sop for Operation and cleaning of moist heat sterilizer
1.0 OBJECTIVE
To lay down a procedure for operation and cleaning of autoclave
2.0 RESPONSIBILTY
Microbiologist./ Q.C Executive
3.0 ACCOUNTABILITY
Head – Quality Control
4.0 PROCEDURE
4.1 : PRE-START UP
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
Indicator.
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.
7.0 : ABBREVIATIONS:
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 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 microbiological testing of water
sop for depyrogenation of apparatus
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
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