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PRINCIPLE, ADVANTAGES,
DISADVANTAGES, APPLICATION
S OF DIFFERENT STERILISATION
METHODS AND IN PROCESS
CONTROL
PREPARED BY
KOSARAJU SAI VIVEK
I M.PHARMACY,
DEPARTMENT OF PHARMACEUTICS
Jss college of pharmacy
contents
1. WHAT IS STERILIZATION
2. METHODS OF STERILIZATION
3. MERITS, DEMERITS
ANDAPPLICATIONS OF DIFFERENT
METHODS OF STERILIZATION
4. PHARMACEUTICAL IMPORTANCE OF
STERILIZATION
5. PHARMACEUTICAL IN PROCESS
CONTROL
WHAT IS STERILIZATION:
Sterilization can be defined as any process that
effectively kills or eliminates transmissible agents
(such as fungi, bacteria, viruses and prions) from a
surface, equipment, foods, medications, or
biological culture medium.
METHODS OF STERILIZATION
 The various methods of sterilization are:
 1. Physical Method
a. Thermal (Heat) methods
b. Radiation method
c. Filtration method
 2. Chemical Method
a. Gaseous method
PHYSICAL METHODS:
1. HEAT STERILIZATION:
 Heat sterilization is the most widely used and
reliable method of sterilization, involving
destruction of enzymes and other essential cell
constituents.
 This method of sterilization can be applied only to
the THERMO STABLE PRODUCTS, but it can be
used for MOISTURE-SENSITIVE MATERIALS.
i) Dry Heat (160-1800˚C) Sterilization for
thermo stable products
ii) moist heat (121-1340 ˚C) sterilization is
used for moisture- resistant materials.
 The efficiency with which heat is able to
inactivate microorganisms is dependent upon
i) the degree of heat, the exposure time and
ii) the presence of water.
 The action of heat will be due to induction of
lethal chemical events mediated through the
action of water and oxygen.
 In the presence of water much lower
temperature time exposures are required to kill
microbe than in the absence of water.
THERMAL (HEAT) METHODS
Thermal methods includes:
i) Dry Heat Sterilization
Ex:1. Incineration
2. Red heat
3. Flaming
4. Hot air oven
ii) Moist Heat Sterilization
1.Dry saturated steam – Autoclaving
2. Boiling water/ steam at
atmospheric
pressure
3. Hot water below boiling point
Dry Heat Sterilization
 It employs higher temperatures in the range of
160-180˚C and requires exposures time up to
2 hours, depending upon the temperature
employed.
 The benefit of dry heat includes good
penetrability and non-corrosive nature which
makes it applicable for sterilizing glass wares
and metal surgical instruments. It is also used
for sterilizing non-aqueous thermo stable
liquids and thermo stable powders.
 Dry heat destroys bacterial endotoxins (or
pyrogens) which are difficult to eliminate by
other means and this property makes it
applicable for sterilizing glass bottles which
are to be filled aseptically
Moist Heat Sterilization
 Moist heat sterilization involves the use of
steam in the range of 121-134˚C. Steam under
pressure is used to generate high temperature
needed for sterilization. Saturated steam acts
as an effective sterilizing agent.
Sterilization methods
Autoclave
 Autoclaves use pressurized steam to destroy
microorganisms, and are the most dependable
systems available for the decontamination of
laboratory waste and the sterilization of
laboratory glassware, media, and reagents.
For efficient heat transfer, steam must flush
the air out of the autoclave chamber.
 Generally the conditions employed are
Temperature upto121-134˚C for 15-20 min under
15 lbs pressure,based on type of metiral used.
Sterilization methods
Radiation Sterilization
 Many types of radiation are used for
sterilization like electromagnetic radiation (e.g.
gamma rays and UV light), particulate
radiation (e.g. accelerated electrons).The
major target for these radiation is microbial
DNA.
 Radiation sterilization with high energy gamma
rays or accelerated electrons has proven to be
a useful method for the industrial sterilization
of heat sensitive products.
