STERRAD™ 1OONX

STERRAD NX™
with

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 STERRAD™ 1OONX and STERRAD NX™

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INTRODUCTION
This document describes the technology, concepts, operating theory and testing of the STERRAD™ 100NX System with ALLClear™ Components and Features of STERRAD NX™ System with ALLClear™ Technology
Technology and STERRAD NX™ System with ALLClear™ Technology. The STERRAD™ Systems with ALLClear™ Technology, developed
by Advanced Sterilization Products (ASP™), represent the next generation of low-temperature hydrogen peroxide gas plasma sterili-
zers. STERRAD™ Systems with ALLClear™ Technology have both hardware and software enhancements made to provide customers
with a sterilization solution that minimizes unexpected delays and downtime.
Cassette Insertion Touchscreen

Key features of the STERRAD™ Systems with ALLClear™ Technology include:

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• Scanner
Ability to sterilize heat and moisture-sensitive instruments due to low moisture environment and load temperatures of 56°C or
less. Chamber
• Multiple cycle options dedicated to sterilizing distinct types of loads, including those containing lumens and endoscopes. The
cycle times range from 24 to 60 minutes.
• Simple, easy-to-use system that reduces operator error. Increased usability with an intuitive hydrogen peroxide cassette*
insertion and a wide-angle touchscreen monitor.
• ALLClear™ Technology, which reduces cycle cancellations through fast, accurate detection and correction of load and system
issues. Cart
• Compatibility with the STERRAD VELOCITY™ System, which provides a rapid and reliable readout in 15 minutes to verify the
effectiveness of the STERRAD™ System sterilization cycles.**

The core technology used by the STERRAD™ Systems with ALLClear™ Technology can quickly and reliably sterilize a wide range of
medical devices currently sterilized with steam, ethylene oxide, formaldehyde, or peracetic acid. The sterilization process is as
follows: A solution of hydrogen peroxide and water
(59% nominal hydrogen peroxide by weight) is delivered to the sterilizer, then vaporized into the chamber. The solution surrounds
and interacts with the devices and creates a biocidal environment that inactivates microorganisms with chemical interactions at
multiple biologically important reaction sites.1 A strong electrical field is applied to the chamber and creates a hydrogen peroxide
gas plasma that dissociates hydrogen peroxide molecules into energized species. Once the electrical field is turned off, the energi- Components and Features of STERRAD™ 100NX System with ALLClear™ Technology
zed species recombine, which turns the hydrogen peroxide into water and oxygen.

TECHNOLOGY OVERVIEW Cassette Insertion Touchscreen

The STERRAD™ Systems with ALLClear™ Technology are designed for maximum efficiency, reliability, and usability. They are compa-
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tible with ASP™ terminal sterilization consumables such as the Scanner
STERRAD VELOCITY™ Biological Indicator / Process Challenge Device (BI/PCD), The STERRAD™ Systems with ALLClear™ Technology
have been developed to be compliant with ISO14937:2009 once installed and validated according to ASP™ specifications.
Chamber

01 STERRAD™ Systems with ALLClear™ Technology System Design

This product features the same low-temperature hydrogen peroxide gas plasma technology1 as previous generations of STERRAD™
Systems, with software and hardware upgrades. The STERRAD™ Systems with ALLClear™ Technology consist of rectangular sterili-
zation chambers and external touchscreen monitors. The touchscreen has on-screen instructions that simplify the system opera-
tion, reducing the potential for operator error. Both the STERRAD™ 100NX System with ALLClear™ Technology and STERRAD NX™
System with ALLClear™ Technology easily integrate within the available facility space. Both STERRAD™ Systems have similar
hardware and software, with key features highlighted below.

Foot activated door

* As a precaution, when handling any part of the system or load items that have been exposed
tohydrogen peroxide, please wear the appropriate PPE (chemical-resistant latex, PVC/vinyl or
nitrilegloves). Refer to the glove manufacturer’s instructions for use for more information.
**15 minutes or 30 minutes to results dependent on software version. Refer to the IFU for actual
time to results.
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Table 1 Figure 1
Components & Features of the STERRAD Systems with ALLClear Technology
™ ™
Hydrogen Peroxide Gas Plasma Sterilization

STERRAD NX™ System with STERRAD™ 100NX System with

ALLClear™ Technology ALLClear™ Technology

Chamber 52 L total volume 152 L total volume

Single door option Single and double door option

8.4” diagonal touchscreen 12.1” diagonal touchscreen

Touchscreen
Projected capacitive touch resolution: 800 x 600 pixels
Allows user to select cycle
Alerts the user if system encounters a problem

Cassette Insertion Cassette insertion and removal is automatic and intuitive

Instrument Tracking System

An optional bar code scanner for reliable instrument tracking 1.2 STERRAD™ Systems Sterilization Procedure
Connectivity through ASP ACCESS™ Technology
Instruments must be cleaned, dried, reassembled, and wrapped in gas permeable packaging material prior to sterilization. The
Electronic data storage up to Electronic data storage up to system requires the use of nonwoven polypropylene wraps or Tyvek™ Pouches with STERRAD™ Chemical Indicator (CI) Strips and
50 cycles 200 cycles specially designed trays available from ASP™. Chemical indicator strips and chemical indicator tape are included in loads to confirm
exposure to hydrogen peroxide.
Data Recording
Internal printer for manual recordkeeping
Electronic cycle data and records via ASP ACCESS® Technology. Once instruments are ready, operators can use the touchscreen monitor to select one of the sterilization cycles (Section 1.3) or scan
USB port allows for data upload and download a STERRAD VELOCITY™ Biological Indicator / Process Challenge Device (BI/PCD) to begin.

Additional Features Portable Foot activated door allows for The STERRAD™ System Sterilization Process consists of a sterilization phase that is repeated twice for maximum sterility assuran-
Can be placed on cart hands-free operation ce.

