Aerosols are two-phase systems with a liquid or solid dispersed phase and a gas continuous phase. They have four main components: propellants, containers, valves and actuators. There are two main types of filling operations for aerosols - cold filling and pressure filling. Cold filling involves chilling the propellant and product concentrate before filling while pressure filling uses compressed gases to add propellants under pressure at room temperature. Quality control testing of aerosols includes checking the propellants, leak testing filled containers, and spray pattern testing to ensure proper valve function. Containers are also checked for weight and leaks before being packaged, labeled and distributed.

2. BUSHRA
RUBAB

3. AEROSOLS
 Aerosols are defined as a disperse phase
system in which solid particles or liquid
droplets constitute the disperse phase and
gas in the continuous phase.

4. HISTORY
 In 1942, First aerosol was developed.
(insecticide)
 In1950, Pharmaceutical aerosol for
topical administration was developed.
 In 1955, Aerosol for the local activity
in the respiratory tract was developed
(Epinephrine).

5. COMPONENTS OF AEROSOLS
Propellant Container
Valve Actuator

6. PROPELLANT
 The propellant is responsible for develop
pressure within an aerosol system to expel
material from the container.
TYPES OF PROPELLENT
Liquefied gas
propellant
• gases that exist
as liquids under
pressure.
• liquid volume is
increased.
Compressed gas
propellant
• occupy the head
space above the
liquid in the can.
• No increased in
liquid volume.

8. CONTAINER
 They must be able to withstand pressures as
high as 140 to 180 psig (pounds per sq. inch
gauge) at 130 ° F.
TYPES OF
CONTAINERS
Metals
• Tin-plated steel
• Aluminum
• Stainless steel
Glass
• Uncoated glass
• Plastic coated
glass

10. VALVES
 Easy to open and
close .
 It can deliver a given
amount of
medicament.
TYPES OF
VALVES
CONTINIOUS
SPRAY VALVE
• Used for topical
aerosols
METERING
VALVE
• Used for
dispensing of
potent
medication.

11. ACTUATORS
 These are specially
designed buttons which
helps in delivering the
drug in desired form.
TYPES OF ACTUATORS
SPRAY
ACTUATORS
• used for topical
preparation.
• antiseptics,
local
anesthetics,
spray on
bandages etc.
FOAM
ACTUATORS
• consist of large
orifice which
ranges from
0.070-0.125
inch .
SOLID STEAM
ACTUATORS
• for dispensing
semi solid
products such
as ointments.
SPECIAL
ACTUATORS
• deliver the
medicament to
the appropriate
site of action
such as throat,
nose, dental
and eyes etc.

12. FORMULATION
It consist of two essential components :
 Product concentrate
 Propellant
Product concentrate :
•Active ingredient or mixture of active ingredients and
other necessary agents such as solvents, anti oxidants
and surfactants.
Propellant :
• Single or blend of various propellants is used.
• Blend of solvents is used to achieve desired solubility
characteristics.
•Since the opening of valve is smaller 0.018-0.030 inches,
limits the production and process become slow
•But with use of rotary filling machine, the production rate
is increased

13. JAVERIA
RAHAT

14. CONTAINER OF
AEROSOLS

15. CONTAINER
 Container must withstand pressure
140-180psig at 130F
Metal container
• Tin plate steel
• Aluminum
• Stainless
steel
Glass
container
• Plastic coated
glass

16. TIN PLATE STEEL CONTAINER
 Tin-plated steel containers are light weight and
relatively inexpensive. For some products the tin
provides all the necessary protection.
 However when required, special protective
coatings are applied to the tin sheets prior to
fabrication so that the inside of the container will be
protected from corrosion and interaction between
the tin and the formulation.
 The coating usually is an oleoresin, phenolic, vinyl,
or epoxy coating. The tin plated steel containers
are used in topical aerosols.

18. ALUMINUM CONTAINER

19. STAINLESS STEEL
CONTAINERS
 Stainless steel is used when the container must be
chemically resistant to the product concentrate.
The main limitation of these containers is their high
cost.

20. GLASS AEROSOLS
CONTAINERS
 glass containers are used in products
that have lower pressures and lower
percentages of propellants.

21. PLASTIC COATING GLASS
CONTAINER
 Glass can be used for various purposes like:
Resistance
to breakage
prevent the
glass from
shattering
into
fragments if
broken
protect the
contents
from
ultraviolet
light
act as a means
of identification
since the
coatings are
available in
various colors.

