Table of Contents

Most Common Sterilization Methods For Medical Devices

medical syringes in a package. medical syringes in packaging as an abstract medical background.

The most common sterilization methods for medical devices include ethylene oxide sterilization, gamma sterilization, electron beam sterilization (E-Beam), X-ray sterilization, wet heat (Steam) sterilization, wet heat sterilization, dry heat sterilization, hydrogen peroxide sterilization, ozone sterilization, and chlorine dioxide (ClO2 or CD) sterilization

Ethylene Oxide Sterilization

EO sterilization is one of the most common sterilization methods for medical devices. It is an alkaline gas sterilization method under relatively hot (typically ≤ 60 ℃) and humid conditions. It kills microorganisms and ensures the items are safe for use.

To ensure the cleanliness and safety of our syringes and IV sets, we utilize a sterilization method called EO gas. This method is chosen because our syringes and IV sets are produced with materials like plastics, rubber, and other polymers, which can be sensitive to heat and moisture. Consequently, they may be unable to withstand traditional sterilization techniques such as steam or high heat. We usually sterilize the outer cartons containing products after due inspection. By utilizing EO gas sterilization, we effectively eliminate any potential microbial contamination, ensuring that our products remain safe for use in medical environments. Check our types of syringe

Considerations for Medical Devices/Sterile Barrier Systems:

a) Medical devices, sterile barrier systems, and inks need to be able to withstand specific conditions to ensure effective sterilization. The typical temperature range is usually below or equal to 60℃, along with relatively high humidity levels. The process involves multiple deep vacuums, the presence of nitrogen, and the EO gas.

Different sterilization cycle designs may have varying temperature and humidity ranges depending on the specific requirements of the items being sterilized. These variations allow for flexibility and adaptability to different materials and devices, ensuring that the sterilization process is both effective and safe.

b) The medical device should allow the gas to infiltrate through certain areas and maintain continuous contact with different parts of the devices. This ensures that the gas can reach all areas and effectively sterilize the device.

c) Sterile barrier systems used in EO sterilization should have gas-permeable areas that allow the sterilizing gas to enter and exit the packaging. The permeable portions of the sterile barrier system are designed in a way that maintains the integrity of the packaging system during vacuum or inflation stages. This ensures that the gas can effectively penetrate the packaging and sterilize the enclosed medical devices.

During the packaging process, it’s important to ensure that the placement of the sterile barrier system or each individual system within the packaging system does not impede its permeability. Care must be taken to avoid close contact between breathable materials and impermeable materials to prevent hindrance to gas permeation.  More details about EO

Gamma Sterilization

Ionizing radiation is applied to packaged medical devices by releasing high-energy gamma light quanta from radioactive sources, destroying the molecular structure of microorganisms and hindering reproduction, such as cobalt 60.

Considerations for Medical Devices/Sterile Barrier Systems:

a) Medical device sterile barrier systems or packaging systems and inks can withstand the effect of radiation. Exposure to ionizing radiation can cause crosslinking and chain scission, leading to changes in the materials’ appearance and functional physical properties or even denaturing them.

When it comes to ionizing radiation sterilization, it’s important to use materials in medical devices, sterile barrier systems, packaging systems, and inks that can withstand the effects of radiation. Exposure to ionizing radiation can cause crosslinking and chain scission, which can lead to changes in the appearance and functional physical properties of the materials or even denature them.

Certain materials, such as plastics, polymers, and elastomers, can be affected by ionizing radiation. The degree of material changes will depend on factors such as the radiation dose, material composition, and the specific type of radiation used.

b) The radiation sterilization method may increase the temperature, which should be considered.

c) Packaging density is an important factor to consider during the radiation sterilization process. Maintaining consistent packaging density throughout the sterilization process is crucial to ensure safe and effective dosimetry release.

d) When certain areas of a medical device cannot be sterilized effectively by gas or require an air-impermeable sterile barrier system or packaging system, using radiation sterilization becomes a viable option.

e) Optimizing package size to match the size of the irradiator frame is an important consideration in radiation sterilization. Ensuring that the package size is compatible with the irradiator frame allows for efficient and effective sterilization.

Electron Beam Sterilization (E-Beam)

Electron beam sterilization is a process that utilizes a beam of high-energy electrons to eliminate microorganisms on various surfaces. It can used to sterilize packed medical devices by a concentrated electron beam.

Considerations for Medical Devices/Sterile Barrier Systems:

a) When choosing medical devices, sterile barrier systems, and inks, it is important to select ones that can withstand electron beam irradiation. Electron beam irradiation has a minimal impact on product materials compared to gamma irradiation.

b) Maintaining consistent density of the package is crucial during the sterilization process to ensure the safety of dosimetry release.

c) Electron beam sterilization is a great choice when certain areas of a medical device cannot be effectively sterilized using gas methods.

X-ray Sterilization

X-ray sterilization is an irradiation process by utilizing photon radiation. When packaged medical devices are exposed to braking radiation X-rays generated by accelerated ionizing particles, the energy can lead to changes in chemical and molecular bonds. This disruption can effectively hinder the ability of microorganisms to reproduce.