1. The ALLClear™ Technology process is an optional feature that runs before advancing to the sterilization cycle. It includes three
steps that are completed in parallel: load check, load conditioning, and system check. The ALLClear™ Technology process takes
1.1 STERRAD™ Systems Sterilization Process approximately 5 minutes to complete for a typical load, and it helps to ensure a successful sterilization cycle.
2. Next, the sterilization cycle begins. Aqueous hydrogen peroxide is delivered to the
The STERRAD™ 100NX System with ALLClear™ Technology and STERRAD NX™ System with ALLClear™ Technology involve the
vaporizer/condenser.
combined use of hydrogen peroxide and low-temperature gas plasma to safely and rapidly sterilize medical devices and materials.
3. Chamber pressure is reduced. In the STERRAD NX™ System with ALLClear™ Technology STANDARD and ADVANCED cycles, as
well as the STERRAD™ 100NX System with ALLClear™ Technology STANDARD and FLEX cycles, water is removed from the peroxi-
Hydrogen peroxide is an oxidizing agent that effects sterilization by oxidation of microorganisms’ key cellular components. Hydrogen
de solution to concentrate it. This does not occur in the STERRAD™ 100NX System with ALLClear™ Technology EXPRESS and
peroxide is a bactericidal, virucidal, sporicidal, and fungicidal agent, even at low concentration and temperature. Gas plasmas are
DUO cycles.
highly ionized gases, composed of ions, electrons, and neutral particles that produce a visible glow.
4. Chamber pressure is further reduced, after which the hydrogen peroxide solution is vaporized to the gas phase and transferred
to the sterilization chamber.
A solution of hydrogen peroxide and water (59% nominal hydrogen peroxide by weight) is delivered to the sterilizer. In the STERRAD
5. Hydrogen peroxide diffuses throughout the chamber, surrounds the items in the load, and initiates the inactivation of microorga-
NX™ System with ALLClear™ Technology STANDARD and ADVANCED cycles, as well as the STERRAD™ 100NX System with ALLClear
nisms.
™ Technology STANDARD and FLEX cycles, the hydrogen peroxide is further concentrated. This does not occur in the STERRAD™
6. Low-temperature gas plasma is generated by applying energy to create an electric field.
100NX System with ALLClear™ Technology EXPRESS and DUO cycles. The hydrogen peroxide solution is then vaporized into a gas and
7. Plasma causes the hydrogen peroxide vapor to break apart into reactive species known as free radicals.
transferred to the chamber, where it surrounds the devices and creates a biocidal environment that inactivates microorganisms with
8. Plasma power is then terminated, which causes the free radicals to lose their high energy and recombine as oxygen and water
chemical interactions. Applying a strong electrical field then creates hydrogen peroxide gas plasma. The plasma is a “cloud” of highly
vapor.
energized species. Once the electrical field is turned off the energized species recombine,
9. Steps 2 – 8 consist of one half cycle. They are repeated for the second half cycle, and then the cycle is complete.
turning the hydrogen peroxide into water and oxygen.1
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Once the cycle is complete, the plasma power is turned off and HEPA-filtered air is introduced to bring the chamber back to atmos- 1.4 STERRAD™ Systems with ALLClear™ Technology Process Control and Monitoring Feature
pheric pressure. When the load is removed, the accompanying STERRAD VELOCITY™ Biological Indicator / Process Challenge Device
Process Parameter Monitoring The STERRAD™ Systems are controlled by a microprocessor. All critical process parameters are
(BI/PCD) can be activated and incubated in the STERRAD VELOCITY™ Reader at 57±2°C for 15-minute rapid readout detection of any
monitored during the operation of the sterilizer. The STERRAD™ Systems feature a control system with a fully integrated hydrogen
surviving spores.*
peroxide monitor as STANDARD equipment for direct measurement of the chamber sterilant concentration. The hydrogen peroxide
monitor provides data to the process controller. The process controller uses this data, and information on acceptable cycle limits
1.3 STERRAD™ Systems Cycles determined by statistical analysis of microbiological efficacy testing, to make decisions regarding the acceptability of each cycle and
ensure a minimum sterility assurance level (SAL) of 10-6.
The STERRAD NX™ System with ALLClear™ Technology STANDARD and ADVANCED cycles, as well as the STERRAD™ 100NX System
with ALLClear™ Technology STANDARD and FLEX cycles, have a vaporization system that concentrates the hydrogen peroxide
ASP ACCESS™ Technology ASP ACCESS™ Technology allows the STERRAD™ Systems to connect with other ASP™ products for
solution before it is transferred to the sterilization chamber. This feature reduces cycle times and allows for processing of longer
better workflow efficiency, process control and audit readiness. The connectivity (1) enhances traceability of Biological Indicators,
lumened devices. The STERRAD™ 100NX System with ALLClear™ Technology EXPRESS and DUO cycles do not further concentrate
(2) simplifies documentation by keeping STERRAD™ System cycle records in a digital repository, and (3) automatically reconciles
the 59% hydrogen peroxide solution delivered from the STERRAD™ System cassettes.
STERRAD™ System records to Biological Indicator result record. The system also provides statistics, updates, and performance data
for users to assess productivity. ASP ACCESS™ Technology allows staff to monitor data via network computer or receive alerts via
The STERRAD NX™ System with ALLClear™ Technology has two cycles: STANDARD and ADVANCED.
email and text message through its secured, redundant application cloud. ASP ACCESS™ Technology stores data for up to a year in
An overview of the two cycles and their processing abilities is in the table below.
its cloud and can transmit STERRAD™ Systems reprocessing data to a hospital’s network server and instrument tracking systems
(ITS).
Table 2
STERRAD NX™ System with ALLClear™ Technology Cycles

Cycle Time Sterilization

- Most surgical instruments

STANDARD 28 minutes
- PE/PTFE tubing

- Single-channel rigid endoscopes

ADVANCED 38 minutes

The STERRAD™ 100NX System with ALLClear™ Technology has four cycles: STANDARD, EXPRESS, FLEX, and DUO. An overview of the
cycles and their processing abilities is in the table below.

Table 3
STERRAD™ 100NX System with ALLClear™ Technology System Cycles

Cycle Time Sterilization

STANDARD 47 minutes - Most surgical instruments

For fast turnaround of:

- da Vinci® 3-D endoscopes
EXPRESS 24 minutes - Rigid telescopes
- Rechargeable batteries
- Many other instruments

Printer A record of the process parameters can be printed on demand through the ASP ACCESS™ Web Application at the end of each
FLEX 42 minutes cycle. If the sterilization cycle was canceled, the printed record for the cycle will state the reason for the cancelation.

Instrument Tracking Systems (ITS) The STERRAD™ Systems have an optional bar code scanner for reliable instrument tracking, as
DUO 60 minutes
- Non-lumened endoscopes well as an option to record the load description in the printout and data file.

Independent Monitoring System (IMS) An optional IMS is also available. The IMS provides additional sensors to monitor temperatu-
re, pressure, and plasma power to provide independent confirmation that process specifications were achieved. The IMS system
supports compliance with
ANSI/AAMI/ISO 14937.**
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1.5 ALLClear™ Technology

ALLClear™ Technology is a pre-cycle process that includes a load check, system check, and load conditioning in 5 minutes or less The UV Lamp Assembly provides a stable UV light source for the Hydrogen Peroxide Monitor.
for typical loads. It removes excess moisture and trapped gas and warms the instrument loads. When the system is unable to A reliable light source results in accurate measurements. The UV source stability depends on multiple factors, including tempe-
self-correct, customers are informed prior to beginning the sterilization cycle and provided details about the error. Both the STER- rature. To control the temperature of the lamp, the UV lamp housing material is made from an insulating material. An insulation
RAD NX™ System with ALLClear™ Technology and the STERRAD™ 100NX System with ALLClear™ Technology have improved proces- cover provides further thermal insulation. Both the housing material and insulation cover limit the lamp’s exposure to environ-
sing efficiency compared to the STERRAD NX™ System and STERRAD™ 100NX System. The STER-RAD NX™ System with ALLClear™ mental temperature effects and increase the temperature stability.
Technology has greater than a 75% reduction in cancelled cycles com-pared to the STERRAD NX™ System. Likewise, the STERRAD™
100NX System with ALLClear™ Technology has greater than a 62% reduction in cancelled cycles compared to the STERRAD™ 100NX
System.
1.6 Biological Monitoring with the STERRAD VELOCITY™ System
1.5.1 ALLClear™ Technology Process The STERRAD VELOCITY™ Biological Indicator / Process Challenge Device (BI/PCD) can be used with both STERRAD™ Systems with
The Load Check, System Check and Load Conditioning features work in parallel to automatically diagnose and correct issues ALLClear™ Technology. STERRAD VELOCITY™ BI/PCD uses G. stearothermophilus spores, which are the same species used to
prior to starting a sterilization cycle. These features form the core of the ALLClear™ Technology’s upgraded reliability and validate the STERRAD™ Systems to an SAL of 10-6 (Section 3.1). The STERRAD VELOCITY™ BI/PCD is comprised of a capped plastic
usability. vial that has the following components: (1) an inoculated glass fiber disc at the bottom of the vial with at least 106 G. stearothermo-
philus spores; (2) a Tyvek™ liner at the open end to act as a hydrogen peroxide permeable microbial barrier. The STERRAD
The Load Check detects issues with outgassing in the sterilization load, and assesses whether these issues can be corrected or VELOCITY™ BI/PCD also have a Class 1 chemical indicator disc on the cap that change color from red/pink to yellow after exposure to
if the load must be reworked. It also checks for residual moisture in the load, that the hydrogen peroxide monitor is not blocked, hydrogen peroxide. The chemical indicator disc on top of the biological indicator indicates that hydrogen peroxide has been introdu-
and that nothing is touching the electrode. During the Load Check, the chamber pressure is reduced and an algorithm monitors ced into the sterilization chamber. The STERRAD VELOCITY™ BI/PCD is compatible with the STERRAD VELOCITY™ Reader, which has
the chamber pressure pump curve and time to identify any irregularities. The system attempts to auto-correct the load by an easy-to-use touchscreen interface. It takes 15 minutes to read the results*.
removing gases or residual moisture. If correction fails, the system will abort the process before beginning the sterilization
cycle and alert the user of the error via the graphical user interface (GUI).

