the power of innovation. for better sterilization...

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the autoclave company The Power of Innovation. For better Sterilization. Horizontal front loading bench-top autoclaves: Systec D-Series Pass-through autoclaves: Systec D-Series 2D

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t h e a u t o c l a v e c o m p a n y

The Power of Innovation. For better Sterilization.Horizontal front loading bench-top autoclaves: Systec D-SeriesPass-through autoclaves: Systec D-Series 2D

Systec D-90Systec D-65

Systec D-Series: Bench-top autoclaves.Systec D-Series: Horizontal front loading bench-top autoclaves.

These autoclaves don't just seem to be different; they are different. Specially developed for sterilization procedures in the laboratory,processes become easier, safer, more precise, more reproducible and validatable.

autoclaves_Systec_D-SeriesPage_2

Systec D-23 D-45 D-65 D-90 D-100 D-150 D-200

Chamber dimensionsØ x depth in mm 260 x 420 344 x 500 400 x 500 400 x 700 500 x 500 500 x 750 500 x 1000Chamber volumein liters total / nominal 25 / 23 50 / 45 70 / 65 95 / 90 110 / 100 160 / 150 210 / 200External dimensions in mmW 555 618 750 750 850 850 850H 500 550 930 630 730 730 730D 650 740 770 970 810 1050 1300Heating power kWSystec DX 2.80 2.80 9.00 9.00 9.00 9.00 9.00Systec DE and DB 2.30 3.00 4.50 4.50 4.50 7.25 7.25

Electrical connections for Systec D-23 and D-45: 220 – 240 V AC, 50/60 Hz, 16 A Electrical connections for Systec D-65 – D-200: 380 – 400 V, 50/60 Hz, 3-phase to neutral, 16 AOther voltages and single-phase operation available on request

Dimensions and performance

Space advantage!

A compact instrument with ideal chambersize in seven sizes. Each size has an optimalloading capacity for most standard mediabottles and Erlenmeyer flasks.

Systec D-45Systec D-23

Systec D-100 Systec D-150

Page_3

A new dimension in technology and design.

autoclaves_Systec_D-Series

Erlenmeyer flasks

Systec D-23 D-45 D-65 D-90 D-100 D-150 D-200250 ml 11 24 23 31 2 x 30 2 x 42 2 x 59500 ml 8 12 15 21 2 x 15 2 x 24 2 x 40

1000 ml 3 8 9 13 12 18 232000 ml - 3 6 8 7 9 143000 ml - – 3 4 6 8 115000 ml - – – – 3 5 7

Loading capacity*

Schott–Duran media flasks

Loading capacity*

Systec D-23 D-45 D-65 D-90 D-100 D-150 D-200250 ml 18 24 31 40 2 x 36 2 x 54 2 x 83500 ml 10 18 23 31 2 x 26 2 x 40 2 x 59

1000 ml 4 10 15 18 18 26 402000 ml - 5 8 10 12 14 235000 ml - – 3 4 6 8 1110000 ml - – – – 2 3 4

*At max. loading, partially without baskets

Systec D-200

Page_4 autoclaves_Systec_D-Series

Autoclaves Systec D-series:Performance categories of the 3 series types.

Horizontal front loading bench-top autoclaves Systec D-series type

From the sterilization chamber separated steamgenerator integrated into the housing xExtension of temperature and pressure to 150 °C / 5bar(only for sizes Systec D-65 — D-150) O ONumber of sterilization programs 25 12 3Password secured access rights for parameterizationand for further security relevant interventions x xPre-programmable automatic door openingat the end of a program x xAdditional PT-100 temperature sensor in the condense exhaust xRapid cooling O OPre- and post-vacuum OAir exhaust filtration O ODrying ‘Superdry’ (only in conjunction with an optional vacuum system) ORS 232 and RS 485 for external data transfer(network-compatible) x xPC-Software for extensive documentation (network-compatible) O OInternal memory for documentation ofup to 500 sterilization cycles x xIntegrated SD-Card-Slot inclusive SD-Card (1024 MB) for data backup of up to 10.000 sterilization cycles and for transmission of process data to a PC via SD-Card reader O OStart by clock, Timer for programmable start time x xSteam exhaust condensation, water cooled, thermostatic controlled x x“Autofill“ - Automatic de-mineralized water feed for steam generation x xSpecial program for waste sterilization with pulsed heat-up for more effecient air exhaust x x xTemperature holding function after the end of program for liquids x xSpecial program for Durham-Tubes x xHousing and basic frame construction out of corrosion resistant stainless steel x x xPrepared for subsequent rapid cooling installation x xPrepared for subsequent installation of vacuum system xPrepared for subsequent drying installation xCalculation of FO value x x

Further options / Special programs (on request)Special accessories like baskets and inserts, lifting devices and wheels, available on request.

