The document covers various methods of sterilization, including physical and chemical techniques, emphasizing the importance of eliminating microorganisms to ensure product safety in pharmaceutical applications. It elaborates on the specifications and validation processes for sterilization equipment, such as autoclaves and dry heat ovens, detailing their operational standards and effectiveness. Additionally, it highlights the regulatory guidelines and ongoing process validation necessary for maintaining product quality throughout manufacturing.

1. Presented by :
Jamdhade Vaishali K.
1st Year M. Pharmacy
(Pharmaceutics)
Guided by :
Dr. Chaudhari Pallavi
Date: 15/11/2017
Semester 1st graded seminar on:

2. CONTENT
 Introduction
 Method Of Sterilization
Physical Method
Chemical Method
 Selection Process
For Aqueous Product
For Non-aqueous Product
 Specification
 Validation Of Process And Equipment
 References
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3. • Sterilization can be defined as any process that
effectively kills or eliminates transmissible agents (such
as fungi, bacteria, viruses) from a surface, equipment,
foods, medications, or biological culture medium.
• Sterilization can be defined as the process through
which all forms of life are destroyed, removed or
permanently inactivated.
INTRODUCTION
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4. Is to provide a product that is safe and eliminates the
possibility of contamination.
To reduce amount of contaminant’s
present in environment, on surface of
container’s, closure’s as well as
equipment’s and to achieve better sterile
condition.
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5. CHEMICAL
METHOD
METHOD OF STERILIZATION
PHYSICAL
METHOD
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6. PHYSICAL METHOD
1. Autoclave
2. Pasteurization
3. Tyndallization
MOIST HEAT
DRY HEAT
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1. Hot Air Oven
2. Red Heat
3. Flaming

7. 1. Non-Ionizing Radiations:
Ultraviolet (UV) Light
2. Ionizing Radiations (Cold Sterilization):
X-rays
Gamma Rays
Cathode Rays (Electron Beam Radiation)
RADIATION
FILTRATION
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1. Depth Filter :
Sintered Glass Filter
2. Screen Filter :
Filter Candle
Membrane Filter

8. CHEMICAL METHOD
GASEOUS
STERILIZATION
BY USING
DISINFECTANT
e.g.
Formaldehyde, Ethylene
oxide
e.g.
Cresol, Phenols
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9. Can product be sterilize by moist heat at 121°C for 15min
Can the product be
sterilize by moist heat with
F0 ≥ 8 min achieving SAL
of ≤ 10-6
NO YES
Use autoclaving
at 1210c for 15
min
Can the formulation
be filtered through a
microbial retentive
filter
YES
Use moist heat
with F0 ≥ 8 min
NO
NO
YES
Use pre- sterilized individual
component and aseptic
compounding and filling
Use combination of
aseptic filtration and
aseptic processing
Selection Of Sterilization Process For Aqueous Liquid, Product
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10. Can product be sterilize by dry heat at
160°C for 120 min
Can the product be sterilize by
dry heat with alternative
combination of time and
temperature to the std cycle
achieving SAL of ≤ 10-6
NO YES
Use Sterilisation
at 1600c for 120
min
Can the product be sterilized by method
different from dry heat e.g. ionizing
radiation with an absorbed with an
absorbed minimum dose ≥ 25 kGy
YES
Use dry heat with alternative
combination of time and
temperature to the std cycle
achieving an SAL of ≤ 10-6
NO
Selection Of Sterilization Process For Non- Aqueous Liquid,
Semi- Solid Or Dry Power Product
9Continued…

11. YES
NO
Can the formulation
be filtered through a
microbial retentive
filter
NO
Use sterilization by
validated irradiation
dose
YES
Use filtration and
aseptic processing
Use pre- sterilized individual
component and aseptic
compounding and filling
Can the product be sterilized
using validated lower
irradiation dose
(ref ISO 11137)
NO
YES
Use sterilization with
an absorbed
minimum dose of ≥
25 kGy
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12. o Microorganisms destroyed by cellular protein
coagulation.
o The objects to be sterilized are exposed to saturated
steam under 1 atmosphere pressure at a minimum
temperature of 121°C for 15 min.
o An autoclave is commonly used for moist heat
sterilization.
o Because it does not require as high temperature, moist
heat sterilization cause less product and equipment
damage compared to dry heat sterilization.
SPECIFICATION
MOIST HEAT STERILIZATION :
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13. Is a device to sterilize equipment and supplies by
subjecting them to high pressure saturated steam at
Temperature
°C
Time
(min)
Pressure
(Ib/sq.inch)
115-118 30 10
121-124 15 15
126-129 10 20
135-138 3 30
AUTOCLAVE
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14. • Lid (door) fitted with clamps and asbestos jacket,
stationary autoclave may be double doors at both ends
one for loading and one for unloading.
• Pressure gauge.
• Thermocouple for measurement of temperature.
• Air vent to remove air before sterilization.
• Safety valve to permit escape of excess steam to prevent
explosion .
• Modern autoclaves are recording (record pressure,
temperature during the whole process) supplied with
timer and are automatically controlled.
Main Features
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15.  Is appropriate for materials that cannot withstand moist –
heat sterilization. (e.g., oily materials and powders)
DRY HEAT STERILIZATION
 Objects are subjected to a
temperature of at least 160º for 120
minutes.
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16. Is a device to sterilize subject and supplies by subjecting
them to direct heat at
Temperature °C Time (min)
170 60
160 120
150 150
140 180
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HOT AIR OVEN

