F2091 BioPharma Large Spec Sheet 1.00biosyscorp.com/equipment/sterilizer-large-pharma.pdfBradley SLC500 Programmable Logic Controller (PLC) with an Allen-Bradley Panel View 1000 Operator

Form 2092-1.00/081607 Page 1

PRIMUS Bio Pharma® – Large Steam SterilizersThese sterilizers are for customers who require a high quality steam pressure sterilizer whose products, operationsand manufacturing facilities are regulated by the FDA. PRIMUS Sterilizers, designed and manufactured in theUSA according to Quality Management Systems, are in compliance with ISO9001:2000, ISO 13485 and FDA’sGood Manufacturing Practice (GMP) for Medical Devices: General Regulation (21CFR Part 820). Large sizesterilizers are one of 19 standard sizes manufactured by PRIMUS, or we can custom manufacture a sterilizer tomeet your specifications.

SPECIFICATIONDA

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PRIMUS Bio Pharma sterilizers are designed for awide range of sterilizing applications suitable for thelaboratory or pharmaceutical industry. Qualitymaterials and workmanship have been incorporatedinto the chamber, piping and controls to provide apharmaceutical sterilizer that exceeds industrystandards. Bio Pharma sterilizers are designed forfully automatic, computer-controlled, operations withvacuum or gravity displacement cycles for terminalsterilization to in-process sterilization of packagingcomponents to production equipment sterilization.Bio Pharma sterilizers are the choice whenversatility, rigorous tolerances and validatable resultsare essential. The sterilizer is designed,manufactured and tested at the PRIMUSBio Pharma factory in Omaha, Nebraska USA.

All large sizes of PRIMUS sterilizers havepneumatically powered horizontal operating doors,designed to be efficient, reliable and inherently safe.To close the door, press and hold the door button, ifbutton is released before door is fully closed the door

STERILIZER DESIGN

Standard cycles can be configured through the use ofthe cycle parameters to process hard goods, wrappedgoods or liquid type products. Configuration of thecycle parameters (i.e., number of PRE or POST-PULSES, EXHAUST & DRY, etc.) is unique to eachcycle and depends upon the specific product beingsterilized. Standard cycles can be designed for steamsterilization of various types of dry goods or liquidproducts. Dry good products such as filter housingsand cartridges, textiles, rubber stoppers or sterilizableplastic packaging may require preconditioning for airremoval from the top of flasks. A slow exhaust is usedfor liquid products with Jacket Off and Flow Coolingselected after exposure to reduce boil-over.

PRIMUS Pri-Matic® controls offer the user access tothirteen password-protected cycles. Cycle parametersfor each cycle are baselined, validate and “locked” byvalidation personnel. Cycle can be custom named toassist and confirm operator selection of correct cycle.

STERILIZER CYCLES

PRIMUS Sterilizer Company, LLC • 117 South 25th Street • Omaha, NE 68131Phone (402) 344-4200 • Fax (402) 344-4242 • [email protected] • www.primus-sterilizer.com

®

opens. An added safety feature, the doors stopautomatically if an obstacle is encountered.

Form 2092-1.00/081607 Page 2

GENERAL (Options italicized)All models include Vacuum, Gravity and Liquidscycles.

VESSEL MATERIAL AND CONSTRUCTIONThe sterilizer features a SA240 TY316L stainlesssteel (SS) rectangular, horizontal completelyjacketed chamber, with fully radiused longitudinalcorners which are fully welded and mirror polishedto provide the most hygienic, long lastingappearance and durability available. The chamberhas a full-length baffle and one drain positioned inthe chamber to maximize steam distribution andcross flow within the chamber.

J 26”x63”x48” N 35”x57”x86”K 26”x63”x78” O 49”x57”x86”L 35”x57”x48” P 49”x86”x86”M 35”x57”x60” Q 61”x86”x86”

The jacket is constructed of SA240 TY304 SS andis mounted to the chamber over channel supportsdesigned to achieve uniform distribution of steam.The jacket enables the stabilization of temperaturearound the chamber thereby reducing the timerequired to bring the chamber up to sterilizationtemperature, providing superior temperaturedistribution, and preventing the formation ofcondensation on the chamber walls.