22. PREPARATION OF PRODUCT
CONCENTRATE
 The aerosol concentrate consists of drug or
combination of drugs, solvents, antioxidants and
surfactants formulated as solution, suspension .
 The aerosol concentrate is first prepared and
filled into the container.
 The propellant is then filled into the container.
Therefore, part of the manufacturing operation
takes place during the filling operation measures
to ensure that both concentrate and propellant
are brought together in the proper proportion.

23. UROOBA IQBAL

24. VALVES
• Capable of delivering the content in the desired form
such as spray, foam, solid stream etc.
TYPES OF VALVES
Continuous
Spray
Valves
Metered
Valves

25. CONTINUOUS SPRAY VALVE
 Used for
topical aerosols
.

26. VALVE ASSEMBLY
 Valves assembly
consists of:
 Ferrule or
mounting cup
 Valve body or
housing
 Stem
 Dip tube
 Gasket
 Spring

27.  FERRULE OR MOUNTING CUP :
• Used to attach valve to container.
• Made from Tin plated steel, Al , Brass .
• Under side of the valve cup is coated with single or double
epoxy or vinyl resins.
 VALVE BODY OR HOUSING :
• Made up of Nylon or Derlin and contains a opening at the
point of attachment of dip tube.
 STEM :
• Made from Nylon or Derlin , brass and stainless steel can
also be used.
 GASKET :
• Made from Buna-N and neoprene rubber.
 SPRING :
• Made from Stainless steel .
• Used to hold gasket in place.

28. METERING VALVES
 DIP TUBE :
• Made from Poly ethylene or poly propylene.
• Inner diameter 0.120 – 0.125 inch.
• However for Capillary dip tube inner diameter is
0.050 inch and for highly viscous products it is
0.195 inch.
•Used for dispensing of
potent medication.
• Operates on the principle
of a chamber whose size
determines the amount of
medication dispensed.
• Approximately 50 to 150
mg ±10 % of liquid materials
can be dispensed at one
time with the use of such
valve.

29. ACTUATORS
 These are specially designed buttons which helps
in delivering the drug in desired form i.e., spray,
wet stream, foam or solid stream .

30. TYPES OF ACTUATORS
Spray
actuators
Foam
actuators
Solid
steam
actuators
Special
actuators

31.  SPRAY ACTUATORS:
• It can be used for topical preparation, such as antiseptics,
local anesthetics and spray on bandages etc.
• It allows the stream of product concentrate and propellant to
pass through various openings and dispense as spray.
 FOAM ACTUATORS :
• It consist of large orifice which ranges from 0.070—0.125
inch .
 SOLID STREAM ACTUATORS :
• These actuators are required for dispensing semi solid
products such as ointments .
 SPECIAL ACTUATORS:
• These are used for a specific purpose.
• It delivers the medicament to the appropriate site of action
such as throat, nose, dental and eyes etc.

32. NIDA
ASHRAF

33. PHASES OF AEROSOLS
There are two phases
of aerosols:
• Two phase
system/solution
system
• Three phase
system/water based
system

34. TWO PHASE SYSTEM/SOLUTION
SYSTEM
 Formed by using liquefied gases in the form
of propellants
 Simplest system
 The two phases are:
Liquid
phase
Vapor
phase

35. Product concentrate is dissolved in
liquefied propellant
This solvent creates a homogenous
system.
Co-solvents are added to enhance
the solubility of the active
ingredients.

37. Advantages
To produce
a fine mist
or wet spray
To formulate
aerosols for
inhalation
nasal
application

38. 1: A layer of water
immiscible liquid propellant
2: A layer of highly aqueous
product concentrate
3: The vapor phase.
THREE PHASE SYSTEM OR
WATER BASED SYSTEM
 The three
phases are:

39. Purpose
when the formulation
requires the presence of a
liquid phase that is not
propellant miscible.
If CFCs, HCFCs, and HFCs are used as the
propellants, they will reside on the bottom of
the container.
• since their density is greater than water.
If hydrocarbons are used as the propellants,
they will reside on the aqueous layer.
• since their density is less than water

40. In this phase, three systems are formed:

41. Water Based System
Active ingredient is insoluble in
propellant.
Surfactants are used (conc. 0.5-2%)
Propellant conc. 25 – 60%
Water act as base

42. Dispersion System
Active ingredient is insoluble in
water and propellant
Active ingredient is dispersed in
the form of suspension
Particle size should be less than
5μm

43. Foam System
Propellant conc. 6-8%
Consist of emulsion of propellant
+water +drug + emulsifier
If the propellant is in the internal phase , a
stable foam is discharged, if the propellant
is in the external phase, a spray or a quick-
breaking foam is discharged.

