Operation of Horizontal Laminar Air Flow in the microbiology laboratory
1.0 OBJECTIVE
1.1 To lay down a procedure for use of Horizontal Laminar Air Flow in Microbiology Laboratory.
2.0 SCOPE
2.1 This procedure is applicable to the operation of Horizontal Laminar Air Flow in the microbiology laboratory to carry out microbiological analysis
3.0 RESPONSIBILITY
3.1 Microbiologist QC
4.0 ACCOUNTABILITY
4.1 Q. C. Manager
5.0 PRECAUTIONS
5.1.1 HLAF platform should be properly cleaned before operation with filtered 70% of IPA solution.
5.1.2 During operations care should be taken that the hands or the elbow does not touch the bench
platform
5.1.3 Make sure that the magnehelic gauge is calibrated and in working condition.
5.1.4 Spraying of filtered 70% IPA solution should not be done directly on the HEPA filter fitted in front of the HLAF bench.
5.2 MATERIAL REQUIRED
5.2.1 Filtered 70% IPA, sterile fine duster, sterilized mops.
5.3 EQUIPMENTS REQUIRED
5.3.1 Horizontal laminar air flow
5.4 PROCEDURE
5.4.1 Clean the HLAF with fine duster followed by mopping with sterilized mop dipped in filtered 70% IPA
Solution and then place the materials for testing.
5.4.2 Connect the power chord of the HLAF bench with the mains and switch “ON” the mains of
the aseptic area.
5.4.3 Switch “ON” blower and UV light with the help of switches present on the control panel of the
equipment. The blower along with the UV light should be kept ”ON” 30 minutes before starting any
operation under the HLAF.
5.4.4 Check the air pressure of the air flow with the help of magnehelic gauges present on the display
panel of the equipment. The pressure gauge reading should in within 10-15mmwc and pascal.
5.4.5 After 30 minutes, switch “OFF” the UV light from the Control panel and switch “ON” the tube light
with the help of switches present on the Control panel of HLAF bench. Blower should be kept in
“ON” position.
5.4.6 During operations care should be taken so that hands or elbow does not touch the bench platform.
5.4.7 After testing operation is over, the HLAF bench should be cleaned thoroughly with filtered 70% IPA
and allow to dry.
5.4.8 Switch “OFF” the tube light and, blower with the help of switches fitted on the control panel and
ensure that the magnehelic gauge reading should indicate ‘Zero’.
5.5 FREQUENCY
Daily
6.0 ABBREVIATIONS
| Abbreviation used | Full form of abbreviation used |
| SOP | Standard Operating Procedure |
| IPA | Iso Propyl Alcohol |
| QA | Quality assurance |
| HEPA | High Efficiency Particulate Air |
| IP | Indian Pharmacopeia |
| HLAF | Horizontal Laminar Air Flow |
| UV | Ultra-Violet |
7.0 ATTACHMENTS (ANNEXES)
Annexure -I
Laminar Air Flow Record
| S.No | Date | Operation | Blower On Time | U.V Light On Time | U.V Light off Time | Purpose | Done By | Checked By | |
| Start Time | End Time | ||||||||
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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