The System Check checks the sterilizer for issues with subsystems that could contribute to sterilization cycle cancellations. 02 Ecosystem
General systems such as the vacuum subsystem, Low Frequency Power Supply (LFPS) power/ circuit, valve operations, and air
flow through the vent filter are tested. As chamber pressure is lowered, the hydrogen peroxide monitor signal is checked to The STERRAD™ Systems with ALLClear™ Technology are designed to work seamlessly with other ASP™ products to create an
ensure it is within the expected range. The plasma subsystem is also verified to ensure it is operating within specifications and integrative sterilization experience. Automatic communication, data collection, and record-keeping between the STERRAD™
that its ignition is successful and stable. System, STERRAD VELOCITY™ Reader, ASP ACCESS™ Technology, instrument tracking system, and hospital network enhances
compliance. The user is notified after an incomplete cycle via the STERRAD™ Systems with ALLClear™ Technology touchscreen as
The Load Conditioning works to correct load issues identified during the Load Check. A plasma is generated to warm surfaces well as through other monitoring devices via the ASP ACCESS™ Technology.
inside the chamber, and then chamber pressure is decreased to remove gases from the load. The chamber is then vented to
atmospheric pressure to allow air molecules to transfer energy from warm surfaces inside the chamber to the load. This
process is repeated up to two times until the load is successfully conditioned or until the system determines the issue cannot 2.1 Compliance
be corrected and the process is aborted.
The STERRAD™ Systems with ALLClear™ Technology incorporate multiple features to automatically enhance compliance. It features
a touch screen graphical user interface that includes on-screen notifications including automatic BI reminders, a graphic display
that indicates proper load placement for the selected cycle, and cycle information screens describing the types of devices that can
1.5.2 ALLClear™ Technology System Hardware Features be processed in each cycle. Automatic communication of information between the STERRAD™ System, ASP ACCESS™ Technology,
The Cassette Insertion system provides hydrogen peroxide to the STERRAD™ System during each cycle. After the user inserts STERRAD VELOCITY™ System, and an instrument tracking system or hospital network enhances compliance through BI usage remin-
the cassette, the system accepts and automatically pulls in the cassette only if it is correctly positioned. This ensures that ders, automatic and immediate reconciliation of sterilizer cycle and BI results, and automated record keeping.
hydrogen peroxide is correctly dispensed throughout the sterilization cycle. The system also has a hands-free cassette dispo-
sal container, which was designed to enhance operator safety.

The Display Assembly Subsystem has an in-plane switching LCD with a wide viewing angle. It includes a Projected Capacitance
Touch Sensor (PCAP) and a LCD scaler board with an on-screen display board. The subsystem can be operated with a finger,
even when the user is wearing gloves, or with a conductive stylus.
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ITS
03 Testing and Validation
A sterilization process must inactivate a broad spectrum of microorganisms, including resistant bacterial spores. Previous studies
conducted with the STERRAD™ 100 Sterilizer, which also uses hydrogen peroxide gas plasma technology, have demonstrated its
INSTRUMENT sterilization ability. These studies were conducted against vegetative bacteria (including mycobacteria), bacterial spores, yeasts,
TRACKING HOSPITAL
SYSTEMS NETWORK fungi, and viruses. The selection criteria for each organism and the test results are presented in Table 4 below. All the organisms
shown in Table 4 were inactivated by an abbreviated STERRAD™ System cycle.

The two viruses tested, Poliovirus Type 1 and Herpesvirus Type 1 represent the major classes of viruses, hydrophilic and lipophilic,
respectively. The hydrophilic group normally exhibits a greater resistance to chemical sterilants than the lipophilic group. The log10
virus titers of 3.98, 3.20, and 2.84 represent the minimum concentration of viruses in these tests. Due to the nature of the virucidal
test, a minimum virus concentration is determined but the actual concentration is not. In all virucidal tests, there was no infectivity
after exposure to the abbreviated STERRAD™ System cycle. This shows that the STERRAD™ Systems are capable of inactivating both
hydrophilic and lipophilic viruses.

Table 4
Spectrum of Activity – Vegetative Bacterial, Spores, and Fungi

Microorganism Type Interest in Testing Control* Results†

Geobacillus H2O2 Resistance;

stearothermophilis Bacterial spore 2.04x 106 0/9
Steam Indicator Organism

Bacillus atrophaeus H2O2 Resistance;

Bacterial spore 2.69x 106 0/9
EtO Indicator Organism

Bacillus pumilus Ionizing Radiation Resistance;

Bacterial spore 1.82x 106 0/9
Indicator Organism

Staphylococcus aureus Gram Positive H2O2 2.82x 106 0/9

Deinococcus radiodurans Gram Positive Ionizing Radiation Resistance 3.10x 106 0/9

Pseudomonas aeruginosa Gram Negative 1.32x 106 0/9

Escherichia coli Gram Negative 9.23x 105 0/9

Serratia marcescens Gram Negative H2O2 1.85x 106 0/9

Moroxelia osloensis Gram Negative Ionizing Radiation Resistance 3.14x 106 0/9

Mycobacterium bovis Chemical Resistance;

Acid Fast 4.20x 106 0/9
Clinical Resistance

Candida albicans Yeast H2O2 Resistance 3.95x 106 0/9

Candida parapsilosis Yeast H2O2 1.07x 106 0/9

Trichophyton Filamentous
mentagrophytes 1.25x 106 0/9
Fungus

Aspergillus brasiliensis Filamentous

H2O2 1.46x 106 0/9
Fungus

* Average titer recovered from nine samples

† # Positive/ # Tested
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Microorganism Type Interest in Testing Virus Titer log 10 Infectivity Microorganism # Positive/ # Tested§

Bacteroides fragilis 0/10

Poliovirus Type 1 Chemical
Hydrophilic Test 1 ≥ 3.98 Not detected
(Brunhilde) Resistance; Fusobacterium sp. 0/10
(non-enveloped) Test 2 ≥ 3.98 Not detected
Anaerobic cocci 0/10
Herpesvirus Lipophilic Test 1 ≥ 3.20 Not detected
Type 1 (enveloped) Test 2 ≥ 2.84 Not detected Candida albicans 0/10

