Steam Sterilizer
Steam Sterilizer
Steam Sterilizer
Purpose
Steam sterilizers use pressurized steam to generate moist heat to
eliminate viable microbes from non-heat-sensitive medical devices,
including heat-tolerant products used for surgical and general patient
care.
Principles of operation
Items to be sterilized are cleaned to remove contaminants, such as
feces, dried blood, and sputum, and rinsed with distilled or demineralized
water to remove any detergent or tap-water residues. They are put into
packs and loaded into baskets or carts that are placed in the chamber. The chamber is closed, and the appropriate
time and temperature settings are selected for the material being sterilized. Some sterilizers allow these
parameters to be preset so the push of a button will start sterilization. Personnel should refer to the
manufacturer’s instructions for settings appropriate for the devices being sterilized.
When steam enters the sterilizer chamber, it contacts the cool outer layer of the wrapped packs and condenses
on it, leaving behind a small amount of water and transferring substantial heat to the fabric. The condensation of
the steam also causes a 99.9% decrease in its volume and thus pulls in more steam to replace the steam that has
changed to water. The steam does not continue to condense on the outer layer, which is now at the steam’s
temperature, but rather condenses on the next layer inward; the process continues until the steam has heated all
items within the packs.
Once the steam has penetrated the packs and heated their contents
to the selected sterilization temperature, the packs are held at that
temperature for a preset length of time. The higher the temperature, UMDNS Information
the less time needed to achieve sterilization; the typical sterilization
This Product Comparison covers the following
temperature range is 121° to 135°C (250° to 275°F). After the device term and product code as listed in
sterilization cycle is complete, the steam is exhausted with the aid of a ECRI Institute’s Universal Medical Device
Nomenclature System™ (UMDNS™):
partial vacuum, and the sterile items are dried using radiant heat from
Sterilizing Units, Steam, Bulk [16-141]
the chamber and the evaporative effect of the vacuum methods.
5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA Tel +1 (610) 825-6000 Fax +1 (610) 834-1275 Web www.ecri.org E-mail hpcs@ecri.org
Sterilizing Units, Steam, Bulk
Large steam sterilizers are used for bulk sterilization processing and are typically found in the hospital’s
central supply department. Most operating suites and labor and delivery areas are equipped with smaller units
for their own routine needs; however, areas that perform
a great deal of sterilization may require large sterilizers.
Air acts as a barrier against the penetration of steam
into a pack and must therefore be removed from the
sterilizer chamber by gravity, vacuum, steam flush-
pressure pulse, or a combination of gravity and vacuum
methods.
In a large gravity steam sterilizer, pressurized steam is
introduced into the chamber from an external source—
typically a dedicated steam line from a boiler in the
physical plant. Steam rises above the cooler, denser air in
the chamber and gradually forces that air out through a
steam trap (a device that allows the exhausting of air but
not steam) at the bottom of the chamber. However, a
certain amount of air inevitably mixes with the steam,
absorbing some of its heat, and therefore limits the
maximum attainable chamber and load temperature at a
given steam pressure. Gravity sterilizers typically operate at 121° to 123°C (250° to 254°F) but can operate at 132°C
(270°F) to achieve flash sterilization, in which the items typically are not wrapped. Instruments may also be put
into containers designed for use in flash sterilization.
Gravity sterilizers can process all types of items, including wrapped packs, instruments, and sterile fluids.
However, a major disadvantage of gravity units is the long cycle time required for adequate steam penetration
and effective air elimination from the chamber. In addition, the lower sterilization temperature requires a
relatively long period of exposure (approximately 30 minutes). Total cycle time for a gravity sterilizer can exceed
one hour.
Vacuum sterilizers (also called prevacuum or high-vacuum sterilizers) provide quicker and more effective air
elimination from the chamber than gravity units. At the beginning of the cycle, steam is injected at the same time
that a partial vacuum is created (preconditioning), rapidly pulling the air out and the steam in and permitting the
load to be heated very quickly to the selected temperature.
Because vacuum sterilizers provide effective air elimination, they can operate at higher temperatures, typically
132° to 135°C (270° to 275°F). Consequently, the load requires less exposure time (approximately three to five
minutes) at the selected sterilization temperature. Additionally higher vacuum levels during the drying phase
allow for shorter drying times. Overall cycle times for vacuum sterilizers are approximately 20 to 25 minutes.