DESIGN and MANUFACTURING APPROVALSThe vessel will be designed and constructed toASME code Section VIII Division I and pressurerated for 45 PSIG and full vacuum. ASME CodeStamp and U-1 form will bear the name of thespecified US manufacturer.

The sterilizer will be manufactured according toQuality Management Systems which are incompliance with ISO 13485 and 9001:2000, will beUL listed and in conformance with CSArequirements.

DOOR CONSTRUCTIONA pneumatically operated horizontally sliding doorwill be operable from the touchpad push button. Toclose door, depress/hold door button. If doorbutton is released while door is closing, doorreverses direction and opens. In the open position,the insulated door will be secured behind a panelpreventing the operator from contact with hotsurfaces. An interlock will prevent cycle startunless the door is fully closed and secured.

GENERAL CONSTRUCTIONThe vessel will be insulated with 1" semi-rigid hightemperature fiberglass board/blanket insulationoverlaid with formed aluminum paneling andmounted in a structural steel frame. The frame willbe enamel coated and fitted with adjustable legson self-centering floor pads. The fascia and sidepanels will be 16-gauge, type 304 stainless-steel,

PURCHASING SPECIFICATION DATA SHEETS

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PRI-MATIC® CONTROL PANELS WITH PRINTER

EQUIPMENT WARRANTYSterilizer pressure vessels manufactured byPRIMUS are warranted against defects inworkmanship and materials under normal use andoperation for fifteen years where the sterilizer iscontinually maintained under PRIMUS servicecontract.

SERVICE and EQUIPMENT ACCESSStandard service access, when facing the unit, willbe from left side and top. Wiring will be laid side-by-side and mechanically secured flat against themetal insulation cover. All wiring will be clearlylabeled and readily visible for visual tracing. Allsterilant piping in the product contact circuit iscomposed of stainless steel with high qualityCLEAN IN Place (CIP), flanged, sanitary fittings.Sanitary pipe clamps are located anywhere CGMPProcedures require frequent maintenance access toprocess piping to allow ease of routine cleaning andmaintenance. Wiring and piping components will benon-proprietary, industry grade, available throughAuthorized Service Agencies, local supply house, ordirect from PRIMUS.

STEAM SOURCESteam will be from an in-house steam source in thequantity and quality specified. Optional electricsteam boiler, clean steam boiler or steam-to-steamgenerator may be specified. Contact PRIMUS forspecific boiler information.

CONTROLSThe Pri-Matic® Control System uses the Allen-Bradley SLC500 Programmable Logic Controller(PLC) with an Allen-Bradley Panel View 1000Operator Interface Terminal (OIT) and the Pri-Matic®software package to provide automatic cycleoperation. The control system hardware is mountedwithin a separate control cabinet. The systemfeatures Pulse Width Modulation (PWM)temperature control. The PLC software meets orexceeds industry standards, is fully documented,validated and maintained under strict configurationcontrol.

Form 2092-1.00/081607 Page 3

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1. Door beams on all units may be split for shipping purpose.2. Shipping dimensions are measured to the edge of the heat exchanger and include plumbing on, split beams removed, where

applicable, front stainless panel and printer removed.

SHIPPING DIMENSIONS, CUBAGE & WEIGHTS

HVAC DATA Heat loss, at ambient of 700 F.S

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Form 2092-1.00/081607 Page 4

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*Refer to General Arrangement (GA) drawings for details and final connection point to utility services(S-Steam, W-Water, D-Drain, E-Electrical, A-Air).

PRIMUS Bio Pharma® - Large Sized Autoclaves®

SINGLE DOORS WS1 A E E1

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TYPICAL ACCEPTED RANGES

Service access space

Typical floor drain and

ancillary equipment area.

Form 2092-1.00/081607 Page 5

PRIMUS Bio Pharma® - Large Sized Autoclaves SPEC

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VOLUME/DIMENSIONS CHARTSINGLE DOOR

1. Fascia extends 1” beyond wall opening on each side overlapping the wall and top sealing the opening.2. Allow minimum 2” clearance at rear of recessed unit only. Cabinet side models have rear clearance built in.3. Contact PRIMUS for alternative wall opening.4. Standard Left Side Service/equipment access shown. Optional right side access is available.