 Radiation sterilization is generally applied to
articles in the dry state; including surgical
instruments, sutures, prostheses, unit dose
ointments, plastic syringes and dry
pharmaceutical products.
 UV light, with its much lower energy, and poor
penetrability finds uses in the sterilization of
air, for surface sterilization of aseptic work
areas, for treatment of manufacturing grade
water, but is not suitable for sterilization of
pharmaceutical dosage forms.
LAMINAR AIR FLOW
CHAMBER
Filtration Sterilization
 Filtration process does not destroy but
removes the microorganisms. It is used for
both the clarification and sterilization of liquids
and gases as it is capable of preventing the
passage of both viable and non viable
particles.
 The major mechanisms of filtration are
sieving, adsorption and trapping within the
matrix of the filter material.
 Ex:HEPA FILTERS
 Sterilizing grade filters are used in the
treatment of heat sensitive injections and
ophthalmic solutions, biological products and
air and other gases for supply to aseptic areas.
They are also used in industry as part of the
venting systems on
fermentors, centrifuges, autoclaves and freeze
driers. Membrane filters are used for sterility
testing
 There are two types of filters used in filtration
sterilization:
(a) Depth filters:
(b) Membrane filters: These are porous
membrane about 0.1 mm thick, made of
cellulose acetate, cellulose
nitrate, polycarbonate, and polyvinylidene
fluoride, or some other synthetic material.
CHEMICAL STERILIZATION
METHOD
GASEOUS METHOD
 The chemically reactive gases such as
formaldehyde, (methanol, H.CHO) and
ethylene oxide (CH2)2O possess biocidal
activity. Ethylene oxide is a colorless,
odorless, and flammable gas.
 The mechanism of antimicrobial action of the
two gases is assumed to be through
alkylations of sulphydryl, amino, hydroxyl and
carboxyl groups on proteins and amino groups
of nucleic acids.
 The concentration ranges (weight of gas per
unit chamber volume) are usually in range of
800- 1200 mg/L for ethylene oxide and 15-100
mg/L for formaldehyde with operating
temperatures of 45-63°C and 70-75°C
respectively.
 Both of these gases being alkylating agents
are potentially mutagenic and carcinogenic.
They also produce acute toxicity including
irritation of the skin, conjunctiva and nasal
mucosa
MERITS, DEMERITS AND
APPLICATIONS OF
DIFFERENT METHODS OF
STERILIZATION
S.no METHOD
MECHANISM
MERITS DEMERITS APPLICATIONS
1 Heat
sterilization
Destroys
bacterial
endo toxins
Most widely
used and
reliable
method of
sterilization,
involving
destruction of
enzymes and
other essential
cell
constituents
Can be
applied only
to the
thermo
stable
products
Dry heat is applicable
for sterilizing glass
wares and metal
surgical instruments
and moist heat is
the most dependable
method for
decontamination of
laboratory waste and
the sterilization of
laboratory glassware,
media, and reagents.
S.no METHOD
MECHANISM
MERITS DEMERITS APPLICATIONS
1
2
Gaseous
sterilization
Radiation
sterilization
Alkylation
Ionization of
nucleic acids
Penetrating
ability of gases.
It is a useful
method for the
industrial
sterilization of
heat sensitive
products
Gases being
alkylating agents
are potentially
mutagenic and
carcinogenic.
Undesirable
changes occur in
irradiated
products,an
example is
aqueous solution
where radiolysis
of water occurs.
Ethylene oxide gas has
been used widely to
process heat-sensitive
devices.