Vacuum sterilization is not suitable for all applications. Some hospitals prepare their own sterile fluids in
reusable glass bottles with covers that allow the passage of air; at prevacuum sterilizing temperatures, the liquid
can boil away, and rapid exhausting can pop the covers off the bottles. Most prevacuum sterilizers, therefore, can
also use gravity to remove air when processing sterile fluids.
In the steam flush-pressure pulse method, the chamber is kept above atmospheric pressure, and air is removed
by a sequence of steam flushes and pressure pulses. Steam flush-pressure pulse units perform at least as rapidly
as vacuum sterilizers and at temperatures of 132° to 135°C (270° to 275°F). Because of operation above
atmospheric pressure, negative-pressure leaks are not a concern and Bowie-Dick monitoring may not be needed.
Sterilizers can be reconfigured to perform this process if they are not equipped to do so already.
Flash sterilization is used to quickly sterilize instruments that have become contaminated during surgery and
need to be reused. This rapid sterilization process does not use full cycles of exposure and drying times. Exposure
cycles are shortened by eliminating wrapping material or using sterilization containers that ensure that all
instruments are fully exposed to the steam. Criticism of the efficacy of this method has caused the Association for
the Advancement of Medical Instrumentation to issue the following recommendations for using flash
sterilization:
Use only when the sterilized items are urgently needed.
Follow proper procedures before sterilization, such as cleaning, decontaminating, and inspecting
instruments, and properly arrange items in the container or tray.
Position the sterilizer close to the point of instrument use.
Develop procedures to ensure proper aseptic instrument handling and safety during the transfer
of sterilized items.
Sterilization cycles and variables can be displayed graphically by a circle-chart recorder or alphanumerically
by a microprocessor-controlled data reporter. Both provide the date and time and indicate if any problems have
occurred that might adversely affect the sterilization cycle. The information can also be digitally displayed on the
control panel. Many autoclaves have audible and/or visible alarms to indicate interference with the sterilization
cycle; some have indicators that signal cycle completion.
The performance and effectiveness of a steam sterilizer should be tested using both biological and chemical
indicators. Biological indicators are heat-resistant bacterial spores that respond to sterilization much like the
actual microorganisms that may be present in a load. Chemical indicators determine whether a pack or container
was processed properly and can help detect sterilization failures resulting from improper packaging or loading or
inaccurate steam temperatures.
Reported problems
The steam sterilizer is an integral component in a complex system used to provide sterile products for patient
care. This system includes collecting, cleaning, and laundering used instruments and linen; wrapping packs;
loading the sterilizer; using biological and chemical indicators; monitoring steam pressure and quality; and
storing the sterilized items. Therefore, it is often difficult to determine the cause of problems associated with
steam sterilization processing.
The most notable problem is occasional false-positive biological indicators, which can occur even though the
steam sterilizer is functioning properly. The biological indicators, or the way in which they are handled or
incubated, may be at fault. Variables among biological indicators can also cause false-positive results.
A common problem with vacuum steam sterilizers is inadequate air removal from the sterilization chamber,
which can usually be traced to a worn door gasket or to problems with the vacuum system. This is tested using a
prevacuum test pack (commonly known as a Bowie-Dick indicator). This problem does not affect steam flush-
pressure pulse sterilizers because they operate above atmospheric pressure.
The mechanical safety of steam sterilizers is a concern because the sterilization chamber is under significant
positive or negative pressure at different times during the cycle. All bulk steam sterilizer chambers manufactured
in the United States must conform to the applicable requirements of the American Society of Mechanical
Engineers (ASME) Code for Boiler and Pressure Vessels (see bibliography). One sterilizer explosion resulted from
improper maintenance of the electric steam generator beneath the sterilizer (a pressure-relief valve was
erroneously replaced with a plug). Other reported problems involve worn parts affecting the mechanical integrity
of the chamber door and defective circuit boards causing smoke and fires within affected units. It is important
that hospitals have regular preventive maintenance and inspection of their steam sterilizers.
Wet steam can cause sterilization problems, including wet or damp packs, standing water on packs, stained
wrapper materials and pack contents, and deteriorated pack wrappers. Wet steam is commonly defined as steam
with a water-vapor content ≥3% (i.e., <97% dry steam) and is primarily caused by condensation in steam lines;
other sources of wet steam include improper operation of steam traps or the hospital’s boiler. As steam travels
from the boiler to the sterilizers, condensation forms, causing an increase in the water-vapor content. Sterilizers
supplied with their own electric steam generator usually have fewer wet-steam problems.