Considerations for Medical Devices/Sterile Barrier Systems:

a) It is essential for medical devices, sterile barrier systems, or packaging systems to be able to endure ionizing radiation. X-ray sterilization can be carried out using low doses for short durations, but it’s worth noting that cross-linking can lead to yellowing in appearance and alterations in functional physical properties.

b) X-rays have the ability to pass through packaging materials and reach medical devices. So, we can use impermeable materials for the sterile barrier systems or packaging systems during the x-ray sterilization.

c) The sterilization cycle process does not involve a vacuum stage, and the pressure applied to the sealing of the sterile barrier system is restricted.

d) Maintaining consistent pallet or tote load density is a crucial factor throughout the sterilization process to ensure the safe release of dosimetry.

e) Optimizing the design of the sterile barrier system or packaging system to align with the sterilizer tray or hand-held material loading and unloading system is important. This helps to minimize the presence of invalid areas within the sterilization cycle and ensures efficiency.

Wet Heat (Steam) Sterilization

Saturated steam and high-temperature sterilization are widely used methods to sterilize medical devices. The goal is to ensure that the sterilizing agent, steam, comes into contact with the medical device through a sterile barrier system or packaging system.

Considerations for Medical Devices/Sterile Barrier Systems:

a) When it comes to sterilization, it’s crucial that the medical devices, sterile barrier systems or packaging systems, and inks used are not sensitive to water vapor, condensation, and high temperatures.

b) When it comes to sterile barrier systems or packaging systems, it’s crucial to have vented areas that allow steam to enter and exit. This ensures optimal sterilization by allowing the steam to reach all areas of the medical device effectively.

The velocity of steam passing through the permeable part of the packaging system should be carefully controlled. This is important to maintain the integrity of the sterile barrier system during processes like vacuum or inflation. By controlling the velocity, we can prevent any damage or compromise to the packaging, ensuring it remains intact and effective.

Care is also taken to ensure that the placement of the sterile barrier system does not impede its permeability. This means avoiding any obstructions or interference that could hinder the steam penetration and compromise the sterilization process.

By maintaining a proper balance between breathable materials and impermeable materials, we can ensure that steam penetration is not hindered. This means avoiding close contact between breathable and impermeable materials, allowing steam to flow freely and effectively sterilize the medical devices.

c) When it comes to sterilizing medical devices, it’s important to have channels that allow the vapor to permeate and continuously contact all areas of the device. These channels ensure that the sterilizing agent, such as steam, can effectively reach every nook and cranny of the medical device.

Wet Heat Sterilization For Airtight Packaging

It is a widely used method for sterilizing airtight packaged medical devices. Steam or pressurized hot water is the media used to heat the packaged devices and achieve sterilization.

Considerations for Medical Devices/Sterile Barrier Systems:

a) It is essential that the materials used in medical devices, packaging systems, and inks can withstand the high humidity and temperature associated with the sterilization process. Insensitivity to these conditions ensures that the integrity and functionality of the materials are maintained throughout the sterilization process.

b) Moisture plays a crucial role in the sterilization process using steam as it is needed to generate the steam and pressure required for effective sterilization inside the sterile barrier system.

During the sterilization process, water is heated to produce steam. This steam, in combination with the pressure within the sterilization chamber, creates the necessary conditions to kill or inactivate microorganisms on the medical devices. The moisture content inside the sterile barrier system contributes to the production of steam, which then permeates throughout the system and contacts the medical devices, ensuring their sterilization.

c) When it comes to sterilizing medical devices using steam or pressurized water, it’s important to have channels that allow the sterilizing agent to penetrate and continuously contact all areas of the device. These channels ensure that steam or pressurized water can effectively reach every nook and cranny of the medical device, promoting thorough sterilization.

Dry Heat Sterilization

Packaged medical devices need to be exposed to high-temperature environments for a long time.

Considerations for Medical Devices/Sterile Barrier Systems:

Medical devices, sterile barrier systems or packaging systems, and inks used in sterilization processes need to be able to withstand high temperatures of 160°C or above for several hours or extended cycle times at lower temperatures, depending on the specific sterilization method employed.

Hydrogen Peroxide Sterilization

Two types of hydrogen peroxide sterilization commonly used include:

a) plasma, also known as low-temperature hydrogen peroxide gas plasma (LTHPGP) sterilization;

b) Hydrogen peroxide, which is a vaporization sterilization process similar to, but not identical to, gas plasma sterilization. Both sterilization processes use vaporized hydrogen peroxide, but gas plasma sterilization also has a plasma generation step.