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Form 2092-1.00/081607 Page 6

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*Refer to General Arrangement (GA) drawings for details and final connection point to utility services(S-Steam, W-Water, D-Drain, E-Electrical, A-Air).

PRIMUS Bio Pharma® - Large Sized Autoclaves®

DOUBLE DOORS1S EAW E1

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Service access space

Typical floor drain and

ancillary equipment area.

Form 2092-1.00/081607 Page 7

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1. Fascia extends 1” beyond wall opening on each side overlapping the wall and top sealing the opening.2. Contact PRIMUS for alternative wall opening.3. Standard Left Side Service/equipment access shown. Optional right side access is available.

VOLUME/DIMENSIONS CHARTDOUBLE DOOR

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PRIMUS Bio Pharma® - Large Sized Autoclaves®

Form 2092-1.00/081607 Page 8

Drawing is a general example of PRIMUS’ pit installation. Refer to PRIMUS’ General Arrangement (GA) drawingsfor exact dimensions and pit installation details. Prior to installing your PRIMUS sterilizer verify the pit dimensionsare correct with the PRIMUS GA Drawing, ensure the pit is square, clean and sealed. Contact PRIMUS for furtherpit installation information.

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PIT DIMENSIONS CHART

NOTE: The industry has set 12” as an acceptable pit depth dimension. PRIMUS recommends 12” to 18”depending on the sterilizer size specified to facilitate easier serviceability and maintenance.

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PRIMUS General Purpose - Large Sized Autoclaves®

PIT INSTALLATION DETAILS

Form 2092-1.00/081607 Page 9

1. Allow sufficient space for traps, shut-off’s, filters and other utility supply components.2. Utility (service disconnects) shall be provided and installed “By Others”.3. Building or structure modifications to accommodate the sterilizer, as well as, sterilizer shoring, rigging,

cribbing and/or crane requirements into the facility shall be provided “By Others”.4. Provide maximum mechanical and service access space, a minimum of 24”, additional space required

when boiler specified. See General Arrangement drawing for placement of ancillary equipment andservice access.

5. Some options affect utility services and overall dimensions.6. Water Quality - Refer to page 12.7. The Manufacturer’s Equipment Warranty does not cover failure due to improper utility provisions.8. Drawings not to scale.9. Wall thickness must be provided on single and double door models recessed through 1 wall, with cabinet

sides.10. Electric Vacuum Pump is standard on Models N, O, P and Q.11. Floor under sterilizer must be water tight and sloped to the drain.

ARCHITECTURAL NOTES:

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UTILITY SERVICESProvide utility services within 6’-0” of final connection to sterilizer. Optimum sterilizer performancerequires the specified utilities.

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Form 2092-1.00/081607 Page 10

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ELECTRIC BOILERSBEBC Electric Heated Boiler - Stainless steel construction for clean steam generation. Includes

stainless steel feedwater boost pump.NOTE: Stainless Steel Boilers shall be operated using only deionizedwater, having a maximum conductance of 1 microSeimen per cm(1 S/cm) [minimum specific resitivity of 1 megohm per cm (1MW/cm)].

1. Controls Current N/A - Not Available

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67x36x620391x0061x4.066

84x75x539121x8411x988

06x75x534251x8441x988

eziSreiloB .rH/Wk 0.441 0.081 0.851 0.081

tuptuOmaetSrelioB rH/.sbl 0.334 0.245 0.574 0.245

enolAdnatS ledoM J-BE K-BE L-BE M-BE

hP3,802.C.A.V serepmA 004 A/N A/N A/N

hP3,042.C.A.V serepmA 743 434 973 434

hP3,084.C.A.V serepmA 371 712 091 712

.zH06,011.C.A.V 1 serepmA 01 01 01 01

LEDOM N O P Q

eziSrebmahCsretemillim/sehcni)lxhxw(

68x75x534812x8441x988

68x75x944812x8441x5421

68X68X944812x4812x5421

68X68X164251X8441X988

eziSreiloB .rH/Wk 0.042 0.063 0.054 0.045

tuptuOmaetSrelioB rH/.sbl 0.327 0.4501 0.5531 0.6561

enolAdnatS ledoM N-BE O-BE P-BE Q-BE

hP3,802.C.A.V serepmA A/N A/N A/N A/N

hP3,042.C.A.V serepmA 875 A/N A/N A/N

hP3,084.C.A.V serepmA 982 434 245 056

.zH06,011.C.A.V 1 serepmA 01 01 01 01

Form 2092-1.00/081607 Page 11

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STEAM TO STEAM GENERATOR (SCS1 & SCS2)

Steam to Steam Generator used to generate either clean or pure steam. The preferred method of generatingClean or Pure steam, when house steam is available to drive the generator. Converts to steam, whateverquality water is delivered.

