Bacterial contaminations

  of pre-sterilized water, liquid

  and products are low than

   ≦100 CFU/ml

   Process sterilization rate

  the cooling point are sterilized at

  expected sterilization tenperature,

  dosage, concentration and times

      8 D (99.999999%)

  Bacterial residues

  of post-sterilized water, liquid

  and products are low than

    ≦10^-6 CFU/ml

aseptic treatment, monitoring

validation of pre-sterilization

sterilization process treatment

 monitoring and validation

aseptic treatment, monitoring

validation of post-sterilization

 conventional

 aseptic treatment:

1. high dosage of ClO2, NaClO,

   formalin to disinfect bacterial

  contaminations down to low

  than ≦100 CFU/ml

2. 0.2 micron filter to purify the

  bacteria contaminations down

  to low than ≦100 CFU/ml

conventional

sterilization process treatment

1. apply the conventional

   sterilization  mode to

   sterilization treatment

121 ^o C, 30 minutes

2. apply the pasteurization mode to

  sterilization treatment

 conventional aseptic

 monitoring and validation:

1. apply culture media to check

   the contaminations of bacteria

   count and pyrogenic bacteria

2. the test data as the reference of

   aseptic process treatment

 conventional sterilization

 monitoring and validation:

1. apply the biological indicator as

   the indication of sterilized water,

   liquid, products up to aseptic free 

   or not

2. apply the chemical indicator as

  the indication of sterilized water,

  liquid, products up to aseptic free 

  or not

3. not to monitor and validate the

  sterilization effect of cooling 

  point

 conventional aseptic

 monitoring and validation:

1. needed 24~72 hours to test the

  sterilized biological indicator

  up to aseptic free or not

2. The 10⁵CFU/ml biological

  indicator only to monitor and

  validate the 5D sterilization rate

3. hard to monitor and validate the

  residues of sterilized products

  up to aseptic free or not

  conventional

 application treatment

1. apply high dosage of ClO2,

   NaClO,formalin to disinfect

  bacterial contaminations down

  to low than ≦100 CFU/ml

2. apply 0.2 micron filter to purify

  bacterial contaminations down

  to low than ≦100 CFU/ml

3. the bacteria test data as the

   reference of aseptic treatment

  conventional

 application treatment

1. apply the biological indicator as

    the indication of sterilized water,

    liquid, products up to aseptic 

    free or not

2. apply the chemical indicator as

    the indication of sterilized water,

    liquid, products up to aseptic 

    free or not

3. extend the sterilization time to

    increase the sterilization rate up 

    to 8D to ensure the sterilization

    completely up to aseptic free

  conventional

 application treatment

1. after the sterilized biologica   

   indicator being validated, the

   sterilized water, liquid and

   products are already used

2. the biological indicator test data 

  as the reference of aseptic

   monitoring and validation

3. apply LAL endotoxin test, or

   animal pyrogen test as the

   aseptic free test

 The analysis of application:

1. not discussed toxic problems,

  high dosage of ClO2, NaClO,

   formalin are easy to disinfect

  bacterial contaminations down

  to low than ≦100 CFU/ml

2. 0.2 micron aseptic filter are

  easy to purify bacterial

  contaminations down to low

  than ≦100 CFU/ml

above method are easy to control the bacteria contaminations low than≦100 CFU/ml without test

 The analysis of application:

1. 10⁵ CFU/ml biological indicator

   are only monitored and validated

   the sterilization rate up to 5D, not 

   8D

2. more sterilization times will be

  increased more sterilization rate

  for more effect to sterilize  the

  sterilized water, liquid, products

  up to aseptic free

more sterilization times are easy to increase the sterilization rate up to 8D or more without test

 The analysis of application:

1. hard to monitor and validate the

   bacterial residues up to low than

   ≦10^-6 CFU/ml or not

2. apply LAL endotoxin test, or

   animal pyrogen test as the

   aseptic free test

the end aseptic monitoring and validation are still needed to apply LAL endotoxin test, or animal pyrogen test as aseptic free test

aseptic treatment, monitoring

validation of pre-sterilization

 sterilization process treatment

 monitoring and validation

aseptic treatment, monitoring

validation of post-sterilization

correct application treatment

1. The bacterial contaminations of

   pre-sterilization water, liquid,

  products are easy to purify up

  to low than≦1~100(10^o~2)

