sop for receipt storage and Determining the population of Biological indicators

sop for receipt storage and Determining the population of Biological indicators

1.1 To describe a procedure for receipt storage and Determining the population of Biological indicators.
2.1 This procedure applies receipt storage and Determining the population of Biological indicators in Microbiology laboratory
3.1 Officer Microbiologist
3.2 Executive Microbiologist

4.1 Head –QC


EZ Test steam self- contained biological indicator
Indicator organism: Bacillus steriothermophillus, ATCC 7953

5.2 Receipt and storage:

5.2.1 On receipt, check for the certificate of analysis, manufacturing date, expiry date and the labeled spore count and entry in register.

5.2.2 Check for the condition of the outer packing. In case of any defect inform the supplier and return it back.

5.2.3 Give the use before date as per the manufacturer’s expiry date.

5.2.4 Store the indicators as per the manufacturer’s instructions.

5.2.5 The ampoule/Strip indicators shall be handled carefully at the time of usage to avoid damage.

5.2.6 The indicators shall be stored and maintained as per the manufacturer’s instructions after receiving until use.

5.3 Identification:

5.3.1 When incubated in Soybean Casein Digest Medium for 17 hrs and under microscopic examination it consists of gram + ve rods with oval endospores. Biochemical tests: Delayed, weak, catalyze positive doesn’t utilize citrate (citrate negative), reduces nitrate, (nitrate reduction positive).

5.4 Population Determination:

5.4.1 Perform the initial count of one strip of B. steriothermophillus spore from the lot/batch
Which are to be used for validation purpose?

5.4.2 Transfer the strip /ampoule aseptically into 100 ml normal saline, keep it for 30 minutes and give heat sock, keep the tube in water bath at 70 0C -80 0C for 15 minutes.
5.4.3 Vortex the tube it to homogenize suspension of the spores.

5.4.4 Depending upon the initial count, dilute further in sterile normal saline.

5.4.5 Take each aliquot in duplicate from different dilutions in such a way that the colony count should not come more than 300 cfu/plate.

5.4.6 Pour the SCDA medium which has been melted & cooled to 45 0C to 50 0Cinto the sterile petriplates, swirl it & let it be solidified.
5.4.7 Incubate the plates in an inverted position at 55 0C – 57 0C for 48 – 78 hrs.

5.4.8 Count the colonies per plate and calculate the average number /strip or ampoule using dilution factor.
5.4.9 Use the strip / ampoule of biological indicator for validation purpose if the ignition count is not more than 150 % of the label claim and not less than 75 % of label claim.
5.4.10 Record the result in format

5.5 Disposal:
5.5.1 Prior to destruction sterilize it by autoclave at 121oC for not less than 30 min.

5.6 Frequency: Whenever a new lot of Biological Indicators are received.

9.1 QCM. : Quality Control Microbiology

9.2 SOP : Standard Operating Procedure
9.3 QA : Quality Assurance
9.4 LAF : Laminar air flow

9.5 CFU : Colony forming unit


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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