Additional sterilization tests for the STERRAD™ Sterilizer were conducted with hospital pathogens.
In one study, clinical isolates of a wide variety of clinically significant organisms were processed in an abbreviated STERRAD™ Based on the spectrum of activity studies, G. stearothermophilus spores have been determined to be the most resistant to the
System cycle consisting of 40 minutes of diffusion with 3 mg/liter of hydrogen peroxide and 10 minutes of plasma at a power of 300 process. Therefore, the tests conducted to validate the efficacy of the STERRAD NX™ System and the STERRAD™ 100NX System
watts. In these tests, conducted in a hospital, approximately 2.5x106 organisms in a serum solution were inoculated onto a paper were all conducted with this organism.
strip and sealed in Tyvek™ /PET/PE film pouches. One-half the samples were in 5% serum and one-half were in 10% serum. The The efficacy of the STERRAD™ Systems was established by demonstrating the ability of the system to:
results of these tests, which are presented in Table 5, show that total kill was obtained with all clinical isolates tested. (1) provide an SAL of 10-6 with G. stearothermophilus spores using established validation methods,
(2) sterilize devices with long, narrow lumens, (3) kill over 106 G. stearothermophilus spores on a mated surface, (4) sterilize flexible
endoscopes, and (5) pass the AOAC Sporicidal test.
Table 5
Clinical Isolates Tested in an Abbreviated STERRAD™ System Cycle‡
3.1 Validation of 10-6 SAL
Microorganism # Positive/ # Tested§

Pseudomonas aeruginosa 0/10 Two well recognized references detail requirements and methods for validation of sterilization processes:
Burkholderia cepacia 0/10 1) AAMI TIR No. 12-2010 Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide
for medical device manufacturers2
Xanthomonas maltophilia 0/10 2) ANSI/AAMI/ISO 14937:2009, Sterilization of health care products -- General requirements for characterization of a sterilizing
Serratia marcescens 0/10 agent and the development, validation and routine control of a sterilization process for medical devices3
Klebsiella (encapsulated) 0/10
These test methods must demonstrate at least a 10-6 SAL for the sterilization process. Since sterilization is a probability function, a
Methicillin-resistant Staphylococcus aureus 0/10 minimum SAL of 10-6 means that the probability of having a nonsterile device after completing the sterilization process is less than
Slime-producing Staphylococcus epidermidis 0/10 one in one million. This is the commonly accepted threshold for a sterilized device.

Listeria monocytogenes 0/10

A reproducible biological monitor is needed to demonstrate 10-6 SAL. The organism used in the biological challenge should represent
Enterococcus faecalis 0/10 a widely recognized test microorganism that is appropriate for the sterilization process.2,4 The AAMI guidelines recommend that G.
Acinetobacter calcoaceticus stearothermophilus be used at a population of 103 to 106 per carrier, and a biological challenge of at least 106 G. stearothermophilus
0/10
spores were used for all STERRAD NX™ System and STERRAD™ 100NX System validation tests.2, 4
Salmonella sp. 0/10
Shigella sp. 0/10 Spore suspension and carrier preparation are critical to having a consistent biological challenge. An unsuccessful inoculation of
spores on surfaces can produce a high concentration of spores in a small area, known as clumping and occlusion. Causes of occlu-
Campylobacter sp. 0/10
sion include using nonwetting hydrophobic materials, inoculations on cracked or irregular surfaces, or the organic or inorganic
Aeromonas sp. 0/10 debris in spore suspensions. Occlusion of spores extends spore survival during the sterilization process. Since the degree of occlu-
Clostridium perfringens 0/10 sion is not reproducible, a consistent endpoint will not be obtained for the characterization of a sterilization process. For consistent
biological test results, relatively clean suspensions of spores need to be uniformly deposited on appropriate substrates. A biological
Clostridium tetani 0/10 indicator (BI) must meet these criteria for acceptable validation of a sterilization process.
Clostridium difficile 0/10
One of the most commonly used methods of sterilizer validation is the half-cycle overkill method.
Bacillus subtilis spores 0/10
This method divides the sterilization process into two half cycles. In the first half cycle, linear semilogarithmic kill kinetics are
Micrococcus sp. 0/10 demonstrated for a total of a 6 log reduction. An idealized “kill curve,” which is the inactivation kinetics of spores on a carrier, is
Mycobacterium tuberculosis 0/10 shown in Figure 2.4
This method requires an understanding that the same kill kinetics occur during the second half cycle. Extrapolating the first half
Mycobacterium chelonei 0/10
cycle inactivation to the second half cycle provides an additional 6 log reduction, for a total of 10-6 SAL for the full cycle.

‡
Clinical Isolates tested in an abbreviated STERRAD™ System Cycle. Abbreviated cycle consisted
of 40 minutes of diffusion with 3 mg/ liter of hydrogen peroxide and 10 minutes of plasma at a
power of 300 watts. § Five tests were conducted in the presence of 5% serum and five tests were
conducted in the presence of 10% serum. The third-party trademarks used herein are the proper-
ties of their respective owners.
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Figure 2 3.2 STERRAD™ Systems with ALLClear™ Technology Claims

Graphic presentation of half-cycle method of sterilization
The STERRAD™ 100NX System with ALLClear™ Technology and the STERRAD NX™ System with ALLClear™ Technology are designed
for sterilizing both metal and nonmetal medical devices at low temperatures. Because the cycle operates within a dry environment
and at low temperatures it is especially suitable for heat and moisture sensitive instruments. The STERRAD™ Systems can also
sterilize instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors, as well as lumened
flexible endoscopes. The addition of the ALLClear™ Technology does not affect the function of the Biological Indicators and Chemical
Indicators.

To test any effect on residual levels, the STERRAD™ Systems were tested with polyurethane, nylon/polyamide, and polyacetal/Del-
rin® , the three plastic/thermoplastic materials known to be the worst-case for hydrogen peroxide absorption. The STERRAD NX™
System was tested using the ADVANCED sterilization cycle and the STERRAD™ 100NX System was tested using the STANDARD steri-
lization cycle. Tests were performed with worst-case parameters, and both STERRAD™ Systems were tested with and without the
ALLClear™ Technology process.

The residual test results determined that each material’s mean hydrogen peroxide residual level was statistically significantly less
(p< 0.05) than the threshold level of 9100 µg/cm.2 The test results also showed that the average residual levels of all materials were
less with the ALLClear™ Technology process compared to without the ALLClear™ Technology process.

Since the STERRAD™ Systems have multiple stages, the demonstration of straight-line, time-based semilogarithmic microbial
3.3 Validation Testing with Lumen Devices
destruction kinetics is difficult. For this reason, the validation of the STERRAD™ 100NX System and STERRAD NX™ System double Spore population reduction was measured as a function of time and peroxide concentration. Testing was conducted using the plate
injection system was conducted with a variation of the half-cycle method. With this method, the sterilization process has two conse- count (enumeration) method as well as the fraction-negative method (sterility test).
cutive, identical phases. The first phase demonstrates a six log reduction of the resistant bacterial spore. Since the second injection
cycle has identical process parameters to the first, an additional six log reduction is obtained at the end of the second phase, and the
total process provides a 12 log spore reduction or 10-6 SAL. The graphical representation of the two-phase method can be seen in 3.3.1 ALLClear™ Technology with Lumen Devices
Figure 3 below.4
The chart below lists the medical devices each STERRAD NX™ System with ALLClear™ Technology cycle can process.