X = Standard O = Optional

DX DE DB

Systec DX

For all laboratory applications even forsophisticated state-of-the-art sterilizationprocesses. With all possibilities to addadditional options for process optimizationto enable validatable sterilization to becarried out.

Systec D-Series autoclaves:Three types with different performance categories.

Systec DE

For basic laboratory applications and mediasterilization. With limited possibilities toadd additional options for process optimi-zation.

Systec DB

For simple process applications. Nooptions available for process optimization.

DX DE DB

SystecDX-90 2D

Double-door (pass-through) autoclaves: Systec D-Series 2D.

autoclaves_Systec_D-SeriesPage_6

View from the non-sterile side

Equipped with the same state-of-the-art technology as our horizontal front loading bench-top autoclave Systec D-Series,the 2D series has the same modern design but now with two doors for fitting between separating walls.

Systec DX-150 2D / DX-200 2D

Clean room side

H

I

Wall frame

Service side

A

B

C

D

Emax.

FG

Wal

l

Wall opening

Wal

l ope

ning

OKFF

J

KL

Dimensions in mmSystec Systec Systec

DX-90 2D DX-150 2D DX-200 2DA 750 850 850B 1030 1130 1130C 1430 1530 1530D 1570 1670 1670E 240 260 260F max. 200 max. 200 max. 200G 900 900 1150H 920 1020 1020I 780 880 880J 820 920 920K 800 800 800L 670 770 770

Systec DX-90 2D Systec DX-150 2D Systec DX-200 2D

Chamber dimensionsØ x depth in mm 400 x 750 500 x 750 500 x 1000Chamber volume in literstotal / nominal 98 / 95 155 / 150 205 / 200

All types: heating power 9 kW, voltage 380 – 400 V, 50/60 Hz, 16 A. Modifications to other voltage as well as single phase operation available on request.

The loading capacities are the same as for the Systec D-90, Systec D-150 and Systec D-200 (see page 2).

View from the sterile side

DX

Page_7

A new dimension in technology and design.

autoclaves_Systec_D-Series

View from the sterile side

Triple safety aspects!

– One door only can be opened at any onetime. If one door is open, the other isautomatically locked.

– If the autoclave is switched off or if nocurrent is available (e.g. power failure),both doors remain locked.

– If the door at the non-sterile side isopened, a sterilization program has tobe performed before the door at thesterile side can be opened.

The locking system can be adapted tocustomers’ wishes.

Doors and control panel are made of heat-insulating plastic, the housing completelyof stainless steel and the edges speciallyprocessed for smooth junctions withwalls.

Operation, however, can be carried outfrom both sides, the position (open or closed) of the opposite door being indicatedon the display.

Clearly laid out control panel with membrane display. Door operated by an ergometric handle.

For use under the most stringent clean room andsafety conditions.

– For biological safety laboratories. Fitting as a sterilization and double-door (pass-through) lock for protectingthe external environment.

– For clean rooms in laboratories and production facilities as a sterilizationand double-door (pass-through) lockseparating sterile and non-sterile areas.

Pass-through autoclave in cross-sectionbuild into dividing wall.

DX

autoclaves_Systec_D-SeriesPage_8

Advanced technology, design and electronic intelligence!

Systec D-Series autoclaves are completelynew designs: innovative mechanical andelectronic components are incorporated andguarantee high sterilization quality in thelaboratory. They thus fulfill those require-ments that will ultimately be demanded ofall laboratory sterilization processes infuture, e.g. higher sterilization temperaturesfor work with prions.

Schematic illustration of the new door-locking system of the Systec D-65 –D-200.

Lid open, circumferential locking ring inthe ready position.

