1.0 OBJECTIVE
To describes the procedure for Operation and Calibration of Digital Zone reader.
2.0 PURPOSE
It is the policy of Analytical Division that a written procedure shall be followed for the Operation and Calibration of Digital Zone reader.
3.0 SCOPE
This SOP shall be applicable for Digital Zone reader in Microbiology Laboratory of Analytical Division
4.0 RESPONSIBILITY
Persons along with their responsibilities are given below:
S. No Designation Responsibility
01 Microbiologist Preparation & revision of SOP.
02 Officer- QA Distribution and retrieval of SOP.
03 Technical manager Training of SOP.
04 Quality Manager Approval & Implementation of SOP.
5.0 PROCEDURE
5.1 OPERATION
5.1.1 Ensure the cleanliness of Digital Zone reader. All exposed parts including lens, zone glass display should be clean and dry.
5.1.2 Switch ‘ON’ the main power supply.
5.1.3 There is a ‘ON / OFF’ switch on the front side of the instrument. Put this switch to ‘ON’ position.
5.1.4 The indicator lamp shall be ‘ON’ and the main light source of the Digital Zone reader shall be ‘ON’.
5.1.5 Place the Microbiological assay plate and measure accurately the zone.
5.1.6 Keep the Petri-dish on the movable Platform. Rotate the Petri dish manually, in a manner so that one end of the Zone image just touches the mark line on the Zone glass display.
5.1.7 Press the ZERO set button and display to zero.
5.1.8 Keep the plate on the stage. Adjust the plate such that one side of circle of the zone touches the marked line of the Zone glass display.
5.1.9 Turn the knob in clockwise direction so that the plate moves across the marked line of the Zone glass display until the opposite edge of the zone is in tangent to the marked line of the Zone glass display.
5.1.10 Note down the measurement of zone by the help of display reading.
5.1.11 Record the ON and OFF time of Digital Zone reader in the Format No. MPL/QM/SOP-56/FR-01/Rev-00.
5.1.12 Switch ‘OFF’ the mains and keep the instrument when not in use.
6.0 CALIBRATION
Frequency: Yearly for External calibration.
7.0 GENERAL CARE AND PRECAUTIONS
Proper handling of instrument.
Instrument should be clean and free from dust.
Zone glass display shall be wiped / cleaned with clean and dry tissue paper.
8.0 MAINTENANCE AND REPAIR
If the instrument does not provide a require light or its response is poor then it should be labeled out of order and should we repair or serviced.
9.0 ATTACHMENTS
Log book format for Digital Zone
10. ABBREVIATIONS
QA Quality Assurance
SOP Standard Operating Procedure
QM Quality Microbiology
FR Format
S. No. Serial Number
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