C E N T R A L S T E R I L E S U P P LY D E PA R T M E N T ( C S S D )

Dr Rahul S Kamble MBBS, MD Microbiology 

Diploma Infectious Diseases (UNSW, Australia) Infection Control
course(Harvard Medical School, USA) International Tropical Medicine
&Vaccinology course(CMC Vellore) Six Sigma Black Belt (Govt of India
certified) Auditor :JCI, NABH, NABL, CSSD, RBNQA, Taxila university
PGDBA,PGDHM,PGDCR,PGDMR,PGDOM,
PGDMLS,PGDIM,PGDHI,PGDBI,PGDHA, CCDHHO Consultant Clinical
Microbiologist &Infectious Diseases
Project Lead -Antimicrobial Stewardship at Americares India Foundation
 EQUIPMENT
CLEANING,
DISINFECTION AND
S T E R I L I Z AT I O N

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  Disinfection is a process where
most microbes except bacterial
endospores are removed from a
defined object or surface.
Definitions  Sterilization is a process by which
an article, surface or medium is
made free from all micro-
organisms including spores. 
 Spaulding’s
Classification 
 Spaulding outlined three categories of risk from
medical instruments based on its potential to
transmit infection if the instrument is
microbiologically contaminated.
 Patient contact Example Device classification Minimum inactivation
level

Intact skin  Non-critical Low level or intermediate

level disinfection 

Mucous membranes or
Semi-critical High level disinfection 
non-intact skin

Sterile areas of the body Critical Sterilisation

including blood contact

Spaulding’s Classification 
 Resistance of Microorganisms to Disinfection
and Sterilization
Resistant    Level
Prions (Creutzfield-Jacob Disease) Prion Reprocessing 
Bacterial Spores (Bacillus atrophaeus)
Coccidia (Cryptosporidium)          High
Mycobacteria (M. tuberculosis, M. terrae)
Nonlipid or small viruses (polio, coxsackie)            Intermediate
Fungi (Aspergillus, Candida)
Vegetative bacteria (S. aureus, P. aeruginosa)            Low
Lipid or medium-sized viruses (HIV, herpes, hepatitis B)
Susceptible

Adapted from CDC Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008, Figure 1 
Types of Disinfectants 
 How to select a disinfection
agent.....?
 A disinfection agent should be
selected based on the following
criterion:
 Intended use and appropriateness.
 Degree of disinfection required. 
 Spaulding’s classification.
 Safety.
 Turn-around-time (TAT).

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 Central Sterile Supply Department

The CSSD is the service within the hospital,

catering for the sterile supplies to all departments
such as specialized units as well as general wards
and OPDs.
It was previously known as:
 TSSU : Theatre Sterile Supply Unit (+)
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 HSSU : Hospital Sterile Supply Unit

 Objectives of a CSSD

TO PROVIDE SAFE TO USE TO REDUCE THE BURDEN OF TO MAINTAIN A COST TO AVOID DUPLICATION OF
MEDICAL AND SURGICAL WORK OF THE NURSING EFFECTIVE PROGRAMM OF EXPENSIVE HOSPITAL
EQUIPMENT. PERSONNEL. INSTRUMENT MANAGEMENT. INSTRUMENTS.
 To maintain records of processes used and
Objectives of a CSSD instruments processed.

To contribute in reducing infection rates in the

hospital. 

To maintain an inventory of supplies and

equipment.

To provide a safe environment for patients and staff.

To keep up to date with developments and advances

Functions of the CSSD 
 CSSD Essentials 
 Zoning : Soiled area, Clean/disinfected. area
and sterile storage area.
 Uninterrupted power supply.
 Compressed air.
 Water with low TDS. (RO water is preferred
for final rinse)
 Environmental controls:
 Temp – 18 - 25 0 C.
 Humidity – 40-60 %.
 Pressure – Cleaning and Decontamination
area - Negative.  Storage area – Positive.
 CSSD Essentials 
 Packing  material – Woven / Non-
woven/ Peel pouches/ Paper/ Plastic/
Closed containers.
 Appropriate PPE - Utility gloves and eye
wear.
 Availability of SDS.
 Periodic checks:
 Equipment monitoring. 
 Audits. 
 Periodic training.
 Documentation.
Types of Sterilization

 Steam sterilisation or autoclave

 ETO sterilisation
 Plasma gas
 Peracetic acid
 Ozone
 Chlorine dioxide
 Hot air oven
  Requires exposure to direct
steam contact at:
 Temperature: 121°  C.
 Pressure: 15 psi.
 Time: 30 mins.
 Should be used for
Autoclave – Steam sterilizing only heat stable
Sterilisation items. 
 Sterilizing discards (45-60
mins).

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 Types of Steam Sterilization
 Gravity air displacement
 Pre-vacuum dynamic air
removal
 Flash autoclave or
Immediate Use Steam
Sterilizers (IUSS)

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Performance Qualification/Batch Process Record
 The following information should be recorded in the steam sterilization batch record:
 Sterilizers identification.
 Cycle number.
 Batch number.
 Date of sterilization.
 Reference number of the master process record.
 Temperature (chamber temperature).
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 The pressure (chamber pressure).

