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Operation and cleaning of air sampler

Operation and cleaning of air sampler

 

1.0 OBJECTIVE

1.1 To lay down the Procedure for operation and cleaning of air sampler.

2.0 SCOPE

2.1 This procedure applicable for operation and cleaning of air sampler of Microbiology Laboratory

3.0 RESPONSIBILITY

3.1 Microbiologist QC

4.0 ACCOUNTABILITY

4.1 QC Manager

 

5.0 PROCEDURE



5.1 Requirement
5.1.1 Sterile SCDA plates
5.1.2 70% IPA solution
5.1 Methodology
5.2.1 Prepare SCDA medium as per SOP for preparation of culture media.
5.2.2 Aseptically pour approximately 15 – 20 ml of sterile molten cooled (45°C) SCDA agar into sterile 90 mm petri plates.
5.2.3 Allow to solidify the plates under LAF, after solidification label all the plates with name of media, and date of preparation.
5.2.4 Invert and incubate the plates at 30 to 35°C for 24 to 48 hours. After incubation check the plates for any contamination,

if there is contamination discard the plates as per SOP for Destruction of microbial waste and expired media by autoclaving.
5.2.5 After pre-incubation, label all the plates with date of sampling and location with the help of marker pen and wrap with aluminum foil.
5.2.6 Autoclave the SS head of Air Sampler at 121°C for 30 minutes. Transfer the container and Air sampler which is sanitized and

 

wrapped in aluminum foil, to sterile area through Dynamic pass box of the respective sterile area and personnel must



be entered through Change room as per SOP for Entry & Exit procedure.
5.2.7 Place the pre incubated SCDA plates in Air sampler holder and operate the air sampler for 10 minutes.
5.2.8 After 10 minutes of Air sampling, remove the plates from Air sampler, close the lid immediately and place aside.
5.2.9 Immediately clean the Air sampler with 70% sterile IPA solution and carry out the air sampling for other specified locations.
5.2.10 After air sampling collect all the plates and send to Incubator room for incubation.
5.2.11 Incubate one plate as negative control.
5.2.12 Invert all the plates and incubate at 20 to 25°C for 72 hrs for fungi and then 30 to 35°C for 48 hrs for bacteria.
5.2.13 After incubation, count the number of colony forming units with the help of colony counter. Operate the colony

counter as per SOP and express the result cfu/m3.
5.2.14 Record the result as per the following formula :
X= Pr X 1000/V
Where:
X = cfu/m3
r = colony forming units counted on 90 mm plates
Pr = Probable count obtained by positive hole correction from table I against r value
V = Volume of air sampled

6.0 ABBREVIATIONS

 

Abbreviation used Full form of abbreviation used
SOP Standard Operating Procedure
IPA Iso Propyl Alcohol
QA Quality assurance
IP Indian Pharmacopeia

 

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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