||ETO Sterilization Unit for Food Crops
Herbs and botanicals contamination is often an issue, and they need to be decontaminated.
Depending on harvesting, drying and processing methods, contamination level can go up to 10 billion/gram. The main solution which was used to reduce TPC was ETO, but it is now banned by many countries and forbidden in the USA since 2007. NAFI ( NAMAH AGRO FOODS INDUSTRIES) Steam Sterilization is a natural process which replaces ETO treatment.
To promote the safe use and handling of ethylene oxide for sterilization purposes.
• Ethylene Oxide (ETO) sterilization is mainly used to sterilize medical and pharmaceutical products that cannot support conventional high temperature steam sterilization
- Such as devices that incorporate electronic components, plastic packaging or plastic containers.
ETO gas infiltrates packages as well as products themselves to kill micro organisms that are left during production or packaging processes. This gas, mixed with air at a ratio of at least 3% ETO gas, forms an explosive mixture. Pure ETO gas boiling point is 10.73 ºC at atmospheric pressure. Most of the time, it is mixed with Nitrogen or CO . This explosive condition requires Intrinsic Safe material (ATEX) zoning, for security of people as well as security of the process itself.
Ethylene Oxide – Advantages
Well characterized process:
Appropriate for a wide variety of
materials and products.
Good for kits:
EO does not penetrate ampules
of drug products,
a common kit component.
Improving EO equipment control
technology is facilitating parametric
release validation for some products
(no end process microbiological
testing and product quarantine
||ETO Sterilization process:
||Most ETO sterilization lines involve three different stages.
These can be separated into three different cells depending
on the size or amount of devices to treat:
• PRE CONDITIONING
||The EO Enhanced Process
During the past several years Cosmed Group
has worked with other members of the
spice industry to develop a new technology
for pasteurization of spices and herbs using
gaseous ethylene oxide (EO). The technology
was developed in response to a mandate
from the US Environmental Protection Agency
to reregister all pesticides registered prior
to 1989. The aim of the preregistration
mandate was to insure that these pesticides
meet the same safety criteria as pesticides
registered more recently under much stricter
Analysis of a 1996 ASTA study of EO residual
levels in spices treated by conventional EO
pasteurization indicated that in order to
meet the current EPA safety requirements
it would be necessary to devise a new
method providing significantly lower EO
The ASTA studies, conducted over a 3-year
period, were guided by technologies originally
developed by Cosmed Group to rapidly reduce
residual levels in medical devices sterilized
with EO. The ASTA studies demonstrated
that it is possible to utilize subatmospheric
vacuum and humidity pulses to effectively
reduce EO residuals to levels which support
the registration of EO as a safe treatment
for spices, herbs and seasonings.
||Enhanced Microbial Reduction
Although the EO Enhanced process was
designed solely to provide lower EO
residuals, it was found that the process
also yields an approximately 10-fold
greater microbial reduction than
conventional EO treatment.
This additional benefit has proven to be of particular importance in view of current efforts to enhance food safety and to guarantee the security of the nation's food supply.
- No Weight Loss
Additional studies conducted during
development of the new technology
suggest that organoleptic qualities
including taste, color and aroma are
indistinguishable from those of
spices treated with conventional
In fact, the only
difference which has been regularly
observed using the new process is
that moisture levels remain at or
near pretreatment levels. This is a
significant advantage over the
conventional EO treatment process
which often results in a 1% to 2%
reduction in product weight through
Most equipment currently being used for EO
treatment of spices will not support the EO
Enhanced process without significant
modification. To achieve optimal results with
the new process the treatment chamber must
be uniformly heated on all surfaces including
the door and must be equipped with a high
performance vacuum system, food grade
high pressure steam supply and a source of
chilled water to supply the condensation and
recovery system for the large quantities of
steam used in the process. A sophisticated
control system is needed to ensure that the
process parameters do not vary significantly
from the conditions required for optimal
microbial inactivation and residual reduction.
The EO Enhanced process requires
approximately 24 hours for completion of
each treatment cycle, a significant increase
over typical cycle times for conventional
A Better Product
The EO Enhanced process for treatment of
spices provides a number of benefits over
conventional EO pasteurization including lower
residuals, enhanced microbial reduction and
little moisture loss without affecting the
organoleptic qualities of the treated spice.
||Ethylene Oxide Sterilization
Ethylene Oxide (EO or ETO) is a simple chemical
compound that is commonly used for gaseous
sterilization of disposable healthcare products.
A wide variety of materials and components
commonly used in the manufacture of these
products may be sterilized with ethylene oxide
in their final breathable packaging configuration.
||History of ethylene oxide
1859 – Ethylene oxide is discovered
1920s/1930s – EO is used for fumigation
1940s – EO is developed as a sterilant by the
Late 1950s – The McDonald process is patented
for medical devices
1998 –technology introduced
||How does ethylene oxide work?
