211650

Actual

_ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ _


RAX1002 Typical load Utensils, Glassware, TextilesParameter


- - -°Cminmin- - -

Range

1 - 99105 - 1353 - (9 h)0 - (9 h)0 - 10

Delivered

3134750

Actual

_ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ _

P4 Cycle type Vacuum Cycle, Ramped

RAX1008 Typical load Filter, utensils

Parameter

1. Pre pulse vacuum2. Sterilizing temperatur3. Sterilizing time4. Drying vacuum time5. Ramps Ramps Ramps

- - -°Cminminbar / minpsi / minkPa / min

Range

1 - 99105 - 1353 - (9 h)0 - (9 h)0.1 - 1.01.45 - 14.510 - 100

Delivered

31211650.22.9020

Actual

_ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ _


RAX1003 Typical load Rubber products, Ampoules

Parameter


- - -°Cminmin- - -

Range

1 - 99105 - 1353 - (9 h)0 - (9 h)0 - 10

Delivered

31211652

Actual

_ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ _

Hazardous waste and explosive material must not be processed in this sterilizer.

RAX176 . . . . . . . P3101

Program combination P 3100P6 Cycle type Leak rate test

RAX1013 Typical load Warm leak test

Parameter

1. Temperature2. Time

Max accepted leak rate 0.013 bar / 10 minMax accepted leak rate 0.19 psi / 10 minMax accepted leak rate 1.3 kPa/ 10 min

°Cmin

Range

1347

Delivered

1347

Actual

_ _ _ _ _ __ _ _ _ _ _


RAX177 . . . . . . . P3200

Program combination P 3101P1 Cycle type Vacuum Cycle, Ramped

RAX1009 Typical load Utensils, Glassware, Textiles, Rubber items

Parameter

1. Pre Puls Vacuum2. Sterilizing temperatur3. Sterilizing time4. Drying vacuum time5. Ramps Ramps Ramps


Range

1 - 99105 - 1353 - (9 h)0 - (9 h)0.1 - 1.01.45 - 14.510 - 100

Delivered

31211651.014.5100

Actual

_ _ _ _ _ __ _ _ _ _ _ _ _ _ _ _ __ _ _ _ _ _ _ _ _ _ _ __ _ _ _ _ __ _ _ _ _ _

P6 Cycle type Leak rate test


Parameter



°Cmin

Range

1347

Delivered

1347

Actual

_ _ _ _ _ __ _ _ _ _ _


PROGRAM COMBINATION CHARTS

Page 9 of 16


RAX1004 Typical load Utensils, Glassware, Empty containers

Parameter


- - -°Cminmin- - -

Range

1 - 99105 - 1353 - (9 h)0 - (9 h)0 - 10

Delivered

3134750

Actual

_ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ _


RAX1001 Typical load Textiles, Plastic & Rubber products

Parameter


- - -°Cminmin- - -

Range

1 - 99105 - 1353 - (9 h)0 - (9 h)0 - 10

Delivered

31211650

Actual

_ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ _

P3 Cycle type Natural cooling cycle

RAX1015 Typical load Liquid in open or vented containersParameter

1. Pre Puls Vacuum2. Sterilizing temperatur3. Sterilizing time4. Pressure ramp Pressure ramp Pressure ramp5. Cooling temp

- - -°Cminbar / minpsi / minkPa / min°C

Range

1105 - 1353 - (9 h)0.02 - 0.20.29 - 2.92 - 2055 - 95

Delivered

1121160.020.29295

Actual

_ _ _ _ _ __ _ _ _ _ _ _ _ _ _ _ __ _ _ _ _ __ _ _ _ _ _ _ _ _ _ _ __ _ _ _ _ _



Parameter



Range

1 - 99105 - 1353 - (9 h)0 - (9 h)0.1 - 1.01.45 - 14.510 - 100

Delivered

31211650.22.9020

Actual

_ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ _



Parameter


- - -°Cminmin- - -

Range

1 - 99105 - 1353 - (9 h)0 - (9 h)0 - 10

Delivered

31211652

Actual

_ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ _

Liquids must be processed with appropriate liquid programs only.