Figure 3
Table 6
Graphic presentation of the two-phase cycle
STERRAD NX™ System with ALLClear™ Technology Lumen Claims

Type of Cycle Lumen claims

Single channel stainless steel lumens with:

- Inside diameter ≥ 1 mm and length ≤ 150 mm
STANDARD - Inside diameter ≥ 2 mm and length ≤ 400 mm
Single channel PE/PTFE tubing with:
- Inside diameter ≥ 1 mm and length ≤ 350 mm

Single channel stainless steel lumens with:

- Inside diameter ≥ 1 mm and length ≤ 500 mm
ADVANCED Single PTFE lumen tubing with:
- Inside diameter ≥ 1 mm and length ≤ 1000 mm

- Inside diameter ≥ 1 mm and length ≤ 850 mm

The third-party trademarks used herein are the properties of their respective owners.
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The worst-case devices were identified as the 1 mm X 350 mm Teflon™ (PTFE) lumens for the STANDARD cycle and the 1 mm X 500 Table 8
mm stainless steel lumens for the ADVANCED cycle. A 10-6 SAL for these worst-case lumens was demonstrated by placing inocula- Half-Cycle Validation Test with G. stearothermophilus Spores on Stainless Steel Carrier in 1 mm by 500
ted carriers containing at least 106 G. stearothermophilus spores at the midpoint. The lumens with spore carriers are called biologi- mm Stainless Steel Lumens in a Standardized Validation Load with Reduced Concentrations of Hydrogen
cal test units. Peroxide.
The test procedure was as follows: ten biological test units were placed in a standardized hospital tray containing medical devices.
STERRAD NX™ System ADVANCED Cycle
Each tray was double wrapped with Halyard™ H400 Sterilization Wrap and placed in the STERRAD NX™ System. The biological test
units were exposed to the STERRAD NX™ System half-cycle process at reduced concentrations of hydrogen peroxide. After exposu- ml of H2O2 Enumeration Test Biological Results
re, the carriers were enumerated or placed in broth media, as appropriate. Enumeration plates were incubated 48 hours at 55 - 60°C Half-Cycle Number
Injected 53% Spore Log Reduction # nonsterile / # tested
and then the plates counted. Sterility test samples were transferred to Tryptic soy broth, incubated for 21 days at 55 - 60°C, and
scored for growth (positive) or no growth (negative). 1 0.19 0.82 -
The results of these tests, which are presented in Table 7 and Table 8, demonstrate that the microbial kill depends on the concentra-
2 0.28 1.49 -
tion of hydrogen peroxide injected into the chamber and that no spores survived the nominal first half-cycle process conditions,
respectively. Surviving organisms were only found when the amount of hydrogen peroxide in the half cycle test was about fifty 3 0.37 - 10/10
percent (50%) or less of the nomInal hydrogen peroxide concentration. Since at least a 6 log reduction was obtained at the end of the
first half cycle, and the second half cycle is identical to the first, the total STERRAD NX™ System Sterilization process provides a 10-6 4 0.75 - 0/10
SAL.
5 0.94 - 0/10

6 1.12 - 0/10
Table 7 7 1.31 - 0/10
Half-Cycle Validation Test with G. stearothermophilus Spores on Stainless Steel Carrier in 1 mm by 350
mm Teflon™ (PTFE) Lumens in a Standardized Validation Load with Reduced Concentrations of Hydrogen 8 1.50 - 0/10
Peroxide.
STERRAD NX™ System STANDARD Cycle

3.3.2 STERRAD™ 100NX System with ALLClear™ Technology

ml of H2O2 Enumeration Test Biological Results with Lumen Devices
Half-Cycle Number
Injected 53% Spore Log Reduction # nonsterile / # tested The chart below lists the medical devices each STERRAD™ 100NX System with ALLClear™ Technology
cycle can process.
1 0.19 1.40 -

2 0.28 3.15 - Table 9

3 0.37 - 2/10 STERRAD™ 1000NX System with ALLClear™ Technology Lumen Claims

4 0.75 - 0/10 Type of Cycle Lumen claims

5 0.94 - 0/10
Single channel stainless steel lumens with:
6 1.12 - 0/10 - Inside diameter ≥ 0.7 mm and length ≤ 500 mm
STANDARD
Single channel PE/PTFE instruments with:
7 1.31 - 0/10 - Inside diameter ≥ 1 mm and length ≤ 1000 mm

8 1.50 - 0/10
FLEX
- Inside diameter ≥ 1 mm and length ≤ 850 mm

DUO - Inside diameter ≥ 1 mm and length ≤ 875 mm

EXPRESS Non-lumened sterilization only

The third-party trademarks used herein are the properties of their respective owners.
STERRAD™ 1OONX and STERRAD NX™

TECHNICAL WHITE PAPER

The STANDARD cycle worst-cases were identified as a 0.7 mm X 500 mm stainless steel lumen and a 1 Table 11
mm x 1000 mm stainless steel lumen. A 10-6 SAL for these worst-case lumens was demonstrat-ed by Half-Cycle Validation Test with G. stearothermophilus Spores on Stainless Steel Carriers in
placing inoculated carriers containing at least 106 G. stearothermophilus spores at the lumen midpoint. 1 mm X 1000 mm Polyethylene and Teflon™ Tubing with Reduced Concentrations of Hydrogen Peroxide.
The lumens with spore carriers are called biological test units.
STERRAD™ 100NX System STANDARD Cycle
A similar test procedure to the STERRAD NX™ System lumen validation procedure was performed, with
ten biological test units for each worst-case scenario. The results of these tests, which are presented in
ml of H2O2 Biological Results
the tables below, demonstrate that the microbial kill obtained is dependent on the concentration of Half-Cycle Number
Injected 53% # nonsterile / # tested
hydrogen peroxide injected into the chamber and that no spores survived the nominal first half-cycle
process conditions. Surviving organisms were only found when the amount of hydrogen peroxide in the 1 0.93 0/10
half cycle test was about fifty percent or less of the hydrogen peroxide concentration. Since the first half
2 1.23 0/10
cycle achieved a six log spore reduction, and the second half cycle is identical to the first, the total
STERRAD™ 100NX Sterilization process provides an SAL of 10-6 for the worst-case scenario. 3 2.45 0/10

4 3.10 0/10

5 3.68 0/10

6 4.26 0/10

7 4.9 0/20
Table 10
Half-Cycle Validation Test with G. stearothermophilus Spores on Stainless Steel Carriers in 0.7 mm X 500
mm Stainless Steel Lumens in a Standardized Validation Load with Reduced Concentrations of Hydrogen
3.4 Validation Tests with Mated Surfaces
Peroxide.
STERRAD™ 100NX System STANDARD Cycle The STERRAD™ Systems’ ability to sterilize mated surfaces to an SAL of 10-6 was demonstrated by exposing double-wrapped trays
containing the mated surfaces and a standardized load of medical devices to half cycle conditions. The mated surface biological
challenge consisted of two material samples inoculated with 106 G. stearothermophilus spores sandwiched between them. Stain-
ml of H2O2 Enumeration Test Biological Results less steel, titanium, and the polymers Ultem®, Delrin® , and Radel® , have been validated.
Half-Cycle Number
Injected 53% Spore Log Reduction # nonsterile / # tested

1 0.62 1.39 - 3.4.1 STERRAD NX™ System Mated Surfaces

2 0.93 3.94 - The STERRAD NX™ System was validated for mated surfaces in the STANDARD cycle since the ADVANCED cycle has more lethal
conditions. G. stearothermophilus spores were inoculated between two identical mated material samples. One tray was used
3 1.23 - 5/10 per test and the test results are presented in Table 12 below. All samples exposed to one half STANDARD cycle showed no
growth after incubating for 21 days at 55 - 60°C in tryptic soy broth, while all positive control samples consisting of the unpro-
4 2.45 - 0/10
cessed mated surface biological challenge were positive. The results demonstrate an SAL of 10-6 with mated surfaces for the
5 3.10 - 0/10 complete STERRAD NX™ System Process.

