Operation and Calibration of Autoclave

admin

1 day ago

Operation and Calibration of Autoclave

1.0 Objective
To lay down a procedure for Operation and calibration of Autoclave.
2.0 Scope
This Standard Operating Procedure is applicable at Quality control department of abc company.
3.0 Responsibility
3.1 Concerned Officer/Executive shall be responsible to follow this SOP.
3.2 Department Head or his designee shall be responsible to implement and ensuring to compliance of this SOP.
4.0 Abbreviations and Definitions
SOP : Standard Operating Procedure
QC : Quality Control
QA : Quality Assurance
SD : Standard deviation
Cal : Calibration
5.0 Procedure
5.1 Operating instructions:
5.1.1 Clean the instrument from outside with clean dry cloth.
5.1.2 Open the lid by unscrewing the fly nuts.
5.1.3 Pour purified water in the chamber up to the top level of the heater cover stand kept at the bottom.
5.1.4 Load the material to be sterilized in the carriers.
5.1.5 Close the lid and tighten all the fly nuts (Opposite ends simultaneously) with equal pressure

to ensure uniform pressure on the rubber gasket.
5.1.6 Switch ‘ON’ the mains switch.
5.1.7 The purging (venting of internal stale air) is done automatically through the vacuum breaker cum purge valve.

You will see steam escaping from same. As soon as the steam starts coming out vigorously, the valve will rise and

close. This process, knows as purging ensuring sterilizing by saturated steam.
5.1.8 The pressure will now steadily rise and stabilize between 12 to 15psi. The valve may start leaking lightly from

12 psi onward, which is normal.
5.1.9 The safety valve is purposely set above 12 to15 psi in order to avoid under sterilization.
5.1.10 Keep the material at least 121 C temp. for 30 minutes or as required.
5.1.11 After the holding time is over, switch off the mains switch; Remove all the steam through the exhaust

valve, before opening the fly nuts. Never prematurely open/ loosen the fly nuts, even at 1-2 psi.
5.1.12 Unload the material. Again add the required quantity of purified water.
5.1.13 Autoclave validation should be once in year by external agency and validation documents will be provide

by calibration agency.
5.2 Cycle Numbering
5.2.1 Allocate an Identification numbering for each cycle of that equipment separately.
5.2.2 A typical cycle number shall be as AXYYZZZ.
5.2.3 In the identification number A shall be abbreviate for Autoclave, X shall stands for single alphabetical

serial number autoclave that are present in the lab which starts from ‘A’ (Table as given in the point No.: 6.4),

YY shall stands for last two decimal of that year, ZZZ is three decimal numerical serial number starts from 001 for autoclave.

Autoclave description	Make /Model	Id Number	Serial number
Horizontal	Equitron		A
Double door	Machine fabrik		B

5.4 Cleaning
5.4.1 To clean the chamber, a drain valve is provided on the sidewall at bottom. Place a vessel of adequate size in

front of it and open the drain valve.
5.4.2 After the chamber is empty, pour additional water in the chamber (all around) so that the residual

matters/particles are flushed out, taking care that the particles are not big enough to block the valve.
5.4.3 After the chamber is empty, pour additional water in the chamber (all around) so that the residual

matters/particles are flushed out, taking care that the particles are not big enough to block the valve.
5.4.4 Close drain valve and pour purified water for next cycle.
6.0 Forms and Records
6.1 None.
7.0 Distribution
7.1 Master copy – Documentation Cell (Quality Assurance)
7.2 Control copy – Quality Control

Revision Number	Details For Change	Reason for Revision
00	New SOP	NA

Operation and Calibration of Autoclave

Reason for Revision