RAX178 . . . . . . . P3201



Parameter



°Cmin

Range

1347

Delivered

1347

Actual

_ _ _ _ _ __ _ _ _ _ _



RAX179 . . . . . . . P3202

Program combination P 3201P1 Cycle type Vacuum Cycle, Ramped

RAX1009 Typical load Utensils, Glassware, Textiles, Rubber items

Parameter



Range

1 - 99105 - 1353 - (9 h)0 - (9 h)0.1 - 1.01.45 - 14.510 - 100

Delivered

31211651.014.5100

Actual

_ _ _ _ _ __ _ _ _ _ _ _ _ _ _ _ __ _ _ _ _ _ _ _ _ _ _ __ _ _ _ _ __ _ _ _ _ _


RAX1015 Typical load Liquid in open or vented containers

Parameter



Range

1105 - 1353 - (9 h)0.02 - 0.20.29 - 2.92 - 2055 - 95

Delivered

1121160.020.29295

Actual

_ _ _ _ _ __ _ _ _ _ _ _ _ _ _ _ __ _ _ _ _ __ _ _ _ _ _ _ _ _ _ _ __ _ _ _ _ _



Parameter



°Cmin

Range

1347

Delivered

1347

Actual

_ _ _ _ _ __ _ _ _ _ _




Page 10 of 16


RAX1004 Typical load Utensils, Glassware, Empty containers

Parameter


- - -°Cminmin- - -

Range

1 - 99105 - 1353 - (9 h)0 - (9 h)0 - 10

Delivered

3134750

Actual

_ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ _

P2 Cycle type Vacuum Cycle, Ramped, Effluent

RAX1011 Typical load Utensils, Textiles

Parameter



Range

1 - 99121 - 13530 - (9 h)0 - (9 h)0.1 - 1.01.45 - 14.510 - 100

Delivered

31213051.014.5100

Actual

_ _ _ _ _ __ _ _ _ _ _ _ _ _ _ _ __ _ _ _ _ __ _ _ _ _ _ _ _ _ _ _ __ _ _ _ _ _





Range

1105 - 1353 - (9 h)0.02 - 0.20.29 - 2.92 - 2055 - 95

Delivered

1121160.020.29295

Actual

_ _ _ _ _ __ _ _ _ _ _ _ _ _ _ _ __ _ _ _ _ __ _ _ _ _ _ _ _ _ _ _ __ _ _ _ _ _


RAX1008 Typical load Filter, utensilsParameter



Range

1 - 99105 - 1353 - (9 h)0 - (9 h)0.1 - 1.01.45 - 14.510 - 100

Delivered

31211650.22.9020

Actual

_ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ _



Parameter


- - -°Cminmin- - -

Range

1 - 99105 - 1353 - (9 h)0 - (9 h)0 - 10

Delivered

31211652

Actual

_ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ _

Hazardous waste must only be processed with effluent cycles.


Explosive material must not be processed in this sterilizer.

RAX180 . . . . . . . P3203



Parameter



°Cmin

Range

1347

Delivered

1347

Actual

_ _ _ _ _ __ _ _ _ _ _




RAX181 . . . . . . . P3204

Program combination P 3203


RAX1011 Typical load Utensils, TextilesParameter



Range

1 - 99121 - 13530 - (9 h)0 - (9 h)0.1 - 1.01.45 - 14.510 - 100

Delivered

31213051.014.5100

Actual

_ _ _ _ _ __ _ _ _ _ _ _ _ _ _ _ __ _ _ _ _ __ _ _ _ _ _ _ _ _ _ _ __ _ _ _ _ _

P2 Cycle type Natural cooling cycle, Effluent


Parameter



Range

1121 - 13530 - (9 h)0.02 - 0.20.29 - 2.92 - 2055 - 95

Delivered

1121300.020.29295

Actual

_ _ _ _ _ __ _ _ _ _ _ _ _ _ _ _ __ _ _ _ _ __ _ _ _ _ _ _ _ _ _ _ __ _ _ _ _ _



Parameter



°Cmin

Range

1347

Delivered

1347

Actual

_ _ _ _ _ __ _ _ _ _ _


Explosive materials must not be processed in this sterilizer.

