sop for entry & exit procedure In Microbial limit test and Biosafety

sop for entry & exit procedure In Microbial limit test and Biosafety


1.1 To lay down a procedure for entry & exit procedure in MLT and Biosafety.


2.1 This procedure applicable to entry & exit procedure In MLT and Biosafety


3.1 Microbiologist QC


4.1 QC Manager


5.1 Entry Procedure

5.2 First change room
5.2.1 Fill Entry/Exit log book and then remove accessories and slippers .
5.2.2 Disinfectant the hand with filtered 70% IPA.
5.2.3 Push the doors of the change room with elbows.
5.3 Second change room
5.3.1 Disinfectant the hand through. 70% IPA.
5.3.2 Wear the sterilized surgical gloves taking care not to contaminate the outer surface of gloves With hands.
5.3.3 Switch OFF the UV light of Garment Cubicle and then open its door.
5.3.4 Take out a set of sterilized garment.
5.3.5 Sanitize the hand with 70% IPA , pull the door and enter MLT and Biosafety area.
5.3.6 Wear the sterilized garments in the following sequence.
5.3.7 Wear the hood, ensuring that the hair is properly tucked inside the hood.
5.3.8 Wear the sterile suit. Check gowning by standing in front of mirror.
5.3.9 Wear & tie the booties.
5.3.10 Disinfect the hands with 70% IPA.
5.3.11Enter in to MLT and Biosafety room by opening door with elbow.
5.4 Precaution
5.5.1 Do not put the sterile dress on the floor while changing, as this could contaminate outer surface of the dress.
5.5.2 Do not allow other person to enter.
5.5.3 Strictly follow the Entry and Exit procedure all the times.
5.5.4 Do not open two door of the Air lock at the same time
5.4.5 Open the doors of change rooms with elbows.
5.4.6 Wear only sterile dress that are kept in garment cubicle.
5.4.7 Sterile dresses kept in garment cubicle should be wrapped in butter paper.


Abbreviation used Extended Form
MLT Microbial limit test
QA Quality Assurance
CH  Change Room
QC Quality Control

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


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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