This document discusses control of microbial contamination in sterile and non-sterile pharmaceutical products. It describes sterilization methods like thermal sterilization using dry heat or moist heat, and non-thermal sterilization using radiation, filtration, or chemicals. It also discusses sources of contamination and control measures like environmental control, housekeeping, disinfecting surfaces, controlling air and personnel, automated processing, and concludes that sterilization requires constant effort to control microbial contamination.

1. Control Of
microbial
contamination in
sterile and non
sterile Products
Presented by : Arslan Ahmad
Presented to : Dr.Maria Rasool

2. Sterile
• Free from bacteria or other living
micro-organisms; totally clean.
• Sterile products :
• These are the dosage form of
therapeutic value which is
extremely free from viable micro-
organisms.

3. Categorized as :
• Parenteral products
• Opthalmic products
• Irrigating preparations
• Examples include :
• Injectable(intravascular,intramascular,s
ubcutaneous,Intradermal and intra
peritoneal.
• Diluents for injectable(water for
injections,sterile water,purified water)
• Vaccines
• Opthalmic preparations(Eye
drops,nasal drops)

4. Non sterile products
• These are the dosage forms which are
other than sterile preparation Like Oral
and topical preparations
• Examples include:
• Tablets(compressed,coated,Effervesce
nt,etc.)
• Ointments
• Syrups
• Oral suspensions andemulsions
• Transdermal/topical patches

5. Sources of microbial
contamination
• External atmosphericair inside the
room
• Personnel contamination
• Surface contamination
• Water contamination
• Sterilization
• a process that destroys or eliminates all
forms of microbial life and is carried out
in health-care facilities by physical or
chemical methods.

7. Thermal
methods
Moisture content
Temperatures
Period of exposure
As the temprature is increased required to
produce a sterile state is decreased.
Thermal methods of
sterilization ia further
subdivided into:
Dry heat
Moist heat

8. Dry heat
• The substances which get degraded at
a temprature range of approximately
140°C
• Contact for 2 hours at 180°C or at
260°C for 45 minutes can produce
killingof all kind of bacteria and there
spores.
• Dry heat Sterilization can be
achieved by :
• Hot air ovens
• Dry heat tunnels

9. Moist heat
In thermal sterilization rather
than dry heat moist heat is
considered more efficient.
However it should be made
into consideration that moist
heat cannot terminate
pyrogens.
Moist heat
sterilization can
be achieved by
Autoclave
Air steam
mixture

10. Non thermal
methods of
sterilization
It is also known as cold
sterilization or non-thermal
method of sterilization.
Further
classified as :
Physical method
Chemical
method
Physical
Sterilization
methods:
It can be further
classified as:
Radiation
sterilization
Filtration
sterilization

11. Radiation Sterilization
• (a) Ultraviolet light:
• For the sterilizationof contamination in
atmosphere and on surfaces, ultraviolet
light is usually employed.
• (b) Ionizing radiations:
• These are the radiations of elevated
energy which are emittedfrom
radioactiveisotopes like caesium-135
(gamma rays) or by highly accelerated
electrons at higher velocity (cathode ray
& ẞ-ray)

12. Chemical
methods of
sterilization
Gas sterilization:
Gases like formaldehyde and sulfur
dioxide are been use from many
years for sterilization purpose.
These chemicals are very reactive
and sometimes are very difficult to
remove from surfaces after exposure
thus have very limiteduse only.

13. Continued…
• Few examples:
• Alkylating gases: Ethylene oxide,
propylene oxide, formaldehyde
and ẞ-propiolactone.
• Oxidizing gases: hydrogen
peroxide, ozone, per- acetic acid
and calcium dioxide.

14. Control Measures
for Microbial
Contamination in
Pharmaceutical
Products:
Environmental
Control
MISSION
CONTROL
Housekeeping
Disinfection
on Surface
Control on Air
Control on
Personnel
Compounding Of
Products
Processing By
Automation

15. Environmental
control
STRICT PHYSICAL AND
BIOLOGICAL ENVIRONMENT
CONTROL MUSTBE
MAINTAINED.
HIGH STANDARD OF
CLEANLINESS SHOULD BE
MAINTAINED IN THE CLEAN-UP
AND PACKAGINGAREAS
OTHER THAN DAILYROUTINE
DISINFECTING PROCEDURES.
ENVIRONMENTAL CONTROL
COULD MORE EASILYBE
ACHIEVED WERE THE
MOVEMENTOF SUPPLIES AND
PERSONNEL IS SMOOTH AND
STRATEGICALLY PLANNED.

16. Housekeeping
• All the equipment should be
thoroughly cleaned at the end of
the day so that no pollutant could
be recognized after the finished
development.
• All the housekeeping tools must be
selected as per there productivity
and liberty from lint generating
affinity. They should be reserved for
aseptic areas only.

17. Disinfection on surface
• After complete cleaning procedure all
the surfaces of the production unit
must go for disinfection at least in
aseptic area, by spraying an effective
liquid disinfectant followed by wiping
on all surfaces and with ultraviolet
radiationexposure.
• Control on Air:
• Use of more than one pre- filter total
eliminationof profoundly pollutedair.
• HEPA filters are employed.It is 99.97%
effectiveto eliminate particles of 0.3µ
and bigger size particles.

18. Continued...
• Laminar air flow principle has
upgraded the effectiveness of
environmental control of aseptic area
to achieve class 100 area. This means
there are not more than 100 particles in
the air of 100 cubic foot area with0.5µ
or more in size.
• Control on Personnel:
• All the employees must examine for
their good health and must be
subjected to regular physical
examination.

19. Continued...
• Sterile overalls, hoods, face mask
and shoe covers are the different
component of apparel worn by a
personnel entering in sterile area.
• A preparatory procedure must be
followed by the personnel while
entering in aseptic area.
• Processing By Automation:
• Machine can be developed to
carry out certain procedures and
functions more efficiently,
accurately and precisely then a
human.
• Moreover the biggest advantage is
the infection caused by human
body as a source of biological
contamination. 11

20. CONCLUSION
STERILIZATION AND CONTROL OF
MICROBIAL CONTAMINATION IS
A CONSTANT PROCESS.
STERILIZATION AND
DISINFECTION MUSTBE
PERFORMED ON DAILYBASIS.
PERSONNEL PERFORMANCE
AND HANDLING HAS A CRITICAL
AND DIRECTIMPACTON
CONTAMINATION.