Tuesday, 27 September 2016
Saturday, 2 July 2016
Learn about the diffrenet parts of ETO Sterilizer
About Author: Shreeji Industries is pioneer manufacture & exporter of range of ETO sterilizer since decade. Company is based in state of Gujarat’s industrial hub at Ahmedabad and has extensive experience in ETO Sterilization field.
Friday, 20 May 2016
ETO Sterilization process in brief
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.
It is quite important to
understand how actually ETO sterilization process takes place in ETO sterilizer.
ETO Sterilization process involves
three different stages. These can be separated into three different cells
depending on the size or amount of devices to treat:
1. Pre Conditioning
2. Sterilizer
3. Degasser
1. Pre Conditioning Stage:
First,
products need to go through a pre conditioning phase to make micro organisms
grow. The batch load goes through a dwell time under a controlled environment
of two main process parameter i.e. Temperature,Humidity
2. Sterilizer Stage:
After
Pre conditioning Stages, Sterilization loads goes through a long and complex
sterilization cycle. Sterilization stage must fulfil following norms during the
process.
- Accurate temperature control.
- Availability of the control system.
- Accurate pressure and vacuum control.
- Easy displays of process phases
- Dedicated customer recipes.
- Auto batching release through tolerance tests.
- Reporting.
- Security interlocks between actuators.
- Alarming.
- Shut down strategies.
- Audit Trail facilities – Trending.
- 21CFR Part11
Process description of Sterilizer Stage:
During
this cycle, accurate temperature control is important and a heating jacket is
used. As the overall duration of this cycle is around 60 hours, high
availability of the system is vital and system redundancy is required. Doubling
sensors, actuators and controllers as well as changeover facilities on these
components, helps to ensure the product is sterilized even on hardware or
software failure.
After
the doors have been shut down and sealed correctly, the cycle can be started
either manually or automatically. If any problem with door sealing is detected
the cycle is interlocked and cannot start. Security interlocks are also used
between air and EtO valves.
Once the cycle is started, easy to use
displays are required to show:
· The
actual phase of sterilization
· All
the key set points and tolerances as loaded by the recipe
· All
the key process values for the auto batch release facility
Control
of vacuum and pressure is also required. Due to the toxic effect of EtO, water
ring rotary pumps are used. The vacuum process needs to perform the emergency
evacuation phase for a fast evacuation of gas.
The sterilization phases are:
- Cycle start delay to enable the system to start in stable conditions
- General cell temperature check
- Initial vacuum phase
- Leak rate test
- First flush
- Second flush
- DEC (Dynamic Environmental Conditioning)
- EtO gas injection
- Sterilization dwell time period under EtO
- Post dwell vacuum level
- First wash
- Second wash
- Final air admission
- Final chamber re-evacuation delay
During
execution of these phases a batch report is generated. This report will
include: tolerance checks, phase changes, alarms, events and critical process
values. A key feature of the system is “auto batch” release. During the
sterilization cycle if any abnormal condition occurs, the batch will be
automatically stopped and condition(s) causing the stoppage will be identified.
With this “auto batch” release facility operators do not have to wait until the
end of the cycle and spend time going through the batch report to understand
why it went wrong. With this feature, provided that batch is completed
satisfactory it will be automatically forwarded to the degassing room without
human check of tolerance, process values and alarms.
For
each batch the operator selects appropriate product recipe. After recipe has
been downloaded, the operator is given the opportunity to check if values are
correct for this particular batch before starting the cycle.
When
the batch is over an automatic print of the report can be performed. Batch
logged files are also archived electronically for future review. Batch logged
files could be searched by the following:
- Batch ID
- Customer name
- Recipe
- Product type
- Start and stop time
3. Degasser Stage :
Finally,
products need to go through a degassing phase to remove any particle of EtO.
The batch load goes over a dwell time under a temperature controlled
environment.
Sunday, 27 December 2015
Saturday, 7 November 2015
Fascinating Video Of Eto Sterilizer
Below is Fascinating video of Eto Sterilizer which is applicable in variety of industries such as Hospital,Laboratories,Pharmaceuticals,Life Saving Equipment,Food & Beverages,Textile & Garments,Medical Surgical Equipment.
Contact your need for state of ETO Sterilizer
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