This document discusses sterilization processes and the central sterile supply department (CSSD). It defines key terms like cleaning, disinfection, sterilization. It describes the functions of CSSD like collecting, processing, sterilizing and distributing patient care items. The typical layout of a CSSD includes receiving, cleaning, packaging, sterilization and storage areas. Common sterilization methods discussed are steam sterilization, hot air oven, radiation, ethylene oxide and chemical sterilization. The document emphasizes the importance of monitoring sterilization using physical, chemical and biological indicators.

3. – an example of the person-machine interface that is
so visible in the delivery of healthcare.

4. entral terile upply
• Responsible for collecting and receiving patient care
items, instruments and devices used during the
provisions of healthcare.
• For decontaminating, processing, sterilizing, storing
and dispensing items to all parts of the hospital.

5. • Receiving Area
• Clean and Decontamination Area
• Preparation and Packaging Area
• Sterilization Area
• Sterile Storage Area

6. FIG. 1 FUNCTIONAL FLOW
Used Instrument from various
department
Sort
Clean and Decontaminate
High level
Disinfection
Pack
Sterilization
Storage
Distribution

7. FIG. 3. Typical Layout of S.S.D.
Used Loads Entry Point
Decontamination Area
Assembly Area
Processing Area
Packaging Area
Sterilization Area
S1 S2 S3
Sterile Goods Storage Area
Sterile Goods
Distribution Point

13. Definition of Terms
Removal usually with detergent and water or enzyme
cleaner and water , Of adherent visible
soil, blood, protein substances
microorganisms and other
debris from the surfaces, crevices,
serrations, joints, and lumens of
instruments, devices, and equipment
by a Manual or mechanical process that
prepares the items for safe handling and
or further decontamination.

14. The first and the most important step in decontamination
is thorough cleaning and rinsing.
To remove all visible debris from an item and to reduce the
number of particulates, microoganisms and potential
pyrogenes.
Definition of Terms

15. • Non abrasive
• Low – foaming
• Free – rinsing
• Biodegradable
• Rapidly dissolve/ disperse soil
• Non Toxic
• Efficacious on all types of clinical soil
• Have long shelf life
• Cost effective
Properties of an ideal cleaning agent:

16. Cleaning Methods
1. Manual Cleaning – Recommended for delicate
or complex medical devices. Example:
Microsurgical instruments, air powered drills.
2. Mechanical Cleaning – Removes soil and
microorganisms through an automated
cleaning and rinsing process. Examples:
Washer sanitizers/disinfectors
Ultrasonic Cleaners.

17. Principle
1. Thorough cleaning is required before high level
disinfection.
2. Surgical instruments should be pre-soaked or Rinse. Pre-
soaking with a specialized product (e.g. enzymatic
solution) referring to the manufacturers instructions,
correct dilution, temperature and soak time.
3. Done Manually in use areas without mechanical units or
for fragile or difficult – to clean instruments.
4. Friction and Fluidics are the two(2) essential
components:
• Friction (e.g. rubbing / scrubbing with a Brush)
• Fluidics (i.e. fluids under pressure) – to remove soil and
Debris from internal channels after Brushing.

18. Cleaning Precautions :

19. Information contained in the Material

21. Cleaning Precautions :

22. Cleaning Agents

23. Washing / Rinsing Methods

24. Drying of instruments

25. Recommended Practice :

28. SHARPS:
• Avoid recapping used needles.
• Avoid removing used needles from
disposable syringes.
• Avoid bending, breaking or manipulating
used needles by hand.
• Place used sharps in puncture-resistant
containers.

29. Standard/Transmission – Based
(enhanced) Precautions:

31. Any micro-organism in the
wrong place at the right
time is a potential
pathogen.

32. Important Points to Remember

33. Decontamination
The use of physical or chemical means to remove,
inactivate, or destroy blood borne pathogens in
surface or item to the point where they are no
longer capable of transmitting infectious
particles and the surface of the item is rendered
safe for handling use, use or disposal of all
pathogenic organisms.
Cleaning and Decontamination should begin as
soon as possible after items have been used .
Adequate cleaning is the first step in the
decontamination and reuse process.

