sop for Operation and cleaning of moist heat sterilizer


sop for Operation and cleaning of moist heat sterilizer




To lay down a procedure for operation and cleaning of autoclave


Microbiologist./ Q.C Executive


Head – Quality Control



4.1.1 : Ensure the cleanliness of the room and machine.

4.1.2 : Ensure that all utilities such as pure steam, water, power etc are available.

4.1.3 : Check that material are ready for auto clave and Load the autoclave as per load pattern
Given in Annexure-1 along with the necessary temperature indicators.

4.1.4 : Ensure AHU of area is working.

4.1.5 : Inside door of the autoclave is closed properly.

4.2 : START UP

4.2.1 : Open pure steam valve from service floor.

4.2.2 : Open main valve of steam line.

4.2.3 : Open steam by-pass valve for condense out let.

4.2.4 : Close steam by pass valve after completely out let of condensate

4.2.5 : Open main valve on steam line connecting to chamber.

4.2.6 : Open the valve before trap on steam line.

4.2.7 : Close the door of the autoclave tightly.

4.2.8 : ON machine by pressing green color OFF/ON switch on loading side panel to start the
Sterilization cycle.

4.2.9 : Press the F1 button of the PLC of autoclave after getting auto mode indicated by a red

4.2.10 : Press F3 for cycle selection , select the cycle and press enter. selection of auto mode.

4.2.11 : Then press start button

4.2.12 : Close the outlet of jacket and chamber steam.

4.2.13 : When the PLC of autoclave shows sterilization cycle complete switch off the autoclave
and open the outlet of chamber and steam.

4.2.14 : After each day of working clean ( by moping) the autoclave with disinfectant solution.

4.3 : SHUT DOWN.

4.3.1 : At the end of cycle, Unload the sterilized material from sterile side

4.3.2 : Check the change in steam clox indicator. It should change as per Manufacturer instructions.

4.3.3 : Attach steam-clox in media preparation record and note down operation.

5.0 : CLEANING :

5.1 : Pre checks.

5.1.1 : Ensure that loading door is open and door to sterile side is closed.

5.1.2 : Ensure that autoclave panel electrical supply cut off.

5.1.3 : Ensure that no material is present inside the autoclave.

5.1.4 : Ensure that outer surface of autoclave is cool and is at room temperature.

5.1.5 : Ensure that all utility supply links to the autoclave are closed.

5.2 : Daily cleaning: At the end of shift.

5.2.1 : Clean the utility inlet holes with a nylon brush and them mop with lint free cloth.

5.2.2 : Mope the chamber, probes, loading trolley & outer surface of autoclave with lint free
cloth dipped in purified water.

5.2.3 : Mope the autoclave chamber and loading trolley with water for injection.

5.2.4 : Wipe the chamber, probes, utility pendants and outer surface of the autoclave with lint
free cloth.

6.0 : Precaution :

6.1 : Jacket pressure should not be less than 1.2 kg per cm square.


AHU = Air Handling Unit
Programmable Logic Control (PLC)

8.0 : REFERENCE : Instrument Manual

sop for calibration and validation of micro autoclave

sop for Sterility failure investigation

cleaning and operation of discard autoclave

sop for operation of fogger machine

sop for Biological assay of lactic acid bacillus

sop for preparation of culture inoculum

STP for sterility testing of sterile gloves

sop for Operation and calibration of active air sampler

sop for transfer of material for testing and sampling in sterile area

entry & exit procedure in microbiology laboratory

Growth Promotion Test In Microbiology Laboratory

Operation of B.O.D in Microbiology Laboratory

Operation of Horizontal Laminar Air Flow in the microbiology laboratory

Operation and cleaning of Pass Box.

Operation and cleaning of air sampler

Cleaning and Sterilization of Glassware

Analysis of water for microbial load in microbiology lab

Operation and temperature monitoring of Refrigerator

Fumigation of Microbiology Laboratory.

Entry & Exit procedure In Sterility Area

SOP for Microbial analysis of Raw Material Finished Products

SOP for Operation & Calibration of pH meter in Micro Department

SOP for Operation & Calibration of pH meter in Micro Department

SOP Operation and calibration of Hot Air Oven In Microbiology

SOP for operation cleaning & calibration of Digital colony counter

SOP for Operation And Cleaning of Microscope

sop for Media Preparation and Consumption

sop for Receipt Storage and Usage of Culture Media

sop for Cleaning Sanitization And Disinfection In Microbiology

sop for Environmental monitoring of all the Classified area

sop for Handling and Sub culturing of Microbial cultures

sop for Media Growth Promotion Test and various Microbiological test

sop for BOD incubator operation and cleaning

sop sampling of water for microbiological analysis

sop for Disinfectant Efficacy Test

sop for for cleaning and operation of vortex mixture

sop for Temperature & Relative Humidity Monitoring

sop for Operation and Calibration of Heating Block

sop for Sterility Testing of Microbiology

sop for Disposal of Culture Media

sop for Drain point of Microbiology

sop for entry & exit procedure In Microbial limit test and Biosafety

sop for Gram Staining of Bacteria in Microbiology Laboratory

sop for Monitoring of Compressed Air/gases for microbiological analysis

sop for BET (Bacterial Endotoxin) test in Microbiology

sop for receipt storage and Determining the population of Biological indicators

sop for qualification of analyst microbiologist

sop for Bioburden test of Packing materials in Microbiology Laboratory

sop for microbiological assay of erythromycin antibiotic

sop for liquid particle counter

sop for operation and calibration of digital zone reader

sop for monitoring of ultraviolet efficiency LAF and pass box

microbiological assay of cyanocobalamin or vitamin B12

gowning procedure for microbiological testing area

swab testing of various surfaces for bioburden determination

sop for endotoxin challenge test

Hold time study protocol for sterilized media

sop for personnel Qualification protocol for aseptic area

sop for sampling and testing of drain water

Sop for Operation of Airborne Particle Counter

sop for Inoculum Preparation

sop for Validation protocol of steam sterilizer autoclave

sop for pathogen detection from drain point

Sop for Analysis of Raw water Purified water water for injection and pure steam water

sop for preservatives efficacy test

sop for collection and preservation of in house isolated microorganisms

sop for Operation Calibration and Maintenance of Micropipette

Sop for UV Efficacy Test

sop for gram staining

Sop for swab testing

sop for microbiological testing of water


sop for depyrogenation of apparatus

sop for media preparation

sop for fertility test growth promotion test of media

sop for Operation and cleaning of moist heat sterilizer

sop for monitoring by active air sampler

sop for swab sampling and testing for clean rooms in production area

sop for monitoring in microbiology laboratory

sop for Fumigation of aseptic area and microbiology lab

sop for monitoring of personnel in aseptic area

sop for maintenance of cultures

sop for Operation and cleaning of laminar bench

preparation of settle plates

sop for monitoring of pure steam

sop for entry and exit procedure to m.l.t and b.e.t room

sop for storage of and use of media

sop for disposal of microbiological media and cleaning of microbiological glassware

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