Radiation sterilization is
generally applied to articles
in the dry state; including
surgical instruments,
sutures, prostheses, unit
dose ointments, plastics
S.n
o
METHOD
MECHANISM
MERITS DEMERITS APPLICATIONS
1 Filtration
sterilization
Does not destroy
but removes the
microorganisms
It is used for both
the clarification and
sterilization of
liquids and gases as
it is capable of
preventing the
passage of both
viable and non
viable particles
Does not
differentiate
between viable
and non viable
particles
This method is Sterilizing
grade filters are used in
the treatment of heat
sensitive injections and
ophthalmic solutions,
biological products and
air and other gases for
supply to aseptic areas
Pharmaceutical Importance of
Sterilization
 • Moist heat sterilization is the most efficient biocidal
agent. In the pharmaceutical industry it is used for:
Surgical dressings, Sheets, Surgical and diagnostic
equipment, Containers, Closures, Aqueous injections,
Ophthalmic preparations and Irrigation fluids etc.
 • Dry heat sterilization can only be used for thermo
stable, moisture sensitive or moisture impermeable
pharmaceutical and medicinal. These include products
like; Dry powdered drugs, Suspensions of drug in non
aqueous solvents, Oils, fats waxes, soft hard paraffin
silicone, Oily injections, implants, ophthalmic
ointments and ointment bases etc.

 • Gaseous sterilization is used for sterilizing
thermolabile substances like; hormones,
proteins, various heat sensitive drugs etc.
 • U.V light is perhaps the most lethal
component in ordinary sunlight used in
sanitation of garments or utensils.
 • Gamma-rays from Cobalt 60 are used to
sterilize antibiotic, hormones, sutures, plastics
and catheters etc.
 Filtration sterilizations are used in the
treatment of Heat sensitive injections and
ophthalmic solutions, biological products, air
and other gases for supply to aseptic areas.
 They are also used in industry as part of the
venting systems on fermentors, centrifuges,
autoclaves and freeze driers. Membrane filters
are used for sterility testing.
PHARMACEUTICAL IN
PROCESS
CONTROL
 In-process controls (IPC) are checks that are
carried out before the manufacturing process
is completed.
 The function of in-process controls is
monitoring and – if necessary – adaptation of
the manufacturing process in order to comply
with the specifications. This may include
control of equipment and environment, too.

 The In-Process Quality Control system lays
emphasis on the responsibility of
manufacturers processors in ensuring
consistency in quality during all stages of
production by adopting quality control drills
and exercising control on raw materials and
bought-out components, manufacturing
process, packing and final testing.
In-Process Quality Control tests of
tablets
• SIZE & SHAPE
• TABLET THICKNESS
• COLOUR
• HARDNESS
• FRIABILITY
• POTENCY & CONTENT UNIFORMITY
• WEIGHT / WEIGHT VARIATION
• DISINTEGRATION TIME
 BLENDING:
Blend Uniformity:
 Not less than 90.0 % and not more than110.0
% of the labeled claim of drug. Relative
standard deviation (RSD) is not more than 5.0
%.
 HARDNESS – Stokes (Monsanto), Strong
Cobb, Pfizer, Erweka, Hebelein or Schleuniger
tester, units: kg/sq inch of kg/sq cm,
 FRIABILITY –Roche , limit less tan 1%
 UNIFORMITY OF CONTAINER CONTENTS.
 Tablets comply with the test for contents of
packaged dosage forms.
 Select a sample of 10 containers and count the
number of capsules, pessaries, suppositories or
tablets in each container. The average number of
the contents in the 10 containers is not less than
the labelled amount and the number in any single
container is not less than 98 per cent and not more
than 102 per cent of the labelled amount.
 If this requirements is not met, count the
number of the contents in 10 additional
containers. The average number in the 20
containers is not less than the labelled amount,
and the number in not more than 1 of the 20
containers is less than 98 per cent or more
than102 per cent of the labelled amount.
Parenteral Preparations
Parenteral Preparations
 1 Particulate matter
2 Uniformity of content
3 Extractable volume
4 Sterility
5 Pyrogens
6 Uniformity of weight
7 Clarity of solution
8 Leakage
Particulate matter
 Parenteral preparations including solutions
constituted from sterile solids are expected to be
free from particles of approximately 50 μm or
more that can be observed byinspection with the
unaided eye
.
Particulate matter
Sterility
Culture Media
 MEMBRANE FILTRATION.