44. ANUM ASLAM

45. FILLING OPERATIONS

46. FILLING OPERATIONS
Cold Filling
FOR NON AQUEOUS
PRODUCTS OR
PRODUCTS WHICH
CAN WITHSTAND
LOW TEMP (-40F),
INCLUDES CHILING
OF PROPELLENT
AND PRODUCT
CONCENTRATE
Pressure
Filling
CARRIED OUT AT
ROOM
TEMPERATURE BY
UTILIZING
PRESSURE
EQUIPMENTS

47. COLD FILLING APPARATUS
 Consist of an
insulated box fitted
with coiled copper
tubing to inc the
area exposed to
cooling.
 The insulated box
should be pre filled
with acetone or dry
ice, that functions
as a refrigerating
system.

48. COLD FILLING PROCESS
PRODUCT
CONCENTRATE
+PROPELLLENT INTO
EQUALLY COLD
AEROSOLE
CONTAINER
Propellant
is Chilled
to a temp
of 30-40F
Product
Concentrate
Chilled To a
Temp of 30-
40F
THE VALVE ASSEBLY
IS INSERTED AND
CRIMPED INTO PLACE
DISPLACEMENT
OF INSIDE AIR OF
THE CONTAINER
BY PROPELLENT
VAPOURS

49. AEROSOL FILLING

50. ALTERNATIVE METHOD
CHILL BOTH
CONCENTRATE
+ PROPELLENT
IN A PRESSURE
VESSEL TO -40F
ADD MIXTURE
TO AEROSOLE
CONTAINER
THE VALVE IS
PLACED AND
CRIMPED ON TO
THE CONTAINER

51. ADVANTAGE DISADVANTAGES

52. TESTING
PASSING THE
CONTAINER INTO
HEATED WATER
BATH
HEAT THE
CONTENTS UPTO 130
C
IF NO BUBBLE
FORMATION,
AEROSOLE
CONTDRIEDAINERS
ARE, CAPPED AND
DISPENSED

53. NAJAF FAROOQ

54. PRESSURE FILLING

55. PRESSURE FILLING
• It consists of a pressure burette capable of metering small volume of
liquefied gas in to aerosol container under pressure.
• Propellant is added from inlet.
• The propellant is allowed to flow with its own vapor pressure in the
container through aerosol valve.
• The trapped air escapes out from the upper valve
• Propellant stop flowing when the pressure of burette and container
becomes equal.
• Additional propellant may be added by increasing the pressure in the
filling apparatus through the use of compressed gas or nitrogen gas

56. pre
PRESSURE BURRETTE

57. PROCESS
Through the opening
of valve propellant is
added.
The trapped air in the
container is removed
before adding the
propellant.
Valve is
placed in the
container
and crimped
Filling of
concentrate
at room
temperature

58. EXCEPTION
Since the opening of valve is smaller
0.018-0.030 inches, limits the
production and process become slow.
But with the introduction of the rotary
filling machine, the production rate is
increased.
Trapped air should be removed.

59. ROTATORY FILLING

60. COMPRESSED GAS
FILLING
Compressed gases are
present under high pressure
in cylinders.
These cylinders are fitted
with a pressure reducing
valve and a delivery gauge
A flow indicator is also
present

61. PROCESS
Gas stop flowing when
pressure become equal.
Nitrous oxide and carbon
dioxide is used if more gas
is required.
Air is removed with
the help of vacuum
pump. Gas is
allowed to flow from
filling head.
The concentrate is
placed in the container.
Valve is placed in the
container

64. ADVANTAGES
It is the preferred method for
solutions, emulsions and suspension
No refrigeration is required, can be
carried out at room temperature.
Less propellant is lost.
Less chances of contamination.

65. DISADVANTAGES
Certain metering valves
cannot handled due to
pressure
Slower process than cold
filling

66. RABIA KHALID NADEEM

67. PACKAGING OF
AEROSOLS A unique aspect of pharmaceutical aerosols as
compared to other dosage forms is that the product is
actually packaged as part of the manufacturing
process.
 Most aerosols have a protective cap that fits snugly
over the valve & mounting cap.
 this protect the valve against contamination with dust
& dirt
 The cap which is generally made up of plastic or
metal also serves a decorative function .

