The sterilization process operation of
Aseptic treatment,
monitoring and validation
(The
sterilization process operation of aseptic treatment, monitoring, validation
of
water,
liquid and products of hospital, pharmaceutical, medical device, biologicals)
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The
right aseptic process treatment, monitoring, validation and application of steam, dry heat, EO-gas and radiation sterilization application treatment |
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correct aseptic treatment, monitoring and validation of autoclave, dry
heat, EO- gas and radiation sterilization treatment and application are
the factor and point to ensure the sterilized water, liquid and products
up to the bacteria-free, germ-free of
aseptic
water, liquid and products for application or not
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The
factor of steam, dry heat, EO-gas, radiation sterilization 1.
The pre-sterilization bacterial contaminations low than:≦100
CFU/ml 2.
The sterilization effect of sterilization functional temperature, dosage,
concentration and times being acted on the cooling point of
sterilized
water,
liquid and products up to 8D (99.999999%) sterilization rate 3.
The post-sterilization bacterial residues up to low than:≦10-6
CFU/ml
Standard
sterilization formula:
F
= D x (Log A – Log B)
Example:
Autoclave:
121oC,
30 minutes sterilization
If
the sterilization factor are validated correctly, the sterilization
effect
can be performed 8D (99.999999%) sterilization rate, the bacterial residues up to low than≦10-6 CFU/ml
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The
conventional culture media are hard to be cultivate the bacterial
contaminations So
most of customer are established the misconcept of disinfection and
sterilization, and they are considered that all the bacteria, virus,
fungi, mold and microorganisms are
easy to be killed, disinfected and destroyed to die completely being
transformed into the inactive organisms to do the bacteria free water,
liquid, products simply and effectively However,
They are always found that the sterilized water, liquid and products after |
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1.
most of customers are applied the standard sterilization procedure of
steam,
dry heat, EO-gas, radiation sterilization to sterilize, why can not destroy the bacterial residues down to low than≦10-6 CFU/ml
a.
autoclave sterilization procedure: 121oC,
30 minutes b. pasteurization sterilization procedure: 80~100 oC, 12~24 hours
≦100 CFU/ml
sterilization rate
aseptic standard
the residues ? ? ≦10-6 CFU/ml ?
[point]
1.
the sterilization temperature, dosage, concentration of sterilization unit
are not
same
as the functional temperature, dosage, concentration being acted on the
sterilized
water, liquid and products
2.
not to make sure the cooling point, the functional temperature,
concentration,
dosage
being acted on the sterilized water, liquid and products up to expected
sterilization
temperature, dosage, concentration or not, the expected functional
times
at expected sterilization temperature, dosage, concentration, how to make
sure
the clear sterilization rate to destroy the residues up to≦10-6
CFU/ml
[analysis]
1.
the conventional culture media are only to monitor and validate the
bacteria
count
up to ≦1
CFU/ml (≦10
0 CFU/ml)
2.
the conventional culture media of membrane filter are only to monitor and validate the bacteria count up to ≦0.01 CFU/ml (≦10 -2 CFU/ml) |
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2.
most of customers are applied the 10 5 CFU/ml biological
indicator as
the
aseptic indicator of sterilized water, liquid and products, however,
when
the sterilized biological indicator to be validated up to aseptically,
the
sterilized water, liquid, products are still contaminated with high
contents
of bacteria, virus, pyrogenic bacteria, fungi contaminations
a.
The
sterilized biological indicator are monitored and validated at the
positive
bacterial
reaction, it’s shown that the microorganisms of biological indicator
are
sterilized incompletely, and the sterilized water, liquid and products are
sterilized
incompletely too
b.
The
sterilized biological indicator are monitored and validated at the
negative
bacterial
reaction, it’s shown that the microorganisms of biological indicator
are
sterilized completely, and the same sterilized biological indicator point
of
sterilized
water, liquid, products are sterilized at the same sterilization rate of
the
biological indicator being sterilized, not shown that all the sterilized
water, liquid, products being sterilized at same sterilization rate
≦100 CFU/ml sterilization rate aseptic standard
the residues
? ? ≦10-6 CFU/ml ?