34. Decontamination

35. Decontamination

36. Decontamination

37. Decontamination

38. Disinfection
• Thermal or Chemical destruction of
pathogenic and other types of
microorganisms.
• Less lethal than sterilization because it
destroys recognized pathogenic
microorganisms but not necessarily all
microbial forms (Bacterial Spores)

39. SPORES
• Relatively water-proof round or elliptical
resting cell consisting of condensed
cytoplasm and nucleus surrounded by an
impervious cell wall or coat.
• Relatively resistant to disinfectants and
sterilant activity and drying conditions
(specifically in the genera Bacillus and
Clostridium).
B subtilis spores
Clostridium_tetani Clostridium botulinum spores

40. Disinfection

41. Disinfection

42. Disinfectant
Usually a chemical agent (but sometimes a
physical agent) that destroys disease – causing
pathogens or other harmful microorganisms but
might not kill bacterial spores
Properties of an ideal Disinfectant
1. Broad Spectrum:
◘ Should have a wide antimicrobial
spectrum.
2. Fast acting:
◘ Should produce a rapid kill.

43. Properties of an ideal Disinfectant

44. Properties of an ideal Disinfectant

45. Properties of an ideal Disinfectant

46. Before Sterilization
and High Level
Disinfection can be done:
MUST decontaminate
MUST clean and rinse
instruments and
equipments

47. Justification for use of Disinfectants
for Non- Critical Environmental
Surfaces
1. Surfaces may contribute to transmission of
epidemiologically important microbes (e.g.
Vancomycin-resistant Enterococci, methicillin-
resistant S. aureus, viruses).
2. Disinfectants are needed for surfaces
contaminated by blood and other potentially
infective material.

48. 3. Disinfectants are more effective than detergents
in reducing microbial load on floors.
4. Detergents become contaminated and result in
seeding the patient’s environment with bacteria.
4. Disinfection of non-critical equipment and
surfaces is recommended for patients on
isolation precautions by the CDC.
6. Advantage of using single product for
decontamination of non-critical surfaces, both
floors and equipment.
7. Some newer disinfectants have persistent
antimicrobial activity.

49. Some of the Common Disinfectants:

50. GUIDELINES
FOR THE USE OF SOME COMMON
DISINFECTANT

51. DISINFECTANT RECOMMENDED USE PRECAUTIONS
Sodium Hypochlorite
(Bleach)
» Should be used in well
ventilated areas, caused
irritation of skin, eyes
and lungs if used in
poorly ventilated areas.
» Protective clothing
required while handling
and using undiluted.
» Do not mix with strong
acids to avoid release of
chlorine gas.
» Corrosive to metal
Bleaching powder Toilets, bathrooms, may be used in
place liquid bleach if liquid bleach
is not available
Disinfection of material
contaminated With blood and
body fluids (remove Gross
contamination before
disinfection).
» Same as above

52. DISINFECTANT RECOMMENDED USE PRECAUTIONS
Alcohol (70%)
isopropyl, ethyl
alcohol, methylated
spirit
» Flammable, toxic, to be
used in well ventilated
area, avoid inhalation, use
for small surface only.
» Kept away from heat
source, electrical
equipment, flames, hot
surfaces.
» Allow it to dry completely,
particularly when using
diathermy as it can cause
diathermy burns.
Smooth metal surface, table
tops surfaces on which bleach
cannot be used. In combination
with skin emollients can be
used for disinfection of hands.
pre operative preparation of
skin.
Alcoholic hand rub
(70% isopropanol to
which 1% glycerine is
added
In all clinical setting for the
Disinfection of hands
» Same as above

53. DISINFECTANT RECOMMENDED USE PRECAUTIONS
Glutaraldehyde (2%) » Eye and nasal irritant, may
cause asthma and skin
allergies, hence use in well
ventilated area, keep
covered with well fitting
lids.
» Toxic : (Colitis, Keratopathy,
Corneal decompensation if
adequately rinse.
» Mucous membrane irritation,
Epistaxis, Rhinitis
» Eye protection, plastic
apron and gloves should
be worn while handling.
» Need 7-15 air exchange/hour
For disinfection of endoscopes,
respiratory therapy equipment
and for materials that are
destroyed by heat. Can work as
a sterilant if contact time is 10
hours and if used under strictly
controlled condition.
Detergent with
enzyme
Cleaning endoscopes, surgical
instrument before disinfection.

54. DISINFECTANT RECOMMENDED USE PRECAUTIONS
Clear soluble
phenolics (2%
solution)
» Protective clothing should
be worn while handling as
it can be absorbed through
the skin and cause
respiratory irritation in
higher concentrations.
» Must not be used in
equipment coming in
contract with skin and
mucous membranes, or
should not be used on
food preparation surfaces.
» Should not be used in Nursery
can cause Hyperbilirubinemia
Only environmental disinfection,
mycobacteria laboratory discard
jars.

