sop for transfer of material for testing and sampling in sterile area



sop for transfer of material for testing and sampling in sterile area




The objective of this SOP is:
1.1 To lay down a procedure for transfer of material for testing and sampling in sterile area

Executive / Microbiologist


Head – Quality Control


4.1 For transferring materials in sterile area of microbiology laboratory ( for testing ):-

4.1.1 Equipments and tools used for testing are unloaded from the door at the sterile side, after completion of sterilization process.
4.1.2 Keep the media required for testing & monitoring in the pass-box under U.V light for 10 minutes. In case when the samples / materials are

enclosed in S-S containers, spray the containers with 70 % I.P.A before transferring it to hatch..
4.1.3 The samples (vials or bottles) for sterility testing should be kept in poly bag, spray inner and outer portion with 70% I.P.A solution and

carry the samples through the hatch taking care that the UV lamp is off.

4.2 For transferring materials in sterile area of (for sampling):-

4.2.1 Transfer containers containing sterile sampling accessories from quarantine area of block to interim R.M room.
4.2.2 Spray the containers for monitoring, with 70% I.P.A solution followed by moping with lint free cloth followed again with 70% I.P.A solution

and then keep the containers and depyrogenated accessories in dynamic pass-box under U.V light for 10 mm.
4.2.3 Then transfer the materials under L.A.F of blending room.
4.2.4 After completion of sampling cover the container with lid tightly and transfer them to dynamic pass-box. In case , when there are

chances of exposure of collected sample to U.V light, ensure that the U.V lamp is turned off when the sample is kept in the pass box and

turned on after collecting the material from the pass box.


Change in procedure

Trainer — Executive – Quality Assurance
Trainees — Microbiologist and QA officer

Certified Copy : Head of Department – Quality Control
Certified Copy : Microbiology Department .
Original Copy : Head – quality assurance.


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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