BSCS1 Pure Steam - stainless steel steam to steam generator with sanitary fittings, double tubesheet construction. Generated from WFI quality depyronegated water. Thewater source to the Pure Steam Generator is either house generated or “ByOthers”.

BSCS2 Clean Steam - stainless steel steam to steam generator with threaded fittings, threadedconnections and single tube construction. Generated from distilled or reverseosmosis water. Clean Steam sterilizers normally include stainless steel pipingfor all wetted surfaces in the product loop.

NOTE: Refer to Page 12 for information on Water Quality.Refer to the boiler/steam to steam generator maintenance manualprovided with the sterilizer prior to using any boiler treatment chemicals.Contact PRIMUS for further recommendations.

W1

D1

E2

S3

S4

Form 2092-1.00/081607 Page 12

Note: Use the above format to determine PRIMUS Model numberand insert below and on Page 19, Specification Worksheet.

Use the following pages to custom design your sterilizer by checking the boxes of the configurationand options required for your project. Transfer all items checked to the Specification Worksheet (Pages19 & 20) and fax to PRIMUS Sales Department or to your local Sales Representative for a quotation. Ifyou do not find an option or size listed to meet your requirements, please contact our Project Managerfor additional information and assistance.

Model Number Notation

Steam Source

SELECT CONFIGURATION

BGDA - Single DoorBDB - Double Door

Cabinet BCD - Panels Both sides BCCL - Left Side Panel BCCR - Right Side Panel

Door Recessed BCA - One wall BCB - Two walls

Left Side (Standard) Right Side

Service and Equipment Access

PRIMUS General Purpose Steam Pressure Sterilizer, Model Number PSS__________.

1. Electric boilers are available in Carbon Steel or Stainless Steel.2. Contact PRIMUS for overall dimensions and utility connections.3. All models are stand-alone.4. GMP Validatable Option Only, sanitary piping required.5. Low Water Cutoff is standard and the “automatic reset” feature is disabled with this option. The boiler will

need to be manually rest.6. Water Quality - For best results, feed water supply should be evaluated prior to initial startup to ensure it is of

the quality necessary for the application, various external treatment processes (water softener, waterconditioning, etc.) may be used. Contact PRIMUS for further recommendations.

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Pri-Matic = 6ControlLogix = 7

Steam to Steam2BSCS1 - Pure Steam Dbl TubeBSCS2 - Clean Steam Sgl TubeBSCS4 - Clean Steam Sgl Tube SanitaryOther

House Supply Clean Steam2 BEBC1 - 208/3 phase3 BEBC2 - 240/3 phase3 BEBC3 - 480/3 phase3

Other BEB05 - Auto Blowdown

SD = Single Door DD = Double Door

PSS_-__-M__ __

J S = House SteamK E = Electric BoilerL P = Steam to SteamMNOPQ

Five models are offered:J - 26" x 63" x 48"K - 26" x 63" x 76"L - 35" x 57" x 48"M - 35" x 57" x 60"N - 35" x 57" x 86"O - 49" x 57" x 86"P - 49” x 86” x 86”Q - 61” x 86” x 86”

A detailed formatted specification,suitable for inclusion in formal contractdocuments, is available on request.

Form 2092-1.00/081607 Page 13

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Clean Steam Sterilizers BP9For cell/tissue culture applications. This option providesdirect connection to a house-source of clean steam.Includes threaded stainless piping and components tochamber. If clean steam is only steam source, specifyoption BP9.1 for stainless piping to jacket. For alternatesources to generate clean steam, specify electric cleansteam boilers (stainless steel), or when house steam isavailable, specify steam-to-steam generators. (Stainlesssteel heat exchanger).

