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ETO Sterilizer Articles

Ethylene Oxide Gas Sterilizer Usage & Their Increasing Demand

Among the sterilization technologies available today, Ethylene oxide sterilization is one of the most common sterilization processes used for medical devices. It is a cold sterilization process which is compatible with different types of materials used in the production of medical instruments, such as metal, glass, polymers and plastics. Automatic ETO Sterilizer is very effective because it works by alkylation with the DNA of microorganisms. If all the variables are evaluated through rigorous process design and development, an effective EtO process can be designed for almost all types of medical devices.

What Is Ethylene Oxide Sterilization?

Ethylene oxide sterilization is a chemical process which has four primary variables: gasoline concentration, humidity, temperature and time. EO is alkylation operators that disturb the genetic material of microorganisms, which prevents cell generation.

The Ethylene Oxide Sterilization Process

ETO Sterilization is a low temperature process that uses Ethylene Oxide gas for the sterilization of devices. The ethylene oxide sterilization process has three processing stages.

Preconditioning: In this stage, the chamber environment is prepared to meet the ideal temperature, humidity and pressure for stimulating the passive microorganisms and bacteria come into the active state.

Sterilization: In this stage, actual sterilization is performed with process phases designed to achieve the required level of ETO exposure for sterilization.

Aeration: In this stage, remaining ETO gas is removed using changes of air in the chamber. It allows absorbed gas to evaporate from the sterilized devices.

Key Parameters of Ethylene Oxide Sterilizer (EO Sterilizers)

Gas concentration
Chamber temperature
Relative humidity
Exposure time

Increasing Demand of ETO Sterilizer (ETO Sterilization Machine)

The sterilization equipment market has experienced significant growth in recent time because of increasing demand for Hospital Sterilizers, also known as EO Sterilizers for hospitals. Based on its usage, the sterilization equipment industry is classified into hospitals & clinics, medical device companies, pharmaceutical companies, the food and beverage industry, and other end users. The hospitals & clinic segment is giving the largest market share. As a result, it is a prime focus area for Industrial ETO Sterilizer manufacturer & exporters. One of the very important factors for the increasing demand of ETO Sterilizers is increasing preference of contract sterilization services by medical equipment producers and increasing outsourcing to expert third party vendors for reducing in-house costs related to sterilization.

The growing number of hospitals and increasing number of surgical procedures are contributing to the increase in demand for Ethylene Oxide Gas Sterilizers, which is resulting in growth opportunities for every ETO sterilizer manufacturer & exporter. Moreover, constantly increasing trend of outsourcing the sterilization processes for reducing health care costs are increasing the demand for EO sterilizes Medical device & Instruments. As a result of continuous technological advancements in the medical equipment industry and innovation by leading Ethylene Oxide Gas Sterilizers manufacturers & exporters, the industry is expected to witness the growth in future as well.

An Overview of Hospital Sterilizer

Sterility Equipment (India) Pvt Ltd manufactures different devices that are most widely been used in pharmaceutical & medical industries as well as in laboratories. Our range of devices includes table top ETO sterilizer, fully automatic ETO sterilizer & ribbon blender. Not only in industries, but we have also established a good position as ETO sterilizer manufacturer for medical colleges as well. The hospital sterilizer has been offered by us are of high quality with excellent features with long life durability.

ETO Sterilizer

In most of the industries manufacturing medical devices, sterilization is one of the important factors to be considered in terms of healthcare. Hence, ETO sterilizer or hospital sterilizer is been used for the process of sterilization of healthcare instruments and devices. There is a sealed chamber present where the products are been exposed to ethylene oxide gas under a vacuum. One of the main aims of using hospital sterilizers for such type of devices is a sterile and safe product is been delivered in the market every time. The equipment or the device goes under the process of ethylene oxide sterilization i.e. a chemical process that includes variables namely as temperature, time, humidity & gas concentration. Hence, the sterilization process takes place.