6 3.68 - 0/10

7 4.26 - 0/10 Table 12

G. stearothermophilus Spores between Mated Surfaces in a Standardized Validation Load at Half-Cycle
8 4.90 - 0/10 Conditions

Test 1 Test 2 Test 3

Material
#Positive/#Tested #Positive/#Tested #Positive/#Tested

Stainless Steel Blades 0/4 0/4 0/4

Titanium 0/4 0/4 0/4

Polyacetal (Delrin®) 0/4 0/4 0/4

Polyetherimide (Ultem®) 0/4 0/4 0/4

The third-party trademarks used herein are the properties of their respective owners.
Polyarylsulfone (Radel®) 0/4 0/4 0/4
 STERRAD™ 1OONX and STERRAD NX™

TECHNICAL WHITE PAPER

3.4.2 STERRAD™ 100NX System Mated Surfaces 3.5.1 STERRAD NX™ System with ALLClear™ Technology Flexible Endoscopes
The STERRAD™ 100NX System was validated for mated surfaces for both the STANDARD and EXPRESS cycles. G. stearother- The following table shows flexible endoscope claims for the STERRAD NX™ System with ALLClear™ Technology.
mophilus spores were sandwiched between the two identical mated surfaces, and two trays were used per test.
Table 15
The results of the STANDARD half-cycle tests are presented in Table 13. All samples exposed to the STANDARD half-cycle STERRAD NX™ System with ALLClear™ Technology Flexible Endoscope Claims
showed no growth after incubating for 21 days at 55 - 60°C in tryptic soy broth, while all positive control samples consisting of
the unprocessed mated surface biological challenge were positive. The results demonstrate the ability of the full STERRAD™ Type of Cycle Lumen claims
100NX System STANDARD cycle, consisting of two consecutive half cycles, to provide an SAL of 10-6 with mated surfaces of
these materials.
ADVANCED
- Inside diameter ≥ 1 mm and length ≤ 850 mm
Table 13
G. stearothermophilus Spores between Mated Surfaces in a Standardized Validation Load at Half-Cycle
Conditions Instruments such as choledochoscopes, bronchovideoscopes or ureterorenofiberscopes were processed
as individual loads under ADVANCED half-cycle conditions, each with at least 106 G. stearothermophilus
Test 1 Test 2 Test 3 spores. A BI was inserted and positioned at the center of the channel of each device. The load, a tray with
Material
#Positive/#Tested #Positive/#Tested #Positive/#Tested one device, was processed through an ADVANCED half-cycle with reduced hydrogen peroxide concentra-
tion. The results of these tests, presented in Table
Stainless Steel Blades 0/10 0/10 0/10
16 below, demonstrated sterility of all BIs throughout the 21-day, 55 - 60°C incubation period. This
Titanium 0/10 0/10 0/10 confirms a SAL of 10-6 was achieved in the devices when processed through the STERRAD NX™ System
ADVANCED sterilization cycle.
Polyacetal (Delrin®) 0/10 0/10 0/10
Table 16
Polyetherimide (Ultem®) 0/10 0/10 0/10
Half-Cycle Validation Test with G. stearothermophilus Spores on Stainless Steel Carrier in 1 mm by 850
Polyarylsulfone (Radel®) 0/10 0/10 0/10 mm. Flexible Endoscope with Reduced Concentrations of Hydrogen Peroxide.
STERRAD NX™ System ADVANCED Cycle
The STERRAD™ 100NX System EXPRESS cycle was also validated for mated surfaces. Sterilization was
achieved at half-cycle with 4.9 ml injection of 53% hydrogen peroxide, which is equivalent to the worst- Cycle # Biological Results: # nonsterile / # tested
-case delivery of hydrogen peroxide at the end of the shelf life. The positive controls showed growth and (per
device) Choledochoscope Bronchovideoscope Ureterorenofiberscope
the negative controls showed no growth, meeting the acceptance criteria.

1 0/1 0/1 0/1

Table 14
Verification Test BI Results of Mated Surface Materials 2 0/1 0/1 0/1

3 0/1 0/1 0/1

Biological Results
Materials Injection Volume of 53% H202 (ml)
# Non-sterile / # Tested

Mated Titanium 4.9 0 / 30 3.5.2 STERRAD™ 100NX System with ALLClear™ Technology Flexible Endoscopes
Mated Stainless steel 4.9 0 / 30 The following table shows the flexible endoscope sterilization claims for the STERRAD™ 100NX System with ALLClear™ Tech-
nology .
This demonstrates that an SAL of 10-6 will be achieved in the STERRAD™ 100NX System EXPRESS full
cycle. Table 17
STERRAD™ 100NX System with ALLClear™ Technology Flexible Endoscope Claims
3.5 Validation Test with Flexible Endoscopes
The STERRAD™ Systems’ ability to sterilize flexible endoscopes to an SAL of 10-6 was demonstrated by exposing biological test units Type of Cycle Flexible Endoscope Claims
to half cycle conditions. The flexible endoscope biological challenge consisted 106 G. stearothermophilus spores placed at the
center of each device.
FLEX
- Inside diameter ≥ 1 mm and length ≤ 850 mm

The third-party trademarks used herein are the properties of their respective owners. DUO - Inside diameter ≥ 1 mm and length ≤ 875 mm
STERRAD™ 1OONX and STERRAD NX™

TECHNICAL WHITE PAPER

These claims represent instruments such as choledochoscopes, bronchovideoscopes, ureteroscopes, or 3.6 AOAC Sporicidal Test
ureterorenofiberscopes.
The AOAC Sporicidal Test is a test listed in the United States Food and Drug Administration (FDA) Guidance Document for the evalua-
The FLEX cycle worst-case is a 1 mm X 850 mm polyethylene or TeflonTM flexible endoscope lumen.
tion of sterilization systems. AOAC tests were conducted with
During FLEX testing, the devices were processed in half-cycle conditions with reduced hydrogen peroxi-
B. subtilis ATCC® 19659TM spores and Clostridium sporogenes ATCC® 3584TM spores on porcelain penicylinders and polyester
de concentration, each with at least 106 G. stearothermophilus spores. A BI was inserted to the center of
suture loops** according to Official Methods of Analysis 966.04 of the AOAC. The tests stipulate that large numbers of carriers,
the channel of each device. Each load consisted of two trays containing one device each. Sterility of all
contaminated with high numbers of spores of aerobic and anaerobic bacteria, must be sterilized without failure. These tests include
BI’s is demonstrated throughout the 21-day, 55-60°C incubation period. The results, presented in Table
a significant organic challenge due to the presence of dried, spent growth media with the spores. Additionally, the sterilizing agent
18, confirm a SAL of 10-6 when a 1mm x 850 mm flexible endoscope lumen is processed through the
must be able to penetrate small crevices to kill spores on the porous porcelain penicylinders and in the knotted portion of the polyes-
STERRAD™ 100NX System FLEX sterilization cycle.
ter suture loops.

Table 18
Half-Cycle Validation Test with G. stearothermophilus Spores on Stainless Steel Carriers in 1 mm X 850
mm Flexible Endoscope with Reduced Concentrations of Hydrogen Peroxide. 3.6.1 AOAC Sporicidal Test for STERRAD NX™ System with ALLClear™ Technology
STERRAD™ 100NX System FLEX Scope Cycle The study results show that, when exposed to a full STERRAD NX™ System STANDARD cycle, no growth was obtained in three
separate tests comprising a total of 720 carriers. The results are
Cycle # Biological Results: # nonsterile / # tested in Table 20 below. By passing the AOAC sporicidal test, the STERRAD NX™ System has met a fundamental FDA requirement for
(per sterilization systems and has demonstrated that it is capable of sterilizing large numbers of porous carriers inoculated with
device) Choledochoscope Ureteroscope Bronchovideoscope Ureterorenofiberscope
resistant aerobic and anaerobic spores in the presence of organic soil and inorganic salts. Testing was repeated for the STER-
1 0/1 0/1 0/2 0/1
RAD NX™ System ADVANCED Sterilization process with identical results.