 After transferring the contents of the container or
containers to be tested to the membrane add an
inoculum of a small number of viable micro-organisms
(not more than 100 CFU) to the final portion of sterile
diluent used to rinse the filter.
 After filtration, aseptically remove the membrane(s)
from the holder, transfer the whole membrane or cut it
aseptically into 2 equal parts. Transfer one half to each
of two suitable media.
 Direct Inoculation. After transferring the contents of
the container or containers to be tested to the culture
medium add an inoculum of a small number of viable
micro-organisms (not more than 100 CFU) to the
medium
Quantity in each container Minimum quantity to be
used
Less than 1 ml Total contents of a
container
40 ml or more but less than
100 ml 20 ml
1 ml or more but less than
40 ml Half the
contents of a container
100 ml or more 10 per cent of the contents
of a
container but not less than
20 ml
 Incubate the inoculated media for not less
than 14 days.
• Observe the cultures several times during the incubation
period. Observe the containers of media periodically
during the 14 days of incubation. If the test specimen is
positive before 14 days of incubation, further incubation
is not necessary.
• For products terminally sterilised by a validated moist
heat process, incubate the test specimen for not less
than 7 days.
• Observation and Interpretation of Results
If no evidence of microbial growth is found, the
preparation under examination complies with the test for
sterility. If evidence of microbial growth is found, the
preparation under examination does not comply with the
Pyrogens
 The test involves measurement of the rise in body temperature of
rabbits following the intravenous injection of a sterile solution of
the substance under examination. It is designed for products that
can be tolerated by the test rabbit in a dose not exceeding 10 ml
per kg injected intravenously within a period of not more than 10
minutes
 Test Animals:
Use healthy, adult rabbits of either sex, preferably of the same variety, weighing
not less than 1.5 kg
 MAIN TEST:
Carry out the test using a group of three rabbits.
PREPARATION OF THE SAMPLE:
Dissolve the substance under examination in, or dilute with, pyrogen-free saline
solution orother solution prescribed in the monograph. Warm the liquid under
examination to approximately 38.5º before injection.
Pyrogens
 INTERPRETATION OF RESULTS:
 If the sum of the responses of the group of three
rabbits does not exceed 1.4º and if the response of
any individual rabbit is less than 0.6º, the
preparation under examination passes the test. If
the response of any rabbit is 0.6º or more, or if the
sum of the response of the three rabbits exceeds
1.4º, continue the test using five other rabbits.
 If not more than three of the eight rabbits show
individual responses of 0.6º or more, and if the sum
of responses of the group of eight rabbits does not
exceed 3.7º, the preparation under examination
passes the test
Uniformity of content
 Determine the content of active ingredient(s) of each of 10
containers taken at random, using the method given in the
monograph or by any other suitable analytical method of
equivalent accuracy and precision.
 The preparation under examination complies with the test if
the individual values thus obtained are all between 85 and
115 per cent of the average value.
 The preparation under examination fails to comply with the
test if more than one individual value is outside the limits
85 to 115 per cent of the average value or if any one
individual value is outside the limits 75 to 125 per cent of
the average value
.
 If one individual value is outside the limits 85 to
115 per cent but within the limits 75 to 125 per
cent of the average value, repeat the
determination using another 20 containers taken
at random.
 The preparation under examination complies with
the test if in the total sample of 30 containers not
more than one individual value is outside the limits
85 to 115 per cent and none is outside the limits
75 to 125 per cent of the average value
Clarity of solution
 Constitute the injection as directed on the label.
a) The solid dissolves completely, leaving no visible
residueas undissolved matter.
b) The constituted injection is not significantly less
clear
than an equal volume of the diluent or of water for
injections contained in a similar container and
examined in the same manner.
Leakage
A LEAKERS TEST :
 It is a useful method for evaluating the efficiency
of the sealing process.
 The test consists of immersing completely the
sterile sealed ampoules in an aqueous dye
bath (0.5 to 1.0% of methylene blue) within a
vacuum chamber.