RAX182 . . . . . . . P3220



RAX1011 Typical load Utensils, TextilesParameter



Range

1 - 99121 - 13530 - (9 h)0 - (9 h)0.1 - 1.01.45 - 14.510 - 100

Delivered

31213051.014.5100

Actual

_ _ _ _ _ __ _ _ _ _ _ _ _ _ _ _ __ _ _ _ _ __ _ _ _ _ _ _ _ _ _ _ __ _ _ _ _ _



Parameter



°Cmin

Range

1347

Delivered

1347

Actual

_ _ _ _ _ __ _ _ _ _ _

Explosive materials must not be processed in this sterilizer.


Page 11 of 16



RAX1000 Typical load Utensils, Glassware, Textiles, Plastic & Rubber productsParameter


- - -°Cminmin- - -

Range

1 - 99105 - 1353 - (9 h)0 - (9 h)0 - 10

Delivered

3134750

Actual

_ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ _


RAX1005 Typical load Macrolon cages

Parameter


- - -°Cminmin- - -

Range

1 - 99105 - 1353 - (9 h)0 - (9 h)0 - 10

Delivered

31211650

Actual

_ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ _





Range

1105 - 1353 - (9 h)0.02 - 0.20.29 - 2.92 - 2055 - 95

Delivered

1121160.020.29295

Actual

_ _ _ _ _ __ _ _ _ _ _ _ _ _ _ _ __ _ _ _ _ __ _ _ _ _ _ _ _ _ _ _ __ _ _ _ _ _

P4 Cycle type Vacuum cycle, Preheat

RAX1017 Typical load FodderParameter

1. Hold temperature2. Hold time3. Sterilization temperature4. Sterilization time5. Drying vacuum time6. Drying ramp Drying ramp Drying ramp

°Cmin°Cminminbar / minpsi / minkPa / min

Range

100 - 500 - (9 h)105 - 1353 - (9 h)0 - (9 h)0.1 - 1.01.45 - 14.510.0 - 100

Delivered

85101211650.22.920

Actual

_ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ _

P5 Cycle type Vacuum cycle, Bedding

RAX1018 Typical load BeddingParameter


- - -°Cminmin- - -

Range

1 - 99105 - 1353 - (9 h)0 - (9 h)0 - 10

Delivered

11211652

Actual

_ _ _ _ _ __ _ _ _ _ _ _ _ _ _ _ __ _ _ _ _ _

Liquids must be processed with appropriate liquid programs only.Hazardous waste and explosive

material must not be processed in this sterilizer.

RAX178 . . . . . . . P3201



Parameter



°Cmin

Range

1347

Delivered

1347

Actual

_ _ _ _ _ __ _ _ _ _ _





RAX1010 Typical load Utensils, Macrolon cages, Glassware, Textiles, Rubber itemsParameter



Range

1 - 99105 - 1353 - (9 h)0 - (9 h)0.1 - 1.01.45 - 14.510 - 100

Delivered

31211651.014.5100

Actual

_ _ _ _ _ __ _ _ _ _ _ _ _ _ _ _ __ _ _ _ _ _ _ _ _ _ _ __ _ _ _ _ __ _ _ _ _ _



Parameter



Range

1 - 99121 - 13530 - (9 h)0 - (9 h)0.1 - 1.01.45 - 14.510 - 100

Delivered

31213051.014.5100

Actual

_ _ _ _ _ __ _ _ _ _ _ _ _ _ _ _ __ _ _ _ _ __ _ _ _ _ _ _ _ _ _ _ __ _ _ _ _ _



Parameter



Range

1105 - 1353 - (9 h)0.02 - 0.20.29 - 2.92 - 2055 - 95

Delivered

1121160.020.29295

Actual

_ _ _ _ _ __ _ _ _ _ _ _ _ _ _ _ __ _ _ _ _ __ _ _ _ _ _ _ _ _ _ _ __ _ _ _ _ _

P4 Cycle type Vacuum cycle, Preheat

RAX1017 Typical load Fodder

Parameter

1. Hold temperature2. Hold time3. Sterilization temperature4. Sterilization time5. Drying vacuum time6. Drying ramp Drying ramp Drying ramp

