CENTRAL STERILE

SERVICE
DEPARTMENT

ARJUN CHATTERJEE
Central Sterile Service
Department(CSSD):

CSSD is a centralised service unit in a hospital

that receives, processes, controls and distributes
textiles ( clothing, gauzes, dressings), biomedical
devices and instruments to all sectors of the
hospital, with the goal of providing a safe input
to be used with the patient.
History:
• The history of CSSD starts in 1928 when
American College Of Surgeons introduced the
word CSSD.
• In1955 the Cambridge Military Hospital
established Regular CSSD in United Kingdom.
• In India, Safdarjang Hospital New Delhi,
established the first CSSD in 1965.
The sterilisation department in a hospital is
known by many acronyms, e.g.:
• CSD: Central Sterilisation Department
• CPA: Central Processing Area
• SSD: Sterile Service Department
• TSSD: Theatre Sterile Service Department
• TSSU: Theatre Sterile Service Unit
• CSSD: Central Sterile Service Department
 Advantages of Centralization
• Efficiency: Provides efficiency through
supervision of the cleaning, maintenance and
sterilization tasks.
• Economy: Avoids the duplication of expensive
equipments.
The life of the instruments is prolonged due to
efficient manipulation overseen by specialized
personnel.
• Safety: Decreases probability of failures within
processes as it is supervised round the clock.
 Primary Function
• The primary function of a CSSD is to provide an
efficient, economic, continuous and quality supply
of sterilised items to all patient-care service points in
the hospital, and to receive returned contaminated
items for cleaning.

• This process is generally referred to as the

“decontamination life cycle”
Decontamination life cycle
Activities in a CSSD can be sorted under the
following primary zones:
Decontamination Zone
Clean Zone(Inspection and Packing Zone)
Sterile Zone
Support zone