 Negative pressure of 27 inches Hg or more is
created, a tiny drop of dye solution can penetrate
an opening of an incompletely sealed ampoule.
 the colored ampoule are sorted out during
washing and 100% inspection that follows after.

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Sterilization methods

  • 1. PRINCIPLE, ADVANTAGES, DISADVANTAGES, APPLICATION S OF DIFFERENT STERILISATION METHODS AND IN PROCESS CONTROL PREPARED BY KOSARAJU SAI VIVEK I M.PHARMACY, DEPARTMENT OF PHARMACEUTICS Jss college of pharmacy
  • 2. contents 1. WHAT IS STERILIZATION 2. METHODS OF STERILIZATION 3. MERITS, DEMERITS ANDAPPLICATIONS OF DIFFERENT METHODS OF STERILIZATION 4. PHARMACEUTICAL IMPORTANCE OF STERILIZATION 5. PHARMACEUTICAL IN PROCESS CONTROL
  • 3. WHAT IS STERILIZATION: Sterilization can be defined as any process that effectively kills or eliminates transmissible agents (such as fungi, bacteria, viruses and prions) from a surface, equipment, foods, medications, or biological culture medium.
  • 4. METHODS OF STERILIZATION  The various methods of sterilization are:  1. Physical Method a. Thermal (Heat) methods b. Radiation method c. Filtration method  2. Chemical Method a. Gaseous method
  • 5. PHYSICAL METHODS: 1. HEAT STERILIZATION:  Heat sterilization is the most widely used and reliable method of sterilization, involving destruction of enzymes and other essential cell constituents.  This method of sterilization can be applied only to the THERMO STABLE PRODUCTS, but it can be used for MOISTURE-SENSITIVE MATERIALS. i) Dry Heat (160-1800˚C) Sterilization for thermo stable products ii) moist heat (121-1340 ˚C) sterilization is used for moisture- resistant materials.
  • 6.  The efficiency with which heat is able to inactivate microorganisms is dependent upon i) the degree of heat, the exposure time and ii) the presence of water.  The action of heat will be due to induction of lethal chemical events mediated through the action of water and oxygen.  In the presence of water much lower temperature time exposures are required to kill microbe than in the absence of water.
  • 7. THERMAL (HEAT) METHODS Thermal methods includes: i) Dry Heat Sterilization Ex:1. Incineration 2. Red heat 3. Flaming 4. Hot air oven ii) Moist Heat Sterilization 1.Dry saturated steam – Autoclaving 2. Boiling water/ steam at atmospheric pressure 3. Hot water below boiling point
  • 8. Dry Heat Sterilization  It employs higher temperatures in the range of 160-180˚C and requires exposures time up to 2 hours, depending upon the temperature employed.  The benefit of dry heat includes good penetrability and non-corrosive nature which makes it applicable for sterilizing glass wares and metal surgical instruments. It is also used for sterilizing non-aqueous thermo stable liquids and thermo stable powders.
  • 9.  Dry heat destroys bacterial endotoxins (or pyrogens) which are difficult to eliminate by other means and this property makes it applicable for sterilizing glass bottles which are to be filled aseptically
  • 10. Moist Heat Sterilization  Moist heat sterilization involves the use of steam in the range of 121-134˚C. Steam under pressure is used to generate high temperature needed for sterilization. Saturated steam acts as an effective sterilizing agent.
  • 12. Autoclave  Autoclaves use pressurized steam to destroy microorganisms, and are the most dependable systems available for the decontamination of laboratory waste and the sterilization of laboratory glassware, media, and reagents. For efficient heat transfer, steam must flush the air out of the autoclave chamber.  Generally the conditions employed are Temperature upto121-134˚C for 15-20 min under 15 lbs pressure,based on type of metiral used.