[point]
1.
the sterilization validation of biological indicator are only applied to
confirm
the
lethal rate of sterilized water, liquid, products, not shown that the
residues
of
sterilized water, liquid, products are sterilized up to aseptic or not
2.
if the biological indicator are not validated the sterilization effect at
the cooling
point,
it can not be shown that all
the sterilized water, liquid and products are sterilized
at least over the same sterilization rate as the biological indicator being
sterilized
[analysis]
1.
the high bacterial count of biological indicator are more easy to monitor
and
validate
the sterilized water, liquid and products being sterilized at more high
sterilization
rate are sterilized up to aseptic or not
2.
the conventional 105 CFU/ml 3M biological indicator are only
confirmed and
validated
the sterilized water, liquid
and products being sterilized at 5D
(99.999%)
sterilization rate |
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3.
most of customers are applied the 10 5 CFU/ml biological
indicator at
the
cooling point as the aseptic indicator of sterilized water, liquid and
products,
however, when the biological indicator to be validated up to
aseptically,
the sterilized water, liquid,
products are still contaminated with high contents of bacteria, virus, fungi contaminations
a.
The
sterilized biological indicator of cooling point are monitored and
validated
at
the positive bacterial reaction, it’s shown that the organisms of
biological
indicator
are sterilized incompletely, and the sterilized water, liquid, products
are
sterilized incompletely too
b.
The
sterilized biological indicator of cooling point are monitored and
validated
at
the negative bacterial reaction, it’s shown that the organisms of
biological
indicator
are sterilized completely, and all the sterilized water, liquid, products
are sterilized at least over the sterilization rate of the
biological indicator being sterilized, but not shown that the sterilized water, liquid, products up to aspetic
≦100 CFU/ml sterilization rate aseptic standard
cooling point the residues ? 5D (99.999%) ≦10-6 CFU/ml ?
[point]
1.
the validation of biological indicator at the cooling point are only
applied to
confirm
the lethal rate of sterilized water, liquid, products, not shown that the
residues
of sterilized water, liquid, products are sterilized up to aseptic or not
2.
the lethal rate of cooling point of biological indicator validation are
needed
to
validate more high than the lethal rate of sterilized water, liquid,
products
at
the pre-sterilization and post-sterilization(the residues up to≦10-6
CFU/ml)
which
are easy to sterilize the sterilized water, liquid, products up to aseptic
[analysis]
1.
the high bacterial count of biological indicator are more easy to monitor
and
validate
the sterilized water, liquid and products being sterilized at more high
sterilization
rate are sterilized up to aseptic or not
2.
the conventional 105 CFU/ml 3M biological indicator are only
confirmed and
validated
the sterilized water, liquid and products being sterilized at 5D
(99.999%)
sterilization rate |
|
4.
most of customers are applied the standard sterilization procedure to
monitor
and validate the sterilization effect of cooling point up to the
expected
sterilization temperature, dosage, concentration and times for
effective sterilization application, why the sterilized water,
liquid and
products
are always found to be contaminated with high contents of
bacteria,
virus, fungi contaminations
a.
The
expected
sterilization temperature, dosage, concentration and times of
cooling
point validation are only approved that the sterilization effect can be
performed
8D (99.999999%) sterilization rate, not validated that the sterilized
water, liquid, products being sterilized up to aseptic free
b.
If the bacterial contaminations of pre-sterilized water, liquid, products
can be
controlled
low than≦100
CFU/ml, the
sterilized water, liquid, products are
easy
to be sterilized up to aseptic free
c.
If the bacterial contaminations of pre-sterilized water, liquid, products
can not
be
controlled low than≦100
CFU/ml, the
sterilized water, liquid, products are hard
to be sterilized up to aseptic free
≦≧100 CFU/ml sterilization rate aseptic standard
cooling point the residues ? 8D (99.999999%) ≦≧10-6 CFU/ml ?
[point]
1.
the sterilization aseptic validation are needed to validate the residues
of
sterilized
water, liquid, products up to≦10-6
CFU/ml,
the 8D sterilization rate
validation
of expected sterilization temperature, dosage, concentration and
times being acted on the sterilized water,
liquid, products are not
enough to
approve the residues of sterilized water,
liquid, products up to≦10-6
CFU/ml,
2.
the sterilization effect of ClO2, NaClO, O3, formalin and other
disinfectant,
steriliants
are easy to be confused the bacterial residues of pre-disinfection
treatment up to low than≦100
CFU/ml,
[analysis]
1.