°Cmin°Cminminbar / minpsi / minkPa / min

Range

100 - 500 - (9 h)105 - 1353 - (9 h)0 - (9 h)0.1 - 1.01.45 - 14.510.0 - 100

Delivered

85101211650.22.920

Actual

_ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ _

P5 Cycle type Vacuum cycle, Bedding

RAX1018 Typical load Bedding

Parameter


- - -°Cminmin- - -

Range

1 - 99105 - 1353 - (9 h)0 - (9 h)0 - 10

Delivered

11211652

Actual

_ _ _ _ _ __ _ _ _ _ _ _ _ _ _ _ __ _ _ _ _ _



RAX184 . . . . . . . V3110



Parameter



°Cmin

Range

1347

Delivered

1347

Actual

_ _ _ _ _ __ _ _ _ _ _




Page 12 of 16

Program combination L 3200




- - -°Cminmin- - -

Range

1 - 99105 - 1353 - (9 h)0 - (9 h)0 - 10

Delivered

3134750

Actual

_ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ _



Parameter



Range

1 - 99105 - 1353 - (9 h)0 - (9 h)0.1 - 1.01.45 - 14.510 - 100

Delivered

31211650.22.9020

Actual

_ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ _



Parameter



Range

1105 - 1353 - (9 h)0.02 - 0.20.29 - 2.92 - 2055 - 95

Delivered

1121160.020.29295

Actual

_ _ _ _ _ __ _ _ _ _ _ _ _ _ _ _ __ _ _ _ _ __ _ _ _ _ _ _ _ _ _ _ __ _ _ _ _ _

P4 Cycle type Jacket cooling cycle

RAX1019 Typical load Liquids in sealed containersParameter

1. Sterilizing temperatur2. Sterilizing time3. Support pressure Support pressure Support pressure4. Cooling temperature

°Cminbar(a)psi(a)kPa(a)°C

Range

105 - 1353 - (9 h)1.5 - 3.521.8 - 50.8150 - 35040 - 80

Delivered

121162.840.628080

Actual

_ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ _



Parameter


- - -°Cminmin- - -

Range

1 - 99105 - 1353 - (9 h)0 - (9 h)0 - 10

Delivered

31211652

Actual

_ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ _



RAX171 . . . . . . . L3202

Program combination L 3200P6 Cycle type Leak rate test


Parameter



°Cmin

Range

1347

Delivered

1347

Actual

_ _ _ _ _ __ _ _ _ _ _







- - -°Cminmin- - -

Range

1 - 99105 - 1353 - (9 h)0 - (9 h)0 - 10

Delivered

3134750

Actual

_ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ _



Parameter



Range

1 - 99121 - 13530 - (9 h)0 - (9 h)0.1 - 1.01.45 - 14.510 - 100

Delivered

31213051.014.5100

Actual

_ _ _ _ _ __ _ _ _ _ _ _ _ _ _ _ __ _ _ _ _ __ _ _ _ _ _ _ _ _ _ _ __ _ _ _ _ _



Parameter



Range

1105 - 1353 - (9 h)0.02 - 0.20.29 - 2.92 - 2055 - 95

Delivered

1121160.020.29295

Actual

_ _ _ _ _ __ _ _ _ _ _ _ _ _ _ _ __ _ _ _ _ __ _ _ _ _ _ _ _ _ _ _ __ _ _ _ _ _





Range

105 - 1353 - (9 h)1.5 - 3.521.8 - 50.8150 - 35040 - 80

Delivered

121162.840.628080

Actual

_ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ _



Parameter


- - -°Cminmin- - -

Range

1 - 99105 - 1353 - (9 h)0 - (9 h)0 - 10

Delivered

31211652

Actual

_ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ _




RAX172 . . . . . . . L3203



Parameter



°Cmin

Range

1347

Delivered

1347

Actual

_ _ _ _ _ __ _ _ _ _ _





Page 13 of 16


P1 Cycle type Vacuum Cycle, Effluent


1. Pre Puls Vacuum2. Sterilizing temperatur3. Sterilizing time4. Drying vacuum time5. Drying pulses

- - -°Cminmin- - -

Range

1 - 99121 - 13530 - (9 h)0 - (9 h)0 - 10

Delivered

31343050

Actual

_ _ _ _ _ __ _ _ _ _ _ _ _ _ _ _ __ _ _ _ _ _ _ _ _ _ _ _


