Comparing key technology differentiators and

the potential impact they present in the

sterilization process
STERRAD™ 100NX
V-PRO® maX 2
with

CAPACITY
The type and number of instruments which can be reprocessed in any single cycle is determined by the sterilizer's indications for use.1 The
configuration and the chamber dimensions contribute also to the usable capacity and therefore output. According to the guidelines for loading,
all surfaces should be directly exposed to the sterilant.2 As such, the total volume of the chamber CANNOT equal to usable volume, by default
MAXIMIZING INSTRUMENT and suggesting it is against guidelines and can eventually jeopardize sterilization.
The STERRADTM 100NX system has a wider chamber configuration, allowing more side to side space, minimizing the risk of trays touching each
TURNOVER other, promoting optimal H2O2 circulation to facilitate effective sterilization.3

STERRAD ™100NX System STERIS V-PRO® maX/2

CHAMBER SHAPE RECTANGULAR RECTANGULAR

Volume Capacity

38.1cm
40.8cm
TOTAL VOLUME: TOTAL CHAMBER SPACE
ASSUMING NO "DEAD" SPACE EXISTS Total Volume: 152 lts Total Volume: 136 lts
The question raised:
USABLE VOLUME: THE TRUE VOLUME what is the true usable volume
ELIGIBLE FOR USE, EXCLUDING THE AREAS THAT BY
DEFAULT CANNOT BE UTILIZED (EX. SHELVE SPACE,
73.4cm 82.5cm of each chamber?
SPACE IN-BETWEEN THE SHELVES AND THE WALL, Usable Volume: 93.4 lts Usable Volume: not communicated
SPACE IN CONTACT WITH THE DOOR AND THE 51 cm 43cm
CHAMBER WALLS ETC) Note: dimensions above represent the total size for both chambers. Source: Highpower validation services and lab services' study n.2109-509.

SAFETY PROTECTING THE PATIENT, THE USER AND THE ENVIRONMENT

The plasma technology utilized in STERRAD™ systems ensures H2O2 emissions, while operating and when opening the chamber door, are kept at
safe levels, without the need of weekly chamber leak tests or quarterly gasket inspection required. In a comparison study, STERIS V-PRO® maX
showed instantaneous peak measurements of H2O2 reaching up to 20ppm at the user’s breathing zone level, above ACGIH® Permissible limits
(5ppm). STERRAD™ systems never exceeded 0.3ppm.4

In line with this, STERRAD™ Sterilization Systems’ H2O2 emissions, at the user’s breathing zone level, are up to 67 times lower than for STERIS V-PRO® sterilizers:

PLASMA PRESENCE 1. STERRAD™ 100NX System FLEX Cycles 2. V-PRO® maX Flexible Cycles 3. STERRAD™ 100NX System STANDARD Cycles 4. V-PRO® maX lumen Cycles
PLASMA DISSOCIATES UNREACTED H2O2 INTO
OXYGEN AND WATER AND REMOVES ANY RESIDUAL
Yes No Morning 0.1 Morning 15.1 Morning 0.0 Morning 15.1
0.2 13.3 0.3 19.3
H2O2 FROM THE LOAD
0.2 16.6 0.2 7.4
Afternoon 0.2 Afternoon 13.8 Afternoon 0.2 Afternoon 12.7
ppm 0 5 10 15 20 ppm 0 5 10 15 20 ppm 0 5 10 15 20 ppm 0 5 10 15 20

Key: Above ACGIH® Permissible limits (5ppm) Peak concentration (ppm)

CHEMICAL INDICATORS ON Yes No The chemical indicator included in the packaging is an additional measure of safety to protect users from being exposed to leaked H2O2.
CASSETTES/ CARTRIDGES

EFFICIENCY THE INCREMENTAL SAFETY A SYSTEM CAN PROVIDE WHEN NEEDED

Yes Yes Cycle abortion can also happen for other reasons besides residual moisture being present. A complete system check during the moisture & gas
MOISTURE & GAS DETECTION PROCESS
detection phase, can further prevent cycle abortion, saving time & costly resources.
THIS PROCESS PREVENTS MOISTURE' RELATED CYCLE
ABORTS, BEFORE THE STERILANT BEEN INJECTED. if required - up to 5 minutes prior to cycle Included in Cycle time

SYSTEM CHECK BEFORE CYCLE START Yes No

A FULL SYSTEM CHECK IS CONDUCTED PRIOR
TO CYCLE STARTING no additional time required - included in the Included in Cycle time
moisture & gas detection check
HANDS-FREE DOOR OPENING Yes Yes The chamber door can be opened and closed using a footpedal, allowing users to load and unload the chamber, even with both hands occupied.