 A signature of the CSSD Technician/ Staff in charge confirming whether the cycle was
satisfactory or not.
 Note: The batch record should be verified and the load authorized.
 ETO Sterilization

 In the ETO method of sterilization, ethylene oxide (EO)

is released is at an ambient temperature and pressure.
 Typical process temperature: 37⁰C to 55⁰C.
 Typical process pressure: 1.0-1.5 kg/cm^2.
 Typical exposure time: 60 to 120 minutes and 8-12 hrs-
Aeration.
 EO kills  by alkylation of macromolecules (nucleic acids,
proteins). 
 It is highly penetrating with minimal material
interaction.
 The aeration time varies according to the material that
is sterilized and the process. 
 The process complies with the EPA requirements and is
safe to use.
 The sterilized packages must be stored only on
stainless steel racks. They should never be
stored on wooden racks.
1. The stainless-steel racks should be placed at
a distance of:
• 45cms from the roof.
• 20-25cms from the floor.

STORAGE • 5cms from the wall.

•The shelf life of the sterilized items depends on
the method of sterilization and package. 
•It is date and event related. 
•The sterilized items are dispatched on the first
in first out (FIFO) basis.
Sterility
 The sterilizing conditions and microbiological status of processed
items must be regularly monitored. But sterility is not visible.
 So, how can we monitor the sterilization process?
Monitoring can be done by physical, chemical and biological
means. 
 
 Types of Sterilization Process
Types of Monitors
Sterilization
Process Monitors
 Physical Indicators

Each sterilization cycle

gives the printout of
temperature and pressure
under which the cycle is
processed. 
Chemical Indicators

These indicators help in monitoring the sterlisiation process through

change of colour. There are six types of chemical indicators:
 Type 1: Process indicators
 Type 2 :Indicators for use in specific test (BD test) 
 Type 3: Single-parameter indicators (not routinely used). 
 Type 4: Multi-parameter indicators
 Type 5: Integrating indicators
 Type 6: Emulating indicators
Releasing an Implant

Only biological indicator results can be used to release implants.

“Every sterilisation load containing implants should be monitored with a PCD containing a BI
(a BI challenge test pack). A Class 5 integrating CI should be included in this PCD. Implants
should be quarantined until the results of the BI testing are available.” (CDC, 2008)

“Releasing implants before the BI results are known is unacceptable and should be the
exception, not the rule.” 
Reprocessing – Single use devices
- DIN EN
ISO 13485:2007
 A single use device (SUD) is a
device that is marketed or
labeled for single patient use or
single procedure use.
 It is not marketed or labeled
with the intent of reusing the
device on another patient. 
 Identification of reprocessing times of SUD.

Labelling of SUD with the name of the device, size

specifications, original manufacturer, number of times the
Principles of device has been used, date of last use and date of
reprocessing. 
Allocation of a non-repeatable batch number to the device in
Reprocessing order to facilitate recall of the device.

Reusable Devices Not reusing original packaging materials from the

manufacturer.

Obtaining consent for use on patients.

Documentation. 
 Conditions when instruments or equipment are
returned to CSSD:

When the biological indicator shows bacterial

growth.

Sterilisation Failure - When it is wet inside the sterilised package.

Recall
When there is no colour change in the chemical
indicator.

If the SUD is found unsafe to use due to repetitive

incidents or due to a report by Microbiology
department or from its manufacturer. 
 Monitoring the Sterile Process: A Quick Recap 

Monitoring Indicators Used Frequency of

Monitoring
Calibration and maintenance  Physical  Yearly
Routine maintenance  Physical Monthly 
Leak test Physical (Optional) Weekly
BD test Chemical Daily once 
BI test (Steam and EO ) Biological Daily once (Ideally)

Class 5 with porous PCD (Steam) Chemical Every load 

BI test in case of implant load Biological Every load 

Steam sterilisation Class 1 and 5  Every pack 
EO sterilisation Class 1 and 4 Every pack 
 Documentation of disinfection and sterilization
practices in the HIC manual .

Daily records of sterilization process.

Evidences  Quality check of sterilization process – Chemical

and biological indicators. §Recall register.

SUDs reprocessing documentation - Record and

in patient files.

Staff training records. 

SDS for all chemicals used. 

 Centers for Disease Control and Prevention (CDC) 

Guideline for Disinfection and Sterilization in Healthcare

Facilities, 2008   

Association for the Advancement of Medical Instrumentation

Evidence-Based (AAMI)

Guidelines Comprehensive guide to steam sterilization and sterility assurance

in health care facilities, ANSI/AAMI ST79:2010 & A1:2011,
A2:2011, A3:2012 & A4:2013 (Consolidated Text)

Association of Perioperative Registered Nurses (AORN)

Perioperative Standards and Recommended Practices (2013

Edition)
Thank
You..