Operation of Double Door Autoclave
1.0 Objective
To lay down a procedure for the Operation of Double Door Autoclave.
2.0 Scope
This Standard Operating Procedure is applicable for Operation of Double door Autoclave in Microbiology
Laboratory Quality control Department ABC Company.
3.0 Responsibility
3.1 Officer / Executive Quality Control are responsible for operation of double door autoclave.
3.2 Head Quality control is responsible for compliance of this SOP.
4.0 Abbreviations and Definitions
SOP : Standard Operating Procedure
PLC : Programmed logic Controller.
LCD : Liquid crystal Display
NST : Non Sterile
5.0 Procedure
5.1 Generation operating Instructions
5.1.1 Ensure the compressed air supply is available at appropriate utility location.
5.1.2 Ensure air pressure of at least 6.00 kg/cm2.
5.1.3 Ensure gasket lubrication is proper and the gasket pressure 3.00 kg/cm2.
5.1.4 Switch ON the main provided on panel board.
5.1.5 Opening the door of the Non Sterile end of the double door autoclave; Press door open button present on
Non sterile side of the panel board.
5.1.6 Now Load the material to be autoclave from NST side.
5.1.7 In HPHV cycle load 120 petri plates, 20 Bottles, 02 dresses & 10 hand gloves or In Media cycle
kept 2.5 liter SCDA & 1.5 liter SCDM media.
5.1.8 After loading the material Press the close button present on the NST Side and Door
pre conduction indicator will glow.
5.2 Start up Parameter
5.2.1 When all faults are clear & both doors are closed then follow the start up parameters
with the help of operating panel present on the panel board.
5.2.2 The Start up parameters of the operating panel along with the LCD display are mentioned as below.
| Parameter | Mode of Operation |
| LCD SHOWS | MAIN MENU |
| Press F1 Key | SET/VIEW PARAMETER |
| Press F2 Key | LOGIN |
| Press F 3 | MAIN MENU-2 |
5.2.3 Press F3 Key for entering main menu-2 and than LCD will display are mention as below
| Parameter | Mode of Operation |
| LCD SHOWS | MAIN MENU- 2 |
| Press F3 Key | START UP SCREEN |
| Press F1 Key | BATCH DATA |
| Press F 2 Key | MONITOR SCREEN |
| Press F 4 Key | MAIN MENU |
5.2.4 Press F3 Key for start up screen and than LCD will display are Mention as below.
| Parameter | Mode of Operation |
| LCD SHOWS | [PLEASE SELECT PRO.] |
| Press F1 Key | START UP PROCESS |
| Press F2 Key | PRINT PARAMETER |
| Press F 3 Key | PRO.SELECT |
| Press F 4 Key | NEXT |
5.2.5 Select the process by press F3 key and use the arrow F2 key for print out the parameter.
5.2.6 For start up process use UP and down arrow key to select F1and pressF1 key for start up cycle.
5.2.7 Similarly switch ON the Dot matrix printer for print the data.
5.2.8 For charter recorder press Func Key than screen will display print data, after that press CHUP Key twice
for print the charte. Now chart printing will start and press the Record key for recording the chart.
5.2.9 When process will complete than LCD screen display End process.
5.2.10 Now press the Open button for Open the Door from sterile side and unload the Material from autoclave.
5.2.11 After unload the material, push the door close button and press Ask button when sterile side door close
indication will glow.
5.2.12 Now check the general parameter for next cycle operation and fallow 5.2.1 to 5.2.11 points.
5.2.13 Start the Dot matrix Printer attached with the PLC so that it will record the complete operating
cycle Parameters and the temperature throughout the cycle. Preserve the Temperature chart in an
authorized record for each and every cycle operation.
6.0 Forms and Records
6.1 Autoclave log Book – Annexure-1
7.0 Distribution
7.1 Master copy – Documentation Cell (Quality Assurance)
7.2 Control copy – Quality Control
8.0 History
| Revision Number | Details For Change |
Reason for Revision |
| 00 | New SOP | NA |
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
Preparation Filtration Usage and Destruction of Disinfectant Solution
Entry Exit and gowning Procedure in Microbiology Laboratory
Safety measures to be followed in microbiology laboratory
Growth Promotion Test of Media
Preservation and Maintenance of Microbial Strain
Entry and Exit in Microbiology Sterile Area
Entry and Exit in Microbiology Limit testing area
Water sampling of raw water purified water WFI and PSG in microbiology Lab
Microbial monitoring of Drain points
sop for Operation of Double Door Autoclave