BP9 Stainless piping to chamber - threadedBP9.1 Stainless piping to jacket - threadedBEBC Clean Steam Stainless Electric

Boiler (specify voltage) BSCS1* Pure Steam Double Tube Sheet,

Sanitary ConnectionsBSCS2* Clean Steam Single Tube Sheet

with threaded connectionsBSCS3* Clean Steam Single Tube, Sanitary

Connections

*Contact PRIMUS for alternate steam generatoroptions.

PHARMACEUTICAL CONFIGURATIONS Air-over Cooling BP11

Provides a means of rapidly cooling sterilized load.Effective to decrease cycle times with liquid loads.Filtered ambient air displaces steam during exhaustcycle to rapidly cool load and prevent boil-over.

CLEAN-IN Place Piping BP15CLEAN-IN Place (CIP) piping is standard for allpiping in the product contact circuit. CIP piping hasan interior finish

Form 2092-1.00/081607 Page 14

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Sterilize Filter Cycle BC13Sterilize filter is a stand-alone cycle used to sterilizethe 0.2 micron sterile air filter, filter housing andrelated piping.

Authorized Operator Access BC32Restricts operation of sterilizer to authorizedpersonnel and provides supervisor with PIN numberof person running the cycle. Access levels areavailable for administrator, supervisor and operatorlevel groups.

CONTROLS AND RELATED OPTIONS (CONT’D Remote Mount Control Panel BC10

Mount control panel in separate housing adjacent toor up to 100 feet away from the sterilizer. Available onboth control systems.

Thermal Printer BR7Thermal dot-matrix printer with take-up reel and 32characters per line printing is standard. Secondsterilization cycle report available at the end of therun.

Conax Adapter BC5Provides two (2) 316L SS CIP chamber penetra-tion, for validation purposes. Conax Adapterprovides a compression gland inside the port,through which 1-24 thermocouple leads are fed tothe chamber interior.

Remote Signaling of Sterilizer Status BC23Control relay connection enabling operation of aremote signaling devise for an alarm condition.Alarm conditions many include Door Open, DoorClosed and Cycle complete. Signal may be usedto activate a buzzer, light or any other On-Offdevice.

Compress Air to Gasket BP10Compressed air is used to seal gasket againstdoor interior during cycles on Bio Pharmasterilizers. Prolongs gasket life. Requires com-pressed air utility service, or option BEAC air-compressor. Optional steam to gasket is available.

BIO-CONTAINMENT OPTIONS

BioSeal Flange BV6Provides a means of isolating load from the unloadends of the sterilizer. A vapor-proof flange is weldedto the vessel on both sides of the flange andaround its full circumference. Penetrations throughthe flange for electrical and piping components aresecured with vapor proof fittings. Optional onsingle door units, standard on double door units.

BioSeal Panels BV7Aluminum panels for attachment to, and extendingfrom, the BioSeal Flange to adjacent buildingsurfaces to complete the barrier between eitherend of the sterilizer.

BV10 Stainless steel in lieu of aluminum

BioSeal Fully Welded Box BV11Provides a fully welded stainless box, welded tothe BioSeal flange forming the complete BioSeal.Check proposed installation site. Install into wallopening with end-opposite box BioSeal, first. Fordouble-door pass-through model B requiring aBox BioSeal and a boiler, specify a stand-aloneboiler .

Form 2092-1.00/081607 Page 15

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UTILITY - STANDARD FEATURES

Quench Effluent on Demand to Drain BP6Assures effluent exhausted to drain is 1400F or below,provides quench water for exhaust effluent only ondemand, to conserve water. Standard on all units.

Stepping Transformers BE1 Reduces line voltage to required 110 VAC for opera-tion of sterilizer controls.

BE1A 220 vac to 110 vacBE1B 480 vac to 110 vacBE1C 480/240/240/120, 1 phase, 0.5 KVA

Uninterruptible Power Supply BE2In the event of electrical power loss and no emer-gency electrical power to sterilizer, this option pro-vides electrical power to operate control system for upto 30 minutes, to complete the cycle. This option isdedicated power source for the electronic controlsonly and will not supply any power requirements forheavy power load components (boiler, pumps, com-pressors, etc.).

Chilled Water Recirculation (ConservationSystem) BP24

Provides water conservation through the use of ChilledWater versus City Water to cool drain effluent.Additional water conservation is provided by reusingthe cooled drain effluent for the water ring seal on thevacuum pump.