Marginal steam quality may not be discovered unless the hospital switches to barrier-type linens and pack
wrappers, which are less penetrable by steam and water vapor. Muslin wrappers and linens are more penetrable
during the sterilization and drying cycles and are therefore less affected by marginal steam quality.
The type of wrapper material, pack density, and chamber-loading technique can contribute to pack damage.
Staining can result from rust contamination of the steam supply lines, chemicals used to treat the boiler feed
water carrying over into the steam, and interaction of minerals and chemicals in the hospital’s main water supply
with boiler-treatment chemicals.
Much of the criticism of flash sterilization focuses on the short time the instrument load is exposed to the
steam. However, contamination of treated instruments may actually result from presterilization and
poststerilization handling and not by an ineffective rapid sterilization method—for instance, users might
inadequately clean and decontaminate items before sterilizing them, or unwrapped items might be contaminated
as they are being carried to the sterile field. Although this belief is gaining widespread acceptance among
infection control experts, at least one state has passed laws limiting the use of flash sterilization to instances when
there is an immediate need for sterilized items and no readily available alternative.
Manufacturers typically provide technical bulletins for each available size or model of sterilizer. These
bulletins include detailed information on design and operating features, options, utilities requirements, and
installation considerations. Potential buyers should obtain specific bulletins once they have defined their needs
regarding sterilizer type (gravity, vacuum, or steam flush-pressure pulse), loading (transfer cart or wheeled floor
cart), and chamber size.
Purchase considerations
ECRI Institute recommendations
Included in the accompanying comparison chart are ECRI Institute’s recommendations for minimum
performance requirements for bulk steam sterilizers; recommended specifications have been categorized into one
group including all sterilizers with chamber sizes >2 m3.
Temperatures for steam sterilization should be at least 121°C (250°F), which is commonly the lowest accepted
temperature. Steam sterilizers should have microprocessor controllers because they allow for more precise control
and monitoring of sterilization cycles. Also, to ensure that sterility is achieved, sterilizers should record date,
time, pressure, and temperature and be accessible by printout. Units should alert users if a malfunction is
detected or if the cycle is aborted; ideal units would indicate the cause of alarm on the display screen. All
chambers must conform with ASME pressure vessel codes to ensure safety.
Other considerations
The initial cost of a bulk steam sterilizer can vary from approximately $20,000 for an 18 ft 3 (0.5 m3) transfer-
cart-loading vacuum sterilizer to about $600,000 for a large floor-loading vacuum unit that can accommodate two
carts. Features that significantly contribute to price include the following:
Method of air removal (i.e., gravity units typically cost less than other units)
Chamber size
Manual or power doors
Controller options
Auxiliary loading equipment
Service contracts
Trade-in equipment
Delivery area
Freight charges
Several of these features also affect the cost of autoclaves, including method of air removal, controller options,
and service contracts.
Cost containment
Because bulk steam sterilizers entail ongoing maintenance and operational costs, the initial acquisition cost
does not accurately reflect the total cost of ownership. Therefore, a purchase decision should be based on issues
such as life-cycle cost (LCC), local service support, discount rates and non-price-related benefits offered by the
supplier, and standardization with existing equipment in the department or hospital (i.e., purchasing all
sterilizers from one supplier).
An LCC analysis can be used to compare high-cost alternatives and/or to determine the positive or negative
economic value of a single alternative. For example, hospitals can use LCC analysis techniques to examine the
cost-effectiveness of leasing or renting equipment versus purchasing the equipment outright. Because it examines
the cash-flow impact of initial acquisition costs and operating costs over a period of time, LCC analysis is most
useful for comparing alternatives with different cash flows and for revealing the total costs of equipment
ownership. One LCC technique—present value (PV) analysis—is especially useful because it accounts for
inflation and for the time value of money (i.e., money received today is worth more than money received at a
later date). Conducting a PV/LCC analysis often demonstrates that the cost of ownership includes more than just
the initial acquisition cost and that a small increase in initial acquisition cost may produce significant savings in
long-term operating costs. The PV is calculated using the annual cash outflow, the dollar discount factor (the cost
of capital), and the lifetime of the equipment (in years) in a mathematical equation.
The following represents a sample 10-year PV/LCC analysis for a medium-sized (0.85 m3) bulk sterilizer.
Operating Costs
Annual load costs (year 1) at $13/load, 8 loads/day = $37,960
Annual load costs (years 2 through 10) at $16/load, 8 loads/day = $46,720
Total Operating Costs = $37,960 for year 1; $46,720/year for years 2 through 10
PV = ($538,440)
The following are costs not included in the above analysis and should be considered for budgetary planning:
Costs associated with replacement trays, carts, shelves, etc.
