CSSD New

AMRI HOSPITALS Ltd.
(DHAKURIA) Document:
AMRI/DHK/SOP/06
SOP-CSSD Page 1 of 36
CENTRAL STERILE SUPPLY DEPARTMENT
(CSSD)
Issue No. : 03 Rev No:00

Issue Date : 15.09.2022 Rev Date:00
AMRI HOSPITALS Ltd. (DHAKURIA) Document:
AMRI/DHK/SOP/06
OWNERSHIP DECLARATION
This document and the information contained herein are the sole property of AMRI
Hospital Ltd. Dhakuria It has been issued to you on account of your official association
with this hospital. This document must be returned to the Quality Department if this
official association ceases. Whenever you feel a need for amendment to the contents of
this document please contact the Quality Department. Please do not make any alternation
to this document of your own. It shall not be reproduced in whole or in parts in any form
whatsoever, without the formal consent of the undersigned or his designated authority.
Place:Kolkata
Date:15.09.2022
(UNIT HEAD)

AMRI/DHK/SOP/06
Document Name :
SOP-CSSD
Date of Issue : 15.09.2022
Issue Number : 03
Revision Date : 00
Revision Number : 0
Designation : CSSD In-charge

Prepared By :
Signature :
Designation : Consultant Microbiologist & ICO
Reviewed By :
Signature :
Designation : Unit Head
Approved By :
Signature :
Designation : Quality In-Charge
Issued By
Signature :

AMRI/DHK/SOP/06
INDEX:
INTRODUCTION.............................................................................................................................6...
PURPOSE..........................................................................................................................................6...
SCOPE................................................................................................................................................6.
EQUIPMENT USED.......................................................................................................................6.-7..
FUNCTIONAL FLOW OF ACTIVITIES OF CSSD...................................................................7-8.....
HIERARCHY CHART........................................................................................................................
LAYOUT....................................................................................................................... .......................8.
ZONING...............................................................................................................................................9
CSSD FUNCTIONAL FLOW......................................................................................................... 10-11.
PROCEDURE AND POLICY FLOW............................................................................................12-14..
RECEIVING OF SOIL INSTRUMENTS FORM USER AREA.................................................15-16..
CLEANING & DECONTAMINATION............................................................................................16
PRECAUTION DURING CLEANING OF INSTRUMENTS.....................................................16-17...
PROCEDURE FOR MAKING INSTRUMENTS PACK.............................................................17-18...
DIFFERENT WRAPPERS FOR STERILIZATION AND METHOD OF WRAPPING
OF SETS ............................................................................................................ ...............................18-19...
PROCEDURE OF MAKING LINEN DRAPE AND GOWN......................................................19-21...
PROCEDURES OF PACKING OF ITEMS FOR PLASMA STERILIZAITON........................
STEAM STERILIZATION..............................................................................................................21-24..
GAS PLASMA STERLIZATION....................................................................................................25 ..
STORAGE,HANDLING AND TRANSPORT................................................................................25-28..
CARE AND MAINTENANCE OF AUTOCLAVE AND PLASMA STERILIZER....................28-29.
CHECKING OF FUNCTIONALITY OF THE STERILIZERS..................................................29-31...
BOWIC-DICK TEST AND LEAK TEST OF PREVACUMM STEAM STERLIZER..............31-32.
RECALL PROCEDURE............................................................................................................. .....32-33...
EXPIRED ITEMS OR RE-CONTAMINATED ITEMS...............................................................33-34...
ENTRY IN THE STERILE AREA......................................................................................................34
MAINTAINANCE OF STERILE AREA........................................................................................34
INFECTION CONTROL PRATICE...............................................................................................35 -36..
SAFETY PROCEDURES............................................................................................................ .....36-37..
TIPS FOR PREVENT FAILURE OF STERILIZATION PROCESS..........................................37-38...
INDEX OF REGISTER............................................................................................................... ......41.
REPROCESSING OF SINGLE USE DEVICE...............................................................................38-39
QUALITY INDICATORS MAINTAINING IN CSSD...................................................................39-41

AMRI/DHK/SOP/06
AMENDMENT SHEET
Sr. Pa Date of Effective Revision

Section Amendment Signature
No. ge Amendment Date No.
1.
2.
3.
4.
5.
6.
7.
8.
9.

AMRI/DHK/SOP/06
1. INTRODUCTION:
Sterile supplies continue to be a major support area in the hospital. There is growing
knowledge and technique available with regard to sterilization. While steam
sterilization retains its paramount importance, Ethylene Oxide (ETO, EO) and Plasma
sterilization is a widely used method for sterilization. An important area in the support
service is that of sterile supplies, the concept of which has also undergone significant
transformation in recent times. Newer and better methods of sterilization, introduction
of more and more disposables into hospital practice and the development of quality
control systems have all been part of the efforts of the health community in the control of
hospital infection.
2. PURPOSE:.To prepare and furnish other departments with sterile equipment and
supplies needed in the patients care for operation theater, ICCU, ICU, Neuro ICU,CTVS
ICU, Dialysis, OPD,Emergency all wards & all departments.To ensure high standards of
sterilization and disinfection so as to minimize the incidence of infection in the Hospital.
3.SCOPE:The scope of CSSD services is to provide sterilized instruments and linen to

all user departments in time by means of autoclaving, ETO sterilizing .
4. EQUIPMENTS USED:
• Ultrasonic Cleaner
• Washer disinfection with inbuilt dryer
• Steam Sterilizer (Autoclave)
• Automatic sealer
• Storage racks
• Linen folding table
• Pre-soaking sinks
• High pressure water jets
• Compressed air gun
• ETO sterilizer