LOADING EQUIPMENT

Loading cart includes one bottom and oneintermediate shelf with four adjustable levels.Additional shelves are available. Cart frames andshelves are 316L stainless steel welded, groundand polished. Shelf surfaces are stainless steelwire mesh. Transfer carriages include swivelcasters with swivel locks and 5” wheels withwheel brakes. Loading cart and transfer carriagesare recommended for chamber lengths greaterthan 48” . Pit Mounted units with chamber lengthequal or great than 60” use one set of 2 floorcarts.

BL4 Loading CartBL5 Additional Cart ShelfBL6 Transfer CarriageBL7 Floor CartBL8 Additional Floor Cart Shelf

NOTE: Loading cart and transfer carriages arerecommended for chamber lengths 48 inches orlonger. Pit Mounted units with chamber lengthequal or greater than 60” use one set of 2 floorcarts.

Contact PRIMUS for special loading equipmentrequirements. Existing loading equipment maybe able to be retained, contact PRIMUS formore information.

GENERAL OPTIONS

Validation Port, 2 inch BV5Provides chamber penetration to accommodatevarious monitoring/control probes. Standard on B, C,and D models.

Seismic Restraints BV8Required in areas prone to seismic hazards.Secures sterilizer to building but allows for leveling.Designed to current California Code.

Electric Vacuum Pump BP4A water-sealed electric vacuum pump is standard onsanitary sterilizers providing a vacuum, in lieu of thestandard water ejector on non-sanitary sterilizers.Check PRIMUS’ General Arrangement drawing toassure the required ancillary equipment space isprovided.

Drain Line Strainer/Valve BP25Provides a means to trap and expel debris from thechamber drain line to protect heat exchanger fromdamage.

Floor Mounted BFMReplaces standard Pit Mount. Special order ‘FloorMounted’ with ramp or carriage/cart.

Air Compressor BEACFor small size sterilizers, (less than 75 cu. ft.), aircompressor mounted on sterilizer frame, for usewhen house supplied air is required but not avail-able. Not available if Air-Over Option BP11 isspecified.

Form 2092-1.00/081607 Page 16

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FLOOR LOADER CART DIMENSIONS

EZISREBMAHC LEDOM ROOLFYTQTRAC

A 1B 2B C D

"84x"36x"62-J J-7L 7L-1 "42 "28.35 "91.06 "64 "61

"67x"36x"62-K K-7L 7L-2 "42 "28.35 "91.06 "5.63 "61

"84x"75x"53-L L-7L 7L-1 "33 "88.64 "81.35 "64 "52

06x"75x"53-M M-7L 7L-1 "33 "88.64 "81.35 "5.82 "52

"68x"75x"53-N N-7L 7L-2 "33 "88.64 "81.35 "14 "52

"68x"75x"94-O O-7L 7L-2 "74 "88.64 "81.35 "14 "93

"68x"68x"94-P P-7L 7L-2 "74 "27 "83.87 "14 "93

"68x"68x"16-Q Q-7L 7L-2 "95 "27 "83.87 "14 "15

LOADING EQUIPMENT (cont’d)

Form 2092-1.00/081607 Page 17

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PRIMUS has earned a reputation for offeringthe premier sterilizer on the market!

The PRIMUS Difference:

Quality and Innovation – Dedicated to sterilizers for over 25 years.

Steam Sterilizers are Our Only Business – Proud to be the only major steam sterilizermanufacturer specializing in Steam Sterilizers

ASME Certified Pressure Vessel Factory – Being the owner of our ASME shop ensures highest ofquality and faster deliver times

USA Designed and Manufactured

19 Standard Sizes, Custom Sizes Available

Steam Sterilizer for Every Need – From Basic Sterilization to Hazardous Waste, to ValidatablePharmaceutical and Bio-Critical Applications

Engineered the Service Out of Sterilizers – “Making it one of the easiest in the industry to service”per our Authorized Service Agents and Customers

Simplicity of Design – less parts to fail

Non-Proprietary Components – Lowers the cost of ownership, minimizes down time and provides amore efficient meantime repair

304 Stainless Steel Fully Jacketed Vessel (no laminates) – reduces heat-up time and loss oftemperature, providing greater uniformity of chamber temperature

Rectangular Chamber - eliminating wasted space and high utility cost

Sliding Doors: Inherently safe doors – seal integrity. Not a burn hazard

PRIMUS Controls with “Evergreen Migration” meaning the hardware and software is continuallysupported lowering total costs of ownership – All controls offer multiple options on 4 differentcontrol platforms. Through constant improvements and development PRIMUS Controls remain aleader in the industry. Simple to operate, reliable and versatile.