Installation costs, which may include removing units that are being replaced and/or fitting a
dedicated steam pipe from the physical plant, as well as either connecting the sterilizer to the
exhaust line of the hospital heating, ventilating, and air-conditioning system or installing a
dedicated exhaust duct to the outside of the building.
As illustrated by the above sample PV/LCC analysis, the initial acquisition cost is only a fraction of the total
cost of operation over 10 years. Therefore, rather than making a purchase decision based solely on the acquisition
cost of a sterilizing unit, buyers should consider operating costs over the lifetime of the equipment.
For further information on PV/LCC analysis, customized analyses, and purchase decision support, readers
should contact ECRI Institute’s SELECTplus™ Group.
Energy consumption is the main factor contributing to a bulk sterilizer’s long-term operating costs. Electricity
costs can vary greatly depending on the unit’s size, method of air removal (i.e., gravity units are less expensive to
run than other sterilizers), and the controller electronics system.
Hospitals can purchase service contracts or service on a time-and-materials basis from the supplier. Service
may also be available from a third-party organization. The decision to purchase a service contract should be
carefully considered; it can be justified for several reasons. Purchasing a service contract ensures that preventive
maintenance will be performed at regular intervals, thereby eliminating the possibility of unexpected
maintenance costs. Also, many suppliers do not extend sterilizer performance guarantees beyond the length of
the warranty unless the system is covered by a service contract.
ECRI Institute recommends that, to maximize bargaining leverage, hospitals negotiate pricing for service
contracts before the system is purchased. Full-service contracts typically cost approximately 10% of the sterilizing
unit’s purchase price. Additional service-contract discounts may be negotiable for multiple-year agreements or
for service contracts that are bundled with contracts on other sterilizers in the department or hospital.
Stage of development
Steam sterilizers have been used in hospitals for more than a century. Other than the method of air removal
and the addition of electronic controls and monitors, their basic theory of operation has changed little in that time.
Microprocessor controls have been incorporated to increase the sterilizer’s reliability and ease of use. Newer
models offer such features as built-in safety devices, the ability to be modified with additional safety components
(e.g., door-interlock systems, audible alarms), and preprogrammed sterilization cycles and may include electronic
record keeping. Electronic record keeping can be advantageous to departments required to keep records of
performance parameters for each sterilization cycle. Future enhancements may include the use of microwave or
ultraviolet radiation to sterilize heat- and steam-sensitive devices.
Bibliography
American Society of Mechanical Engineers (ASME). Pressure relief devices [standard]. ASME PTC-25-1994. 1994.
Caporino PP. How effective are chemical and biological sterilization indicators? J Healthc Mater Manage 1991 Jan-
Feb;9(1):32-44.
Crow S. Steam sterilizers: an evolution in design. Infect Control Hosp Epidemiol 1993 Aug;14(8):488-90.
Favero MS. Sterilization and infection prevention: what you need to know. Asepsis 1994 4th Quarter;16(4):16-9.
Harris MH. Flash sterilization: is it safe for routine use? AORN J 1992 Jun;55(6):1547-51.