  • 14. Radiation Sterilization  Many types of radiation are used for sterilization like electromagnetic radiation (e.g. gamma rays and UV light), particulate radiation (e.g. accelerated electrons).The major target for these radiation is microbial DNA.  Radiation sterilization with high energy gamma rays or accelerated electrons has proven to be a useful method for the industrial sterilization of heat sensitive products.
  • 15.  Radiation sterilization is generally applied to articles in the dry state; including surgical instruments, sutures, prostheses, unit dose ointments, plastic syringes and dry pharmaceutical products.  UV light, with its much lower energy, and poor penetrability finds uses in the sterilization of air, for surface sterilization of aseptic work areas, for treatment of manufacturing grade water, but is not suitable for sterilization of pharmaceutical dosage forms.
  • 17. Filtration Sterilization  Filtration process does not destroy but removes the microorganisms. It is used for both the clarification and sterilization of liquids and gases as it is capable of preventing the passage of both viable and non viable particles.  The major mechanisms of filtration are sieving, adsorption and trapping within the matrix of the filter material.  Ex:HEPA FILTERS
  • 18.  Sterilizing grade filters are used in the treatment of heat sensitive injections and ophthalmic solutions, biological products and air and other gases for supply to aseptic areas. They are also used in industry as part of the venting systems on fermentors, centrifuges, autoclaves and freeze driers. Membrane filters are used for sterility testing
  • 19.  There are two types of filters used in filtration sterilization: (a) Depth filters: (b) Membrane filters: These are porous membrane about 0.1 mm thick, made of cellulose acetate, cellulose nitrate, polycarbonate, and polyvinylidene fluoride, or some other synthetic material.
  • 20. CHEMICAL STERILIZATION METHOD GASEOUS METHOD  The chemically reactive gases such as formaldehyde, (methanol, H.CHO) and ethylene oxide (CH2)2O possess biocidal activity. Ethylene oxide is a colorless, odorless, and flammable gas.  The mechanism of antimicrobial action of the two gases is assumed to be through alkylations of sulphydryl, amino, hydroxyl and carboxyl groups on proteins and amino groups of nucleic acids.
  • 21.  The concentration ranges (weight of gas per unit chamber volume) are usually in range of 800- 1200 mg/L for ethylene oxide and 15-100 mg/L for formaldehyde with operating temperatures of 45-63°C and 70-75°C respectively.  Both of these gases being alkylating agents are potentially mutagenic and carcinogenic. They also produce acute toxicity including irritation of the skin, conjunctiva and nasal mucosa
  • 22. MERITS, DEMERITS AND APPLICATIONS OF DIFFERENT METHODS OF STERILIZATION
  • 23. S.no METHOD MECHANISM MERITS DEMERITS APPLICATIONS 1 Heat sterilization Destroys bacterial endo toxins Most widely used and reliable method of sterilization, involving destruction of enzymes and other essential cell constituents Can be applied only to the thermo stable products Dry heat is applicable for sterilizing glass wares and metal surgical instruments and moist heat is the most dependable method for decontamination of laboratory waste and the sterilization of laboratory glassware, media, and reagents.
  • 24. S.no METHOD MECHANISM MERITS DEMERITS APPLICATIONS 1 2 Gaseous sterilization Radiation sterilization Alkylation Ionization of nucleic acids Penetrating ability of gases. It is a useful method for the industrial sterilization of heat sensitive products Gases being alkylating agents are potentially mutagenic and carcinogenic. Undesirable changes occur in irradiated products,an example is aqueous solution where radiolysis of water occurs. Ethylene oxide gas has been used widely to process heat-sensitive devices. Radiation sterilization is generally applied to articles in the dry state; including surgical instruments, sutures, prostheses, unit dose ointments, plastics
  • 25. S.n o METHOD MECHANISM MERITS DEMERITS APPLICATIONS 1 Filtration sterilization Does not destroy but removes the microorganisms It is used for both the clarification and sterilization of liquids and gases as it is capable of preventing the passage of both viable and non viable particles Does not differentiate between viable and non viable particles This method is Sterilizing grade filters are used in the treatment of heat sensitive injections and ophthalmic solutions, biological products and air and other gases for supply to aseptic areas
  • 26. Pharmaceutical Importance of Sterilization  • Moist heat sterilization is the most efficient biocidal agent. In the pharmaceutical industry it is used for: Surgical dressings, Sheets, Surgical and diagnostic equipment, Containers, Closures, Aqueous injections, Ophthalmic preparations and Irrigation fluids etc.  • Dry heat sterilization can only be used for thermo stable, moisture sensitive or moisture impermeable pharmaceutical and medicinal. These include products like; Dry powdered drugs, Suspensions of drug in non aqueous solvents, Oils, fats waxes, soft hard paraffin silicone, Oily injections, implants, ophthalmic ointments and ointment bases etc. 