Lid closed, circumferential locking ring in lock position. The internal steam pressure presses the lip seal between lidand chamber.

Pressure-safe upto 5 bar/150 °C.

Tomorrow's requirements are catered for intoday's design! The Systec D-Series auto-claves are the first of there kind to bedesigned for higher pressures and temper-atures. The standard pressure chamber isdesigned to cope with 5 bar/150 °C. If theexpanded pressure and temperature modelis selected as an option, all control andsafety components are adapted to thehigher temperature and pressure. Thisoption may be fitted retrospectively.

Systec D-Series autoclaves are equippedex-factory for sterilization temperaturesup to 140 °C and a pressure of 4 bar.Systec D-23 standard temperature andpressure range 136 °C / 3.8 bar.

The extension of pressure and temperatureto 5 bar / 150 °C is not available for SystecD-23 and Systec D-45.

Novel automatic lid-openingsystem

Easy but safe – on closing, the lid is auto-matically locked by a circumferential ringsystem. A special lip seal made of heat-resistant silicone provides reliable tightness;the more the steam pressure increases, thetighter the seal becomes – without theneed for additional compressed air or othermedia!

The lid is unlocked either by pressing abutton or automatically at the end of a program. The door-locking system is temperature dependent – according tonational and international standards. Also, the door remains locked as long asthere is excess pressure in the chamber.

The lid, like other parts of the pressurevessel and housing, is made of stainlesssteel. The attractively designed frontcovers are made of heat-resistant, insulating plastic. There is thus no risk of the operator coming into contact with hot components of the system.

Automaticdoor-opening

In types DX and DE, the autoclave doorfunctions automatically – either by pres-sing a button or automatically at the endof a program. A simple system but usefulin practice. Residual steam is exhaustedautomatically without having to interruptthe process. Residual heat is used to drythe items being sterilized during the finalshort stage in the autoclave. Automaticdoor-opening is restricted to approx. 15°to avoid possible contamination from theoutside. This is especially important andfacilitates the working process whenitems to be sterilized have to remain inthe autoclave for cooling and drying. Sub-sequently, for removing the sterilizeditems, the door can be completely openedmanually.

DX DE DX DE

Available programs*

1-3 Solids4-5 Waste bags6 Liquid waste with regulated steam

exhaust for cooling7 Liquid waste for self-cooling8-10 Liquids with regulated steam

exhaust for cooling11 Liquids for self-cooling12 Cleaning13 Vacuum test**14 Bowie-Dick Test**15-25 Free for individual programming

**Only in combination with a vacuum device

Available programs*

1-3 Solids4-5 Waste bags6 Liquid waste with regulated steam

exhaust for cooling7 Liquid waste for self-cooling8-10 Liquids with regulated steam

exhaust for cooling11 Liquids for self-cooling12 Cleaning

Available programs*

1 Solids2 Waste bags3 Liquid waste with regulated steam

exhaust for cooling

* All programs can be individually parametered

New generation – with microprocessor and software!

Pressure and temperature regulation is viaan electronic pressure sensor in the steri-lization chamber or a flexible temperaturesensor in a reference vessel (for liquids). A microprocessor specially developed forour autoclaves regulates and controls allrelevant systems. In addition to vaporpressure, temperature and sterilizationtime all options such as rapid cooling, pre-and post-vacuums and drying are included.

DX DE DB

Immediate documentation

Optional, with integrated printer for program type, batch number, date, time,temperature, pressure and sterilizationphase.

Menu-presented instructionsin text form

These can be selected from German,English, French, Spanish and Italian. Otherlanguages are available as options. Large,easy-to-read display. Membrane keyboardwith acoustic confirmation signal. Ergono-mically located – everything is logical andeasy to operate.

Documentation,dialog and diagnosis via PC

Includes a standard RS 232 and RS 485interface for direct connection to a PC.Special software for use with Windowsoptional. Suitable for documentation of allprocess data including relevant diagrams.In addition, dialog for adapting programs,changing parameters, calibrating andadjusting. Distant diagnosis via modem isalso possible.

DX DE

autoclaves_Systec_D-Series Page_9

SteamGenerator

Design – pure innovation!

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Condensationinstead of steamremoval!

