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Virus inactivation method of blood components and application of ultraviolet UV lamp sterilization technology

Virus inactivation of blood components is of great significance to ensure the safety of blood components from the perspective of ensuring medical and health care.
Blood virus inactivation technology refers to the production process of blood products (referring to products prepared from human blood) and specific virus removal/inactivation methods, including the selection of indicator viruses and virus removal/inactivation methods, and the design of verification programs , results judgment, etc., currently known viruses transmitted through blood products mainly include HBV, HCV, HIV-1, HIV-2, HTLV and B19.
Related viruses and indicator viruses of blood-borne diseases (cases )

Virus Genome lipid envelope virus diameter example virus
HIV RNA Y 80-100nm AIDS
HBV GOUT Y 45nm Duck hepatitis B virus, pseudorabies virus
HCV RNA Y 40-60nm Sindbis virus
SEA RNA N 27nm HAV, poliovirus, encephalomyocarditis virus (EMC)
B19 GOUT N 20nm canine parvovirus
 
       In the field of blood testing, although blood products have been tested for viruses, the risk of virus transmission through blood still exists. In the medical environment, various internal and external factors can easily lead to contamination of blood products directly. The sensitivity of testing methods and reagents is limited, and the window Period problems, limited types of virus detection, emergence of new viruses, etc., lead to certain deviations in blood test results. Effective blood virus inactivation and sterilization can reduce the risk of blood-borne diseases and prevent detection deviations to a certain extent. In order to improve the safety of blood products, the detection and reprocessing of blood in the medical field must have certain technical means to remove/inactivate some viruses, and specific virus removal/inactivation methods should be used in the production process.
Status of blood product safety (risk factor for virus missed detection)
  Hepatitis B (HBV) Hepatitis C (HCV) AIDS (HIV)
International (Japan) 1/10000~1/100000 1/1000000~1000000 1/1000000~1/10000000
domestic 1/3000000 1/4000000 1/50000000
The data comes from the 2019 network data literature, if there is any deviation, please point out.
How to choose a technical solution for virus removal/inactivation in blood products, because different blood products have different potential for virus contamination, the focus of choosing virus removal/inactivation methods should also be different. Under the background of existing medical technology, there are mainly the following types:
  • Pasteurization (pasteurization)
Mainly used in human albumin products and other blood products (liquid preparations). The composition of blood products, stable doses (such as citrate, amino acids, sugars, etc.) and the concentration of the products will all have a certain impact on the virus inactivation effect. Therefore, the virus inactivation effect verification must be carried out when the pasteurization inactivation method is used. Decades of clinical application results show that albumin pasteurization is safe for HIV and hepatitis viruses, but when pasteurization is used, the facility must be verified that the parameters of pasteurization meet the requirements, including Homogeneity of temperature distribution within the article and inactivation time.
  • dry heat
The dry heat method can be used to inactivate viruses in blood products. For example, continuous heating of blood products at 80°C for 72 hours can inactivate viruses including HBV, HCV, HIV, etc.
  • Organic Solvent/Detergent (S/D) Treatment
Organic solvents such as tributyl phosphate (TNBP) and non-ionized detergents, ritongX-100 or Tween-80 in combination can inactivate lipid-enveloped viruses, but not non-lipid-enveloped viruses.
  • Ultraviolet germicidal lamp UVC radiation sterilization method
Ultraviolet light is a broad-spectrum sterilization method. The principle of sterilization is to use ultraviolet light of appropriate wavelength to destroy the molecular structure of DNA (deoxyribonucleic acid) or RNA (ribonucleic acid) in microbial cells, causing growth cell death and (or) Regenerative cells die to achieve the effect of sterilization and disinfection. Ultraviolet disinfection technology is based on modern epidemiology, medicine and photodynamics, and uses specially designed high-efficiency, high-intensity and long-life UVC band ultraviolet light irradiation to irradiate various bacteria, viruses, parasites in water, air and object surfaces. Insects, algae and other pathogens are killed directly. Ultraviolet radiation can make the bases of bacterial and viral DNA and RNA to form dimers or adducts to inhibit virus replication. The titer of virus decline is related to the intensity of light radiation and exposure time. In an early study, ultraviolet rays inactivated the virus and also inactivated plasma proteins, which was temporarily stopped. With the progress of science, researchers tried to add protein protectants before the experiment to protect the protein from ultraviolet radiation and reduce it. Or fully grasp the radiation dose and exposure time, so that short-wave ultraviolet (UVC) can achieve a good inactivation effect on viruses, especially for non-enveloped viruses, under the premise of little damage to plasma proteins.
The sterilization efficiency of ultraviolet UV on common bacteria and viruses (ultraviolet radiation intensity> 30mj/c㎡)
type name Time to kill 100% (seconds)
 


Bacteria
Bacillus anthracis 0.30
Tetanus bacillus 0.33
Shigella 0.15
Escherichia coli 0.36
Salmonella 0.51
Chigella 0.28
 



virus
flu virus 0.23
phagocytosis virus 0.20
Rotavirus 0.52
Hepatitis B virus (HBV) 0.73
 
Hepatitis C virus (HCV)
60
(irradiation intensity≥60 μW/cm2)
AIDS (HIV)  
Echovirus 0.73
 

mold spores
Aspergillus 0.73-8.80
fecal fungus 8.0
Mucor 0.23-4.67
Aspergillus niger 6.67
       There are also membrane filtration and low pH incubation methods for blood virus inactivation/qu removal, which we will not explain in depth.
       The low-voltage DC DC12V/24V ultraviolet germicidal lamp developed by LONGPRO has high intensity and short sterilization time. During the research and development process of this UV lamp, Langpu Technology has developed two general-purpose UV lamps, such as smart and universal, according to the application fields and usage patterns of blood inactivation and sterilization. The DC12V/DC24V UV lamp has high radiation intensity, short sterilization time, high bacterial killing rate, resistance to start-up shock, and the service life of the switch can reach more than 10,000 times (Lump experimental test data). Among them, the smart model is equipped with the preheating and starting circuit of the patented technology of Langpu low-pressure discharge lamp, which is optimized and safe to match different types of ultraviolet lamps, with less electronic powder loss, less blackheads, and switching times > 10,000 times (Lamp experimental test data), higher UV output = less germicidal lamps + lower system cost + lower maintenance cost, effectively suitable for sterilization in the field of blood inactivation,
       today, the safety of blood products is the main purpose, and the effective removal/inactivation of viruses Due to the large or small limitations of a single virus removal/inactivation method, there is a possibility that some viruses (especially non-enveloped viruses) cannot be completely inactivated. Therefore, the current blood product production process generally The combination of two or more virus removal/inactivation technologies can more effectively and safely ensure the safety of blood products. Ultraviolet UVC blood inactivation technology, as one of the fastest, efficient and low-cost blood inactivation methods, has been widely used in various fields of blood production and extraction research.