The following colours are used to indicate the

respective zones in order to identify the functional
relationship between the various spaces.
• Access to the red, blue and green zones is
restricted by the red-line
• The decontamination zone is secluded from the
IAP area with a hard barrier
 Activities in a CSSD
• Receiving of soiled and contaminated returns
• Sorting, disassembling, cleaning and drying of
all returned medical devices
• Checking functionality and cleanliness of
cleaned devices
• Assembling and packing
• Sterilisation
• Cooling of sterile packs
• Storage of sterilised items
• Cleaning of trolleys
• Dispatching of orders
• Quality control
• Maintenance
• Record keeping
• Receiving new supplies
 Infrastructure Requirements
1. Space:
• The general recommendation is one square
meter per hospital bed.
2. Mechanical systems: requirements of
• Mechanical, energy, water and steam system
• Pressurized systems such as compressed air,
nitrogen and vacuum systems
• Water distillation system
3. Floors and walls:
• Constructed with washable materials
• Must not release fibers or particles
• Not be affected by chemical agents
4. Ceilings:
• Must have only one surface and no unexposed
angles
5. Temperature and moisture:
• The ideal temperature range is from 18ºC-25ºC
and relative humidity of 35% – 50%.
6. Ventilation:
• The air must flow from the clean to the dirty areas
• Released into the exterior or into a filtered
recirculation system
• There should be no less than 10 air changes per
hour
7. Sinks:
• The sinks should be deep to avoid splatters and
permit correct immersion of the elements
8.Fire extinguishing systems:
• The service should have at least two fire
extinguishers
The physical areas of the CSSD are divided into:
A. Technical area
B. Administrative area
C. Support area
 Technical area
1.Decontamination zone:
• Receiving and sorting
• Manual cleaning
• Automated cleaning
• Waste disposal
• Trolley wash
• Raw materials and chemicals storage
Areas related to the Decontamination Zone
Minimum necessity:
• Washable floors and walls
• Two deep sinks
• Bench made of washable material
• Lavatory or toilet to discard large amounts of
organic matter
• Separation from the other areas by a physical
barrier
• Easily accessible from an exterior corridor
• All air expelled to the exterior without
recirculation
2.Inspection and packing zone (clean
zone):
• Inspection and packing
• Checking of instruments and devices for
integrity and functionality
• Textile folding
• Raw materials storage
Areas related to the Clean Zone
Minimum necessity:
• Washable floors and walls
• Bench and chairs made of washable material
• Magnifying glasses for confirmation of the
cleaning
• Sink for personnel
• Exit for compressed air
• Cabinets with doors to store non-sterile
material and supplies
3.Sterile zone:
• Sterilisation
• Cooling
• Sterile pack storage
• Dispatch
Areas related to the Sterile Zone
Minimum necessity:
• Washable floors and walls
• Cabinets to store material after the sterilization
process
• Prior to entry, a sink for the personnel
 Support Zone
• Office
• Staff rest room
• Kitchenette
• Female change room
• Male change room
• Manager’s office
• Steriliser plant room.
Areas related to the Support Zone
Minimum necessity:
• Administrative area for carrying out
administrative activities
• A dressing area for changing and storing
personal objects
• A deposit area for chemical products,
detergents and cleaning products
• Additional sink to wash the accessories used to
clean the environment
 Human Resources
• The number of CSSD employees will depend
on the volume of the work carried out
• The decontamination zone should have one
exclusive professional
• Each remaining area should have one or more
professionals performing activities in the
different cleaning areas
• 2 technicians and 1 technical supervisor is
recommended per 100 beds in a hospital
 Personal Protective
Equipment(PPE)
A.PPE in Decontamination area:
• Eye or face protector
• Cap, mask
• Exclusive clothing
• Plastic apron
• Thick, long latex gloves
• Rubber boots or waterproof footwear
protectors
B.PPE in IAP and Sterile area:
1. Review of materials:
• Simple latex gloves
• Cap and exclusive clothes
2. Machine operation:
• Thermal protective gloves
• Cap and exclusive clothes
 Hand washing
Hands should be washed with common soap or
alcohol solution on the following occasions:
• When entering and leaving work
• Following contact with contaminated material,
even if gloves or mitts have been used
• Before and after preparing instruments
• Before and after eating or drinking
• Before and after using the washroom
• After removing gloves
• When passing from one area to another in the
CSSD
Activities in a CSSD
 Cleaning of Materials:
Steps in the process for cleaning materials
• Reception
• Classification
• Prewashing or soaking
• Manual washing
• Mechanical cleaning (if there is access)
• Rinsing with water
• Rinsing with alcohol
• Drying
• Lubrication
Reception:
• Materials and instruments are received in the
decontamination area using a pass through
window
• Personnel should use PPE during reception
Classification:
After receiving the material, it will be classified
according to type of material, which can be:
a. Metal
b. Polyethylene
c. Rubber
d. Plastic
e. Glass
Prewashing:
• Materials are submerged in a tray containing
enzymatic detergent and then passed under a stream
of running water
• Prior to every cleaning, materials should be
completely disassembled
• At least 1 minute of soaking is recommended
Manual washing:
• Soft, non-metal bristle brush or a soft cloth and water
used to clean all of the surfaces of medical devices
• Brushing should be carried out underwater
• Rinse vigorously
Mechanical cleaning:
Some centers may have the assistance of machines
for mechanical cleaning. These include:
1. Ultrasonic washer:
• Uses sound waves along with water and detergent
• Two types of waves are generated: high pressure
and low-pressure
• Produces microscopic bubbles on the surface and
cavities of the instrument
• Implosion produces localized vacuum areas that
are responsible for cleaning the surfaces of the
objects
• This process is called cavitation
2. Washer-disinfector:
• Combination of detergent and water at 93 ºC
for 10 mins
• Vigorous cleaning of the articles through
streams of water
• Semi-critical devices are ready for use at the
conclusion of the process
Various Types Of Automated Washers And
Washer-disinfectors
Validation of functionality:
Once dry, a thorough inspection of the material
is done for:
• Functionality of closures
• Absence of cracks or tears
• Absence of lint or fibers
• Correspondence of parts (arm/piston;
body/cover)
The medical device is now ready for high-level
disinfection or sterilization.
 Preparing and packaging
materials
Packages should be selected according to the
sterilization method and the article to be
prepared
• Every package should have:
1. Exposure control
2. Identification or label of the content
3. Lot number
4. Expiry date
5. Initials of the operator
• Once articles are processed in the red area,
they will be taken through the pass thru
window to the blue (clean) area.
• This stage includes:
a. Inspection and verification of the articles
b. Selection of packaging
c. Packaging of the article
d. Sealing and labelling
e. Evaluation of the package
 Criteria for selecting a packaging system:

A. Porosity / permeability:
• Should allow the sterilizing agent to penetrate
and leave the package
• Provide a highly effective bacterial barrier
• The flow of air or permeability is expressed in
litres per 100 sqcm per minute
B. Strength:
• Strength of a package is measured by
resistance to bursting, tearing and abrasion
C. Lint or particles:
• A material that does not release lint should be
selected
D. Repellence:
• Packaging should be repellent to liquids such
as water or saline solution
• It should also demonstrate resistance to
alcohols
E. Memory:
• All packaging has memory, or the ability to
remain where it is placed
• The opening process should be both easy and
maintain the asepsis of its contents
F. Ease of handling:
• Should be easy to handle, soft, ductile
• Permit packaging without resistance
The packaged product should contain the
following information:
• Name of the material
• Destination
• Preparation and/or sterilization date
• Code of the person responsible
• Lot number
• Any other clarification that is considered
necessary (expiry date)
Evaluation of the packaging process:
Packages should undergo continuous evaluation
in order to confirm the following:
• Integrity of the external layer
• Integrity of the seals
• Correct identification
• Gauge of the chemical indicator
• Reading of the expiry date
 Basic Guidelines for Disinfection and
Sterilization
• In 1968, Earle H Spaulding established the
first rationalized guideline for processing
materials and instruments
• He categorised the instruments and items as
critical, semi critical, and noncritical according
to the degree of risk for infection involved in
use of the items
 Spaulding’s Classification
Classification Definition Levels of •Examples
processing
Critical Equipment that Sterilisation •Surgical instruments
enter sterile •Vascular, skeletal and
other prostheses
tissues including •IV and angiography
vascular system catheters
•Urinary catheters
•Needles, Forceps,
Implants etc.
Semi-critical Equipment that High level •Respiratory assistance
comes into disinfection devices
•Anaesthesia devices
contact with non- (sterilisation is •Endoscopes
intact skin or preferred) •Laparoscopes
mucous •Bronchoscopes
membrane •Endotracheal
cannulas
•Probes etc.
Classification Definition Levels of Examples
processing
Non-critical Equipment that Low level •Stethoscope
comes in contact disinfection •BP cuff
•Objects for patient
with intact skin use: bedpans,
urinals and
bedclothes
 Levels of Disinfection
A. High-level disinfection (HLD): Kills all
microbial pathogens along with a significant
number of bacterial spores if contact time is
increased.eg,
• Orthophthaldehyde
• Glutaraldehyde
• Peracetic acid
• Chlorine dioxide
• Hydrogen peroxide
• Formaldehyde
B. Intermediate-level disinfection (ILD):
Eliminates all microbial pathogens and some
bacterial spores.eg,
• Phenol group
• Sodium hypochlorite
• Cetrimide
• Benzalkonium chloride
C. Low-level disinfection (LLD):Eliminates
vegetative bacteria, fungi and some viruses.eg,
• quaternary ammonium compounds
 Disinfection methods
A. Physical methods:
1. Pasteurization
2. Boiling
3. Water and water jet disinfectors
4. Ultraviolet radiation
B. Chemical methods:
1. Orthophthaldehyde
2. Glutaraldehyde
3. Chlorine and chlorinated compounds
4. Formaldehyde
5. Hydrogen peroxide
6. Peracetic acid
7. Phenols
8. Quaternary ammonium compounds
 Sterilization methods
A. Physical methods:
1. Dry heat
2. Moist heat
B. Chemical methods:
1. Liquids
2. Gases (ethylene oxide)
C. Physical-chemical methods:
1. Low-temperature steam (formaldehyde)
2. Gas plasma (hydrogen peroxide)
 Physical Methods
A. Dry heat:
Types of Hot Air Ovens used,
1. Gravity convection oven
2. Mechanical convection oven
B. Moist heat or steam sterilization:
Types of steam sterilizers used,
1. Gravity displacement or gravitational
autoclave
2. Pre-vacuum autoclave
3. Instantaneous (flash) autoclave
 Guidelines
• Exposure time should be recorded after the required
temperature is reached
• During the sterilization cycle, the door of the
sterilizer should not be opened
• Poor heat conductor (talcum) should be taken in a
thin layer in the quantity necessary for a single use
• Packages should not touch the walls
• There must be sufficient space between each package
in order to obtain good circulation
• Chemical and biological controls in order to
guarantee the effectiveness of the process
Chemical methods:
A. Liquid chemical:
1. Glutaraldehyde
2. Hydrogen peroxide
3. Formaldehyde
4. Peracetic acid
B. Gaseous chemical:
Ethylene oxide
Physical-chemical methods:
1. Low temperature steam formaldehyde
(LTSF)
2. Hydrogen peroxide plasma
 Sterilization controls
Sterilization control is achieved by,
1. Physical indicators
2. Chemical indicators
3. Biological indicators
Physical indicators: These are
measurement elements that are incorporated in
the sterilizer.
1. Thermometer
2. Pressure manometer (Barometer)
3. Chronometer
4. Load censor
Chemical indicators:
• Used in every cycle
• Should meet the following conditions:
– printed on non-toxic tapes
– stable over time
– easy to read and interpret
Non-sterile:

Sterilized:
 Biological indicators
Confirm the sterilization of an article and determine
the effectiveness of the sterilization process
Indicators used for different processes are,
• Moist heat: Geobacillus stearothermophilus
• Dry heat: Bacillus subtilis subsp. niger
• Ethylene oxide: Bacillus subtilis subsp. globigii
• Steam - formaldehyde: Geobacillus
stearothermophilus.
• Hydrogen peroxide gas plasma: Geobacillus
stearothermophilus
Handling, Transporting and Storing
Materials

Handling:
• Product handling begins from the time the
material comes out of the sterilizer.
• Handling should always be kept at the
minimum amount necessary.
Before touching containers that contain
sterile products,
• Allow them to cool to avoid condensation
• Hands should be clean and dry
• If the operator carried out another activity prior
to the current one, carry out exhaustive hand
washing
• Transport materials in carts
• Work clothes should be clean
 Storage:
• The storage area should be separated from
other areas
• Access to the area should be restricted
• Packages should be placed on shelves or in
cabinets
• If they are small packages, they should be
placed in drawers or baskets
• They should be located at a minimum distance
of 30 cm. from the floor, 45 cm. from the
ceiling and 5 cm. from the wall
• The material should be far from sources of
moisture or heat
• There should be at least 10 air changes per
hour
• There should be an adequate level of
illumination
• The material should be placed in a position
that makes it simple to label and visualize the
expiry date
• Materials should be grouped homogeneously and
vertically
• Other materials should not be touched when
removing the one that is needed
• Every container should be inspected to verify that
it meets the requirements of a sterile product
• Shelving and cabinets should always be in
optimal conditions
 Distribution
• The sterilized product should be distributed
while preventing dropping and unnecessary
manipulation
• The discharge of the product should be
documented
• Clean bags or containers should be used to
distribute the sterilized product
• Once distribution is complete rapid
replenishment of stock should be implemented
 Sterilization Failure
If there is a potential sterilization failure, the
following steps should be undertaken:
• The CSSD technician should notify the supervisor
at the first sign that a biological indicator is
positive
• The sterilizer that fails should immediately be
taken out of service
• The lot number of the batch affected should be
reviewed
• All objects listed under the lot should be removed
from patient care areas
• They are sent to the CSSD for reprocessing
• It should be assumed that objects that have not
been located have been used with patients
• All possible efforts are made to identify the
patients who are affected
• The head of the CSSD should report the
possible failure immediately to Infection
Control Personnel