Vacuum, Gravity, Liquid and Test Cycles - Standard on all Sterilizers

Pri-Mirror® Chamber Finish – Most sanitary in the industry. Providing a mirror finish of

Form 2092-1.00/081607 Page 18

This document and data contained within is intended for the exclusive use of PRIMUScustomers, including architects or designers. It shall not be reproduced in whole or in partwithout permission of PRIMUS Sterilizer Company, LLC. Any authorized reproductionmust bear the entire page to include Headers and Footers.

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EET “PRIMUS Sterilizer...

...First In Quality Sterilization Products”

QUALITY AND INTEGRITY FORM THE FOUNDATION OFPRIMUS STERILIZER COMPANY

OUR VISION FOR CONTINUAL IMPROVEMENT IS REALIZEDTHROUGH THE ESTABLISHMENT OF QUALITY OBJECTIVES

ACHIEVED THROUGH TEAMWORK WITH A GOAL OFRETURNING SIGNIFICANT VALUE TO OUR CUSTOMERS.

PRIMUS Sterilizer Company, LLC • 117 South 25th Street • Omaha, NE 68131Phone (402) 344-4200 • Fax (402) 344-4242 • [email protected] • www.primus-sterilizer.com

®

Three 26” x 63” Pit-mounted Units

Form 2092-1.00/081607 Page 19

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GENERAL CONFIGURATIONSBDA Single DoorBDB Double DoorBDE Door(s) Manually Operated (Std)BCD Cabinet, 2 sidesBCCL Cabinet, 1 Side LeftBCCR Cabinet, 1 Side RightBCA Recessed, 1 WallBCB Recessed, 2 WallNPN Left Side Service (Std)BC30 Right Side Service Access & ControlBC31 Control Panel Opposite Side of ServiceBCF Rear PanelBCG Hinged Access Panel thru Fascia

STEAM SOURCEBEB1 Boiler, 208/3phBEB2 Boiler, 240/3phBEB3 Boiler, 480/3phBEBC1 Clean Steam, 208/3phBEBC2 Clean Steam, 240/3phBEB3 Clean Steam, 480/3phBSCS1 Pure Steam Double Tube, SanitaryBSCS2 Clean Steam Single TubeBSCS3 Clean Steam Single Tube, SanitaryBEBO Automatic boiler blow-downBLWC Low Water Cutoff, Manual Reset

PHARMACEUTICAL OPTIONSBP9 Clean Steam to Chamber, Threaded

PipingBP9.1 Clean Steam to Jacket, Threaded PipingBP11 Air-Over CoolingBC24 Control Cycle on Load Temperature

CONTROLS & RELATED OPTIONSBC1 Pri-Matic Control System, PSS6BC1.1 Pri-Matic Control System, PSS7

(ControlLogix)BC2 Pri-Matic F0 control F0 accumulated, 4

pointsBC8 SCADA Data File

REBMUNLEDOMSUMIRP YTITNAUQ

EMANTCEJORP

SSERDDATCEJORP

EMANYNAPMOC ENOHP

EMANTCATNOC XAF

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.ONGNIWARDNONWOHS .ONMOOR

.ONETOUQSUMIRP

CONTROLS & RELATED OPTIONS (con’t)BC11 Serial Data OutputBC13 Sterilize Filter CycleBC32 Authorized Operator AccessBC10 Remote Mount Control PanelBR7 Thermal Printer, Take-up Reel (Std)BR7 Thermal Printer, 32 Character (Std)BIO-CONTAINMENT OPTIONSBV6 One BioSeal FlangeBV7 BioSeal Extension PanelsBP10 Compressed Air to GasketBC5 Conax AdapterBC23 Remote Alarm SignalBV11 Fully Welded BioSeal BoxGENERAL OPTIONSBV3.1 Validation Port, 1.0” diameterBV8 Seismic RestraintBP4 Electric Vacuum Pump (Std)BP25 Drain Line Strainer/ValveBDF Automatically Operated DoorBEAC Air CompressorUTILITY - RELATED OPTIONSBP6 Quench Water to Drain, on Demand (Std)BE1A Stepping Transformer from 220V to 110VBE1B Stepping Transformer from 480V to 110VBE1C Stepping Transformer from 480/240-240/

