1. The unclear disinfection, aseptic, sterilization effect of conventional

  disinfection, aseptic and sterilization treatment and design are hard to

  do effective disinfection, aseptic and sterilization effect to disinfect,

  purify and sterilize the water, liquid, products into aseptic free

2. The conventional bacterial culture media are always existed the false

  aseptic free test and monitoring, also hard to be monitored and verified

  the low bacterial residues of sterilized water, liquid and products up to

  aseptic free or not

3.The conventional biological indicator are best aseptic free sterilization

  validation test and monitoring, but still existed the false aseptic free

  sterilization validation test and monitoring,

4.The conventional endotoxin and in vivo pyrogen test(rabbit test) are

  best aseptic free water, liquid and products test and monitoring, but

  still existed the false aseptic free water, liquid and products test and

  monitoring,

and the conventional bacteria, aseptic and sterilization validation test and monitoring are hard to test, monitor and verify the clear bacterial residues of disinfected, aseptic and sterilized water, liquid and products which are the key factor to form the incorrect disinfection, aseptic and sterilization treatment and application

[The bacterial residues of aseptic free, germ free and bacteria free]

1. The bacterial residues definition of aseptic free, germ free and bacteria

  free water, liquid and products for in vitro application

  a. good-for-you microbes: ≦30000 CFU/ml, like yeast, lactobacillus

  b. non-pyrogenic microbes: low than 1, 100 CFU/ml

  c. pyrogenic organisms: ≦0.01 CFU/ml, like E.coli, salmonella, enterovirus,

    and cryptosporidium will be new pyrogenic organisms at city water

2. The bacterial residues definition of aseptic free, germ free and bacteria

  free water, liquid and products for in vivo application

  a. aseptic treatment: low than≦0.001 CFU/ml and endotoxin/pyrogen residues

                  low than≦0.2 EU

  b. sterilization treatment: low than≦0.000001 CFU/ml and endotoxin/pyrogen

                       residues low than≦0.2 EU

1.The definition of disinfection treatment:

  to kill, disinfect and inhibit the bacteria, virus, spores and protozoans into

  inactive organisms to reduce down the bacterial contaminations, and to prevent

  and inhibit the bacteria, virus, spores and protozoans being wide contaminated,

  spreaded and infected effectively are called disinfection treatment

  The conventional disinfection treatment method: like sun, light, burn, boiling,

  heat, ozone, ultraviolet, chlorine, formalin, chemical disinfectant, cleaner,

  Normally, The most of people are misconsidered that the bacteria, virus, spores

  and protozoans will be disinfected into inactive completely and the disinfected

  water, liquid and products should be aseptic free, germ free and bacteria free

  after disinfection treatment

2.The definition of sterilization treatment:

  to kill and destroy the bacteria, virus, spores and protozoans into inactive

  organisms completely, and reduced down the bacterial residues of sterilized

  water, liquid and products low than 0.000001 CFU/ml effectively are called

  sterilization treatment

  The conventional sterilization treatment method: like steam, dry heat, EO-gas

  and radiation sterilization treatment

  Normally, The most of people are misconsidered that the bacteria, virus, spores

  and protozoans will be sterilized into inactive completely and the sterilized

  water, liquid and products should be aseptic free, germ free and bacteria free

  after sterilization treatment

3.The definition of aseptic treatment:

  to purify the bacteria, virus, spores and protozoans of water ,liquid and products

  clear completely and effectively by the aseptic 0.2 micron and UF/NF/RO filter

  membrane up to aseptic free of germ free, bacteria free, endotoxin free and

  pyrogen free water, liquid and products, the bacteria residues low than≦0.001

  CFU/ml and endotoxin/pyrogen residues low than 0.2 EU are called aseptic

  treatment

  The conventional aseptic treatment method are applied the 0.2 micron aseptic

  filter cartridges and aseptic UF/NF/RO membrane to filter and adsorb the 0.2~

  22 micron particle size of bacterial microbes and 0.1~0.001 micron particle size

  of virus, endotoxin and pyrogen clear

  Normally, The most of people are misconsidered that the bacteria, virus, spores

  and protozoans will be filtered and purified clear completely and the filtered and

  purified water, liquid and products should be aseptic free, germ free, bacteria

  free, endotoxin free and pyrogen free after 0.2 micron filter cartridges and UF/

  NF/RO membrane aseptic treatment

 sterilization validation and endotoxin/pyrogen test]