2 0/1 0/1 0/2 0/1

3
0/1 0/1 0/2 0/1 Table 20
AOAC Sporicidal Test with STERRAD NX™ System STANDARD Cycle

Testing for the DUO half-cycle was performed using a 1 mm x 875 mm flexible endoscope with light cords. Test # Carrier # of Failures/# Tested
BIs made from stainless steel carriers were inoculated with at least 106 G. stearothermophilus spores
were placed in the mid-point position of the channel of the flexible endoscopes. The flexible endoscope B. subtilis C. sporogenes
load with BIs was processed in the STERRAD™ 100NX System with ALLClear™ Technology DUO half-cycle
with 1.42 mL of 53% hydrogen peroxide, equivalent to the worst-case delivery of hydrogen peroxide at the 1 0/60 0/60
Suture Porcelain
0/60 0/60
end of shelf life, with hydrogen peroxide transfer times equivalent to 10%, 25%, and 50% of total exposu-
re. Upon cycle completion, the processed samples were recovered by the direct culture method.
2 0/60 0/60
Suture Porcelain
0/60 0/60
Table 19
STERRAD™ 100NX System DUO Cycle 0/60 0/60
3 Suture Porcelain
0/60 0/60
Transfer Time Biological Results
Phase % of Transfer Time
(in Seconds) # Nonsterile / # Tested

Transfer 10 36 6/6
3.6.2 AOAC Sporicidal Test for STERRAD™ 100NX System
Transfer 25 90 5/6
The study results show that, when exposed to a full STERRAD™ 100NX System, no growth was obtained in three separate tests
comprising a total of 720 carriers. The results are in Table 21.
Transfer 50 180 0/6 By passing the AOAC sporicidal test, the STERRAD™ 100NX System has met a fundamental FDA requirement for sterilization
systems and has demonstrated that it is capable of sterilizing large numbers of porous carriers inoculated with resistant
Growth was observed at 10% and 25% of the transfer time. There were no survivors at half-cycle condi- aerobic and anaerobic spores in the presence of organic soil and inorganic salts. Testing was repeated for the FLEX, DUO, and
tion processed with 50% of the transfer time. The positive controls showed growth and the negative EXPRESS Sterilization cycles with identical results.
(media) controls showed no growth.

** Polyester suture loops have been recognized as a viable alternative carrier for an oxidizer sterilant by AOAC and FDA Office of Science and Techno-
The third-party trademarks used herein are the properties of their respective owners.
logy. Polyester suture loops are low hydrogen peroxide absorbers and are more suitable carriers for hydrogen peroxide concentrating technology.
 STERRAD™ 1OONX and STERRAD NX™

TECHNICAL WHITE PAPER

Table 21 Table 22
AOAC Sporicidal Test with STERRAD™ 100NX System STANDARD Cycle Representative Medical Devices Evaluated for Compatibility with the and STERRAD NX™ System

Test # Carrier # of Failures/# Tested Device Property Mesaured Total Cycles

B. subtilis C. sporogenes
Resectoscope Power Output 50

1 0/60 0/60
Suture Porcelain
0/60 0/60

Forceps Mechanical Properties 50

2 0/60 0/60
Suture Porcelain
0/60 0/60

0/60 0/60 Power Output Compared to Charge Taken 50

3 Suture Porcelain
0/60 0/60

Subjective Evaluation of Instrument

Microsurgical Instruments Appearance and Sharpness by Visual
50
Observation, and Mechanical Function
of Moving Parts
04 STERRAD™ Systems Safety
Fiberoptic Ureteroscope Optics, Mechanical Properties, Subjective
50
4.1 Effect of Sterilization Cycles on Medical Devices Evaluation of Instrument Appearance
Sterilization systems must not alter the functional properties of medical devices. Since the STERRAD™ Systems use a secondary
plasma, surface modification is minimized. Laboratory tests were conducted on many medical devices to quantify the effect of expo- Optics, Mechanical Properties, Subjective
Rigid hysteroscope 50
sure to repeated STERRAD NX™ System and STERRAD™ 100NX System Sterilization Cycles on the functional properties. Evaluation of Instrument Appearance

ASP™ has an extensive evaluation program and has worked with over 200 medical device manufacturers
to establish the material compatibility of their devices with the STERRAD™ System Sterilization Process.
4.1.1 Laboratory Functionality Tests
The online STERRAD™ Sterility Guide (www.sterradsterilityguide.com) has over 23,000 authorized device
Laboratory functionality tests were conducted on devices that represent a wide range of materials including metals, plastics, listings.
rubber, and optical surfaces, which must retain properties including sharpness, flexibility, optical clarity, and electrical Additionally, assessments documenting the material compatibility of these devices with the STERRAD™
discharge, after repeated sterilization. The list of devices evaluated is presented in Table 22. The table also describes the Systems are kept up to date. This program provides the STERRAD™ Systems user with the most complete
property measured and the total number of sterilization cycles to which the devices were exposed. material compatibility information possible and helps to ensure that future medical devices are compa-
tible with the STERRAD™ Systems.
In all tests, the devices were manipulated between sterilization cycles to simulate actual use of the product. The total number
of 50 cycles was chosen for devices that normally undergo repeated sterilization and use. If no adverse effect is seen in 50
cycles, it is unlikely that any effects would occur because of additional exposures. Functionality tests were conducted per the 4.2 Worker Safety
device manufacturer’s protocol, when available, or by a quantifiable test procedure developed by ASP™.
4.2.1 Exposure to Hydrogen Peroxide
After exposure to the specified number of STERRAD™ 100NX System or STERRAD NX™ System Sterilization cycles, all test The STERRAD™ Systems have been designed to prevent hospital personnel from contacting hydrogen peroxide in either the
devices passed the manufacturer’s functionality test and showed no statistically significant change in the measured functional liquid or vapor phase. The 59% nominal hydrogen peroxide solution required for the sterilization process is packaged in a sealed
property. These test results demonstrate that the functional properties of the test devices are not impaired by exposure to cassette. The patented cassette design contains a chemical leak indicator, visible through a clear plastic overwrap, that chan-
repeated STERRAD™ System Sterilization cycles. ges color should a leak occur. In the unlikely event of a leak, the overwrap further protects operators from exposure to any
hydrogen peroxide solution. Once the cassette has been inserted in the sterilizer, it is automatically ADVANCED by the machine,
eliminating any danger of exposure to liquid hydrogen peroxide through handling of the cassette. After several sterilization
cycles, the used cassette is automatically discarded into a collectionbox for disposal.
The sterilizer injects the hydrogen peroxide into the system where it is concentrated and vaporized.