If the bacterial contaminations of pre-disinfection water, liquid and
products
are
monitored and validated low than≦100
CFU/ml,
the post-sterilization
bacterial
residues are easy to reduce down to low than≦10-6
CFU/ml
2.
If the bacterial contaminations of pre-disinfection water, liquid and
products
are
monitored and validated high than≧100
CFU/ml,
the post-sterilization bacterial residues are hard to reduce down to low than≦10-6 CFU/ml
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5.
The disinfected water, liquid, products by the
disinfectant
and steriliant
of
ClO2, NaClO,O3, formalin are easy to be monitored
and validated up
to
aseptic free at conventional culture media, why not applied high
dosage
of ClO2, NaClO,O3, H2O2,
formalin disinfectant and steriliant to
replace
the steam, dry heat, EO-gas, radiation sterilizer for effective
sterilization
application treatment
a. after ClO2, NaClO,O3, H2O2,
formalin disinfection treatment, the bacterial
contaminations
of sterilized water, liquid, products monitored and validated
no
colony growth at conventional culture media are easy to be validated up to
bacteria
free and aseptic free
b.
during ClO2, NaClO,O3, formalin disinfection
treatment, the sterilized water,
liquid,
products will be generated one kind of toxic chemical to inhibit the
microorganisms
growth and kill the microorganisms to die, to ensure the
sterilized
water, liquid, products up to bacteria free and aseptic free
c.
the toxic chemical of ClO2, NaClO,O3, H2O2,
formalin generated will be
increased
the anti-immune, anti-toxic and compatible reaction of human being
≧100 CFU/ml
sterilization dosage, time
aseptic standard
?
higher
dosage for
≦10-6
CFU/ml
higher
sterilization rate
the
residues?
No
colony growth at
High
dosage disinfection 2. for poor country, society and people to survive the life and live
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The
following correct sterilization process unit operation
of
aseptic treatment, monitoring and validation for your reference and application
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1.
before sterilization, the correct sterilization unit operation of aseptic
treatment,
monitoring
and validation to control the bacterial contaminations of pre-sterilized
water,
liquid, products down to low than ≦100
CFU/ml 2.
during sterilization, the correct sterilization unit operation of aseptic
treatment,
monitoring
and validation to sterilize the sterilized water, liquid, products at the
clear
expected sterilization rate up to 8D(99.999999%) sterilization effect
under
expected
sterilization temperature, dosage, concentration and functional times 3.
after sterilization, the correct sterilization unit operation of aseptic
treatment,
monitoring
and validation to monitor and validate the bacterial residues of
post-sterilization
water, liquid, products down to low than≦10-6
CFU/ml up
to aseptic free
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一.
before sterilization, the correct sterilization unit operation of aseptic
treatment,
monitoring and validation to control the bacterial
contaminations
of pre-sterilized water, liquid, products down to low than≦100 CFU/ml
1)
The simple, economic, convenient way to control the bacterial
contaminations
of
pre-sterilized water, liquid, products down to low than≦100
CFU/ml
add
the ClO2, NaClO,O3, H2O2,
formalin disinfectant and steriliant into pre-sterilization
water,
liquid, products to kill and disinfect the bacterial contaminations of
pre-sterilized
water,
liquid, products down to low than≦100
CFU/ml
like
SARS virus sterilization, it’s only applied the 1.0~1.5 ppm dosage of
ClO2, NaClO
disinfectant
into city water treatment, the city water will be out of SARS virus
infection
effectively
If
the sterilization effect of ClO2, NaClO,O3, H2O2,
formalin disinfectant and steriliants
are
clear, effective and without care the problems of toxic chemical
generated, they will
be
widely used at the pre-sterilization water, liquid and products
disinfection treatment
of
hospital, food, pharmaceutical, beverage, mineral water, cans food,
medical device,
biological
products to reduce bacterial contaminations down to low than≦100
CFU/ml,
even
low than≦10
–2 ~ -6 CFU/ml up to aseptic free
after
ClO2, NaClO,O3, H2O2, formalin
disinfectant and steriliants disinfection treatment,
the
correct bacteria residues are needed to be cultured, monitored and
validated at the
de-ClO2,
NaClO,O3, H2O2, formalin disinfectant and
steriliants treatment; If not, you
will
be found that the bacteria residues of post-sterilization water, liquid
and products
are
always higher than ≦10
-6 CFU/ml
2)
The correct way to purify the bacterial contaminations of pre-sterilized
water,
liquid,
products down to low than≦100
CFU/ml are very expensive, high
costs
and investment, and complicated job
The
following correct way of hospitals, pharmaceutical, medical device and
biological products
are applied at autoclave, dry heat, EO-gas, radiation sterilization
treatment to
purify
the bacterial contaminations of pre-sterilized water, liquid, products
down to low
than≦100
CFU/ml
1.
microbiological test, monitoring and validation:
a.