1.The aseptic test, monitoring and validation of bacterial culture test

  apply the culture media to cultivate the bacteria, virus, spores and protozoans

  into colony to test, monitor and validate the bacterial contents of water, liquid

  and products up to aseptic free or not

  Due to the formation of colony are designed to be cultivated at the 1, 10, 100

  CFU/ml and also inhibited by the disinfectant, steriliant and antibiotics, So the

  culture media are easy to be cultivate the false aseptic free test, monitoring and

  validation result

  Normally, The culture media are unavailable used at the low bacterial residues

  and conatined the disinfectant, steriliant and antibiotics of disinfected and

  sterilized water, liquid and products test, monitoring and validation

  Although the low bacterial residues of membrane, ATP (adenosine triphosphate)

  test have already been development and application, but still confined at the

  bacterial residues range of 0.01~0.001 CFU/ml aseptic test, monitoring and

  validation

2.The aseptic test, monitoring and validation of sterilization validation

  apply the sterilization validation factor of the pre-sterilization bacterial contents

  of water, liquid and products, and the process sterilization temperature, dosage,

  concentration and times being acted on the cooling point of sterilized water,

  liquid and products to test, monitor and validate the post-sterilization bacterial

  residues of sterilized water, liquid and products up to 0.000001 CFU/ml or not

  The aseptic test, monitoring and validation of sterilization validation are

  included the process steam, dry heat, EO-gas and radiation sterilization test,

  monitoring and validation of biological indicator, not included the process

  steam, dry heat, EO-gas and radiation sterilization application of chemical

  indicator

  Normally, all most of customers are misconsidered that the sterilization dosage,

  temperature, concentration test, monitoring and validation of chemical indicator

  can be acted as the sterilization validation indicator of aseptic test, monitoring

  and validation, and the lethal rate of biological indicator can be acted as the sterilization

  validation indicator of aseptic test, monitoring and validation,

  In factually, The aseptic test, monitoring and validation of sterilization

  not so simple and easy to test, monitor and validate the sterilized

  water, liquid and products up to aseptic free being performed by the above

  individual test, monitoring and validation

  The correct aseptic test, monitoring and validation of sterilization validation are

  needed to test, monitor and validate the bacteria contaminations of pre-sterilized

  water, liquid and products, the sterilization temperature, concentration and

  dosage of the cooling point of sterilized water, liquid and products being

  functioned up to the expected sterilization temperature, concentration and

  dosage, the resistance (D-value) of sterilized bacterial contaminations, and the

  bacterial residues of post-sterilized water, liquid and products being sterilized up

  to 0.000001 CFU/ml simultaneously

  Although the biological indicator are real, correct and best aseptic test,

  monitoring and validation of sterilization validation to test, monitor and validate

  the bacterial residues of sterilization validation,, If the biological indicator are

  not tested, monitored and validated the populations and the resistance (D-value)

  of sterilized spores, and the sterilization validation being tested, monitored and

  validated at the cooling point of process sterilization , It’s still belonged to

  non-aseptic test, monitoring and validation of sterilization validation and hard to

  confirmed the bacterial residues of sterilized water, liquid and products being

  sterilized up to 0.000001 CFU/ml or not

  More high populations of biological indicator for more high efficiency aseptic

  test, monitoring and validation of sterilization validation, but costs and expense

  are too expensive.

  Normally, most of customers are applied the low populations, unknown D-value

  of biological indicator and the unstability growth promotion rate of self-made

  culture media (soy bean broth) for low costs and expense, economic and cheap

  aseptic test, monitoring and validation of sterilization validation which are hard

  to test, monitor and validate the sterilized water, liquid and products up to low

  bacterial residues low than 0.000001 CFU/ml of aseptic free water, liquid and

  products or not

  Most important at the EO-gas sterilization validation application, The EO-gas

  biological indicator are hard to do effective sterilization validation to test,

  monitor and validate the sterilized water, liquid and products being sterilized up

  to aseptic free or not

3. The aseptic test, monitoring and validation of aseptic free validation

  The aseptic test, monitoring and validation of aseptic free validation are applied

  the endotoxin, pyrogen test to test, monitor and validate the endotoxin, pyrogen

  residues of aseptic free water, liquid and products up to low than 0.2 EU, and

  the bacterial residues low than 0.001~0.000001 CFU/ml or not

  a. LAL endotoxin test: to test, monitor and validate the gram-negative bacterial

                     endotoxin residues low than 0.2 EU, gram-negative

                     bacterial residues low than 10 ^{–3 ~ –6} CFU/ml or not

  b. in-vivo pyrogen test: to test, monitor and validate the gram-negative and

                     gram-positive bacterial endotoxin residues low than 0.2

                     EU, gram-negative and gram-positive bacterial residues

                     low than 10 ^{–3 ~ –6} CFU/ml or not

The self-contained biological indicator and specfici incubator for international sales and service, Please contact: bright@bge.com.tw