55. DISINFECTANT RECOMMENDED USE PRECAUTIONS
Formaldehyde (40%
solution: formalin)
» Potent eye and nasal
irritant may cause
respiratory distress and
skin allergy.
» Protective clothing such
as gloves, eye protection
and gowns should be
worn.
» Use in well ventilated area.
» Carcinogenic
Chlorhexidine:
combined with
alcohol or detergents
(eg Hibiscrub).
Antiseptic, for skin and mucous
membranes, preoperative skin
preparation, disinfection of
hands.
» Inactived by soap,
organic matter.
» Relatively non toxic
» Do not allow contact with
brain meninges, eye or
middle ear.
For preparing viral vaccine
(e.g. polio virus and influenza), as an
embalming agent to preserve
anatomic specimens.

56. DISINFECTANT RECOMMENDED USE PRECAUTIONS
Iodine or iodophors:
Can be combined with
alcohol or detergents
(eg betadine, tincture
Iodine)
» Iodophor is less irritant
than iodine.
» Can cause skin allergy.
» Gloves to be used for
prolonged contact
» May corrode metals
Antiseptic, for pre operative skin
and hand disinfection.
Quaternary
Ammonium
Compounds:
(eg dettol) May be
combined with
chlorhexidine.
Antiseptic, for cleaning dirty
wounds.
(Low level disinfection only)
» Relatively non toxic
» Contamination and growth
of gram negative bacteria
are likely in use dilutions.
Hence:
» Use in correct dilution in
high level disinfected
containers.
» Change in use solution
every 8 hours.
» Do not top up stock bottle

57. DISINFECTANT RECOMMENDED USE PRECAUTIONS
Hydrogen Peroxide » Stains skin, clothing and
environmental surfaces,
Eye irritation with contact
Bactericidal, virucidal, sporicidal,
and fungicidal properties
Use in endoscopes, inanimate
surfaces, ventilators, fabrics

58. “When properly used, Disinfection
and Sterilization can ensure the
safe use of invasive and non-
invasive medical devices.”
“However current Disinfection and
Sterilization Guidelines must be
strictly followed”

59. Hp decontamination system
Outcome:
C. Difficile incidence
Results:
HPV decreased environmental
contamination with C. Difficile
Rates on high on floors from 2.28to
1.28cases per 1,00o pt days and throughout
the hospital from 1.38 to 0.84 cases per
1,000 pt days
(Boyce,JM,et al)

60. Advantages of HP system
1. Reliable biocidal activity against wide
range of pathogens
2. Surfaces & equipment decontaminated
3. Demonstrated to decrease disease
incidence(C.Difficile)
4. Residual free does not give rise to health
& safety concerns (aeration units convert
HP to oxygen & water
5.Useful for disinfecting complex equipment
& furnitures.

61. C. difficile spore can survive in the hospital
environment for up to 5 months.
Vegetative C. difficile can remain viable on moist surfaces
(toilets. sinks, moist dressing) up to 3 hours in room air.
Recently, room disinfection with vaporized hydrogen peroxide
has also been found to reduce C.difficile incidence rates

62. Survival of Selected Microbes on Environmental Surfaces
MICROORGANISM Duration of Survival
Acinetobacter spp. 3 days – 5 months
Clostridium difficile 5 months – 1 year? Spore
15 min- 3 hrs: vegetative form
Enterococci (incl. VRE) 5 days to 4 months
Serratia marcescens 3 days – 2 months
Dry floor = 5 weeks
Staphylococcus aureus (incl. MRSA) 7 days – 7 months
Hepatitis B virus (HBV)
≥ 1 week
Human Immunodeficiency virus (HIV) 3 – 4 days
Norovirus 8 hrs – 7 days
Kramer A. BMC ID 2006; McFarland L, et al. AJIC 2007

63. Metals as Microbicides
• Metals such as silver, iron and copper could
be used for environmental control,
disinfection of water or reusable medical
devices or incorporated into medical
devices.
References:
• RUTALA, WA (editor) Disinfection, Sterilization and Antisepsis
Principles, Practice, Current Issues, New Research & New
Technology, Association for Professionals in Infection Control
and Epidemiology, Washington DC,2010.
• Practical Guideline for Infection Control in Health Care
Facilities, WHO
• disinfectionandsterilization.org