   CFU/ml

  a. ClO2, NaClO, formalin +

    0.2 micron filter

  b. UV sterilizer +0.2 micron

      filter

 correct application treatment

1. apply 10⁶ CFU/ml biological

  indicator as the sterilized water,

  liquid, products being sterilized up

  to aseptic free or not

2. to monitor and validate the cooling

  point of sterilization effect

3. apply process chemical indicator as

  the 8D sterilization rate indicator of

  autoclave sterilization

correct application treatment

1. apply 15~30 minutes of LAL

  endotoxin test as the gram-

  negative bacteria residues low

  than≦10^-6 CFU/ml indicator

2. apply IPT pyrogen test as the

  gram-negative bacteria, gram-

  positive, virus residues low than

  ≦10^-6 CFU/ml indicator

3. apply instant process chemical

  indicator as the 8D sterilization

  rate indicator of autoclave

  sterilization treatment

4. apply 10^6~8 CFU/ml biological

   indicator as the 6D~8D

  sterilization rate indicator

 The analysis of application:

1. the pre-sterilization bacterial

  contaminations are purified the

more clear low than≦1~100

(10 ^0~2)CFU/ml, the sterilization

  effect are more easy to sterilize

  the sterilized water, liquid and

  products up to aseptic free

 The analysis of application:

1. the more high sterilization rate of

   sterilization effect over 6~8 D are

   more easy to sterilize the sterilized

  water, liquid and products up to

  aseptic free

 The analysis of application:

1. instant aseptic free test of sterilized water, liwuid and products will be new direction

  point and application of

  sterilization process operation

  of aseptic treatment, monitoring

  and validation

 [point] 1. the biological indicator can be validated the sterilization bacterial residues low

                than 10 ^-6 CFU/ml up to aseptic free

             2.the 10 ⁶ CFU/ml biological indicator can be validated the effective sterilization

                effect up to 6D (99.9999%) sterilization rate

             3.the bacterial contaminations of pre-sterilized water are easy to be sterilized and

                purified up to low than 10 ⁰ CFU/ml, but hard to be sterilized and purified up

                to low than 10 ^-1 CFU/ml

[description] 1. the conventional culture media are hard to be monitored and validated

                         the bacterial contaminations residues low than 10 ^–3 ~10 ^–6 CFU/ml

                     2. the conventional culture media are hard to be monitored and validated

                         the 6~8D sterilization rate of sterilization effect at the low bacterial

                         contaminated water, liquid and products being sterilized

                     3. the conventional culture media are hard to be monitored and validated

                         the sterilized water, liquid and products which can be sterilized at 6~8D

                         sterilization rate and the sterilized bacterial residues can be sterilized

                        low than 10 ^–6 CFU/ml up to aseptic free or not

  10 ⁶ CFU/ml biological indicator

  10 ⁵ CFU/ml biological indicator

 10 ⁶ CFU/ml biological indicator are applied at the

 sterilization monitoring and validation

1. the bacterial contaminations of pre-sterilized

   water, liquid, products are needed to be purified   

   and sterilized up to low than≦1 CFU/ml (≦10 ⁰

   CFU/ml), the sterilization bacterial residues of

   post-sterilized water, liquid, products are easy to

   be monitored and validated low than10 ^-6 CFU/ml

2. the bacterial contaminations of pre-sterilized

   water, liquid, products are easy to be purified and

   sterilized up to low than 1 CFU/ml (10 ⁰ CFU/ml)

3. the conventional bacterial culture media are easy

   to be monitored and validated the bacterial count

   low than ≦1 CFU/ml (10 ⁰ CFU/ml)

 10 ⁵ CFU/ml biological indicator are applied at the

 sterilization monitoring and validation

1. the bacterial contaminations of pre-sterilized

   water, liquid, products are needed to be purified   

   and sterilized up to low than≦0.1 CFU/ml (≦10 ^-1

   CFU/ml), the sterilization bacterial residues of

   post-sterilized water, liquid, products are able to

   be monitored and validated low than10 ^-6 CFU/ml

2. the bacterial contaminations of pre-sterilized

   water, liquid, products are hard to be purified and

   sterilized up to low than 0.1 CFU/ml (10 ^-1 CFU/ml)

