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ETO Sterilizer

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Home  »  Food & Processing Plant  »  ETO Sterilizer

ETO Sterilizer

Ethylene Oxide (ETO) sterilizer is mainly used to sterilize medical and pharmaceutical products that cannot support conventional high temperature steam sterilization - such as devices that incompany electronic components, plastic packaging or plastic containers. Normally the ETO used for gas sterilization is mixed with diluents such as carbon dioxide or nitrogen in different proportions from 10 % ETO to 90 % ETO. The commonly used gas concentration in the sterilizers is 450 to 1000 mg/lit of chamber volume (measured as pure ETO).

Features :
  • Single or double door With Sliding or Hinged door options to suit client specific requirements.
  • Dimple steam Jacketed for better Uniformity of the heat Distribution. (Technology for fast Sterilization cycle and low cost operating)
  • Gas evaporation system is provided to ensure gaseous sterilant even at low temperature
  • Gas circulation system in place to achieve uniform concentration of ETO gas. This is imperative for chamber volumes above 3 cubic.meter.
  • Gas detection system is provided as a safety measure for ETO gas at minimum 3 locations to detect ETO leakage and set an audiovisual alarm.

Emission Control Equipment
  • *Acid Base Scrubbers
  • *Catalytic Oxydizers

Sterilization Process Temperature and Relative Humidity Recorders

Fully Automatic PLC with Touch screen Control with all Parameter Online Printing facility, Computer Interface Facility with software and remote support facility.

Contamination Seal to prevent cross-flow of air between the clean and un-clean area.

Sizes available from 100 lts. to 20000 lts.


Technique :
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
  • Sterilization
  • Degassing

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:
  • Temperature
  • Humidity

STERILIZATION STAGE
Then the load goes through a long and complex sterilization cycle. Requirements of such a system are:
  • 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.

During this cycle, accurate temperature control is important and a heating jacket is used. As the overall duration of the cycle is depend upon the Product to be sterilised and ETO Concentration used.

After the doors have been sealed correctly, the cycle can be started either automatically. If any problem with door sealing is detected the cycle is interlocked and cannot start.

Once the cycle is started, easy to use displays:
  • 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 varification of tolerance, process values and alarms.

For each batch the operator selects appropriate product recipe. After recipe has been downloaded, the operator can verify 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.

DEGASSER STAGE
Finally, products need to go through a degassing phase to remove any particle of ETO.

AUTOMATION :

Saturated Steam Steriliser
Saturated Steam Steriliser


In compliance with :
cGMP, GAMP, ISO 9001 : 2008

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