Exhaust steam is condensed automaticallyvia a PT 100-regulated cooling system.This prevents odors and protects wastewater piping that may be made of plastic.

Steam generation!

A separate steam generator is incorporatedin the housing. This has substantial advantages:

– No heating elements and no reservoirfor dirty water in the chamber

– In conjunction with the stand-by pre-heating option, only 10 min. heatingtime to 121 °C with an empty chamber

– Improved removal of air from the emptychamber via pulsed heating (rapidattainment of optimal steam atmosphere)

– Accuracy better than ± 0.3 K with emptychamber

– Quicker cooling as neither hot water in the chamber nor the separate steamgenerator need be cooled

– On cooling, steam is immediately available for the next sterilization run.

Systec D-23 and D-45 With feed water reservoir!

This makes both autoclaves mobile and flexi-ble. As there is no need for a fixed waterconnection, they can be used in differentrooms at different times. They can be alloca-ted directly to a particular working areaaccording to the task on hand.

DX DX DE

autoclaves_Systec_D-Series Page_11

Conventionalsteam generation.

In this system, powerful heating elementsare integrated directly on the floor of thesterilization chamber. As required, deionizedwater can be fed in, heated and convertedto steam. The deionisized water for steamgeneration can be fed in manually, and forDE-series also automatically with demine-ralised water connection.

DE DB

autoclaves_Systec_D-SeriesPage_12

Guaranteed sterilization ofliquids

During the entire sterilization process thetemperature is measured by a PT 100 flexible temperature sensor in a referencevessel. In this way it is guaranteed thatthe sterilization process begins only whenthe sterilization temperature of the liquidhas been attained. The cooling temperatureis also continuously monitored. As requiredby the operating standards and to preventdelayed boiling, the door can only be opened when the temperature of the liquidhas cooled to at least 80 °C.

Innovative design – to the last detail!

autoclaves_Systec_D-Series Page_13

High, all-round quality!

The pressure vessel is made of corrosion-resistant electro-polished stainless steel1.4571 (V4A) AISI 316 Ti and is thus easyto clean. The excess pressure release safetyvalve is of the approved component type.Autoclave framework and housing are alsomade of stainless steel. The highly efficient,high-quality Hanno-Tect insulation mate-rial releases no particles; thus, the SystecD-Series can be used under clean roomconditions.

Compressed air connection (optional)

Demineralized waterfeed for steam generation

Cooling water feed

Collection outlet (drain)

Interface RS 232/485

Flexible power connectionwith CEE plug

autoclaves_Systec_D-SeriesPage_14

Intelligent process engineering for quicker and safer processes!

The actual sterilization time of e. g. 15 – 20 minutes at 121°C is only a fraction of the total time required for the entire sterilization process. Especially when sterilizing liquids, the heating up and cooling down times are far longer (fig. 1).

The conventional process.

In conventional systems, the set steriliza-tion temperature may in fact be reachedwithin the autoclave; however, the liquidsto be sterilized may only have reachedapprox. 100°C. The temperature equilibriumtime between chamber and liquid temper-ature is usually much longer.

The cooling process for liquids is also veryslow as the heat under 100 °C can only bedispersed by convection via the chamberinsulation if there is no rapid cooling facil-ity.

* The times indicated in the diagram aredependent on the size and number ofitems to be sterilized.

tCH S

100°C1 bar

121°C2,1 bar

80 °C

°C/bar

= 10 min

fig. 1

H = Heating up phase S = Sterilization phaseC = Cooling down phase

TemperaturePressure

autoclaves_Systec_D-Series Page_15

Up to 50 % shorter heat-uptimes possible as standard!

Due to the combined temperature andpressure regulation, the chamber pressureis increased during the heat-up phase. Theresult: more rapid temperature equilibriumin the liquids and a shorter heat-up time.

New system and process technology have made it possible to shorten the entire process considerably. Several hours can be saved in this way! In addition, the media need not be exposed to temperatures unnecessarily (fig. 2).

Up to 90 %shorter coolingtimes!

Various optional rapid cooling systemsenable the cooling times for liquids to be significantly reduced. This conservesnutrient media and makes for efficientutilization of the autoclave.

Time saving through new process technology.