A sliding door allows convenient loading & unloading with both hands carrying the load even in small rooms/space where systems are placed
DOOR OPENING MECHANISM Sliding Swinging
one next to the other and ergonomics do not allow space for the door to swing and remain open.

STERILITY ASSURANCE
PROVIDING A COMPLETE SET OF TECHNOLOGIES TO
MAKE AN ASSURED DECISION TO RELEASE THE LOAD
WITH CONFIDENCE

REAL-TIME CONCENTRATION Using technologies to directly monitor conditions in the chamber, provide solid evidence and allow the user to take informed decisions. In case
H2O2 MONITORING of a non-identified failure, absence of direct measurement in the chamber can create a false feeling of assurance, when conditions are not trully
DIRECTLY MONITORING H2O2 INSIDE THE CHAMBER
Yes No met. (example: If the pressure inside the chamber remains at proper levels but instead of H2O2, air is leaking, a system would not necessarily
ENSURES APPROPRIATE QUANTITY WAS PRESENT recognize the difference and the user will end up with a completed cycle but a non-sterile load. With an H2O2 monitor present in the chamber,
TO ENSURE STERILIZATION the system will detect the low levels of H2O2 and would interrupt the process).

INDEPENDENT MONITORING
SYSTEM (IMS) fully independent monitoring
operating by the main
A SEPARATE SET OF SENSORS MONITORING IMPORTANT processor, including data
PARAMETERS WITHIN THE STERILIZER TO PREVENT A monitoring processor
HARDWARE OR SOFTWARE FAILURE, processing
BEING UNDETECTED

ALL IN ONE BI/PCD Yes No Biological Indicators demonstrate whether conditions were adequate to achieve sterilization. Process Challenge Devices (PCDs/Test Packs)
(BIOLOGICAL INDICATOR / PROCESS simulate a challenge to the process that is equal to or greater than the challenge posed by the most difficult item routinely processed.5 AAMI,
CHALLENGE DEVICE)
AORN & other associations, recommend using a PCD in every cycle.4 By combining the most-difficult-to-reprocess device scenario with the
READOUT TIME (MIN) 15-30* 20 hardest-to-kill spores in every cycle, BI/PCDs assure sterility by confirming sterilization is reached at the greatest-possible challenge.6

CHEMICAL INDICATOR TAPE Yes Yes

CHEMICAL INDICATOR Yes Yes

THROUGHPUT OPTIMIZING INSTRUMENT TURNOVER

CYCLE TIME (MIN) - 16 Fast Non Lumen Cycle Time can be a key driver for efficiency when aligned with the type and volume of instruments a hospital is routinely reprocessing. Each
24 Express 28 Non Lumen instrument should be reprocessed with the cycle and system it is validated for, according to its manufacturer. After assessing the type and
CYCLE TIME INDICATES THROUGHPUT POTENTIAL.
FASTER INSTRUMENT TURNAROUND IS ALSO 47 Standard 52 Lumen number of cycles required per shift, the sterile services department can improve its efficiency, by scheduling the cycles according to instrument
IMPACTED BY CYCLE TIME 42 Flex 35 Flexible turnaround requirements, to serve the demanding Operating Room (OR) needs.
60 Duo -
The Medical Device Manufacturer (MDM), the Sterilizer Manufacturer (SM) and Healthcare Professionals (HCPs) each play a critical role to
INSTRUMENT VALIDATIONS IN prevent inapropriate device reprocessing and the potential of Surgical Site Infections (SSIs) from occuring. Working always in partnership with
PARTNERSHIP WITH THE MDM the Medical Device Manufacturer to validate effective sterilization and functional compatibility of a medical device, is critical for sterility
EACH DEVICE NEEDS TO BE TESTED FOR FUNCTIONAL always often assurance and patient safety.
COMPATIBILITY AND STERILE EFFICACY, FOR EACH Similarly, assuming sterilizers using the same sterilant provide equal sterility assurance, risks inadequate sterilization and, ultimately, may put
CYCLE AND STERILIZER SEPARATELY
patients at risk.7

COMPLIANCE RECORD KEEPING AND WORKFLOW OPTIMIZATION MADE EASY

AUTOMATIC RECORD KEEPING Yes Yes

AUTOMATIC DATA RECONCILIATION Yes No Automatic Data Reconciliation allows cycle records to connect with BI records in one single entry for efficient record keeping and audit readiness.

CONNECT TO TRACKING SYSTEMS & Yes Yes

HOSPITAL NETWORK
Detailed analytics accessible remotely, can provide useful insights that related to the operations of the department, enabling decision making,
DATA ANALYTICS & REMOTE ACCESS Yes No improved department efficiency & remote diagnostics.