120V, 1 ph, 0.5KVABE2 UPS maintains sterilizer operation for 30

minutes during power outageBE3 GFI Receptacle

(Continue on the next page)

Std = Standard ComponentSS = Stainless SteelCIP = Clean-in-PlaceN/A = Not Available

PRIMUS Specification Data WorksheetComplete the following by selecting the options or transferring the options, checked on precedingpages, required to meet your needs. Tear off and forward completed worksheet to PRIMUS SalesDepartment, fax 402-344-4251, or your local PRIMUS Representative. If you do not find an option or sizelisted to meet your requirement, please contact our Sales Department for additional information andassistance with a custom design to meet your specifications.

Form 2092-1.00/081607 Page 20

YOUR LOCAL PRIMUS REPRESENTATIVE:

Manufacturer reserves the right to modify materials or specification without notice.

Specification Data Worksheet (con’t)S

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FOR ADDITIONAL ASSISTANCETo discuss your sterilization design needs, please contact PRIMUS.

PRIMUS Sterilizer Company, LLC • 117 South 25th Street • Omaha, NE 68131Phone (402) 344-4200 • Fax (402) 344-4242 • [email protected] • www.primus-sterilizer.com

®

OTHER PIPING OPTIONSBP1 Heated Air-In, Heat Exchanger SSBP5 Safety Valve Over Rupture DiskBP15 CIP Piping (Std)BP16 Air to Jacket CoolingBP18 Passivate ChamberBP19 Passivate Chamber and PipingBP20 Steam Quality Sampler

VESSEL OPTIONSBV1 Stainless Steel FrameBV2 Jacket Type, 316 L SSBV3 Jacket Insulation Cover, SSBV6.1 Additional BioSeal FlangeBV8 Seismic RestraintsBV10 BioSeal Panels, StainlessGMP DOCUMENTATION OPTIONSBD1 GMP Validation DocumentationBD2 IQ/OQ Protocol, PSS500BD3 IQ/OQ Protocol, Pri-Matic

Std = Standard ComponentSS = Stainless SteelCIP = Clean-in-PlaceN/A = Not Available1 = NEMA 12 (IP55), Dustproof, Painted Steel Enclosure2 = NEMA 4, Waterproof, Stainless Steel Enclosure3 = NEMA 4X (IP66), Waterproof, Stainless Steel Enclosure

OTHER CONTROL OPTIONSBC3 Blind Flange Assembly, Sanitary FittingBC4 Jacket Pressure Display, DigitalBC5 16/24 Thermocouples Conax AdapterBC7 Second PanelView 1000BC14 WFI InterfaceBC15 Pri-Matic in NEMA 121 enclosure

(Dustproof)BC15.1 Stainless Steel Enclosure for Pri-Matic

Control PanelBC16 Pri-Matic mounted in NEMA 42 Enclo-

sure (Waterproof)BC16.1 Pri-Matic mounted in NEMA 4X3 SS

EnclosureBC17 Remote Sterilizer “OFF” SignalBC18 Remote Sterilizer “In-Cycle” SignalBC23 Remote Alarm SignalBC26 PanelView 550, Service AreaBC29 Additional Operational Manuals (2 hard

copies and 1 CD provided) QtyBC30 Modem PLCBC31 Second RTD Load ProbeBR2 Dot Matrix Printer, 80 columnBR3 Strip-Chart RecorderBR4.1 Thermal Printer, Flush Mount 24 Col.BR5 Circular Chart RecorderBR6 Impact Printer, 24 Column

LOADING EQUIPMENTBL1 Removable Bottom Shelf (Std)BL2 Extendable Bottom ShelfBL3 Additional Chamber ShelvesBL4 Loading CartBL5 Additional Cart ShelvesBL6 Transfer CarriageBL7 Floor Cart (chamber lengths greater than

60” use 1 set of 2 floor carts)BL8 Additional Floor Cart Shelves

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