Supplier information
ARS
ARS Enterprises [105285]
12900 Lakeland Rd
Santa Fe Springs, CA 90670-4517
Phone: (562) 946-3505, (800) 735-9277 Fax: (562) 946-4120
Internet: http://www.arsenterprises.com
E-mail: info@arsenterprises.com
BAUMER
Baumer S/A [179534]
Avenida Prefeito Antonio Tavares Leite Nr 181 Parque da Empresa
Mogi Mirim-SP 13803-330
Brazil
Phone: 55 (19) 38065955 Fax: 55 (19) 38063317
Internet: http://www.baumer.com.br
E-mail: baumer@baumer.com.br
BUXTON
Buxton Medical Equipment Corp [107013]
1178 Rt 109
Lindenhurst, NY 11757-1004
Phone: (631) 957-4500 Fax: (631) 957-3884
Internet: http://www.buxtonmed.com
E-mail: pmccann@buxtonmed.com
CISA
CISA Middle East [439656]
Alsafa Wa Almarwa Building Almadina Almonawara Street Telaa Al Ali
Amman
Jordan
Phone: 962 (79) 5649290 Fax: 962 (655) 11596
E-mail: middleeast.sales@cisasrl.it
CONSOLIDATED STILLS
Consolidated Stills & Sterilizers [102416]
76 Ashford St PO Box 297
Boston, MA 02134
Phone: (617) 782-6072 Fax: (617) 787-5865
Internet: http://www.consteril.com
E-mail: info@consteril.com
ETC
ETC Singapore [173257]
10 Jalan Kathi
Singapore 468662
Republic of Singapore
Phone: 65 4444812
Internet: http://www.etcbiomedical.com
E-mail: hyperbaric@etcusa.com
FEDEGARI
Fedegari Autoclavi SpA [309507]
SS 235 KM 8
Albuzzano (PV) I-27010
Italy
Phone: 39 (0382) 434111 Fax: 39 (0382) 434150
Internet: http://www.fedegari.com
E-mail: sales@fedegari.com
GETINGE
Getinge Australia Pty Ltd [193768]
154 Lytton Rd
Bulimba 4171
Australia
Phone: 61 (7) 33993311 Fax: 61 (7) 33956712
Internet: http://www.getinge.com
E-mail: info@getinge.com
H & P LABORTECHNIK
Thermo Fisher Scientific Inc [451895]
PO Box 9046
Waltham, MA 02454-9064
Phone: (781) 622-1000, (866) 984-3766 Fax: (781) 622-1207
Internet: http://www.thermofisher.com
INTERNATIONAL PBI
International pbi SpA [232376]
via Novara 89
Milano (MI) I-20153
Italy
Phone: 39 (02) 487791 Fax: 39 (02) 40090010
Internet: http://www.internationalpbi.it
E-mail: info@internationalpbi.it
KSG
KSG Sterilisatoren GmbH [158824]
Buchhoferstrasse 5
Olching D-82140
Germany
Phone: 49 (8142) 29570 Fax: 49 (8142) 40384
Internet: http://www.ksg-sterilisatoren.de
E-mail: info@ksg-sterilisatoren.de
LTE SCIENTIFIC
LTE Scientific Ltd [227235]
Greenbridge Lane Greenfield
Oldham OL3 7EN
England
Phone: 44 (1457) 876221 Fax: 44 (1457) 870131
Internet: http://www.lte-scientific.co.uk
E-mail: info@lte-scientific.co.uk
MATACHANA
Matachana SA [195242]
Calle Almogavares 174-176
Barcelona E-08018
Spain
Phone: 34 (93) 3008012 Fax: 34 (93) 3005924
Internet: http://www.matachana.com
E-mail: marketing@matachana.com
MMM
MMM Muenchener Medizin Mechanik GmbH [160098]
Semmelweisstrasse 6
Planegg/Muenchen D-82152
Germany
Phone: 49 (89) 899180 Fax: 49 (89) 89918118
Internet: http://www.mmmgroup.com
E-mail: info@mmmgroup.com
NUVE
Nuve Sanayi Malzemeleri Imalat Ve Ticaret AS [318339]
Esenboga Yolu 22 km Akyurt
Ankara TR-06287
Turkey
Phone: 90 (312) 3992830 Fax: 90 (312) 3992197
Internet: http://www.nuve.com.tr
E-mail: sales@nuve.com.tr
OPPICI
Oppici SA [339124]
Avenida Vicuna Mackenna 98 Providencia
Santiago
Chile
Phone: 56 (2) 7990450 Fax: 56 (2) 7990457
Internet: http://www.oppici.cl
E-mail: ventasclinicas@oppici.cl
PRIMUS STERILIZER
Primus Sterilizer Co LLC [153891]
117 S 25th St
Omaha, NE 68131
Phone: (402) 344-4200 Fax: (402) 344-4242
Internet: http://www.primus-sterilizer.com
E-mail: info@primus-sterilizer.com
PRIORCLAVE
PriorClave Ltd [192831]
West Thamesmead Business Park
London SE28 0AB
England
Phone: 44 (20) 83166620 Fax: 44 (20) 88550616
Internet: http://www.priorclave.co.uk
