SOP FOR AUTOCLAVE
1.0
OBJECTIVE
To lay down the procedure for Cleaning, Operation & Calibration
of the Vertical Autoclave.
2.0
SCOPE
This
SOP shall be applicable for the Cleaning, Operation & Calibration of the Vertical
Autoclave in the Microbiology Laboratory.
3.0
RESPONSIBILITY
3.1
Microbiologists and above shall be responsible for
the preparation of this SOP.
3.2
Manager-QA shall be responsible for the approval of this SOP.
4.0
ACCOUNTABILITY
Sr. Microbiologist
5.0
PROCEDURE
5.1
Cleaning
5.1.1
Ensure that the power supply to the vertical autoclave is switched
‘OFF’ and the plug shall be removed from the socket before cleaning.
5.1.2
Dust shall be removed from the surface of the vertical autoclave
with a clean dry cotton cloth.
5.1.3
Water shall be drained out from the vertical autoclave.
5.1.4
Inside of the vertical autoclave shall
be cleaned with a clean cotton cloth wetted with 70% I.P.A
5.2
Operation
5.2.1
Ensure the water
level in a vertical autoclave. If the level is below the minimum level, distilled
water shall be added, and ensure that heating rods shall be dipped into the water.
5.2.2 Material to be sterilized
shall be wrapped with brown paper/silver foil and stick a vertical autoclave
indicator strip on the material and place the material inside the chamber of the vertical
autoclave and inside wiring of Stainless steel.
5.2.3
Ensure that the lid of
the vertical autoclave shall be closed and tighten the screws of the lid.
5.2.4 Ensure that the power
supply of the autoclave is switched “ON” and allow the temperature to reach 100°
C. Keep the steam vent open for 5 minutes for escaping the inside air. Close the
steam vent and allow the temperature and pressure to attain 121°C & 15 psi respectively
above atmospheric pressure for 15 minutes. Note down the time when temperature
and/or pressure are achieved
5.2.5
After a holding time switch
“OFF” the power supply of the autoclave.
5.2.6
Ensure when the pressure
comes to zero, slowly open the vent to release the steam.
5.2.7
Open the screws of the lid and allow it to cool.
5.2.8
Ensure the color
change in the indicator strip and take out the sterilized material from the inner
chamber of the vertical autoclave.
5.2.9
Enter the cycle period in the daily usage logbook as per annexure I&
II
5.3
Cycle Numbering
5.3.1
Allocate an Identification numbering for each cycle of that
equipment separately.
5.3.2
A typical cycle number shall be as Q__/AC/MM/YY/000.
5.3.3
In the identification number Q-- shall be abbreviate for Quality
Control, AC shall stand for autoclave cycle number, MM &YY shall stand
for the month and last two digits of that year respectively, and 000 present three
numerical serial number which starts from 001.
5.4
Internal Calibration
Procedure
5.4.1
Self-adhesive
autoclavable tape initially off-white in color, after sterilization changes to
black or dark brown shall be affixed on a flask during sterilization by
autoclave.
5.4.2
This shall be done for each
& every cycle of sterilization.
5.4.3
Calibration of the Instrument:
·
External calibration shall be done for
Instrument once in 12 months.
5.5
Precautions
5.5.1
Thermal gloves shall be used to open the autoclave.
5.5.2
Do not touch the vertical autoclave when it is hot.
6.0
REFERENCE
Not
applicable
7.0
ANNEXURE
|
Annexure No. |
Title of the Annexure |
Format No. |
|
Annexure I |
Sterilization
record of Autoclave |
|
|
Annexure-II |
Discarding record
of Autoclave |
|
8.0
ABBREVIATIONS :
SOP : Standard Operating
Procedure
QCD : Quality Control Department
EQP : Equipment
QA : Quality Assurance
PSI : Pounds Per Square Inch
No. : Number
I.P.A : Isopropyl alcohol
END OF DOCUMENTS
ANNEXURE-II: DISCARDING RECORD OF AUTOCLAVE
Sr. No. | Date | Name of Item | No. of Cycle | Sterilization Cycle | Holding Time | Status of Indicator | Done by | ||
Autoclave started at | 1210C&15psi attain time | Completed at | |||||||
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You may like to read these links:
1. List of All SOPs and Documents for the Microbiology Laboratory
2. List of All SOPs and Documents for In-vitro Laboratory
3. List of All SOPs and Documents for the Animal House Facility
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