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 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 microbiological testing of water
sop for depyrogenation of apparatus
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
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