Considerations for Medical Devices/Sterile Barrier Systems:

a) In a confirmed cycle, where medical devices, sterile barrier systems or packaging systems, and inks undergo a specific sterilization process, it is important that they can withstand a temperature of 55℃ and a relative humidity of 80%.

b) When plasma is used for sterilization, it is essential that medical devices, sterile barrier systems or packaging systems, and inks are compatible with both the plasma itself and the plasma generation process.

c) Medical devices, sterile barrier systems or packaging systems and inks are not sensitive to deep vacuum or hydrogen peroxide.

d) When it comes to sterilization, it is crucial for medical devices to be able to withstand the pressure change rate allowed by the sterilization equipment.

e) To ensure effective sterilization, it is important for a medical device to have a gas inlet and outlet part, allowing the sterilizing gas to contact all areas of the device.

f) When it comes to sterile barrier systems or packaging systems used in gas sterilization methods, it is crucial to have a gas-permeable area that allows gas to enter and exit. This gas-permeable area ensures that the sterilizing gas can effectively penetrate the packaging and reach the medical device inside.

However, while allowing gas permeability, it is equally important to maintain the integrity of the sterile barrier system. The velocity of gas passing through the gas-permeable area should be carefully controlled to prevent any compromise to the packaging’s structural integrity during vacuum or inflation processes.

g) When it comes to hydrogen peroxide sterilization, cellulosic materials should not be used. Hydrogen peroxide can react with cellulose, leading to potential degradation or discoloration of the material.

Ozone Sterilization

Ozone sterilization is a gas sterilization process that operates at low temperatures. During the process, high humidity is maintained, and the packaged medical devices are exposed to ozone. The main mechanism behind microbial inactivation during ozone sterilization is oxidative in nature. Ozone acts as a powerful oxidizing agent, effectively destroying microorganisms by damaging their cell walls and other essential structures.

Considerations for Medical Devices/Sterile Barrier Systems:

a) It is crucial for medical devices and sterile barrier systems or packaging systems (including inks), to be able to withstand high humidity, multiple deep vacuum, and ozone environments. These conditions are often encountered during sterilization processes to ensure the products remain free from contamination.

b) The sterile barrier system or packaging system needs to have a gas-permeable area that allows gas to enter and exit. The velocity of gas passing through the permeable part should be able to maintain the integrity of the sterile barrier system during vacuum or inflation;

c) Medical devices need to have gas entry and exit sections that allow gas to contact all areas of the medical device.

Chlorine Dioxide (ClO2 or CD) Sterilization

Chlorine dioxide gas sterilization is commonly used for heat-sensitive medical devices, as it operates at lower temperatures compared to other sterilization methods. By utilizing chlorine dioxide gas, the sterilization process can effectively kill or inactivate microorganisms on the surfaces of medical devices without compromising their integrity or functionality.

Chlorine dioxide is an oxidizing agent that achieves microbial inactivation through an oxidation mechanism. When it comes to spore inactivation, chlorine dioxide gas has shown comparable effectiveness to other sterilization agents like vaporized hydrogen peroxide and formaldehyde. These agents are well known for their sporicidal properties, meaning they effectively eliminate spores, which are highly resistant forms of microorganisms.

Considerations for Medical Devices/Sterile Barrier Systems:

a) When it comes to chlorine dioxide gas sterilization, polyolefin nonwovens, various transparent films, aluminum foil composites, rigid plastics, and certain papers are compatible materials. These materials have been tested and proven to withstand the sterilization process without degradation or compromising the effectiveness of the sterilization.

Certain papers that have undergone appropriate bleaching processes can also be used with chlorine dioxide gas sterilization. These papers have been treated to minimize the potential for adverse reactions with the sterilizing agent. However, it is important to note that unbleached corrugated boxes should not be used with chlorine dioxide gas sterilization.

b) When it comes to sterilization, medical devices, and sterile barrier systems or packaging systems (including inks) should be designed to withstand oxidation and high humidity conditions, typically ranging from 55% to 70% relative humidity.

Additionally, the gas concentrations and humidity levels may vary depending on the specific sterilization cycle design. Gas concentrations typically range from 5 mg/L to 30 mg/L, while humidity levels are maintained within the specified range. These conditions are carefully controlled to ensure effective sterilization while minimizing any potential negative effects on the materials.

c) In order to achieve thorough sterilization, it is important for a medical device to have a gas inlet and outlet part. These components allow the sterilizing gas to contact all areas of the medical device, ensuring comprehensive sterilization.

d) In sterile barrier systems or packaging systems used for sterilization, it is essential to have gas-permeable areas that allow the ingress and egress of gases. These gas-permeable areas enable the sterilizing gas to enter and circulate within the packaging, ensuring effective sterilization of the enclosed medical device.

However, it is equally important to maintain the integrity of the sterile barrier system during the sterilization process. The velocity of gas passing through the gas-permeable portion should be carefully controlled to prevent any compromise to the structural integrity of the packaging. This is particularly crucial during vacuum or inflation stages, where the pressure and gas flow can have a significant impact on the packaging.

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Tag: production time Tag: Electron Beam Sterilization (E-Beam) Tag: Infusion set Tag: reuse needles and syringes Tag: Hydrogen Peroxide Sterilization Tag: Gamma Sterilization Tag: Chlorine Dioxide (ClO2 or CD) Sterilization Tag: Wet Heat (Steam) Sterilization Tag: X-ray Sterilization Tag: EO Tag: Ethylene Oxide Sterilization Tag: Wet Heat Sterilization For Airtight Packaging Tag: Ozone Sterilization Tag: ethylene oxide

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