MARGIN OF SAFETY THE INCREMENTAL SAFETY A SYSTEM CAN PROVIDE

WHEN NEEDED
In a recent, peer-reviewed journal article by William A. Rutala, PhD, detailed comparative testing was performed on different sterilization moda-
lities under simulated inadequate cleaning conditions to understand differences in sterilizer efficacy and the critical nature of proper cleaning
when reprocessing medical devices. According to the article for comparing the largest margin of safety as it relates to microbicidal failure rate,
researchers found Steam, Ethylene oxide gas sterilization (ETO), and Hydrogen Peroxide Gas Plasma (HPGP) sterilization techniques were
capable of inactivating the test organisms on stainless steel carriers with a failure rate of 0% (0 of 220), 1.9% (6 of 310), and 1.9% (5 of 270),
respectively. The failure rate for Vaporized hydrogen peroxide (VHP) was 76.3% (206 of 270) (graph below).8
Given the prevalence of STERRAD™ & VPRO technologies in low-temperature sterilization where material compatibility necessitates alternati-
ves to steam sterilization and considering innadequate instrument reprocessing is responsible for almost 22% of SSIs, the incremental margin
of safety prevailing under challenging conditions is key for sterility assurance and patient safety.
INACTIVATING VEGETATIVE BACTERIA
(INCLUDING MYCOBACTERIA), YEASTS, 90.00%
FUNGI, VIRUSES, AND BACTERIAL SPORES 85.56%

Yes - incremental Yes 80.00%

71.67% 76.30%
LIKE ALL STERILIZATION PROCESSES, 70.00%
THE EFFECTIVENESS CAN BE ALTERED BY LUMEN
60.00%
LENGTH, LUMEN DIAMETER, INORGANIC SALTS, MICROBICIDAL Vegetative Cells
AND ORGANIC MATERIALS1 FAILURE
50.00%
Spores
40.00%
RATE Total
30.00%

20.00%

10.00%
2.78% 2.73% 1.94%
1.85%
0% 0% 0% 0% 0%
0.00%
V-PRO® maX STERRAD NX™ System ETO Steam

References 1. International Organization for Standardization. ISO17664:2017. 2017 2. CDC.Guideline for Disinfection and Sterilization in Healthcare Facilities (2008) Rutala et al. 3. Advanced Sterilization Products.
STERRAD™ Superiority#2: Defining Chamber Capacity. 4. Advanced Sterilization Products. Comparison Study of Environmental Hydrogen Peroxide Levels of STERRAD™ Systems and STERIS V-PRO® Low Temperature Sterilizers
Reveals Striking Differences. 5. Association for the Advancement of Medical Instrumentation (AAMI) ST58:2013/(R)2018; ISO 14937. 6. ASP’s STERRAD VELOCITY™ BI/PCD utilizes a highly resistant ISO 1113801 Biological
asp.com
0123
Indicator equivalent to more than 6 log of geobacillus stearothermophilus placed at the most challenging location of the most challenging lumen device. 7. Advanced Sterilization Products. The Importance of
Instrument Validation 8.. William A. Rutala, Maria F. Gergen, Emily E. Sickbert-Bennett, David J. Weber, Comparative evaluation of the microbicidal activity of low-temperature sterilization technologies to steam ADVANCED STERILIZATION PRODUCTS, INC.
sterilization, Infection Control and Hospital Epidemiology (2020). STERIS data https://www.steris.com/healthcare/products/v-pro-sterilizers/v-pro-resources/low-temperature-sterilizer-comparison_LTSC-3. The third-
ASP International GmbH, Zug Branch 33 Technology Drive, Irvine CA 92618, USA
party trademarks used in this document are the properties of their respective owners. Bahnhofstrasse 2, Zug 6300, Switzerland
ASP, The Netherlands BV
* 15-30min fastest BI/PCD currently marketed for STERRAD™ Sterilization Systems. 15 or 30 minutes to result dependent on the software version on the STERRAD VELOCITY™ Reader. 15 minutes to result for SW version ©ASP 2022. All Rights Reserved. EC REP
BIC 1, 5657 BX Eindhoven, The Netherlands
1139260410 or greater; 30 minutes to result for SW version 1139260317 or below.
As a precaution, when handling any part of the system or load items that have been exposed to hydrogen peroxide, please wear the appropriate PPE (chemical-resistant latex, PVC/vinyl, or nitrile gloves). Refer to the glove The third-party trademarks used in this document are the properties of their respective owners.
Important information: Prior to use, refer to the complete instructions for use supplied with the device(s) for proper use, indications, contraindications, warnings and precautions. AD-210052-01-CT_B-MDR
manufacturer’s instructions for use for more information. Capitalized product names are trademarks of ASP Global Manufacturing, GmbH.