E-mail: sales@priorclave.co.uk
RAUTOCLAVE
Rautoclave cc [325875]
PO Box 331
Mulbarton 2059
South Africa
Phone: 27 (11) 6135616 Fax: 27 (11) 6135617
E-mail: rauserv@iafrica.com
RODWELL
Rodwell Scientific Instruments [358088]
Bentalls Pipps Hill Industrial Estate
Basildon SS14 3SD
England
Phone: 44 (1268) 286646 Fax: 44 (1268) 287799
Internet: http://www.rodwell-autoclave.com
E-mail: sales@rodwell-autoclave.com
SAL PHARMA
SAL Pharma [399233]
Invicta Works Houghton Road
Grantham NG31 6JE
England
Phone: 44 (1476) 515550 Fax: 44 (1476) 515551
Internet: http://www.salpharma.com
E-mail: general@salpharma.com
SAUTER
Sauter AG [186709]
Alviereg 17
Vaduz CH-9490
Switzerland
Phone: 41 (42) 32375730 Fax: 41 (42) 32320336
STERILIZING SYSTEMS
Sterilizing Systems [146777]
PO Box 1388
Alpharetta, GA 30009
Phone: (770) 475-1099 Fax: (770) 751-1256
Internet: http://www.sterilizingsystems.com
E-mail: sterilizingsys@speedfactory.com
STERIS
STERIS Corp [107114]
5960 Heisley Rd
Mentor, OH 44060-1834
Phone: (440) 354-2600, (800) 548-4873 Fax: (440) 354-2321
Internet: http://www.steris.com
E-mail: info@steris.com
TECNO-GAZ
TECNO-GAZ SpA [152517]
strada Cavalli 4
Sala Baganza (PR) I-43038
Italy
Phone: 39 (0521) 833926 Fax: 39 (0521) 833391
Internet: http://www.tecnogaz.com
E-mail: info@tecnogaz.com
TOMY TECH
Tomy Tech USA Inc [161286]
40479 Encyclopedia Circle
Fremont, CA 94538
Phone: (510) 440-1976, (800) 545-8669 Fax: (510) 440-1975
Internet: http://www.tomytech.com
E-mail: info@tomytech.com
TUTTNAUER
Tuttnauer Europe bv [183737]
Paardeweide 36 Postbus 7191
Breda NL-4800 GD
The Netherlands
Phone: 31 (76) 5423510 Fax: 31 (76) 5423540
Internet: http://www.tuttnauer.com
E-mail: info@tuttnauer.nl
WESA
Wesa AG [151037]
rue de l'Industrie 41
Eupen B-4700
Belgium
Phone: 32 (87) 740404 Fax: 32 (32) 744673
Internet: http://www.wesasteri.com
E-mail: info@wesasteri.com
XINHUA
Shinva Medical Instruments Co [452207]
Shinva Medical Scientific Zone Zibo New & High Tech Zone
Zibo City 255089
People's Republic of China
Phone: 86 (533) 3587719 Fax: 86 (533) 3587722
Internet: http://www.shinva.com
E-mail: sales@shinva.com
ZIRBUS APPARATEBAU
Zirbus Apparate- und Maschinenbau GmbH [285266]
Hilfe Gottes 1
Bad Grund D-37539
Germany
Phone: 49 (5327) 83800 Fax: 49 (5327) 838080
Internet: http://www.zirbus.de
E-mail: info@zirbus.de
Note: The data in the charts derive from suppliers’ specifications and have not been verified through
independent testing by ECRI Institute or any other agency. Because test methods vary, different products’
specifications are not always comparable. Moreover, products and specifications are subject to frequent
changes. ECRI Institute is not responsible for the quality or validity of the information presented or for any
adverse consequences of acting on such information.
When reading the charts, keep in mind that, unless otherwise noted, the list price does not reflect supplier
discounts. And although we try to indicate which features and characteristics are standard and which are not,
some may be optional, at additional cost.
For those models whose prices were supplied to us in currencies other than U.S. dollars, we have also listed the
conversion to U.S. dollars to facilitate comparison among models. However, keep in mind that exchange rates change
often.
Policy Statement
The Healthcare Product Comparison System (HPCS) is published by ECRI Institute, a nonprofit organization.
HPCS provides comprehensive information to help healthcare professionals select and purchase diagnostic and
therapeutic capital equipment more effectively in support of improved patient care.