DX DE

* The times indicated in the diagram are dependent on the size and number of items tobe sterilized.

tCH S

100°C1 bar

121°C2,1 bar

80 °C

°C/bar

= 10 min

fig. 2*

H = Heating up phase S = Sterilization phaseC = Cooling down phase

TemperaturePressure

autoclaves_Systec_D-SeriesPage_16

Magnetic stirrer

For the homogeneous mixing of liquidsduring the sterilization processes. Can beplaced directly in the chamber as requiredand is provided with power via a flexiblecable through the validation port.

Options: prepared for special applications!

SuperDry

For the efficient drying of solids, hollowitems and porous items such as filters andtextiles. In this case, the series-installedsteam generator supplies the heat for drying. Rapid surface drying with open lidor penetrating vacuum drying in combina-tion with the optional vacuum facility arepossible. Subsequent drying in a separatedrying cabinet is thus unnecessary!

Exhaust air filtra-tion and steriliza-tion of condensate

When working with infectious material, theexhaust air is filtered via an autoclavablesterile filter comprising a filter cartridge withPTFE membrane, pore size 0.2 µm, incorpo-rated in a pressure-resistant housing andeasily replaced. The filter is automatically sterilized during each sterilization process,monitored by a PT 100 temperature sensor.The condensate is retained during the heat-ing and sterilization phases and thus alsosterilized. In this way, neither aerosole particles nor microorganisms can escapebefore the sterilization process is completed.

DX DE Vacuum facility

For the highly effective ventilation of hol-low items, tubes, porous material, textilesand destruction bags, where the steam isable to fully penetrate the items to be ste-rilized. The facility enables a straight-for-ward vacuum or – in combination with theseries-installed steam generator – a fractio-nated pre-vacuum (several sequential vacu-um/pressure cycles) to be used. Only thus avalidatable sterilization of porous materials,hollow items, textiles and waste bags canbe obtained, even with high contamination.

DX

DX

autoclaves_Systec_D-Series Page_17

Up to 90 %quicker cooling!

Systec autoclaves are equipped with classical cooling systems (regulated steamexhaust down to 100 °C) and subsequentextremely slow self-cooling to min. 80 °C;however, optional systems for rapid cooling are available:

– Mantle cooling with cooling water– Mantle cooling with cooling water and

support pressure

Radial ventilator

Together with the optional cooling system,the ventilator ensures accelerated removalof heat, through air circulation, from thesterilization load to the cooled mantle.

The fan is located in the convex lid (hen-ce no reduction of chamber depth!) and isdriven via a magnetic clutch by a motorfitted under the lid cover.

– Mantle cooling with cooling waterrecirculated through a heat exchanger

– Radial ventilator for air circulation andaccelerated heat removal in the chamber

– Spray cooling with recirculated andrecooled sterile water and support pressure

– Cooling with ambient air ventilation

Optional: technology for special applications

For the sterilization of liquids in closedvessels, plastic bottles, bags, cans, blistersor food packs, e. g.:– System and program for sterilization

in a mixture of steam and air– System and program for sterilization

with hot water spraying and spray cooling

for the tasks on hand. A validatable sterilization process with confirmable biological efficiency can only be obtainedif the instrument configuration has beencorrectly thought out. The table belowprovides help in establishing the desiredconfiguration; however, we recommendobtaining additional advice from ourexperts.

Important notice for effective sterilization!

As already described, several options areavailable should it be necessary to obtaincorrect and validatable results or rapidcooling times, especially in the case ofliquids. The options that can be useddepend on the type of items to be sterili-zed. It is thus important for you to thinkcarefully about your requirements so thatthe autoclave can be optimally configured

DX DE DX DE

The right process for your sterilization application:

+ recomended procedure ? eventually accetable - not possible

Air release Cooling Drying Other

Gravitation Single Pulsed Fractionated Conventional Rapid cooling Surface drying Drying with Exhaust airpre-vacuum heat up pre-vacuum cooling with system without subsequent filtration

(over pressure slow steam with support vacuum vacuumApplication: pulses) release pressure (+SuperDry) (+SuperDry)

Liquids + ? - - ? + - -Unpacked non hollow items + + + + ? +Porous materials(filters, textiles) - ? ? + - +Hollow items(pipette tips,empty glassware, tubes and hoses) - - - + - +Contaminated waste in “destruction bags” - - ? + - - +

Procedure/Process:

System accessories for ease of handling!