68. STORAGE
 Expose to temp.
above 49 C (120 F)
may burst an
aerosol container.
 When the
containers are cold
less than the usual
spray may result.
 These products are
generally
recommended for
storage between
15C - 30C (59F &
86F)

69. LABELING
 Medicinal aerosols are labeled by the
manufacturer with plastic peel-away
labels or easily removed paper labels.

70.  Aerosols have
special
requirements for
use & storage:
 For safety, labels
must warn users
not to use or
store them near
heat or an open
flame.
 Aerosols are
labeled with
regard to shaking
before use &
holding at the
proper angle.

71. Proper Administration & Use
Of Pharmaceutical Aerosols
 The pharmacist
should make every
attempt to educate
the patient about
aerosol dosage
forms.
 The pharmacist
should provide the
patient written as
well as verbal
instructions for
proper use.

72. ORAL METERED
AEROSOLS
 The patient
should be
told how to
hold it &
how to use
it properly?

74. EXTENDER DEVICE
 If the patient can not
use the inhaler it is
advisable for the
pharmacist to
recommend to the
patient or the patient’s
physician the use of
an extender device
with the inhaler.
 They can effectively
assist the delivery of
medication .

75. TOPICAL ADMINISTRATION
 The patient should first
clean the affected area
gently & pat it dry.
 Holding the canister
with the nozzle
pointing towards the
body area.
 Then press down the
button to deliver
enough medication to
cover the area.
 Not cover the area
with the bandage or
dressing unless
instructed to do so.

76. VAGINAL & RECTAL
AEROSOLS
 The foams are
used intravaginally
 Inserter filled with
foam & placed in
the vagina through
activation of the
plunger .

77. NAMEERA AHMED

78. PROPELLAN
TS
VALVES,
ACTUATORS
, DIP TUBES
CONTAINER
S
WEIGHT
CHECKING
LEAK
TESTING
SPRAY
TESTING
QC TESTING

79. PROPELLANTS
Vapor pressure, density, purity &
acceptability of the propellant are
determined & compared with specification
sheet.

80. VALVE,ACTUATORS,DIP
TUBES
•Valve acceptance, delivery rate
•Sampling is done according to standard procedures as
found in Military Standards “MIL-STD-105D”.
•For metered dose aerosol valves ,test methods were
developed by:
Aerosol Specifications Committee
Industrial Pharmaceutical Technology Section
Academy Of Pharmaceutical Sciences
•The objective of this test is to determine magnitude of valve
delivery & degree of uniformity between individual valves.
•Standard test solutions were proposed to rule out variation in
valve delivery.

81. Placed 25
valve
(container)
Actuator
Attached
Temp -25+-1C
Valve actuated
(for 2
sec)+weighed
Again valve
actuated (2
sec)+ wt
d/f represent
delivery (mg)
From 25 test
units
Repeat it for
total 2
individual
deliveries.
PROCEDURE

82. • Examined for defects in lining.
• Q.C aspects includes degree of conductivity of electric current as
measure of exposed metals.
• Glass containers are examined for Flaws.
•Done by periodically adding to the filling line tarred empty aerosol
containers, which after filling with concentrate are removed &
weighed.
• Same procedure is used for checking weight of Propellants being
added.
CONTAINERS
WEIGHT CHECKING

83. •Means of checking crimping of the valve & detect the defective
containers due to leakage.
•Done by measuring the Crimp’s dimension & comparing.
•Final testing of valve closure is done by passing the filled containers
through water bath.
•Most ph aerosols are 100% spray tested.
•This serves to clear the dip tube of pure propellant and pure
concentrate.
•Check for defects in valves and spray pattern.
LEAK TESTING
SPRAY TESTING

84. FARAH ALI KHAN

85. ADVANTAGES OF
AEROSOLS
Drug delivery is
targetted
Fewer side
effects
Rapid response
of the drug

86. Small
aerosol doses
Ease of
Application
Self
administration

87. Suitable when drugs
degrade in GIT
Prevent Oxidation of
drugs
Maintain sterility and
easy to portable

88. DISADVANTAGES OF
AEROSOLS
Dose estimation is
difficult
Expensive
Flammable Nature

89. Propellant may cause
chillness to the skin
Aerosols container must
not be exposed to higher
temperature
Toxicity