17. o Is appropriate for the materials like oily materials
(fixed oil, liquid paraffin) glassware, powders ( talc,
kaolin).
o If higher temperature can be used, less exposure time is
required.
o Door fitted with the clamps and
asbestos jacket has the single door.
o Regulator for temperature control.
o Fan attached inside for air circulation.
o Perforated shelf for keeping subject
inside.
Main Features
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18. ◦ Energy transmitted through space in variety of forms is
generally called radiation.
◦ This method is also called as cold sterilization because it
produce relatively little heat.
◦ Thus, it is possible to sterilize heat sensitive materials
such techniques are being in
food industries mainly.
RADIATIONS
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19. ◦ UV in region of 2537 A° has been shown to posses the
greatest activity in destroying Microorganisms.
◦ Commonly employed in reduction of airborne
contamination in the maintenance of aseptic areas &
rooms.
◦ Source of artificial UV radiation s is UV lamps (generally
called sterilizing lamp or germicidal lamp).
◦ UV light is absorbed by the nucleic acid of the cell where
it does the greatest damage.
Non Ionizing Radiations (UV)
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20. ◦ X-rays, gamma rays & cathode rays are lethal to DNA
& other vital cell constituents.
◦ They have high penetration power & considerable
energy.
◦ The factors that effect the lethal activity of ionizing
radiations are oxygen effect, protective compounds,
sensitizing agents, pH of cultures, freezing, moisture &
recovery conditions.
Ionizing Radiations
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21. ◦ This is a non-thermal method of sterilization used
widely in the pharmaceutical industry where heat labile
solutions are to be sterilized.
◦ This is useful for large volume solutions, eye drops,
antibiotic solutions, sera & carbohydrate solutions.
◦ This also useful for separation of bacteriophages &
bacterial toxins from bacteria for the isolation of
Microorganisms which are scanty in fluids.
FILTRATION
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22. Three Main Stages Involved In Filtration
Passage of the solution through a previously sterilized
bacteria-proof filter unit
Aseptic transference of filtrate to sterile containers then
sealed aseptically
Testing of sample for sterility
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23. ◦ The destruction of all living Microorganisms with
chemical in gaseous or vapours state.
◦ When material is affected by the dry or moist heat then the
gaseous sterilization is used.
◦ All these gases are toxic to human being above certain
concentration and may exhibit other undesirable side
effect.
◦ Ethylene oxide is most widely used gaseous sterilization
agent in pharmaceutical industry.
◦ In addition to these various glycols, methyl bromide and
alcohol have been used for room sterilization.
GASEOUS STERILIZATION
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24. ◦ It is colorless liq. with BP 10.8°C.
◦ Highly inflammable and may be explosive when mixed
with air in concentration Greater than 3%. Its mixture
with CO2 in certain proportion makes it inflammable.
◦ Concentration & time relationship commonly for
sterilization is as below
Concentration (Mg/Lit) Exposure Time(hrs.)
44 24
88 10
442 4
Ethylene Oxide
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25. ◦ Chemical agents most commonly used as disinfectant and
antiseptic.
e.g. phenols, alcohols, halogens, dyes, aldehyde etc.
DISINFECTANT OR ANTIMICROBIAL AGENTS
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26. DEVELOPMENT & VALIDATION OF
PROCESS & EQUIPMENT
• It is analysis of data gathered throughout the design &
manufacturing of product in order to confirm that the
process can reliably output products of determined
standard.
• Regulatory authorities like EMA (European medicine
agency) & FDA have published guidelines relating to
process validation.
Process Validation:
• The purpose of validation is to ensure varied inputs lead to
consistent & high quality outputs.
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27. • Process validation is an ongoing process that must be
frequently adapted as manufacturing feedback is
gathered.
• End to end validation & production is essential in
determining product quality because quality can not
always be determined by finished product inspection.
Process validation can be broken in to 3
steps :
1. Process design
2. Process qualification
3. Continued process verification
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28. In this data from the development phase are gathered &
analyzed to define the commercial manufacturing process.
The data used to establish benchmark for quality &
production control.
Process Design:
In this stage the process design assessed to conclude if the
process is able to meet determine manufacturing target.
All the process & manufacturing equipment is proofed to
confirm quality & output capabilities.
Process Qualification :
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29. Continued Process Validation:
It is the ongoing monitoring of all aspects of production
cycle. It aims to ensure that all levels production are
controlled & regulated.
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30. EQUIPMENT VALIDATION/
QUALIFICATION
Equipment validation is divided into
1. Design qualification
2. Installation qualification
3. Operational qualification
4. Performance qualification
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31. DQ
It define the functional & operational specification of the
instrument & details for the continues design in selection of
supplier.
IQ
Demonstrates that the process or equipment meets all
specifications, is installed correctly, and all required
components and documentation needed for continued
operation are installed and in place.
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32. OQ
Demonstrates that all facets of the process or equipment are
operating correctly.
PQ
It is the process of demonstrating that an instrument
consistently performed according to specification appropriate
for it’s routine work.
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33. REFERENCES
 Dr. Kokare “ PHARMACEUTICAL MICROBIOLOGY- Principle
& Application”, 9th edition, reprint 2013, Nirali Prakashan, Pune.
Page No.16.1-16.28.
 Lachman, Lieberman’s “The Theory & Practice of Industrial
Pharmacy” 4th edition, CBS Publisher Pvt ltd, New Delhi.
Page No.804-827.
 Cooper and Gunn’s “Dispensing for Pharmaceutical Student ”
Indian edition 2007 CBS Publisher, New Delhi.
Page No. 395,614,623,663.
 http://www.ema.europa.eu/docs/en_GB/document_library/Scientifi
c_guideline/2009/09/WC500003520.pdf
 https://en.wikipedia.org/wiki/Sterilization
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