Support Tables

There is a special table for each of theSystec D-Series autoclaves. These arecustom-dimensioned for the instrument in question. The tables are 72 cm high(other heights available at no extra charge) and make for ease of handling.They have a practical shelf e. g. for storing baskets etc.

autoclaves_Systec_D-SeriesPage_18

Loading trolley

Large autoclaves in particular can be easilyand securely filled using a special loadingtrolley. The items to be sterilized can eitherbe placed on the sliding platform of thetrolley or in a filling basket. The trolleycan now be moved to the autoclave andfixed in position by a clamp. The clampcan then be loosened to allow the plat-form to slide into the autoclave on fixedrails. .

Loading shelves

To fully utilize the available space in thechamber, especially when sterilizing smallitems, every autoclave can be fitted witha set of loading shelves. The entire shelv-ing system or individual trays can beremoved.

Stainless steel quality!

All parts are made of stainless steel andcleanly welded. Bench-top autoclaves arefitted with adjustable leveling screws toensure stability; the filling trolleys havelarge rollers, two of them fitted withbrakes, to ensure smooth running.

Each and every component used is subjectedto stringent controls and each autoclave isthoroughly checked for function beforebeing delivered. An acceptance protocol isissued.

Step-by-step documentationoptionally available!Our Quality Management fulfills the high-est requirements with regard to testing anddocumentation. Within the scope of ourservice, we also provide qualification andvalidation work with GMP-compliant docu-mentation, e. g.: – DQ Design Qualification– IQ Installation Qualification– OQ Operation Qualification– PQ Performance Qualification

Our Quality Assurance

autoclaves_Systec_D-Series Page_19

Wire mesh baskets out of stainless steel, stackableInner Dimensions D-90 D-150 D-200

Art. No. L x W x H (mm) D-23 D-45 D-65 DX-90 2D D-100 DX-150 2D DX-200 2DHold capacity per autoclave

1552 390 x 168 x 132 11553 490 x 265 x 180 14072 490 x 310 x 210 15074 688 x 310 x 210 16071 490 x 360 x 290 1 26072 490 x 360 x 140 2 47071 355 x 360 x 290 27072 735 x 360 x 290 17075 355 x 360 x 140 47076 735 x 360 x 140 2

Closed tubs out of stainless steel for waste sterilizationInner Dimensions D-90 D-150 D-200

Art. No. L x W x H (mm) D-23 D-45 D-65 DX-90 2D D-100 DX-150 2D DX-200 2DHold capacity per autoclave

1554 395 x 180 x 135 11555 495 x 265 x 180 14073 495 x 318 x 219 15075 696 x 318 x 219 16070 495 x 368 x 300 1 27070 368 x 368 x 300 27073 747 x 368 x 300 1

Loading baskets and inserts

t h e a u t o c l a v e c o m p a n y

Systec GmbH Labor-SystemtechnikSandusweg 11D-35435 WettenbergTel. +49 (0) 641-98211-0Fax +49 (0) 641-98211-21E-Mail: [email protected]: www.systec-lab.com

Subsidiary Switzerland:Systec Schweiz GmbHBösch 23CH-6331 HünenbergTel. +41 (0) 41 781 52 80Fax +41 (0) 41 781 52 79E-Mail: [email protected]: www.systec-lab.ch

Performance and competence!

We only make one thing: laboratory autoclaves.But we do this exceptionally well!

Our goal is always to make laboratory worksafer, easier, more accurate and more eco-nomical. With over 25 years of experienceand constant cooperation with experts inpractice, we know how to tackle and pro-vide optimal solutions for even the mostcomplex of sterilization tasks.

We have the knowledge and know-how toproduce the results!

Our expertise and know-how are availablefor you worldwide through specializedpartners.

Product expertise:

– Development– Design– Production of series products– Production of specialty products– Application and technical advice

Additional services:

– Installation and start-up– Special technical developments– Tests and process development– Individual service on-call– Contract service – Qualification and validation– GMP-compliant documentation

Performance and competence!

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Rights reserved to change technical aspectsas required.