TSI laser particle counter application in vaporized hydrogen peroxide (VHP) environment
- 2020-10-19
- 877
- Esky Purify
Along with the wide application of Vaporized Hydrogen Peroxide (VHP) sterilization in the pharmaceutical industry, the method of VHP sterilization is more and more into everyone's view.
Vaporized hydrogen peroxide (VHP) method of sterilization, also known as vaporized hydrogen peroxide sterilization, that is, Vaporized Hydrogen Peroxide, VHP, in the late 80's, the United States Sterilse Co first found that the gas hydrogen peroxide relative to the liquid hydrogen peroxide, only a lower concentration to achieve the same sterilization effect. Experimentally confirmed, vaporized hydrogen peroxide, its ability to kill bacterial spores is about 200 times greater than liquid hydrogen peroxide. People use this characteristic, VHP as a new type of sterilization process, is widely used in the pharmaceutical industry sterilization process, generally we use 3% concentration of VHP to the clean room surface sterilization, 35% concentration of VHP is used to the isolator, the transfer bin and so on the surface sterilization.
Undoubtedly, vaporized hydrogen peroxide (VHP) sterilization has the advantages of low temperature, fast, non-toxic and non-residue, etc. However, hydrogen peroxide has strong oxidizing property, so while VHP sterilizes the surface, it also has certain corrosive ability to the surface of the object. For sterile pharmaceuticals, the Good Manufacturing Practice (GMP) requires 7 * 24 hours non-stop supervision of drug production, which requires companies to install laser particle counters to ensure real-time data monitoring records. Take the filling machine as an example, in the class A environment, the laser particle counter should not only meet the GMP requirements for real-time uninterrupted monitoring and recording of drug filling, but also in the VHP sterilization with the characteristics of anti-VHP.
Currently in the laser particle counter market, TSI and other laser particle counter suppliers can provide anti-VHP laser particle counters to meet the needs of the majority of pharmaceutical companies. For laser particle counters, since the principle of light scattering is used to measure the particle size and number of particles in the air, when the particle counter is exposed to VHP, it will cause damage to the optics of the particle counter, which will affect the precision of the measurement, resulting in poorer accuracy and affecting the life of the counter. Generally, we usually use two testing methods to test the laser particle counter. One method is to use the same VHP sterilization process environment of pharmaceutical companies to sterilize the laser particle counter and to meet the requirements of the indexes to test the sterilization effect. Another method is to design a simulation experiment to test the anti-VHP performance of laser particle counters according to the VHP sterilization method, and we will briefly discuss the two test methods below:
TSI's AeroTrak series laser particle counters are coated with a special VHP-resistant coating on the surface of the optical device to achieve anti-VHP properties, and the test experiment uses the first test method, i.e., the same process as a pharmaceutical company with the same VHP concentration to test the particle count. TSI commissioned Bioquell, a leader in the VHP generator industry, to conduct independent testing, as shown below:
Another test method, based on the VHP sterilization method, was designed as follows:the particle counter sampling probe was placed in a 30% VHP beaker, with the probe positioned 6mm (1/4inch) above the liquid surface, and pumped through an external vacuum pump to test the effect of hydrogen peroxide on the particle counter. Macroscopic and microscopic tests were performed to confirm the anti-VHP properties of the laser particle counter.
To sum up, VHP sterilization is used by more and more enterprises as a kind of sterilization, but due to the oxidizing nature of VHP itself, it is inevitable that the surface in contact with VHP has a certain degree of corrosiveness, which puts forward higher requirements on the surface of the relevant instruments, and only after special treatment can it meet the needs of anti-VHP.
Vaporized hydrogen peroxide (VHP) method of sterilization, also known as vaporized hydrogen peroxide sterilization, that is, Vaporized Hydrogen Peroxide, VHP, in the late 80's, the United States Sterilse Co first found that the gas hydrogen peroxide relative to the liquid hydrogen peroxide, only a lower concentration to achieve the same sterilization effect. Experimentally confirmed, vaporized hydrogen peroxide, its ability to kill bacterial spores is about 200 times greater than liquid hydrogen peroxide. People use this characteristic, VHP as a new type of sterilization process, is widely used in the pharmaceutical industry sterilization process, generally we use 3% concentration of VHP to the clean room surface sterilization, 35% concentration of VHP is used to the isolator, the transfer bin and so on the surface sterilization.
Undoubtedly, vaporized hydrogen peroxide (VHP) sterilization has the advantages of low temperature, fast, non-toxic and non-residue, etc. However, hydrogen peroxide has strong oxidizing property, so while VHP sterilizes the surface, it also has certain corrosive ability to the surface of the object. For sterile pharmaceuticals, the Good Manufacturing Practice (GMP) requires 7 * 24 hours non-stop supervision of drug production, which requires companies to install laser particle counters to ensure real-time data monitoring records. Take the filling machine as an example, in the class A environment, the laser particle counter should not only meet the GMP requirements for real-time uninterrupted monitoring and recording of drug filling, but also in the VHP sterilization with the characteristics of anti-VHP.
Currently in the laser particle counter market, TSI and other laser particle counter suppliers can provide anti-VHP laser particle counters to meet the needs of the majority of pharmaceutical companies. For laser particle counters, since the principle of light scattering is used to measure the particle size and number of particles in the air, when the particle counter is exposed to VHP, it will cause damage to the optics of the particle counter, which will affect the precision of the measurement, resulting in poorer accuracy and affecting the life of the counter. Generally, we usually use two testing methods to test the laser particle counter. One method is to use the same VHP sterilization process environment of pharmaceutical companies to sterilize the laser particle counter and to meet the requirements of the indexes to test the sterilization effect. Another method is to design a simulation experiment to test the anti-VHP performance of laser particle counters according to the VHP sterilization method, and we will briefly discuss the two test methods below:
TSI's AeroTrak series laser particle counters are coated with a special VHP-resistant coating on the surface of the optical device to achieve anti-VHP properties, and the test experiment uses the first test method, i.e., the same process as a pharmaceutical company with the same VHP concentration to test the particle count. TSI commissioned Bioquell, a leader in the VHP generator industry, to conduct independent testing, as shown below:
Another test method, based on the VHP sterilization method, was designed as follows:the particle counter sampling probe was placed in a 30% VHP beaker, with the probe positioned 6mm (1/4inch) above the liquid surface, and pumped through an external vacuum pump to test the effect of hydrogen peroxide on the particle counter. Macroscopic and microscopic tests were performed to confirm the anti-VHP properties of the laser particle counter.
To sum up, VHP sterilization is used by more and more enterprises as a kind of sterilization, but due to the oxidizing nature of VHP itself, it is inevitable that the surface in contact with VHP has a certain degree of corrosiveness, which puts forward higher requirements on the surface of the relevant instruments, and only after special treatment can it meet the needs of anti-VHP.
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