Table Top ETO Sterilizer

Another type of design used for sterilizing medical devices or equipment is the table top ETO sterilizer. The table top ETO sterilizer is been uniquely designed for the devices that are sensitive to heat as well as moisture. It offers to sterilize equipment at low temperatures and is also cost-effective. It is been specially been designed for industries like laboratories, research centers, etc. who require sterilization at low temperatures. For the process of high-quality sterilization, we at Sterility Equipment (India) Pvt Ltd use 100% pure Ethylene Oxide & is also one of the best-proven methods of low-temperature sterilization.

Ribbon Blender

For the fast & efficient blending of materials, we offer a ribbon blender for various industries. In pharmaceutical and other industries, it is widely been used for the homogenous mixing of formulations and ingredients. The ribbon blender consists of ‘U’ shaped trough and shaft along with spiral ribbons. The process of mixing takes place by rotation in linear and radial motion that is supported by the ribbon mixer. With the help of triple mixing action, the high-quality blending of materials is been achieved.

Fully Automatic & Industrial ETO Sterilizer Machines

The hospital sterilizers are further available for industrial requirements also. These EO sterilizers are capable of working for a longer duration as compared to other regular ETO sterilizer machines. They can also be categorized into fully automatic ETO sterilizers and industrial ETO sterilizers. As the name suggests, the fully automatic ETO sterilizers are completely automated beginning from the preconditioning process to the aeration process followed by sterilization. Thereby making the process easier & faster. Considering industrial ETO sterilizer machines, they have most opted in research centers as well as big hospitals due to their comparatively bigger needs than normal hospitals & labs.

Conclusion

The above-stated machines are widely been used in different industries that give the efficiency of the products. Sterility Equipment (India) Pvt Ltd is one of the best manufacturers & exporter in machines like hospital sterilizer, table top ETO sterilizer, and ribbon blender. Our products give one of the best sterilization solutions for equipment and products to a wide range of industries.

All About ETO Sterilization with ETO Sterilizer

Sterilization is a process which eliminates, removes or kills all form of microbial life including fungi, bacteria, viruses, etc. Microbial life thrives everywhere; on the surface, in fluids, in medication, on food. Various means of sterilization available are: Heat, Chemical, Radiation, Pressure and Filtration. ETO sterilization is one of the most widely used sterilization methods. It is a chemical form of sterilization and provides high efficiency with deep penetration power. Because of this ETO is preferred for sterilization of Medical and Pharmaceutical Products.

What is ETO?

ETO or Ethylene Oxide is a colorless and flammable gas having a faintly sweet odor. The chemical structure of the compound has a strained ring that makes it participate quite readily in the addition reactions causing the ring (of the structure) to open. The ethylene oxide sterilization or ETO sterilization is primarily used to sterilize the medical & pharmaceutical products. It kills the microorganisms that is accumulated during the production or packaging process. Apart from microorganisms, ETO also kills the spores. It is basically used to sterilize items that are heat or moisture sensitive and is suited for semi-industrial applications.

ETO sterilizer carried out the process in 3 stages, namely- Pre Conditioning, Sterilizer, Degasser. In the pre conditioning stage, the batch is made to stay under an environment of controlled temperature and humidity. For the sterilizer stage, the system requires an accurate temperature control and pressure & vacuum control. The actuators require security interlocks. This stage also include checking for tolerance change, phase changes, etc. In the degasser stage, the products are degassed to remove any remaining particles of ETO. The entire batch is made to dwell under the temperature controlled environment.

What is ETO Sterilization?

ETO Sterilization, also known as Ethylene Oxide Sterilization, is a chemical process done with the device called ETO Sterilizer. The primary factors affecting this process include chemical concentration, humidity, temperature and time. ETO is a colourless and odourless gas and is used as a low-temperature sterilant. It is considered to provide sterilization as a result of alkylation of protein, DNA and RNA. This prevents cellular metabolism in microbial life and also prevents them from replicating. ETO gives more effective results by penetrating through most materials including plastics.

Why and Where ETO Sterilization is used?