RAX1012 Typical load Filter, Utensils

Parameter



Range

1 - 99121 - 13530 - (9 h)0 - (9 h)0.1 - 1.01.45 - 14.510 - 100

Delivered

31213050.22.9020

Actual

_ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ _

P3 Cycle type Natural cooling cycle, Effluent


Parameter



Range

1121 - 13530 - (9 h)0.02 - 0.20.29 - 2.92 - 2055 - 95

Delivered

1121300.020.29295

Actual

_ _ _ _ _ __ _ _ _ _ _ _ _ _ _ _ __ _ _ _ _ __ _ _ _ _ _ _ _ _ _ _ __ _ _ _ _ _

P4 Cycle type Jacket cooling cycle, Effluent




Range

121 - 13530 - (9 h)1.5 - 3.521.8 - 50.8150 - 35040 - 80

Delivered

121302.840.628080

Actual

_ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ _

P5 Cycle type Vacuum Cycle, Effluent


Parameter


- - -°Cminmin- - -

Range

1 - 99121 - 13530 - (9 h)0 - (9 h)0 - 10

Delivered

31213052

Actual

_ _ _ _ _ __ _ _ _ _ _ _ _ _ _ _ __ _ _ _ _ _




RAX173 . . . . . . . L3300



Parameter



°Cmin

Range

1347

Delivered

1347

Actual

_ _ _ _ _ __ _ _ _ _ _








- - -°Cminmin- - -

Range

1 - 99105 - 1353 - (9 h)0 - (9 h)0 - 10

Delivered

3134750

Actual

_ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ _



Parameter



Range

1 - 99105 - 1353 - (9 h)0 - (9 h)0.1 - 1.01.45 - 14.510 - 100

Delivered

31211650.22.9020

Actual

_ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ _



Parameter



Range

1105 - 1353 - (9 h)0.02 - 0.20.29 - 2.92 - 2055 - 95

Delivered

1121160.020.29295

Actual

_ _ _ _ _ __ _ _ _ _ _ _ _ _ _ _ __ _ _ _ _ __ _ _ _ _ _ _ _ _ _ _ __ _ _ _ _ _





Range

105 - 1353 - (9 h)1.5 - 3.521.8 - 50.8150 - 35040 - 80

Delivered

121162.840.628080

Actual

_ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ _



Parameter


- - -°Cminmin- - -

Range

1 - 99105 - 1353 - (9 h)0 - (9 h)0 - 10

Delivered

31211652

Actual

_ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ _



RAX174 . . . . . . . L3302



Parameter



°Cmin

Range

1347

Delivered

1347

Actual

_ _ _ _ _ __ _ _ _ _ _




Page 14 of 16





- - -°Cminmin- - -

Range

1 - 99105 - 1353 - (9 h)0 - (9 h)0 - 10

Delivered

3134750

Actual

_ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ _



Parameter



Range

1 - 99121 - 13530 - (9 h)0 - (9 h)0.1 - 1.01.45 - 14.510 - 100

Delivered

31213051.014.5100

Actual

_ _ _ _ _ __ _ _ _ _ _ _ _ _ _ _ __ _ _ _ _ __ _ _ _ _ _ _ _ _ _ _ __ _ _ _ _ _



Parameter



Range

1105 - 1353 - (9 h)0.02 - 0.20.29 - 2.92 - 2055 - 95

Delivered

1121160.020.29295

Actual

_ _ _ _ _ __ _ _ _ _ _ _ _ _ _ _ __ _ _ _ _ __ _ _ _ _ _ _ _ _ _ _ __ _ _ _ _ _





Range

105 - 1353 - (9 h)1.5 - 3.521.8 - 50.8150 - 35040 - 80

Delivered

121162.840.628080

Actual

_ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ _



Parameter


- - -°Cminmin- - -

Range

1 - 99105 - 1353 - (9 h)0 - (9 h)0 - 10

Delivered

31211652

Actual

_ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ __ _ _ _ _ _




TESTING AND DOCUMENTATION

FUNCTIONAL TESTING

Getinge tests each sterilizer to stringent standards developedfrom years of experience within the pharmaceutical and healthcare industries. European and North American standards aswell as other international standards are met duringengineering, construction, and factory testing. Records ofinspection and testing are stored at our facility for the lifetimeof the sterilizer. These documents may be provided to thecustomer if requested.