  • 27.  • Gaseous sterilization is used for sterilizing thermolabile substances like; hormones, proteins, various heat sensitive drugs etc.  • U.V light is perhaps the most lethal component in ordinary sunlight used in sanitation of garments or utensils.  • Gamma-rays from Cobalt 60 are used to sterilize antibiotic, hormones, sutures, plastics and catheters etc.
  • 28.  Filtration sterilizations are used in the treatment of Heat sensitive injections and ophthalmic solutions, biological products, air and other gases for supply to aseptic areas.  They are also used in industry as part of the venting systems on fermentors, centrifuges, autoclaves and freeze driers. Membrane filters are used for sterility testing.
  • 30.  In-process controls (IPC) are checks that are carried out before the manufacturing process is completed.  The function of in-process controls is monitoring and – if necessary – adaptation of the manufacturing process in order to comply with the specifications. This may include control of equipment and environment, too. 
  • 31.  The In-Process Quality Control system lays emphasis on the responsibility of manufacturers processors in ensuring consistency in quality during all stages of production by adopting quality control drills and exercising control on raw materials and bought-out components, manufacturing process, packing and final testing.
  • 32. In-Process Quality Control tests of tablets • SIZE & SHAPE • TABLET THICKNESS • COLOUR • HARDNESS • FRIABILITY • POTENCY & CONTENT UNIFORMITY • WEIGHT / WEIGHT VARIATION • DISINTEGRATION TIME
  • 33.  BLENDING: Blend Uniformity:  Not less than 90.0 % and not more than110.0 % of the labeled claim of drug. Relative standard deviation (RSD) is not more than 5.0 %.
  • 34.  HARDNESS – Stokes (Monsanto), Strong Cobb, Pfizer, Erweka, Hebelein or Schleuniger tester, units: kg/sq inch of kg/sq cm,  FRIABILITY –Roche , limit less tan 1%
  • 35.  UNIFORMITY OF CONTAINER CONTENTS.  Tablets comply with the test for contents of packaged dosage forms.  Select a sample of 10 containers and count the number of capsules, pessaries, suppositories or tablets in each container. The average number of the contents in the 10 containers is not less than the labelled amount and the number in any single container is not less than 98 per cent and not more than 102 per cent of the labelled amount.
  • 36.  If this requirements is not met, count the number of the contents in 10 additional containers. The average number in the 20 containers is not less than the labelled amount, and the number in not more than 1 of the 20 containers is less than 98 per cent or more than102 per cent of the labelled amount.
  • 38. Parenteral Preparations  1 Particulate matter 2 Uniformity of content 3 Extractable volume 4 Sterility 5 Pyrogens 6 Uniformity of weight 7 Clarity of solution 8 Leakage
  • 39. Particulate matter  Parenteral preparations including solutions constituted from sterile solids are expected to be free from particles of approximately 50 μm or more that can be observed byinspection with the unaided eye .