The information in Product Comparisons comes from a number of sources: medical and biomedical
engineering literature, correspondence and discussion with manufacturers and distributors, specifications from
product literature, and ECRI Institute’s Problem Reporting System. While these data are reviewed by qualified
health professionals, they have not been tested by ECRI Institute’s clinical and engineering personnel and are
largely unconfirmed. The Healthcare Product Comparison System and ECRI Institute are not responsible for the
quality or validity of information derived from outside sources or for any adverse consequences of acting on such
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Many of the words or model descriptions appearing in the Healthcare Product Comparison System are
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MODEL PELTON & CRANE PRIMUS STERILIZER PRIMUS STERILIZER PRIMUS STERILIZER
Magna-Clave Model MC BioPharma Sterilizer Series Clinical Sterilizer Series Laboratory Sterilizer Series
100 (PSS6, PSS7, PSS8) (PSS5, PSS6, PSS7, PSS8)
WHERE MARKETED North America Worldwide Worldwide Worldwide
FDA CLEARANCE No Yes Yes Yes
CE MARK (MDD) No Not specified Not specified Not specified
AIR REMOVAL Gravity Vacuum, gravity, vacuum- Vacuum, gravity, vacuum- Vacuum, gravity, vacuum-
assisted gravity, assisted gravity, assisted gravity,
prevacuum, water ejector or prevacuum, water ejector or prevacuum, water ejector or
vacuum pump vacuum pump vacuum pump
CHAMBER SIZES
W x H x D, cm (in) 38.7 x 38.1 x 66 (15.3 x 15 190 sizes from 40.6 x 40.6 x 10 sizes from 40.6 x 40.6 190 sizes from 40.6 x 40.6 x
x 26) 66 (16 x 16 x 26) to 154.9 x x66 (16 x 16 x 26) to 66 x 66 (16 x 16 x 26) to 154.9 x
218.4 x 218.4 (61 x 86 x 160 x 193 (26 x 63 x76) 218.4 x 218.4 (61 x 86 x
86); larger custom 86); larger custom
VOLUME, m³ (ft³) 0.08 (2.8) 0.11-7.4 (3.9-261.1), ≤17 0.11-2.04 (3.9-72.0) 0.11-7.4 (3.9-261.1), ≤17
(600) custom (600) custom
CHAMBER MATERIAL Stainless steel 316L stainless steel 316L stainless steel 316L stainless steel
chamber and door; 304 chamber and door; 304 chamber and door; 304
stainless steel jacket stainless steel jacket stainless steel jacket
LOADING Removable bin/tray Shelving, cart, transfer Shelving, cart, transfer Shelving, cart, transfer
carriage, floor loading carts carriage, floor loading carts carriage, floor loading carts
for pit mounts for pit mounts for pit mounts
TEMPERATURE RANGE,
°C (°F)
Gravity cycle 121-130.6 (250-267) 122.8-134 (253-273); 122.8-134 (253-273); 122.8-134 (253-273);
optional 70-104 (180-205) optional 70-104 (180-205) optional 70-104 (180-205)
low temperature low temperature low temperature
Vacuum cycle NA 122.8-134 (253-273) 122.8-134 (253-273) 122.8-134 (253-273)
Steam flush-pressure NA 1-6 PREVACS 1-6 PREVACS 1-6 PREVACS
pulse
CONTROLLER Manual Pri-Matic programmable Microcomputer Microcomputer, Pri-Matic
logic controller or color programmable logic
touchscreen controller and
programmable logic
controller or Trinity Control
color touchscreen
ALARM CONDITIONS None specified Door open, gasket error, Door open, gasket error, Door open, gasket error,
over- and overtemperature, low over- and
undertemperature, max temperature, time-out, undertemperature, low
chamber pressure, precharge time-out, temperature time-out,
precharge timeout, prevacuum time-out, precharge time-out,
prevacuum timeout, postvacuum time-out, power prevacuum time-out,
postvacuum timeout, power failure postvacuum time-out, power
failure, cycle interrupt, failure
rupture disk, water-in-drain,
sensor failure, low water
pressure, low air pressure,
low steam pressure,
emergency stop
Indicator type Not specified Audible, visual, printer Audible, visual, printer Audible, visual, printer
MODEL PELTON & CRANE PRIMUS STERILIZER PRIMUS STERILIZER PRIMUS STERILIZER
Magna-Clave Model MC BioPharma Sterilizer Series Clinical Sterilizer Series Laboratory Sterilizer Series
100 (PSS6, PSS7, PSS8) (PSS5, PSS6, PSS7, PSS8)
DATA MANAGEMENT
Recorder Optional 24 hour Thermal printer, 32- Thermal printer, 32- Thermal printer, 32-
temperature recorder character; optional impact character; optional impact character; optional impact
printer and multichannel printer and multichannel printer and multichannel
chart recorders chart recorders chart recorders
Data type Not specified Not specified Not specified Not specified
Printer Not specified Not specified Not specified Not specified