DOCUMENTATION

Three (3) copies of manuals are provided. Operator- andservice manuals are provided in the selected language; othermanuals are in English. Electrical wiring and P&I diagram are astandard part of the documentation.

COMPONENT DOCUMENTATION:

Vendor data sheet package. Data sheets for majorcomponents will be provided.

WELD DOCUMENTATION:

Basic documentationExtended documentation

A documentation and identification package of the sanitarypiping, including numbering of each weld accompanied byweld logs and material certificates, including:• Weld & inspection report• Material (heat) certificates• Isometric drawings of the process piping

Full documentation, as extended but also includingvideotaped boroscoping (VHS or CD)

FUNCTIONAL AND DESIGN SPECIFICATIONS

The Functional Specification (FS) is developed todescribe sterilizer functions and features, to supportdesign, testing and qualification. The specificationincludes basic and process functions, performance,mechanical, electrical and PLC design features. Thedocument holds acceptance criteria and expectedresponses and will be used during the subsequentqualification if included.The Software Design Specification (SDS) describesdetailed process and software functions. The HardwareDesign Specification (HDS) describes PLC hardwarelayout, design and performance. The documents are usedto support design, testing and qualification. Bothdocuments hold acceptance criteria and expectedresponses and will be used during the subsequentqualification if included.

FAT PLAN AND REPORT

The purpose of this document is to ensure that there isdocumented evidence of what activities should be undertakenduring the Factory Acceptance Testing. There are threeoptions:

Factory inspection without document requirements. Oneengineer for customer disposal during 2 days.Heat distribution test for each process type but maximum5 run.Pre-Qualification: The pre-qualification protocol isdeveloped to verify that the unit performs as defined in thespecifications. This protocol is conducted at the manufac-turing site following completion of the build and finaltesting phase of the unit’s production. The documentationprovides for verification that the unit and all correspondingcomponents and control systems are functional and reactin a reproducible manner. Pre-programmed phases,alarms, CPU time, safety features and inputs/outputs arechallenged to ensure proper operation. All testing is doneutilizing an empty chamber and multiple independentmeasurement devices. The protocol defines allprocedures, acceptance criteria, expected responses anddocumentation of actual responses.

PACKING FOR SHIPMENT

All equipment is prepared for seaworthy freight in air tightplastic wrap to prevent moisture damage, and fully enclosedwooden crates to prevent physical damage. Units can beshipped in multiple crates to facilitate ingress. Please refer toequipment drawings for the respective dimensions.

LOADING EQUIPMENT

See separate documentation for loading equipment speci-fications.