AMRI/DHK/SOP/06
5. Functional Flow of activities of CSSD:RINSING: - Rinsing of articles immediate

after use must be done in the respective patient care areas by a trained staff-nurse.
TRANSPORTATION: - All soiled items should be transported in a closed trolley with
the proper requisition.
CLEANING: - All reusable medical devices should be thoroughly cleaned prior to
disinfection or sterilization.Pretreatment of instrument----Once used instruments are
received by CSSD following steps are followed----1. Rinsing;-Instruments rinsed with
warm water and cleaned for blood and body fluid stains in bowl at "washing
bath”.Instruments are dipped in 10 ml/lit with "Multienzyme" solutions and Acidic and
Alkaline (Neodisher FA and NA) in 2:3 ratio. After rinsing of instruments, sorting is done
for all these instruments.1) Micro instruments should be cleaned (10ml/litre with
multienzyme& 10 ML/Ltr "Getinge Clean" Enzymatic detergent solution) by vibration in
ultrasonic cleaner. Time &temperature--20mins & 45 Degree-55Degree C respectivly. .2)
All common surgical instruments are cleaned, washed & disinfected in washer
Dis-infector machine ("Neodisher Clean" Universal detergent (3:1)) in water & kept at
least 45mins.
DRYING: - all articles should be dried appropriately. Instruments are placed in drying
cabinet at least 20 mins at temp 70 °C.
INSPECTION AND ASSEMBLY: - Each item should be inspected for functionality,
defects, breakage and then appropriately assembled according to the check list. At that
time Neodisher spray are used for lubrication of instruments.
PACKAGING: - Articles should preferably be packed in SMMS packaging materials
and peel pouches as per requirement.
LABELLING: - Each pack should contain item description, department‟s name and also
a batch monitoring label with load no., sterilization date, expiry date and mentioning
operators‟ name.
STERILIZATION: -After proper packing and labeling the items should be sterilize as
per their temperature sensitivity. The operation of the sterilizer should be entrusted to a
responsible and fully trained person. It should be kept in a state of good maintenance and
repair.
STORAGE: - Should be properly managed separately for sterile and non-sterile stores.
For sterile goods, clean room conditions with temperature and relative humidity should
be followed.
DISTRIBUTION: -Refers to clean and dirty articles exchange system. A program should
be established for the collection of used items from patient care areas and distribution of
AMRI/DHK/SOP/06
sterilized goods. All items should be issued as per requisition.
7.Layout
The CSSD department will have the following sections
• Washing & decontamination area
• Linen Packing area
• Instrument packing area
• Steam sterilizer area
• Sterile storage area
• Material storage room
• ETO room
• Staff changing room
• HOD room/in charge CSSD room

Toilet
8.ZONING:
CSSD will be divided into 3 major areas-
1.RECEIVING, CLEAN& DECONTAMINATION AREA
2. PACKING & STERILIZED AREA
3.STERILE STORAGE AREA
DECONTAMINATION AREA will consist of:
• Washing & Disinfecting room
• Receiving area
• Automatic Washer-Disinfection with inbuilt Dryer
• Ultrasonic Cleaner.

AMRI/DHK/SOP/06
PACKING & STERILIZED AREA will consist of:

• Clean Storage
• Steam Sterilizer
• Gas Sterilizer (ETO)
• Rotary Sealer
• Linen Packing Room
• Instrument Packing room
STERILE STORAGE AREA will consist of

• Sterile Item Store
9.CSSD FUNCTIONAL FLOW:
Used instruments from OT/ Wards
Items received Checking Washing and Drying

cleaning
Assembling
Issue to Packing & labelling

OT/Wards
Sterile storage Loading in

Unloading Sterilization
sterilizers

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For Clean Linen from Laundry
Linen Checking Folding & Loading in sterilizers

received linen Packing
Issue to Sterile storage Unloading Sterilization

OT/Wards
Sterilization of Linen
The main building 2nd floor coridor is connected with CSSD & OT entrance and service
lift & through lift non sterile & clean linen come in CSSD as per laundry requisition book.
Used linen(Soil linen) from OTs taken out through OT front door & kept in Basket by OT
boy through 3rd floor back stair & store at the Mazzanine floor.
Soiled linen segregated & counted in presence of linen Dept. & OT personnel.
↓
All soiled linen after disinfection are send to outside laundry for wash daily.
↓
Supply of clean linen to CSSD.
↓
Linen checking & folding & packing for sterilization.
(Daily check the linen for any holes or torn)
↓
Supply of sterile linen to the users(All OTs & Cath Lab).
(As per their requirement)

AMRI/DHK/SOP/06
10.PROCEDURES& POLICY FLOW:
Location: CSSD is located at 2nd floor in Main

building of the Hospital. It caters to all the
needs of the OT, Critical Care Units,
Dialysis and OPD and other patient care
areas.
TIMING:
C.S.S.D. Functioning (24x7) weekly and
Staff requirement in CSSD even in the holidays.
Morning-01
It covers mainly five shifts.
General-01
•
Evening-02
Night-01
•
2 staff is required for CSSD department.
** Clean the Instruments as soon as possible after use. Never allow blood & debris to dry
on the instruments & primary cleaning of articles immediate after use must be done in the
respective patient care areas by a trained staff nurse and immediate send to CSSD as per
sterilization rule.
Use of PPE:
PURPOSE: To minimize cross –infection through proper

dress code and training to the CSSD staff.
SCOPE: It defines the action and responsibilities of the

CSSD Staff.
PROCEDURE Entry to the CSSD will be via the service lift

entrance corridor where outdoor footwear will be

AMRI/DHK/SOP/06
exchanged with inside chapels.

All persons entering the CSSD, change into scrub
suits and cover the head with caps and face with
mask.
• The used scrub suits are sent to laundry daily.
• Staff assigned to work in the decontamination

areas will also wear slippers and plastic aprons.
They also wear rubber gloves, masks along with
caps, goggles, gum boot. Staff in the receiving
room will wear aprons, gloves, masks while
checking the soiled instruments.
• Staff assigned to either the „dirty‟ or „clean‟ areas

of the CSSD will as far as is practicable remain in
their designed zones for the duration of the shift
duty. Should there be a need to crossover from
one zone to another they must change their
footwear accordingly, also caps, masks, aprons
etc. and wash their hands on both leaving one
zone and when entering the next.
• Staff leaving their work stations for toilet and

refreshment breaks will also remove masks and
aprons and in the case of staff assigned to the
decontamination areas they will remove aprons
and boots also.
• Caps must cover all hair and staff with facial hair
will wear face mask.
• Minimal jewelry should be worn.
• Hair and nails must be clean with no nail varnish.
• Staff with broken or infected skin should report

same to the Incharge CSSD/Supervisor and at the
same time cover all cuts and abrasions with a
water proof dressing.
• Visitors to the department including maintenance

staff shall be required to wear suitable protective
AMRI/DHK/SOP/06
clothing gown, overshoe, cap, any protective

clothing which become contaminated during the
course of the working day should be changed
immediately or as directed by CSSD
Supervisors/in charge or CSSD Technician.
10.1 .RECEIVING OF SOILED INSTRUMENTS FROM USER AREA:

RECEIVING OF GENERAL SOILED ITEMS :
 Rinsing of articles immediate after use must be done in the respective patient care
areas by a trained staff-nurse.
 Then all the items\sets will be entered in the CSSD receiving section with the name of
instruments or set and proper signatures of the sender in the requisition book.
Instruments should be send within a closed transport trolley.
 Instrument packs will be received in CSSD by checking thoroughly by putting
counter signatures of the CSSD personal.
 Soil items from wards are received everyday at 9.00am to 11.00am and OT items are
received any time in a day. Soil items from only critical care units are received
everyday at 9 am-11am & 2pm-2.30pm.
10.2 RECEIVING OF SERO POSITIVE INSTRUMENTS FORM USER AREAS:
 Rinsing of articles immediate after use must be done in the respective patient care
areas by a trained staff-nurse (First in multi-enzyme solution for 10-15 min. then in
hospital authorized HLD)
 Positive instruments does not come along with general instruments.
 Staff nurse are informing us at least a hour before sending the positive instruments
prior to making decontamination solution.
 Instruments are sending in a yellow bag through a closed transport trolley.
 Then all the items\sets will be entered in the CSSD receiving section with the name
of instruments or set and proper signatures of the sender with case history of the
patient and the surgery.
AMRI/DHK/SOP/06
 Instruments will be received in CSSD by checking thoroughly by putting counter

 Signatures of the CSSD personal.
 Immediate after receiving the particular instruments all are soaking into a HLD
solution for a specific time as per the instruction of the manufacturer.
10.3.CLEANING& DECONTAMINATION:
 Sorting of used items is accomplished in the decontamination area prior to washing.
 Collecting soiled instruments from OT/ WARDS by check list and proper requisition.
 All soiled items should be rinsed in the respective user area and if infected should be
soaked into a high level disinfection solution for a minimum period of 30 minutes
before sending to the CSSD.
 Open all instruments except those with sharp teeth, such as towel clips (this allows
water to come in contact with serrations). Disassemble parts prior to cleaning.
 Special attention to be paid to items with lumens. Air jets and/or water jets along
with long fine brushes are used to clean the narrow lumen.
 Sharp instruments shall be handled separately to remove soil. Instruments, which are
allowed to lie for several hours before they are cleaned, may acquire tarnish, which is
difficult to remove.
 Utensils and other big instruments are preferably cleaned using the Washer
Disinfector. Delicate micro instruments such as those used for ENT surgeries are
cleaned using Ultrasonic Cleaner. Thoroughly clean all surfaces of the cables
(which are not to be soaked in water) with approved disinfectant, followed by wiping
using water, let air dry and return to appropriate clean area.
10.4.PRECATION DURING CLEAING OF INSTUMENTS:

Cleaning operations have three major objectives:
 Removal of visible soiled contamination
 Removal of invisible soil pathogens
 Removal of as many harmful micro-organisms as possible
 Soaking will remove gross soiled contamination and make washing easier.
AMRI/DHK/SOP/06
 Washing may be done manually or by using machines like Washer Disinfector or

Ultrasonic Cleaner. Cleanliness is essential for proper sterilization. After gross soil
has been cleaned from items, they may be placed into the washer disinfector or
ultrasonic cleaner as per requirements . All items shall be cleaned while being held
under water to prevent aerosolization of contaminated fluids.
 All items washed with detergent (pH-7) shall be rinsed in RO water to remove
residuals that may cause discoloration and pitting of instrument surfaces.
 All items should be dried with hot air dryer prior to packaging and sterilization. Items
shall be hand dried with absorbent towels or by air-drying.
 Inspect instruments to make sure that they are clean, dry and functioning properly.
 Soiled objects shall be returned for decontamination again.
10.5. PROCEDURE FOR PACKING INSTRUMENTS:

Fundamentally important to fight against cross-infection and make a bacteriological
barrier and remain sterile till the time of use.
PROCEDURE:
 Check all the instruments for proper cleaning. There should be no residues of blood,
tissues or soil.
 In case not cleaned properly, send the instruments back to the decontamination area
for another cycle of decontamination.
 Check whether the instruments are 100% dry. If not, dry them again by dryer or
wiping by soft linen.
 Count the number of the instruments according to the standard check list.
 Check the instruments for their functionality (sharpness, movement etc.)
 Replace the instruments in case not working properly.
 Put chemical indicator & list of instruments along with the signatures of the packer
and date inside the packs.
 Arrange the instruments in the tray according to the standard list.
 Instruments are washed & disinfections by washer disinfector & ultrasonic bath.
 Before packing the instrument tray, check the wrapper under light for any cuts and

AMRI/DHK/SOP/06
holes.
 Wrap the sets with double SMMS wrapper sequentially.
 There should be five parameters on each packet.
 Department‟s Name (From where the item has come)
 Item‟s Name
 Machine no. and load no
 Sterilization Date
 Expiry Date
 Process Indicator/ Expose control.
 Limit the size of the pack should be 12” x 12” x 20”. Maximum weight should not
exceed 12 pounds (5.44 Kgs).
 Hand over the set for sterilization.
10.6. DIFFERENT WRAPPERS FOR STERILIZATION AND METHOD OF
WRAPPING OF SETS:
(a)SMS Non-woven Sterilization Wraps:
(i) High degree of tensile strength, water repellent, lint free, good
bacteriological barrier.
Advantage: Aseptic presentation of sterile instruments/ items, dressing
materials, trays and medical devices.
(ii) These kinds of wrappers are suitable for both steam and Plasma sterilization
processes. But all these wrappers are made for single use only.
(b) FLAT REELS/ PLASTIC PEEL POUCH:
(i)Good barrier to micro-organisms, resist tearing and puncturing, excellent seal
integrity that is tamper evident.
(ii)Suitable for both steam and gas sterilization process.
Advantage: Readily visible after packaging to allow easy identification.
(c) TECHNIQUE/ METHOD :
AMRI/DHK/SOP/06
The total weight of a properly wrapped tray of instruments should preferably not
exceed 17 pounds for a better probability of steam contact and drying
(i) ENVELOPE METHOD
(ii) OBLONG METHOD
The above method will be applied as per requirements to pack.
Secure the package with exposure control (indicators) and identify the set
content.
SMS & Medical grade peel pouch are used for knife dish & instrument trays,
also disposable hand towel is needed for surgeon gown packs in future.
10.7 PROCEDURE OF PACKING LINEN DRAPE AND GOWN:

 Sort the laundered linen received form linen store.
 Check the linen whether laundered properly. There should be no stains or dust. In
case not clean, reject the linen & send back to linen store for washing once again.
 Check the linen for any holes or torn.
 Fold the linen as per the OT requirement.
 Arrange the linen pieces according to the needs
 Place the chemical indicator in the middle of the pack.
 Wrap the contents with double SMS wrapper sequentially.
 Write the name of the pack over the pack for identification.
 Limit the size of the pack to 12” x 12” x 20”. Maximum weight not to exceed 12
pounds (5.44 Kg)
 Department‟s Name
Item‟s Name
Machine no and load no
Sterilization Date
Expiry Date

AMRI/DHK/SOP/06
Hand over the pack for steam sterilization.

LABELING:
 After packaging, all trays or sets will be labeled with a description of contents
and with the technician's initials.
 Date of Sterilization
 The expiration date (where applicable) for the tray or set will be indicated on
the outside of the packaging, or the "event related" label will be attached to the
wrapped item.
 All trays and sets will have an external chemical sterilization indicator
(sterilizer tape).
 Initials of the technician
10.9 STEAM STERILIZATION:
 Instrument packs will be received in the sterilizer area from instrument packing area
and linen packs will be received from the linen packing area.
 Sterilizer operator will check the labels of the packs for the contents of the pack,
whether linen or instruments.
 Sterilizer operator will put the chemical indicator (Batch monitoring label)over the
packs and on one side,one dummy pack with a chemical indicator at the center of the
pack and one Biological Indicator(as per organization guidelines)
 Following information are given on the batch monitoring lebel over the chemical
indicator:
Name of organization
sterilizer no and load no
Date of sterilization
Expiry date of the pack
st
Frequency daily at 1 cycle and every cycle where an implant is sterilized Inspection 1.
Door Gaskets, 2.Broiler water Drain Screens, 3.Internal and External Surface of Machine.
 In case, instrument packs and linen packs are required to be sterilized in the same
sterilizer at the same time, then place instrument packs on the bottom shelf and linen
packs up.
 Load the packs in vertical position into the loading trolley or basket.
 After loading, place the baskets or trolley into the sterilizer chamber.

AMRI/DHK/SOP/06
 Close the sterilizer door.

 Choose the programme to be run and start the cycle.
 Following parameters will be used for different loads:
Type Temperature Pressure Sterilization Time

Cycle I 134 deg C 3.1 bar 4 minutes
Cycle II 121 deg C 2.2 bar 20 minutes
 After completion of the cycle, automatically open the sterilizer door in the sterile
side.
 Give at least 15mins for cooling down the entire load in the chamber.
 Unload the materials form the sterilizer chamber aseptically.
 Check the color change in the batch monitoring level and dummy pack as per
manufacturer‟s recommendation. In case, the color has not changed as per desire
level after the cycle completion, reject the load and inform the supervisor /HOD.
 Check the temperature – pressure record of the sterilization cycle printed by the
sterilizer. In case the above-mentioned parameters are not met, reject the load and
inform the Supervisor / HOD.
 Above-mentioned information will be kept for future record.
 Record the temperature & Humidity of the three areas Decontamination, Packaging
& Sterile Storage Area 8 hoursevery day.
 Also check hardness of RO water by hydrometer 3 times daily from RO water supply
line.
Shelf life: The expiry of the materials is event related and should be decided depending
upon storage conditions, handling of the items etc.
Expiry of steam sterilized items:
All surgical instruments, drapepack,gown pack-30days
Expiry of ETO sterilized items.

Multiuse and single use device – 1 year

AMRI/DHK/SOP/06
Sets for autoclaving will be arranged in accordance to a checklist mentioning the contents
of the tray/set.
Common sets:
 Bypass set
 Ortho General set
 Laminectomy set
 Craniotomy set
 Dental Set
 Laporatomy set
 Angio set
 ENT set
 Lap Chole Set
Preparation of Supplies for Autoclaving:
Loading the steam sterilizer:

When loading, leave sufficient space for steam to circulate freely. Do not overload
 Linen and instrument packs will preferably be loaded and sterilized separately.
 In case, instrument packs and linen packs are required to be sterilized in the same
sterilizer at the same time, then place instrument packs on the bottom shelf and linen
packs up.
 In the loading trolley or baskets, place linen packs in vertical position on edges rather
than the flat side up to permit steam to pass from the top of the chamber through
multiple folds in the packs towards bottom.
 Place instrument packs flat on the loading trolley or baskets.
 Arrange the packs in such a way that steam can penetrate easily to the every corner
of the load.
 Instrument sets should not exceed 8 kg (18 lbs). Basin sets should not exceed 3 kg (7
lbs). This is to limit the amount of condensation which forms when steam contacts
cool metal. Using these limits ensures that the items will dry during the sterilization
AMRI/DHK/SOP/06
cycle.
 Linen packs should not be too large (size 12”x12”x20”) and weigh no more than 20
pounds in order to assure steam penetration of the pack in 30 minutes (the time
allowed for sterilizing wrapped items).
 Give at least 3 inches gap from the chamber wall.
 Do not place the packs on the floor of the sterilizer chamber.
 Maximum 80% of chamber volume can be filled up by the materials to be sterilized.
Unloading the steam sterilizer:

 After the completion of the sterilization cycle, automatically sterile side door will
open.
 Give at least 15 min for cooling down the entire load.
 Visually check the outside wrappers for dryness. Reject the packs in case there are
water droplets or visible moisture on the exterior of the pack.
 To prevent entry of moisture and micro-organisms into the packs, do not handle
sterilized items before they are entirely cool.
 Check the colour change of the batch monitoring indicator.
 Do not place the sterilized items during cooling on cold metal surfaces as moisture
will condense onto the items and contaminate them.
 Sterile load to be kept on wire mesh racks till it cools down.
• Note: If a pack is dropped, tears or comes in contact with moisture, it must be

considered contaminated.
ETO STERILIZATION

AMRI/DHK/SOP/06
Operation of ETO Sterilizer
SOP for operation of ETO Sterilizer
Follow the requisition form
Drying the instruments & catheter by compresure air supply
Proper packing & sealing by sealer machine
Stick the step process indicator over packing instruments stery bag by labeling gun
Load the basket with all packs for ETO Sterilizer machine
At the same time follow the reading & printer paper of Sterilizer machine
After Sterilizing properly unload the packs keep the sterilized packs on shelf in sterile storage
area
Finally distribute the packs as per requisition form
Before distribute the packs check the expiry date.
Time and temperature parameters :

For ethylene oxide sterilization. A--Temperature--37*c & 55*c, Expose Time--6hrs
&3hr, Aeriation-8 hrs.
Total cycle Time--11--13 hrs. Name of the EO Sterilized items---a) Sternal saw, b)
catheter, c) suction tube, d)Diathermy pencil, e)Ambu bag, f)Ventilator tube, others.
Also all rubber & heat sensitive items.
10.11 STORAGE,HANDLING AND TRANSPORT:

 The environmental conditions of the areas designated for storage and distribution
should ensure the integrity of all materials and products ie clean, well ventilated and
secure.
 The accommodation should afford adequate protection to prevent contamination or
deterioration of the product. Stock rotation will be used for storage i.e., FIFO (First
in, first out). Expiry time and date will be marked on the sterile pack. If unused

AMRI/DHK/SOP/06
within the expiry date, the pack will be sent for re-sterilization.
 The integrity of the packaging material (Wrap, peel pouch) must be verified prior to
the release and prior to the use of sterile items. Any sterile package that shows
evidence of breach of integrity will be considered unsterile. It must be returned to the
Sterile Processing department.
 The persons responsible for handling, storage, cleaning and inspecting of sterile
supplies should receive training including the following; (time related vs event
related shelf life, inspecting the condition of sterile packages, handling transportation
and storage of sterile supplies, consequences of using unsterile supplies, stock
rotation, and consequences of excessive dust on outside wrapping).
 Users of sterile supplies should also be educated to inspect all products prior to use.
 All sterile patient items require storage in the following manner:
 10" away from the floor
 At least 18" from the ceiling
 At least 2" from the outside walls
 Away from potential moisture contamination(sinks, steam pipes etc)
 Packages will be positioned in a way that avoids crushing, bending or compression.
 It is recommended that sterile items be stored in cabinets or closed containers.
 All sterile supplies will be carefully checked before delivery to the clinical area to
make certain the package is not damaged or has an expired expiration date. (for items
that are not part of the “Event related Shelf Life”)
 Periodic inspections of the sterile stock must be conducted to make certain no
outdated or damaged items remain in stock.
 Outdated supplies will be removed from stock and removed from their package,
inspected, then repackaged and resterilized or discarded, as necessary.
 Good personal hygiene, especially good hand washing, is required when handling
sterile items.
 Sterile items must never be allowed to come in contact with water, unsanitary
surfaces or other sources of contamination.
 Shelves containing sterile supplies will be maintained in an orderly manner and will
AMRI/DHK/SOP/06
be cleaned on a routine basis.

 Any sterile item that is dropped onto the floor must be carefully and thoroughly
inspected. If it is found to be undamaged; then it may be returned to the shelf. If
there is any damage or contamination to the packaging or contents, the item must be
repackaged and resterilized or discarded.
 Food and beverages are not allowed in areas where sterile supplies are stored.
 The temperature shall be controlled between 18*c to 22*c. and the relative humidity
between 35% and 70% at all times.
 The Sterile Storage area will have good ventilation, with at least 10 air changes per
hour, and be balanced with a positive air pressure.
 Sterile supplies will be transported in covered transport trolley.
 Inspections: All departments or clinics storing sterile patient items must inspect their
stock for evidence of tampering, punctures, moisture or other signs of compromised
packaging.
 The final user is responsible for carefully inspecting all sterile packages for signs of
contamination, damage, or for expired shelf life.
 Request for operating instruments shall be forwarded to the CSSD in a requisition
book a day ahead in accordance with the surgeries planned. The CSSD supervisor
shall ensure the timely supply of the required items to the OT through dumbwaiter
 1.Sterile instrument and linen packs will be transported from CSSD to OT and other
user areas with a closed transport trolley.
 Following will be checked before dispatching the packs for use in the OT or other
user areas.
 Name and quantity of the packs
 Date of sterlization and expiry of the packs.
 Batch monitoring indicator's colour change.
 Whether the pack has any cuts and holes.
10.12 CARE AND MAINTENANCE OF AUTOCLAVE AND :/ ETO STERILIZER

AMRI/DHK/SOP/06
1.Daily Care of the Sterilizer

2.Remove plug screen strainer and remove lint and sediment from the pores with a brush.
It is through this screen that air and condensate particles are removed from the chamber.
If this detail is neglected, the sterilizer cannot be depended on to provide proper
sterilization.
3.All accessible surfaces of the carriage shall be washed with a mild detergent solution.
Use a damp cloth, begin at the top and work downwards.
4.In case of a minor error refer to Equipment Manual File. If problem persists in the
functioning of the sterilizer, shut down sterilizer. Cycle printout and report of Biological
Indicator is filed for analysis and further reference in Steam Sterilizer Record File.
5.Notify Biomedical Engineer. Record details of failure in Biomedical Equipment
Register. The status of the sterilizer to be informed to CSSD In-Charge and other
departmental members. Communicate for other shifts by recording in Communication
Log if you are unable to sterilize any particular requirement due to a major failure then
inform user department.
6.After any major repair of the sterilizer, three Bowie and Dick tests shall be run and
passed before the sterilizer is returned to service.
7.A preventative maintenance contract with the supplier is maintained for all sterilizing
equipment. They are responsible for all repairs and regular checks. Biomedical
department maintains record of equipment failure, repair, downtime and servicing done
8.Minor repairs, adjustments and changing of paper roll for recorder is the responsibility
of CSSD technician.
9.Cleaning and monitoring of the sterilizers is the responsibility of CSSD technician.
10Three indicators are used to validate sterilization process.
10.13 CHECKING OF FUNCTIONALITY OF THE STERILIZERS:

Quality control indicators in the form of physical, chemical and biological indicators
have been incorporated into our sterilization assurance program. Issue to users of any
processed items will be done only after checking the various indicators.
Mechanical/Physical indicators:- The computer printout describes the sterilizer cycle
accurately. It gives information regarding heat up time, holding time, exhaust creation
time etc. This enables to have a check on the sterilizer. The printout of every cycle is filed
in Steam Sterilizer Record register after Steam Sterilization and in ETO record register
after ETO sterilization.
AMRI/DHK/SOP/06
Chemical indicators: - This is a chemical indicator strip placed inside of the every pack.
It will changed its colour after the sterilization parameters reached there desire level.
a. Every pack must have an indicator affixed on the label. After sterilization these
packs are issued for use only if the indicator shows the prescribed color change.
b. An integrator strip that changes color only if all three parameters – temperature,
time and steam match with prescribed values is used as a check for every load.
This strip is placed near the drain and the load is considered sterile only if there is
an appropriate color change. The changed integrator is filed along with the cycle
printout in Steam Sterilizer Record register and ETO sterilizer record register
Biological indicators: - They are designed for use with specific types of sterilization.
Geo Bacillus Sterothermophilus for steamand the load with Implants for steam.
Control of Biological Indicators (Steam and ETO) should be sent to Microbiology Dept
for checking vialbility
ETO - Bacillus atrophaeus .Biological monitoring shall be done daily in the load cycle
for ETO.
Place the biological indicator over the drain in the steam sterilizer or beside the doors of
the sterilizer.
After the completion of the cycle the exposed biological indicator should be send to the
Micro- Biology Department for culture. The incubation time for the steam and plasma
biological indicator are72 hours and 24 hours respectively . It there is no colour change
after the specific duration of incubation then sterilization cycle is perfect.
Any positive biological indicator shall be considered evidence of inadequate sterilization.
This evidence shall not be ignored; nor shall it be regarded as a "false" positive test. The
biological should continue to be cultured to make sure that what is growing is the same
substance as was in the capsule.
Re challenge the sterilizer with several bio indicators placed in the load.
The sterilizer in question shall not be returned to regular service until the results of this
retesting are satisfactory (i.e., negative).
Documentation of test results is done in Steam Sterilizer Record register after Steam
Sterilization.
There are many potential Causes of Sterilization Failure: It should be remembered that
AMRI/DHK/SOP/06
sterilization is a process; a deficiency in any of the variables necessary to effect

sterilization can result in unsterile product. These variables include:
1. Sterilizer performance (including sterilant quality).
2. Choice of packaging materials
3. Packaging technique
4. Sterilizer loading techniques
5. Operator error
6. Biological failure - contamination of biological indicator.
7. Proper incubation steps must also be checked (include human
error check).
8. To challenge the steriline penetration of hollow device
instrument ,PCD are used for both Autoclave & ETO
Sterilization.
10.14 BOWIC-DICK TEST AND LEAK TEST OF PREVACUMM STEAM

STERLIZER:
The functional checking of a pre-vacumm steam sterilizer shall be tested daily and
weekly by Bowic-Dick Test and Leak Test respectively.
BOWIC-DICK TEST :
This test should be done in every day morning in empty chamber.
1. Check chamber drain trap, remove all debris (ensure that sterilizer is empty).
2. Turn sterilizer on.
3. Run a warm-up cycle.
4. Place a ready made(recommended by some international organization) Bowic-Dick
testpcak over the drain line
5. Make sure that the sterilizer is empty.
6. Close the door.
7. Select the Bowic-Dick Test Programme.

AMRI/DHK/SOP/06
8. Start Bowie Dick Test Cycle

9. End of the cycle remove the test pack and check the test sheet.
A uniform colour change denotes a PASS. However, if light area is observed repeat
test. If the result is PASS after the repetition then use the sterilizer, if not then inform
CSSD In-Charge and biomedical engineer to rectify error. After the problem is solved
perform BD Test once again if result is PASS then continue to use the sterilizer.
Steriliser runs only after getting satisfactory Bowie-Dick test pack results.
LEAK TEST:
This test should be done once in a week.
1.Turn the sterilizer on.
2.Select the Leak Rate Test Programme.
3.Close the doors.
4.Run the Cycle.
5.Check the initial and terminal chamber pressure during leak test.
6.Difference between the pressures is the leak rate of the chamber.
7.If the difference is zero then there is no leak in the chamber and the sterilizer is
functioning properly and the maximum consider able difference is 0.013bar.
8. If the result is PASS then use the sterilizer, if not then inform CSSD In-Charge
and biomedical engineer to rectify error. After the problem is solved perform Leak
Test once again if result is PASS then continue to use the sterilizer.
Result is passed, then continue to use the steriliser.
10.15 RECALL PROCEDURE:

RECALL POLICY-
Recall is usually related to in case there is growth in the Biological Indicators and
this can be taken as a failure of the equipment to attain the required parameter to
pass a process
All the packs and its content will be recorded in a register, against which a cycle
number is recorded.

AMRI/DHK/SOP/06
Each pack is also packed with a strip mentioning the sterilization date, Equipment
number, cycle number & Expiry date.
In case any sterilization failure happens(growth in B.I.) the sterilizer is under
question mark and should not run any more.
Biomedical Engineer will be notified.
The particular load will be reviewed and any items that have left the department as per
the load and batch no. will be tracked.
Nursing staff of the concerned unit where the batch has been issued will be contacted.
The supplied items will be collected back.
After problem is corrected and a negative biological spore test is obtained, the CSSD in
charge, after consultation with Infection Control, can allow the sterilizer be returned to
operation.The details of action taken is documented in full.
We have to maintain proper record of each sterilization cycle & proper batch
monitering system.
Traceability- for any recall procedure, traceability is the first step.
 Traceability can be maintained only if records are kept for all stage which are
distributed, will contain
i. Date of sterilization
ii. Cycle no /Batch no
iii. Autoclave number
iv. Date of expiry
10.16 EXPIRED ITEMS OR RE-CONTAMINATED ITEMS:
i. CSSD sends out information regarding expiry of lots to the all user area.
ii. Concerned department sends expired items to CSSD on the day immediately
after the expiry date. In case of suspected contamination, items are sent back to
CSSD on same day.
iii. CSSD received expired or re-contaminated items and reprocesses for
sterilization.