EO sterilization is a chemical process consisting
of four primary variables: gas concentration,
humidity, temperature and time. Ethylene
oxide is an alkylating agent that disrupts the
DNA of microorganisms, which prevents them
from reproducing. EO sterilization assures
that a safe and sterile product will be delivered
to the market each and every time.
What is ethylene oxide used for?
The EO process is ideal for:
Custom procedure kits
Cellulose and plastic products that may exhibit discoloration with irradiation devices manufactured from materials whose physical properties degrade with heat or irradiation various materials
not compatible with other methods of sterilization, such as tissue and collagen.
Used to preheat and humidify product loads to predefined conditions. This will assure a repeatable sterilization process regardless of pre-processing load storage conditions.
Performed using process phases specifically
designed to provide the required level of
ethylene oxide exposure to assure sterility
for a device or family of devices
Used to accelerate out gassing of exposed
product loads and to contain and eliminate
residual ethylene oxide emissions.
Traditional Ethylene Oxide Processing
Biological indicators are placed into the
sterilization load, and the load is placed
into a preconditioning room. The product is
then moved into the sterilization chamber
where it is treated with EO gas Following
exposure, the product is transferred into
an aeration cell for dissipation of the EO
Biological indicators are removed from the
product and tested Product is shipped to
the Customer while still in quarantine.
Product is released once the biological indicators
have completed testing and the EO residual
levels are acceptable Expedited Processing
Product is loaded into the sterilization
chamber, where it is exposed to all three
phases of the sterilization process.
(pre-conditioning, sterilization and aeration)
This process uses parametric release, which
eliminates the labor and time of post-process
sterility testing, In-chamber aeration prevents
products from having to be held for EO residual
dissipation, Products can be processed and
released to market within one day.
||EO Cycle Validation
Designed for process validation of industrial-sized
vessels, this TIP option is for Customers who lack
in-house validation resources, or prefer to use
outside validation services. We also have the
capability to perform small-volume validations
for limited production or small lots on our premises
or at your location of choice. Periodic revalidation
(a single half-cycle) is available.
||BI Incubation Time Reduction
This TIP option uses an FDA approved guideline to
reduce the incubation period for post-exposed
biological indicators. Appropriate for routine
processes only, it is an acceptable way to
decrease unreleased inventory time.
Note: To benefit from this program, your residual hold
time must be shorter than your indicated incubation period.
||EO Residual Reduction (Hold Time Reduction)
Through state-of-the-art equipment that removes
residues during the sterilization process, this TIP
option reduces the time required for dissipation
(off-gassing) of residuals that remain after
sterilization. Reducing residual hold time
(when it is longer that the biological indicator
incubation time) results in reduced "in-process"
inventory and a faster release of products to
||EO Cycle Optimization
This TIP option improves the EO process for routine sterilization of existing devices. Through
manipulation of temperature and gas concentration,
EO cycle optimization can also help achieve further
cycle improvements, such as reduced residual hold
times, shorter total cycle times and lower
temperatures for temperature-sensitive products.
||Product/Package Functionality Evaluation
This TIP option gauges post-sterilization material
compatibility and function. It is appropriate if you
do not have in-house sterilization or small-volume
||NAFI Services EO Technology center
The NAFI Services EO Technology Center is an
organization designed for and committed to the
assistance of NAFI Services Customers in all facets
of the ethylene oxide sterilization validation process.
The Center develops and optimizes your ethylene
oxide sterilization processes. It assures that you
receive the most complete, cost-effective, and high
quality ethylene oxide contract sterilization
The EO Technology Center
can help you:
Determine if your product can be
sterilized with ethylene oxide.
Determine if ethylene oxide is the
best sterilization method for your
product. Determine which ethylene
oxide sterilization process is best
for your product Validate a reduced
incubation time for biological
indicators. Reduce EO residue
dissipation time. Save money by
using equipment that is specifically
designed for either small-volume
applications or large-scale production
Our equipment delivers industrial EO
sterilization processes, both 100%
ethylene oxide (deep vacuum) and
nitrogen "soft" cycles (shallow vacuum).
It ranges in size from 30 cubic feet
(24" x 36" x 60") to 2100 cubic feet
(60" x 112" x 540").
- Validation Support
- Same Day Service
- New Product Qualification
- Dose Mapping
- Laboratory Coordination
- Protocol Generation
- Materials Selection
- Engineering Studies
- Technical Support and Analysis
- Sterility Validation
- Dose Validation/Setting
- Education and Consultative Services
All spices and herbs
different areas of the world
and dried in
different conditions need thorough and
specialized research work (investigation).
We have our own laboratories on site
and the most modern
All raw materials & semi-finished
through very strict quality
control processes and testing.
We deliver proven
products of the highest
quality with the
of their health safety.