Sop for UV Efficacy Test
1.0 OBJECTIVE
1.1 To lay down a procedure for UV Efficacy Test.
2.0 SCOPE
2.1 This procedure applicable for UV Efficacy Test in Microbiology Laboratory
3.0 RESPONSIBILITY
3.1 Microbiologist QC
4.0 ACCOUNTABILITY
4.1 Q. C. Manager
5.0 PROCEDURE
5.1 Prepare SCDA medium as per SOP for preparation of culture media.
5.2 Aseptically pour approximately 15–20 ml of sterile molten cooled (40-45ºC) SCDA agar into sterile 90 mm petri plates under LAF.
5.3 Allow the media to solidify the plates under LAF, after solidification label all the plates with name of media, preparation lot No. and date of preparation.
5.4 Invert and incubate the plates at 30 to 35ºC for 24 hrs. in Incubator. After incubation physically inspect the plates for any contamination (Macroscopic growth of evidence), if there is contamination discard the plates as per SOP for Destruction of Microbial waste by Autoclaving.
5.5 After pre-incubation, transfer 1-1 ml of not less than 105 cfu per ml culture of Bacillus subtilis to two SCDA Petri plates & spread the colony using sterile spreader. (Prepare 106 cfu per ml suspension of Bacillus subtilis as per SOP inoculum preparation.
5.6 Now wrap one Petri plate containing Bacillus subtilis in Aluminium foil and do not wrap other Petri plate. Now transfer both the Petri plates in LAF. Open the lid of unwrapped Petri plate.
5.7 Now switch on UV light for 30 minutes.
5.8 After 30 minutes exposure, switch off the UV light & close the lid of unwrapped Petri plate.
5.9 Incubate both the Petri plates in incubator at 30-35ºC for 24-48 hours.
5.10 Prepare positive control by streaking Bacillus subtilis culture and negative control as it is without streaking.
5.11 Apply the same procedure for UV Light of other LAF & Pass Box. For checking Efficiency of UV Light of LAF of Sterility Room, do not perform the test in Sterility Room. For the test, the UV light of Sterility LAF should be fitted to MLT or BET LAF.
5.12 After incubation observe the plates for total bacterial count. Record the results on UV Light Efficiency test record.
5.13 Acceptance Criteria: The number of colonies observed in plates exposed to UV should be 10 times less than the number of colonies observed in control/ wrap plates
5.14 Precaution
5.14.1 Switch on the UV light after exposing the plates on the work station of the LAF.
5.14.2 Switch off the UV light before collecting the plates.
5.15 Frequencies
5.15.1Once in month.
6.0 ABBREVIATIONS
| Sr. No. | Abbreviation used | Full form of abbreviation used |
| 1.0 | SOP | Standard Operating Procedure |
| 2.0 | BET | Bacterial endotoxin test |
| 3.0 | SCDA | Soyabean Casein Digest Agar |
| 4.0 | SCDM | Soyabean Casein Digest Medium |
| 5.0 | IP | Indian Pharmacopeia |
7.0 ATTACHMENTS (ANNEXES)
NA
8.0 REFERENCE
| Sr. No. | Reference Title |
| 01 | In House |
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