The third-party trademarks used herein are the properties of their respective owners.
 STERRAD™ 1OONX and STERRAD NX™

TECHNICAL WHITE PAPER

By the end of the plasma phase, the hydrogen peroxide turns into water and oxygen. Additionally, during • Cytotoxicity: Cytotoxicity testing is valuable as a method to screen for biocompatibility of materials intended for use in medi-
the STERRAD™ System cycles all vapor removed from the chamber passes through a filter that is cal devices. Because cytotoxicity tests are so sensitive, some materials with a history of safe clinical use in medical devices can
specially designed to decompose hydrogen peroxide into nonhazardous water and oxygen. Monitoring of produce positive cytotoxic responses.
the area around the STERRAD™ Systems during operation has demonstrated that the concentration of
hydrogen peroxide in the atmosphere is less than the OSHA-established limit of 1.0 ppm (8 hour time • Medical devices and materials were tested by the extraction/minimal essential medium (MEM) elution tissue culture respon-
weighted average). The normal use of the STERRAD™ Systems, therefore, do not emit harmful, toxic se cytotoxicity method. In all these tests, the bioreactivity of devices and materials, after processing in the STERRAD™ 100
chemicals into the atmosphere. Sterilization System, was comparable to the bioreactivity of materials and devices before sterilization.

• Acute Systemic Toxicity: Acute systemic toxicity tests demonstrate the symptomatology and lethality caused by a substance.
4.2.2 Toxicity of Hydrogen Peroxide No toxic responses were seen in mice injected with extracts of materials sterilized in the STERRAD™ 100 Sterilization System.
Concentrated hydrogen peroxide liquid will irritate skin and, like other oxidants, can cause severe damage to eyes if direct
contact occurs. The safeguards built into the STERRAD™ Systems make any direct contact with hydrogen peroxide unlikely. In • Ocular Irritation: Ocular irritation tests are a sensitive means of identifying substances that can cause local surface irritation
the vapor phase, concentrated hydrogen peroxide is irritating to the eyes, nose, throat, and lungs. Generally, this irritation or mucosal irritation. Extracts of materials sterilized by the STERRAD™ 100 Sterilization System were non-irritating in this test.
subsides soon after exposure to the vapor ceases. Because hydrogen peroxide has a low vapor pressure, the concentration of
hydrogen peroxide vapor above a hydrogen peroxide solution at atmospheric conditions is very low and presents no special • Intracutaneous Test: The intracutaneous test is used to determine the irritant effect of any leachables present in extracts of
safety hazard. A significant concentration of hydrogen peroxide vapor occurs only at the reduced pressure conditions that exist test materials. No irritation was observed in rabbits injected intracutaneousl with extracts of materials sterilized in the STER-
inside the sterilization chamber during the STERRAD™ Systems cycle. This means that hydrogen peroxide vapor will not leak RAD® 100 Sterilization System.
out of the chamber under normal operating conditions.
• Blood Compatibility: Tests for hemolysis and complement activation were conducted to establish the compatibility of mate-
Hydrogen peroxide has been commonly used as a general disinfectant for many years. The widespread use of hydrogen peroxi- rials processed in the STERRAD™ Systems with blood. These tests are designed to detect the potential of materials to cause
de and extensive laboratory testing has shown that hydrogen peroxide is not mutagenic or carcinogenic. blood cells to lyse and to initiate certain inflammatory responses. Test results demonstrated that the STERRAD™ Systems do
not result in blood compatibility issues with safe materials.

4.2.3 Electronic Emissions

The plasma power supply used to generate the low-temperature gas plasma in the STERRAD™ Systems can only be turned on Additionally, the STERRAD™ Systems have been tested for material biocompatibility and found to be safe. The extensive
when the sterilization chamber door is closed and the chamber is under vacuum. The power supply operates at a frequency of biocompatibility data available for the STERRAD™ Systems provides historical precedent that devices processed in the STER-
49 to 54 KHz. The STERRAD™ Systems complies with the following STANDARDS: RAD™ 100NX System and STERRAD NX™ System will also be safe.
To confirm this, a range of materials was processed in the STERRAD™ 100NX System and evaluated for biocompatibility. The
• CAN/CSA-C22.2 No. 61010-1/R:2009; Safety Requirements for Electrical Equipment for Measurement, Control, and Labora- biocompatibility evaluation included cytotoxicity, acute systemic toxicity and intracutaneous tests and demonstrated that the
tory Use. STERRAD™ Systems are biocompatible. The medical devices processed in the STERRAD™ Systems do not pose a risk to the
• UL 61010-1/R:2008-10; STANDARD for Safety for Electrical Equipment for Laboratory Use. health of patients or personnel handling the devices.
• EN 61010-1: 2001; Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use.
• EN 61010-2-040: 2005; Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use –
Particular Requirements for Sterilizers and Washer Disinfectors Used to treat Medical Materials.
• EN 60601-1-2: 2014; Medical Electrical Equipment, Part 1: General Requirements for Safety, Section 2: Collateral STAN-
05 CONCLUSION
DARD: Electromagnetic Compatibility.
The development of the STERRAD™ Systems with ALLClear™ Technology is a continuation of ASP™’s leadership in the development
• EN 55011, Group I Class A limits, based on CISPR 11:2010, Group I Class A limits.
and validation of sterilization processes. ASP™ is a leader in infection prevention and has a long legacy of hydrogen peroxide gas
plasma sterilization that began with the launch of the STERRAD™ 100 Sterilization System in 1993. Now, over 20,000 STERRAD™
Systems are processing instruments worldwide, impacting millions of patients annually.
4.3 Safety for Patient Use
The STERRAD™ Systems with ALLClear™ Technology enhance productivity, compliance and usability. It is the only sterilization
Medical devices and commonly used medical materials sterilized by the STERRAD® Systems were subjected to extensive toxicologi-
system with upgradable technology that enhances system capability, and it has full network integration between the STERRAD™
cal tests as part of the original biocompatibility studies. These tests included:
Systems, STERRAD VELOCITY™ System and ASP ACCESS™ Technology. Refer to the STERRAD™ 100NX System with ALLClear™
Technology and STERRAD NX™ System with ALLClear™ Technology User’s Guide for a complete description of the operation of this
sterilizer.

The third-party trademarks used herein are the properties of their respective owners.
 REFERENCES

1 Jacobs, P. T. Mechanism and Validation Issues in Gas Plasma Sterilization, in Frontiers in Sterilization Practice, The Future of Low-Tempera-
ture Technology, ed. Robins, D. S., Communicore, Newport Beach, CA, pp. 73-84 (1996).
2 AAMI TIR No. 12 Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device
manufacturers (2010).
3 ANSI/AAMI/ISO 14937:2009, Sterilization of health care products -- General requirements for characterization of a sterilizing agent and the
development, validation and routine control of a sterilization process for medical devices
4 Pflug, I. J. Microbiology and Engineering of Sterilization Processes. Eighth ed. Minneapolis, MN: University of Minnesota Environmental
Sterilization Laboratory, September 1996 printing.

STERRAD™ 1OONX
STERRAD NX™
with

Please refer to the STERRAD™ 100NX System with ALLCle-

ar™ Technology and STERRAD NX™ System with ALLClear
™ Technology User’s Guides for detailed information on
how to effectively use your system. If you have questions
about whether a particular device can be sterilized in the
STERRAD™ 100NX System with ALLClear™ Technology
and STERRAD NX™ System with ALLClear™ Technology,
consult with the device manufacturer or visit www.ster-
radsterilityguide.com. For more information, please
contact an ASP™ representative.
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 manu-
facturer’s instructions for use for more information.

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ADVANCED STERILIZATION PRODUCTS, INC.

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Bahnhofstrasse 2, Zug 6300, Switzerland
ASP, The Netherlands BV
©ASP 2021. All Rights Reserved. EC REP
BIC 1, 5657 BX Eindhoven, The Netherlands

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.
Capitalized product names and ALLClear™ are trademarks of ASP™ Global Manufacturing, GmbH. AD-190024-01-CT_C-MDR