AMRI/DHK/SOP/06
iv. The steam sterilized items have an expiry period of 30 days (for items packed in
medical grade paper) and up to a year for ETO sterilized items when stored in
proper storage conditions (dry packs, packs not dropped/kept on ground, no
visible damage to the pack, temperature range 18 – 24 degree C, and Relative
Humidity of 35-70%). If recommended storage conditions are not met, the expiry
period for items maybe shorter.
10.17 ENTRY IN THE STERILE AREA:

1.Wash your hands with alcohol based hand wash and water.
2.Disinfect you hand with alcohol based hand rub.
3.Change your shoes and wear a sterile gown.
10.18 MAINTAINANCE OF STERILE AREA:

1.Following temperature and humidity conditions will be maintained in the sterile area.
Temperature – 18-22 deg C
Relative Humidity – 35-70%
2. CSSD personal will must check the air exchange rate per hour(min 10 air exchange per
hour.)
3. All the surfaces (storage racks, floor, wall, issue counter) will be disinfected every
morning with approved disinfectant.
4.Swab should be send from rack, wall, floor weekly once.
5.Only one glass door of the pass box will be opened at a time for the issue of material.
6.Person in the sterile area will maintain the principle of minimum movement.
10.19 INFECTION CONTROL PRACTICE:
Cleaning of Department:
o Personnel are expected to maintain their assigned workstation in an orderly fashion.
o All counter surfaces are to be disinfected with 0.4% Virex II at least daily.
o Daily cleaning of the area includes damp mopping floors with 0.4% Virex II and
emptying trash and linen containers.
High cleaning is performed on a less frequent schedule.
AMRI/DHK/SOP/06
o Vacuuming the air vents and cleaning out the light fixtures is recommended at least
twice per year to prevent the build up of dust and lint.
o Regular schedule will be established for clean the walls, storage shelves, floors and
other surfaces as needed. Care must be taken in this process to avoid compromising
the integrity of packaging. Attention must be paid to the sequence of cleaning, to
avoid transferring contaminants from "dirty" to "clean" areas.
General:
o Surgical scrub attire, cover gowns or lab coats will be worn in the processing area of
the department.
o Hair must be covered in the processing areas of the department.
o When handling contaminated items, wearing personal protective equipment (PPE) is

required. PPE‟s include: eye protection, gloves, surgical mask, moisture resistant
gown, shoe covers and hair covering. After task is completed, remove and discard
all PPE‟s and thoroughly wash hands.
o All surgical scrub uniforms/cover gowns must be laundered by the laundry facility
and must not be taken home.
o All visitors must comply with the departmental as well as medical Center's dress
codes.
o Utilize the space allocated to assure a division between dirty,clean, and sterile area.
10.20 SAFETY PROCEDURES:

Decontamination Area :
Standard precaution including the following recommendations will be observed:

AMRI/DHK/SOP/06
 Caution will be taken while handling sharps.

 Contaminated needles should not be recapped..
 Sharps must be placed in puncture resistant containers.
 Hands and other skin surfaces that are contaminated with potentially infectious
fluids will be immediately and thoroughly washed.
 Eating and drinking is prohibited in the work areas.
 Proper body mechanics must be employed while moving carts and lifting equipment
to avoid back injuries.
To protect staff members against biological and chemical hazards, the following
personal protection equipment must used when working in the decontamination
area:
o Eye protection
o Water resistant gown
o Gloves
o Hair covering
o Mask
o Shoe Covers
o Sharps Container
o Frequent hand washing is required, even though gloves are worn.

Tray Assembly Area - “Clean Area."
o Frequent hand washing is recommended.
o Proper body mechanics must be used to avoid injury.
o Caution will be used when handling sharp instruments.
o Handle any chemicals in accordance with manufacturers recommendations;
o Caution will be taken when handling ETO gas cartridge

AMRI/DHK/SOP/06
10.21 TIPS FOR PREVENT FAILURE OF STERILIZATION PROCESS:
• Failure to clean the object being sterilized adequately. Any coating of

soil can protect the microorganisms from direct steam contact. In
addition, the effectiveness of sterilization is dependent on the “bioload”
(number of microorganisms) present prior to the sterilization cycle.
• Instruments closed, locked or stacked. All instruments must be packed

in an open and unlocked position, or disassembled, so that steam can
reach all surfaces (e.g., Place gauze or linen in between bowls so that
steam can reach all surfaces of each bowl).
• Packages wrapped too tightly. Air and steam do not mix readily. Air,
being heavier than steam, normally is displaced to the bottom of the
sterilizer and is then forced out through the drain. If the packs are
wrapped too tightly, however, air is trapped and cannot escape. It forms
cool air pockets at the center of the packages, preventing the items from
reaching temperatures sufficient to kill all microorganisms.
• Packs too crowded. It is essential that the packs be arranged loosely on

the cart or the same type of problem as that in the above example will
occur. Packs will be placed on the edge because it is easier for air to be
displaced downward between the packs than to go through the many
layers of fabric of horizontally placed packs.
• Clogged strainer. At the bottom of most sterilizers is a small drain

strainer used to keep lint, pins and other small objects from entering the
exhaust line. It is essential that these screens be cleaned daily, or they will
become clogged and trap air in the sterilizer.
• Other mechanical problems. Several other problems can occur, such as

a defective steam trap and clogged exhaust lines. Often, the sterilizer
operator cannot repair such problems. In some cases, however, a weekly
flush of hot liquid soap through the exhaust line will keep it cleaned out.
If the sterilizer manual calls for this weekly flush, it must be performed or
sterilization failure may occur.
• 12. REPROCESSING OF SINGLE USE DEVICE:
• DIFINITION:A medical device is intended to be used on an individual

patient during a single procedure and the discarded. It is not intended
to be reprocessed and used on another patient.