For industries like Pharmaceuticals, it has become essential to perform sterilization to avoid contamination. Even plastics and Electronics industries are praising this method. Other methods of sterilization available, for example, steam; is cost-effective but will damage sensitive materials like biological materials, fibre, electronics and plastics. For such materials, chemical sterilization methods are preferred which has high penetration power and gives no damage. Sterilization of tools and other materials in any medical procedure is very essential. As these materials are delicate ETO process is preferred. Similar usage of this process can be seen in different places including hospital, electronics industry, plastic industries, etc.

ETO Process for pharmaceutical products:

ETO is a colourless and odourless gas and has high penetration power. It is highly explosive so it should be handled with care. For its non-damaging effects, it is readily used in sterilization of pharmaceutical materials. A series of steps need to be followed to perform sterilization using ETO.

1.Preconditioning:

Like most other sterilization processes, ETO sterilization process starts with preconditioning of products that are to be sterilized. Preconditioning is usually done in a separate room or specially designed room for preconditioning. In this process, the product is heated and humidified at a stable internal temperature and moisture. The preconditioning step assures that the sterilization process is reproducible regardless of external atmospheric condition. After preconditioning, the product is placed in a heated chamber.

2.Initial Evacuation:

This step involves removal of most of the air from the chamber. It is done to ensure the safe use of ethylene oxide and hence safely deliver the results. Evacuation of air from the chamber is usually accomplished by performing deep pumping using a vacuum pump. The same results can also be achieved by performing a series of partial vacuums and a series of nitrogen injections. This two steps combined, when performed repetitively, will the air.

3.Humidification:

During the preconditioning step, the heat was applied to the product. This may lead to loss of a significant amount of moisture from the product. This loss of moisture can affect the final results hence it is necessary to provide additional moisture. The amount of moisture required is determined and the same is injected in form of steam injections. After injecting the steam, the product is left for some time to soak the moisture and replace the lost moisture.

4. Gas Injections:

The next step is an injection of ETO gas in the chamber. Since ETO is available in the liquid state, it has to be heated into gaseous state first, before injecting it into the chamber. This step involves a long and complex sterilization cycle and requires a system with:

Accurate temperature control
Reliable control systems
Advance reporting and warning systems
Shutdown strategies in critical conditions

The concentration of the gas to be injected depends on two primary factors. The first factor is the minimum amount of gas that is required to attain complete sterility of the product. The second factor is the maximum amount of gas that can be injected without causing any difficulty due to high levels of EO-residuals. After the injection of gas; the product is exposed to heat and humidity for q certain period of time. The exposure time depends on the difficulty of sterilization of product. The more difficult the product is to sterilize, the longer the exposure time.

5.Post-exposure Gas Purge:

Once the gas injection process is complete, all gas from the chamber is removed. This is done because ETO is highly flammable, so to ensure safety the level of gas should be below the flammable limit.

6.Aeration:

Once the ETO sterilizer completes the sterilization, products are placed in a room with elevated temperatures. In this room, airborne residue gases are contained and removed continually.

What is Ethylene Sterilization process used For?

ETO sterilizers are widely used in the pharmaceutical industry to sterilize products sensitive to moisture or heat. Ethylene oxide can penetrate multiple layers of breathable packaging, which makes it suitable for the sterilization of a wide range of materials:

Assembled complex devices
Catheters
Syringes
Saline bags
Stents
Multi-lumen tubing products
Products with integrated-electronics
Custom procedure packs

An effective ETO process can be designed for almost all types of medical devices and permeable packaging configuration, if the variables are assessed through thorough process design and development.

Advantages of this method:

This sterilization is carried out at low temperatures. Many other sterilization methods involve the use of extreme heat which might damage the products.
Its non-corrosive nature makes it preferable for sterilizing metal, plastic and rubber.
Its high penetration capacity makes it very efficient.
It can be used to sterilize a large number of products.

Challenges to be faced during ETO sterilization:

The chemical used is harmful to humans, so the procedures should be carried out carefully.
Flammable nature of ETO gas raises safety concerns.
The time required for the sterilization process is high.
Requires strict environment causes the overall cost to rise.

We are ETO Sterilizer Specialist

Category: ETO Sterilizer