DOORS Single Single or double (pass- Single or double (pass- Single or double (pass-
through) through) through)
Operation Manual Manual, optional automatic; Manual, optional automatic; Manual, optional automatic;
automatic standard on units automatic standard on units automatic standard on units
66 x 91.3 x 99 cm (26 x 36 x 66 x 91.3 x 99 cm (26 x 36 x 66 x 91.3 x 99 cm (26 x 36 x
39 in) or larger 39 in) or larger 39 in) or larger
INSTALLATION
Cabinet enclosed Yes Yes Yes Yes
Recessed in wall No Yes Yes Yes
Pit mounted No Available on units 66 x 160 Available on units 66 x 91.3 Available on units 66 x 160
x 122 cm (26 x 63 x 48 in) x 99 cm (26 x 36 x 39 in) or x 122 cm (26 x 63 x 48 in)
or larger larger or larger
SUPPLY STEAM PRESS, 1-1.7 (15-25) 3.5-5.6 (50-80) 3.5-5.6 (50-80) 3.5-5.6 (50-80)
kg/cm² (psig)
ELECTRICAL POWER
Gravity models, VAC 208, 240; 50/60 Hz 110-120; 50/60 Hz; 10 A; 110-120; 50/60 Hz; 10 A; 110-120; 50/60 Hz; 10 A;
single-phase single-phase single-phase
Vacuum models, VAC NA Additional circuits may be Additional circuits may be Additional circuits may be
required for vacuum pumps required for vacuum pumps required for vacuum pumps
and boilers and boilers and boilers
Steam flush-pressure NA NA NA NA
pulse, VAC
PLANNING & PURCHASE
List price, std $18,460, $20,215 with Not specified Not specified Not specified
configuration recorder
Warranty 1 year, parts 1 year, parts; 90 days, 1 year, parts; 90 days, 1 year, parts; 90 days,
labor; 15 years, pressure labor; 15 years, pressure labor; 15 years, pressure
vessel vessel vessel
Delivery time, ARO 3 weeks 12-18 weeks 4-12 weeks 6-16 weeks
Training Not specified On-site in-service, factory On-site in-service, factory On-site in-service, factory
technical service school technical service school technical service school
optional optional optional
Year first sold 1968 1990 1990 1990
Number installed 7,500 (est.) Not specified Not specified Not specified
worldwide
Fiscal year January to December January to December January to December January to December
MODEL PELTON & CRANE PRIMUS STERILIZER PRIMUS STERILIZER PRIMUS STERILIZER
Magna-Clave Model MC BioPharma Sterilizer Series Clinical Sterilizer Series Laboratory Sterilizer Series
100 (PSS6, PSS7, PSS8) (PSS5, PSS6, PSS7, PSS8)
OTHER SPECIFICATIONS Meets requirements of Liquid cycle with auto Liquid cycle with auto Liquid cycle with auto
ASME Boiler and Pressure compensating slow exhaust compensating slow exhaust compensating slow exhaust;
Vessel Code. standard; low-temperature standard; microcomputer low-temperature flowing
flowing steam models control package with cycle- steam models available;
available; microcomputer advance; nonproprietary nonproprietary replacement
control package with cycle- replacement parts; optional parts; microcomputer
advance; nonproprietary low-temperature flowing control package with cycle-
replacement parts; optional steam models available advance; optional
authorized operator authorized operator authorized operator
security, sterilize filter cycle, security, custom control security, custom control
automatic vacuum leak test packages, and custom packages, vessel size or
cycle; custom control vessel size or design design features; RS232
packages, vessel size and features; RS232 serial port, serial port; automatic door
design features; RS232 optional automatic door via via mushroom button and/or
serial port; automatic door mushroom button and/or footpedal for handsfree
via mushroom button and/or footpedal for handsfree loading and unloading;
footpedal for handsfree loading and unloading; vertical door units; water
loading and unloading; vertical door units; water conservation and
vertical door units; water conservation; electric boilers recirculation; validation port;
conservation and 208/3, 240/3, or 480/3. electric boilers 208/3, 240/3,
recirculation; validation port; Meets requirements of or 480/3. Meets
BioSeal flange, panels; fully ASME, CRN, UL, ISO requirements of ASME,
welded box; electric boilers 13485:2003, ISO CRN, UL, ISO 13485:2003,
208/3, 240/3, or 480/3. 9001:2000, and CMDCAS; ISO 9001:2000, and
Meets requirements of seismic preapproval. CMDCAS; seismic
ASME, cGMP, CRN, UL, preapproval.
ISO 13485:2003, ISO
9001:2000, and CMDCAS;
seismic preapproval.
UMDNS CODE(S) 16141 16141 16141 16141
LAST UPDATED January 2008 January 2008 January 2008 January 2008
Supplier Footnotes
Model Footnotes
Data Footnotes