AMRI/DHK/SOP/06
• PURPOSE:To established safe guidelines for reprocessing a single use

device in healthcare organization.
• PROCEDURE:
• 2.Single-use devices identified for user department
• 3. How many times it will be reprocessed that have an written

documentation to the user and CSSD(used & soiled linen(for 240days),
Heat sensitive items,(ex-suction tube,catheteretc). These items (used &
soiled linen) to be Discarded after 240 days as per hospital protocol
and Soiled suction tube &catheter to be discarded after used.
• 4.After recommended reprocessing will over that particular single use

device will be discarded.
• 5.Fresh linen is usable for 240 days after date of sterilization.
13. QUALITY INDICATORS MAINTAINING IN CSSD:

Environmental sterility check; ---- Swab samples are collected from different location like
Ceiling, wall & Air colony, once in every week. Biological indicator is tested daily for
ETO and weekly for others, as well placed along with transplant sets and sent to
Microbiology for reporting.
JUSTIFICATIONS OF THE BENCHMARK OF THE QUALITY INDICATORS
WET PACKS:
WET PACK- The autoclave machine uses a separate vacuum pump for post process
drying .Every load for every cycle is calculated so that the chances of overloading and
having wet packs due to overload are eliminated.
The tolerance level has been set to zero to ensure perfect process every time the unit is run,
even one percent tolerance can have effects in the quality of the packs processed by the way
of cross contamination due to wet pack, which is turn will lead to reprocessing by the
running the unit multiple times increasing the operating cost per cycle.
EXPIRY ITEMS-
The expiry of packs can be avoided if the personnel handling such packages keep a proper
track record with the expiry in notice so that the FIFO(First In-First Out) process can be
implemented to minimize expiry packages there by again minimizing extra operating cost.

AMRI/DHK/SOP/06
Quality Assurance
1. Bowie Dick test pack is placed in a empty chamber of the autoclave as a first run of cycle,
it monitor the process of time, pressure& temperature at 2.2kg/cm2 , 134 ºC,3.5 minutes.
2. Chemical indicators A. Process indicator-Placed on exterior of the pack, indicates that
the pack has been exposed to sterilization process.
3. Integrated Indicator (Chemical indicator) indicates that the pack as be exposed to the
required temperature & pressure.
4. Biological Indicator - This indicator is used to monitor sterilisation process for daily &
weekly.
5. Check the recording printer for proper print out paper in everyday.
One or more of these indicators are used to monitor the quality control the steriser.
A.Class-1
B.Class-2
C.Single parameter indicators(Class-3)
D.Multi parameter indicator (Class-4) to indicate exposure to a sterilisation cycle.
E.Integrator (Class -5 /6) are designed to resct to all critical parameters over a specified
range of a sterilization cycle and their performance has been correlated to the
performance of a biological indicator.
Date Wet pack Re call Chemical Biological Remarks(Daily/

indicators indicator Monthly/Yearly)

AMRI/DHK/SOP/06
11 INDEX OF REGISTER:
1. Instruments‟ check list.
2. Instruments Sterilization Register(Both steam and ETO sterilization)
3. Register for Expiry items.
4. Incident Report Form.
5. Physical Monitoring of Sterilization& Daily Check list.
6. Biological Indicators results register.
7. Service Report and PM Report of the equipments.
8. Bowie & Dick Test Pack Report as per Sterilization register.
9. Biological Indicator Report(Both steam and ETO sterilization)
10. Random Swab Test Report.
11. Leak Test Report as per Sterilization register.
12. Training Register.
13. Store Register.
14. Quality Indicator Register as per Sterilization register.
15. Recall Register.
16. Cleaning & Packing Register.


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AMRI HOSPITALS Ltd.

CENTRAL STERILE SUPPLY DEPARTMENT

Issue No. : 03 Rev No:00

Issue No. : 03 Rev No:00

Designation : CSSD In-charge

Issue No. : 03 Rev No:00

Issue No. : 03 Rev No:00

Sr. Pa Date of Effective Revision

Issue No. : 03 Rev No:00

3.SCOPE:The scope of CSSD services is to provide sterilized instruments and linen to

• Washer disinfection with inbuilt dryer

• Steam Sterilizer (Autoclave)

• Linen folding table

• High pressure water jets

• Compressed air gun

Issue No. : 03 Rev No:00

5. Functional Flow of activities of CSSD:RINSING: - Rinsing of articles immediate

sterilized goods. All items should be issued as per requisition.

• Washing & decontamination area

• Linen Packing area

• Instrument packing area

• Steam sterilizer area

• Sterile storage area

• Material storage room

• Staff changing room

• HOD room/in charge CSSD room

• Automatic Washer-Disinfection with inbuilt Dryer

Issue No. : 03 Rev No:00

PACKING & STERILIZED AREA will consist of:

• Gas Sterilizer (ETO)

• Linen Packing Room

• Instrument Packing room

STERILE STORAGE AREA will consist of

9.CSSD FUNCTIONAL FLOW:

Used instruments from OT/ Wards

Items received Checking Washing and Drying

Issue to Packing & labelling

Sterile storage Loading in

Issue No. : 03 Rev No:00

For Clean Linen from Laundry

Linen Checking Folding & Loading in sterilizers

Issue to Sterile storage Unloading Sterilization

Issue No. : 03 Rev No:00

10.PROCEDURES& POLICY FLOW:

Location: CSSD is located at 2nd floor in Main

PURPOSE: To minimize cross –infection through proper

SCOPE: It defines the action and responsibilities of the

PROCEDURE Entry to the CSSD will be via the service lift

Issue No. : 03 Rev No:00

exchanged with inside chapels.

• The used scrub suits are sent to laundry daily.

• Staff assigned to work in the decontamination

• Staff assigned to either the „dirty‟ or „clean‟ areas

• Staff leaving their work stations for toilet and

• Minimal jewelry should be worn.

• Hair and nails must be clean with no nail varnish.

• Staff with broken or infected skin should report

• Visitors to the department including maintenance

clothing gown, overshoe, cap, any protective

10.1 .RECEIVING OF SOILED INSTRUMENTS FROM USER AREA:

 Instruments will be received in CSSD by checking thoroughly by putting counter

10.4.PRECATION DURING CLEAING OF INSTUMENTS:

 Washing may be done manually or by using machines like Washer Disinfector or