3. the conventional bacterial culture media are hard

   to be monitored and validated the bacterial count

   low than ≦0.1 CFU/ml (10 ^-1 CFU/ml)

 Sterilization application mode

 Pre-sterilized

 Bacterial count

 Sterilization rate

 Post-sterilized

 Bacterial residues

 Standard sterilization

 application mode

 ≦100 CFU/ml

 8 D (99.999999%)

 ≦10^-6 CFU/ml

 10 ⁵ CFU/ml biological indicator

  ≦0.1 CFU/ml

 5 D (99.999%)

 ≦10^-6 CFU/ml

 10 ⁶ CFU/ml biological indicator

  ≦1 CFU/ml

  6 D (99.9999%)

 ≦10^-6 CFU/ml

LAL endotoxin test:  apply to be tested, monitored and validated the endotoxin contents

                  of gram-negative bacteria higher than≦0.2 EU/ml, if the endotoxin

                  contents of sterilized water, liquid, products are monitored low than

                  ≦0.2 EU/ml, it can be validated the gram-negative bacteria residues

                  low than≦10 ^{- 6} CFU/ml, which can be verified the post-sterilized

                  water, liquid, products up to aseptic free or not

pyrogen test:  apply to be tested, monitored and validated the pyrogen contents of gram-

            positive bacteria, gram-negative bacteria, fungi and virus higher than≦0.2

            EU/ml, if the pyrigen contents of sterilized water, liquid, products are

            monitored low than≦0.2 EU/ml, it can be validated the pyrogenic residues

            of sterilization and aseptic treatment of gram-positive bacteria, gram-

            negative bacteria, fungi and virus low than≦10 ^{- 6} CFU/ml, which can be

            verified the post-sterilized water, liquid, products up to aseptic free or not

Process chemical indicator: can be applied to test, monitor and validat the cooling point of

                      sterilization effect up to the expected sterilization temperature,

                      dosage, concentration and times to do 8D (99.999999%)

                      sterilization rate or not, If we can be pre-treated the bacterial

                      contaminations of pre-sterilized water, liquid, products low

                      than≦100 CFU/ml, it can be verified the sterilization bacterial

                      residues low than≦10 ^{- 6} CFU/ml up to aseptic free rapidly

standard sterilization

application mode

 the bacteria count

 of pre-sterilization

  low than

 ≦100 CFU/ml

 sterilization effect

 of sterilization rate

 8 D (99.999999%)

 the bacteria residues

 of post-sterilization

  low than≦10^-6 CFU/ml

 up to aseptic free

LAL Endotoxin test

 directly to check the endotoxin

 content low than 0.2 EU/ml

 and the pyrogenic residues of

 gram-negative bacteria low

 than≦10^-6 CFU/ml or not

Pyrogen test

 directly to check the pyrogen

 content low than 0.2 EU/ml

 and the pyrogenic residues of

 gram-negative/gram-positive

 bacteria, fungi and virus

 low than≦10^-6 CFU/ml or not

sterilization process chemical indicator

 the bacteria count of

 pre-sterilization are

 suggested to be

 purified up to low

 than 100 CFU/ml

directly to check the cooling point of sterilization temperature, dosage, concentration and sterilization times

to do 8D (99.999999%)

sterilization rate or not

 After sterilization, the bacteria

 residues of sterilized water,

 liquid, products can be rapidly

 monitored and validated up to

 low than≦10^-6 CFU/ml or not

 by process chemical indicator

Biological indicator

 the bacteria count of

 pre-sterilization are

 normally suggested

 to be purified up to

 low than 100 CFU/ml

directly to check the lethal rate of cooling point of sterilized biological indicator

10 ⁵ CFU/ml for 5D

10 ⁶ CFU/ml for 6D

 After sterilization, according to

 the bacterial growth rate of

 sterilized biological indicator to

 monitor and validate the

 sterilization rate up to 8D and

 sterilized bacterial residues up

 to low than 10^-6 CFU/ml or not