Shanghai JPS Medical Co., Ltd.

Vaporized Hydrogen Peroxide Biological Sterilization

Short Description:

Vaporized Hydrogen Peroxide Biological Sterilization is a highly effective and versatile method for sterilizing sensitive medical devices, equipment, and environments. It combines efficacy, material compatibility, and environmental safety, making it an ideal choice for many sterilization needs in healthcare, pharmaceuticals, and laboratory settings.

Process: Hydrogen Peroxide

Microorganism: Geobacillus stearothermophilus (ATCCR@ 7953)

Population: 10^6 Spores/carrier

Read-Out Time: 20 min, 1 hr, 48 hr

Regulations: ISO13485: 2016/NS-EN ISO13485:2016

ISO11138-1: 2017; BI Premarket Notification[510(k)], Submissions, issued October 4,2007


Product Detail

Product Tags

Products

PRPDUCTS TIME MODEL
Vaporized Hydrogen Peroxide Biological Sterilization (Ultra Super Rapid Readout) 20min JPE020
Vaporized Hydrogen Peroxide Biological Sterilization (Super Rapid Readout) 1hr JPE060
Vaporized Hydrogen Peroxide Biological Sterilization (Rapid Readout) 3hr JPE180
Vaporized Hydrogen Peroxide Biological Sterilization Indicators 24hr JPE144
Vaporized Hydrogen Peroxide Biological Sterilization Indicators 48hr JPE288

Process

Preparation:

The items to be sterilized are placed in a sterilization chamber. This chamber must be airtight to contain the vaporized hydrogen peroxide.

The chamber is evacuated to remove air and moisture, which can interfere with the sterilization process.

Vaporization:

Hydrogen peroxide solution, typically at a concentration of 35-59%, is vaporized and introduced into the chamber.

The vaporized hydrogen peroxide spreads throughout the chamber, contacting all exposed surfaces of the items being sterilized.

Sterilization:

The vaporized hydrogen peroxide disrupts cellular components and metabolic functions of microorganisms, effectively killing bacteria, viruses, fungi, and spores.

Exposure times can vary, but the process is generally completed within 30 to 60 minutes.

Aeration:

After the sterilization cycle, the chamber is aerated to remove residual hydrogen peroxide vapor.

Aeration ensures that the items are safe to handle and free from harmful residuals.

Applications

Medical Devices:

Ideal for sterilizing heat-sensitive and moisture-sensitive medical devices and equipment.

Commonly used for endoscopes, surgical instruments, and other delicate medical tools.

Pharmaceutical Industry:

Used for sterilizing manufacturing equipment and cleanrooms.

Helps maintain aseptic conditions in pharmaceutical production environments.

Laboratories:

Employed in laboratory settings for sterilizing equipment, work surfaces, and containment units.

Ensures a contamination-free environment for sensitive experiments and procedures.

Healthcare Facilities:

Used to decontaminate patient rooms, operating theaters, and other critical areas.

Helps control the spread of infections and maintain high standards of hygiene.

Advantages

Efficacy:

Effective against a broad spectrum of microorganisms, including resistant bacterial spores.

Provides high levels of sterility assurance.

Material Compatibility:

Suitable for a wide range of materials, including plastics, metals, and electronics.

Less likely to cause damage compared to other sterilization methods like steam autoclaving.

Low Temperature:

Operates at low temperatures, making it ideal for heat-sensitive items.

Prevents thermal damage to delicate instruments.

Residual-Free:

Breaks down into water and oxygen, leaving no toxic residues.

Safe for both the sterilized items and the environment.

Speed:

Relatively quick process compared to some other sterilization methods.

Enhances workflow efficiency by reducing turnaround times.

Monitoring and Validation

Biological Indicators (BIs):

Contain spores of resistant microorganisms, typically Geobacillus stearothermophilus.

Placed inside the sterilization chamber to verify the efficacy of the VHP process.

After sterilization, BIs are incubated to check for spore viability, ensuring the process has achieved the desired sterility level.

Chemical Indicators (CIs):

Change color or other physical properties to indicate exposure to VHP.

Provide immediate, though less definitive, confirmation that sterilization conditions were met.

Physical Monitoring:

Sensors and instruments monitor critical parameters such as hydrogen peroxide concentration, temperature, humidity, and exposure time.

Ensures that the sterilization cycle conforms to specified standards.


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