66. STERILIZATION PROCESS
 Cleaning
 Inspection/ assembly
 Packaging
 Sterilizer loading
 Sterilization
 Storage
METHOD OF STERILIZATION
 Moist and Heat
 Hot air Oven
 Ionizing radiation
 Ethylene Oxide
 Low Temperature steam and formaldehyde
 Chemical disinfection sterilization

67. METHOD OF STERILIZATION
◘ Moist heat (autoclave)
• Autoclave at 121°C for 15 min or 134°C for 3 min
◘ Hot air oven (oils, powder, glassware & needles)
• 160°C for 2 hours • 180°C for 30 min
◘ Ionizing radiation
• i.e. sutures • 3 to 6 hours exposure
◘ Ethylene Oxide (EO)
• For heat and moisture sensitive product like
plastic goods and sharps
• 37°C -55°C up to 6 hours

68. METHOD OF STERILIZATION
◘ Chemical Sterilization
• Sporicidal disinfectant (sterilant)
• 2% Glutaraldehyde used for heat
sensitive equipment 3 to 10
hours

70. All sterilizing systems have inherent
limitations and no single system can
be used effectively for all instruments
and devices.

71. Methods to Control the Sterilization Process
Monitoring the Sterilization process is an important quality – assessment
procedure for Infection Control in CSS . The three forms of monitoring are :
1. Physical Monitoring : Observing and recording the parameters of sterilization
functioning (e.g. time, temperature, pressure,
gas concentration)
2. Chemical Monitoring : Color or physical changes indicators that monitor
exposes to sterilizing agents or conditions.
3. Biological Monitoring : Spore testing, the most important check on sterilization
Function.
Physical and Chemical Indicators are used to indicate that the sterilization
procedure are performed and to ensure proper packing, sterilizer load
configuration and function of the process equipment.

72. Sterilization Process
• Decontamination
• Inspection / assembly
• Packaging
• Sterilizer loading
• Sterilization
• Storage / distribution /documentation

73. Surgical Instrument Cleaning Decontamination
Process
Receiving
Disassembly
Cleaning
Rinsing
Disinfecting
Drying

74. Factors that can affect the efficacy of
Steam Sterilizers
◘ Air tightness of the sterilizer
◘ Atmospheric pressure
•Low Atmospheric pressure = Air leak
◘ Quality of steam
• Need 100% saturated steam & water in the system
• Need steam separator and baffle to remove
the water from the steam at required velocity
• Decreased steam quality = Trapped air
= WET PACKS
◘ Leaks in the system = uneven heating and spot
dry condition

75. Monitoring the Sterilization Process
Chemical Indicator
◘ External - shows only exposure to a process
- does not indicate all parameters were met.
- safeguards distribution
◘ Internal Indicator
- shows exposure to the internal contents
- demonstrate exposure to one or more
of the conditions necessary for sterilization
- sterilant must penetrate the package long
enough to change the color indicator or
- change the color to a certain distance along
the bar of an “Integrator”

76. Biological Indicator (BI)
A device that has been impregnated
with a Known population and type of
micro-organisms (Spores) used to
verify that all conditions necessary
for sterilization have been met.
Most BI’s contains from 100,000 to
1,000,000 bacterial spores.

77. Sterility Maintenance
After sterilization, items should be placed in low
traffic area.
Steam load should be allowed to cool for a
minimum of 30 minutes.
Never transport warm items from the sterilizer to
cold surface (racks, shelves, counters, etc) as this
can cause condensation to form, resulting in
contamination.

78. HANDLING AND INSPECTION
Sterile items that are torn or wet are considered
contaminated and should be reprocessed.
STERILE STORAGE
Sterility maintenance bags (dust covers) may be
used to protect items that could be subjected
to environmental challenges or multiple
handling before use.
Close or cover cabinets are ideal for Storing
sterile items.
They limit dust accumulation, minimize handling
and inadvertent contact.

79. Open shelving maybe used,
but should be :
• 2” from outside walls
• 8 to 10” from floor
• 18” from ceiling
• not crunched, bent, compressed, punctured or
near any location that could become wet.
SHELF LIFE
“ Shelf life of packaged sterile items is event
related and depends on the quality of the
Packaging material, the storage conditions,
the conditions during transport and the amount
of handling.”

80. Distribution
Sterile items should be visually inspected for
Integrity and labeling prior to being issued.
Transporting sterile items in “uncontrolled
environments” should be in a covered or
enclosed cart with a solid bottom shelf
Carts should be decontaminated and dried before
reuse for transporting sterile supplies.
Transporting sterile items inside plastic bags or
boxes should be arranged within the containers
as to prevent crushing, damage or
contamination.