  • 42.  MEMBRANE FILTRATION.  After transferring the contents of the container or containers to be tested to the membrane add an inoculum of a small number of viable micro-organisms (not more than 100 CFU) to the final portion of sterile diluent used to rinse the filter.  After filtration, aseptically remove the membrane(s) from the holder, transfer the whole membrane or cut it aseptically into 2 equal parts. Transfer one half to each of two suitable media.  Direct Inoculation. After transferring the contents of the container or containers to be tested to the culture medium add an inoculum of a small number of viable micro-organisms (not more than 100 CFU) to the medium
  • 43. Quantity in each container Minimum quantity to be used Less than 1 ml Total contents of a container 40 ml or more but less than 100 ml 20 ml 1 ml or more but less than 40 ml Half the contents of a container 100 ml or more 10 per cent of the contents of a container but not less than 20 ml
  • 44.  Incubate the inoculated media for not less than 14 days. • Observe the cultures several times during the incubation period. Observe the containers of media periodically during the 14 days of incubation. If the test specimen is positive before 14 days of incubation, further incubation is not necessary. • For products terminally sterilised by a validated moist heat process, incubate the test specimen for not less than 7 days. • Observation and Interpretation of Results If no evidence of microbial growth is found, the preparation under examination complies with the test for sterility. If evidence of microbial growth is found, the preparation under examination does not comply with the
  • 45. Pyrogens  The test involves measurement of the rise in body temperature of rabbits following the intravenous injection of a sterile solution of the substance under examination. It is designed for products that can be tolerated by the test rabbit in a dose not exceeding 10 ml per kg injected intravenously within a period of not more than 10 minutes  Test Animals: Use healthy, adult rabbits of either sex, preferably of the same variety, weighing not less than 1.5 kg  MAIN TEST: Carry out the test using a group of three rabbits. PREPARATION OF THE SAMPLE: Dissolve the substance under examination in, or dilute with, pyrogen-free saline solution orother solution prescribed in the monograph. Warm the liquid under examination to approximately 38.5º before injection.
  • 46. Pyrogens  INTERPRETATION OF RESULTS:  If the sum of the responses of the group of three rabbits does not exceed 1.4º and if the response of any individual rabbit is less than 0.6º, the preparation under examination passes the test. If the response of any rabbit is 0.6º or more, or if the sum of the response of the three rabbits exceeds 1.4º, continue the test using five other rabbits.  If not more than three of the eight rabbits show individual responses of 0.6º or more, and if the sum of responses of the group of eight rabbits does not exceed 3.7º, the preparation under examination passes the test
  • 47. Uniformity of content  Determine the content of active ingredient(s) of each of 10 containers taken at random, using the method given in the monograph or by any other suitable analytical method of equivalent accuracy and precision.  The preparation under examination complies with the test if the individual values thus obtained are all between 85 and 115 per cent of the average value.  The preparation under examination fails to comply with the test if more than one individual value is outside the limits 85 to 115 per cent of the average value or if any one individual value is outside the limits 75 to 125 per cent of the average value .
  • 48.  If one individual value is outside the limits 85 to 115 per cent but within the limits 75 to 125 per cent of the average value, repeat the determination using another 20 containers taken at random.  The preparation under examination complies with the test if in the total sample of 30 containers not more than one individual value is outside the limits 85 to 115 per cent and none is outside the limits 75 to 125 per cent of the average value
  • 49. Clarity of solution  Constitute the injection as directed on the label. a) The solid dissolves completely, leaving no visible residueas undissolved matter. b) The constituted injection is not significantly less clear than an equal volume of the diluent or of water for injections contained in a similar container and examined in the same manner.
  • 50. Leakage A LEAKERS TEST :  It is a useful method for evaluating the efficiency of the sealing process.  The test consists of immersing completely the sterile sealed ampoules in an aqueous dye bath (0.5 to 1.0% of methylene blue) within a vacuum chamber.  Negative pressure of 27 inches Hg or more is created, a tiny drop of dye solution can penetrate an opening of an incompletely sealed ampoule.  the colored ampoule are sorted out during washing and 100% inspection that follows after.

Editor's Notes

  1. The process is more effective in hydrated state where under conditions of high humidity, hydrolysis and denaturation occur, thus lower heat input is required. Under dry state, oxidative changes take place, and higher heat input is required.