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Operation of Horizontal Laminar Air Flow in the microbiology laboratory

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
                   

 

                   

 

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 Inoculum Preparation

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 UV Efficacy Test

sop for gram staining

Sop for swab testing

sop for microbiological testing of water

PROCEDURE FOR FUMIGATION

sop for depyrogenation of apparatus

sop for media preparation

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

preparation of settle plates

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

 

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