RAX175 . . . . . . . P3100



Parameter



°Cmin

Range

1347

Delivered

1347

Actual

_ _ _ _ _ __ _ _ _ _ _




Page 15 of 16

LEGEND:Special Documentation can be supplied on requestAR-1 Single Door. Recessed in Wall.ER-1 Single Door. Recessed in Wall. Integrated Electric Steam Generator.AC-1 Single Door. Cabinet Enclosed.EC-1 Single Door. Cabinet Enclosed. Integrated Electric Steam Generator.AR-2 Double Door. Recessed in Two Walls.ARB-2 Double Door. Recessed in Two Walls. Cross Contamination (SPF).ER-2 Double Door. Recessed in Two Walls. Integrated Electric Steam Generator.ERB-2 Double Door. Recessed in Two Walls. Integrated Electric Steam Generator. Cross Contamination (SPF).ARC-2 Double Door. One End Recessed in Wall. Other End Cabinet Enclosed.ARCB-2 Double Door. One End Recessed in Wall. Other End Cabinet Enclosed. Cross Contamination (SPF).ERC-2 Double Door. One End Recessed in Wall. Other End Cabinet Enclosed. Integrated Electric Steam Generator.ERCB-2 Double Door. One End Recessed in Wall. Other End Cabinet Enclosed. Integrated Electric Steam Generator.

Cross Contamination (SPF).

Rev 1: 1st edition PN 2002-01-31

NOTE1 Optional sidemounted panel not available as standard for 2 door configuration.NOTE2 Optional sidemounted panel.

INSTALLATION DRAWINGS

UTILITY DATA

Model GE(L) 6661 GE(L) 6610 GE(L) 6613 GE 6617

AR-1 566 56 80

ER-1 AR-1

AC-1 566 56 81

EC-1 AC-1

AR-2 566 50 20 566 56 82

ARB-2 566 47 23 567 21 022, 566 56 83

ER(B)-2 AR(B)-2

ARC-2

ERC-2 567 48 10 566 66 23

ARCB-2

ERCB-2 567 48 08 567 48 19

ESG 1-4x60 kW 566 90 42CSG 200/500 T631

LEGEND:

P310X Vacuum process 121ºC 20 min and Postvacuum. Normal load with Utensil according toDIN 98 546 => 6 kg/STE (300 x 300 x 600 mm) which is approximated to 90 kg/m3

P320X Single Prevacuum, sterilization 121ºC 20 min, gravity displacement-assisted cooling.Liquid load appr. 5% of chamber volume equals appr. 25% of full load with 500 ml bottles.

P322X Vacuum process 121ºC 20 min and Postvacuum. Full load of Macrolon Animal Cageswith Bedding and 50cc of Drinking Water

L32XX Sterilization 121ºC 20 min, gravity displacement-assisted cooling with Jacket Cooling.Liquid load appr. 10% of chamber volume equals appr. 50% of full load with 500 ml bottles.

L33XX Same as L32XXESG Electrical Steam GeneratorCSG Clean Steam Generator

Model P310X P320X P322X L32XX L33XX

GE(L) 666 T210 T234 T258 T269 T293

GE(L) 6610 T211 T235 T259 T270 T294

GE(L) 6613 T212 T236 T260 T271 T295

GE 6617 T213 T237 T261 T272 T296

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Getinge provides complete solutions for effective andefficient cleaning, disinfection and sterilization in thehealthcare and life science sectors. Our know-howcomprises everything from architectural planning,production and handling equipment, to systems forfull traceability of sterile goods. Our commitment covers expert advice, training and long-term technicalsupport.

THE GETINGE GROUP is a leading global provider of equipment andsystems that contribute to quality enhancement and cost efficiency withinhealthcare and life sciences. Equipment, services and technologies are supplied under the brands ARJO for patient hygiene, patient handling andwound care, GETINGE for infection control and prevention within healthcareand life science and MAQUET for surgical workplaces, cardiopulmonary and critical care.

Getinge USA, Inc.1777 East Henrietta RoadRochester, New York 14623-3133U.S.A.Phone: (800) 475-9040Fax: (585) [email protected] www.getingeusa.com

Documents

CUSTOMER: REFERENCE - EquipNet · CUSTOMER: REFERENCE: GE 600 SERIES LIFE SCIENCE STERILIZERS PRODUCT SPECIFICATION PRODUCT Getinge GE 600 series sterilizers are microcomputer controlled