3M aerobic count plate:
for water, liquid
test
b.
MW504 total bacteria count swab:
for water, liquid, products, powder test
2.
aseptic process treatment and application
(needed
to be established the concentration, screening, purification, separation
and
dilution
design for reduce down bacterial contaminations effectively) a. water, liquid aseptic treatment一: like bacteria free water, injection solutions
b.
water, liquid aseptic treatment二:
like pyrogen free water, injection solutions
1.
if disinfection solutions are always aseptic, not bacterial contaminations
the
disinfected products will be low than ≦100
CFU/ml
2. if disinfection solutions are not aseptic, with bacterial
contaminations
the
disinfected products will be high than ≧100
CFU/ml d. needle, pipe, operation parts and accessory aseptic disinfection treatment二:
Keep
filter cartridge at aseptic free
e.
needle, pipe, operation parts and accessory aseptic disinfection treatment三:
↑
↓
Keep
disinfection cleaning solutions at pyrogen free
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二.
during sterilization, the correct sterilization unit
operation of aseptic
treatment, monitoring and validation to sterilize the
sterilized water,
liquid and products at the clear expected sterilization
rate up to 8D
(99.999999%) sterilization effect under the clear
expected sterilization temperature, dosage, concentration and functional times
The correct autoclave, dry heat,
EO-gas and
radiation sterilization treatment
and application are needed to validate the
cooling point sterilization effect of
autoclave, dry heat,
EO-gas and radiation
sterilizer, So the correct sterilization
process unit operation are needed to do the
following sterilization process
monitoring and validation for effective
sterilization treatment and application
1.
to monitor, confirm and validate the cooling point of sterilized water, liquid
and products
2.
to monitor, confirm and validate the sterilization temperature, concentration
and dosage
of cooling point of sterilized
water, liquid and products being functioned to the expected
sterilization temperature,
concentration and dosage or not
3.
to monitor, confirm and validate the sterilization functional time being acted
on the
cooling
point after the cooling point sterilization temperature, concentration and
dosage
being functioned to the expected
sterilization temperature, concentration and dosage
The following chemical indicator, biological
indicator for correct autoclave,
dry heat, EO-gas and radiation sterilization unit operation of aseptic
process
treatment, monitoring and validation
application
1. self contained biological
indicator: (economic, cheap, convenient)
1) bacterial count: 10 6 CFU/ml for 6 D sterilization validation
2) kind:
a. bacillus stearothermophilus for steam, autoclave sterilization application
b.
bacillus subtilis for dry heat, EO-gas sterilization application
2. spores strip of biological indicator:
1) bacterial count: 10 4~8 CFU/ml
for 4~8 D sterilization validation
2) kind:
a. bacillus stearothermophilus for steam, autoclave sterilization application
b.
bacillus subtilis for dry heat, EO-gas sterilization application
c.
bacillus pumilus for radiation sterilization application
3. chemical indicator: 121~250 oC
to monitor the sterilization temperature
4. radiation indicator:
to monitor the radiation sterilization dosage
5.
EO-gas test tube:
to monitor the EO-gas sterilization concentration
6. process chemical indicator: to
monitor the sterilization process temperature
and times:
a. 121 oC, 30 minutes process chemical indicator
b. 131 oC, 3 minutes
process chemical indicator |
Bright Glory enterprise,Co.Ltd/
SanDa membrane &
Nano,Co.Ltd
5F-3,
No.162, Sec. 4, Chunghsiao E. Road, Taipei, Taiwan
Tel:
886-02-2731-8306
Fax: 886-02-2731-8221
web site: www.bge.com.tw web site: http://3w.bge.com.tw Email: hong@bge.com.tw