Sop for Operation of Airborne Particle Counter
1.0 OBJECTIVE
1.1 To lay down a Procedure for Operation of Airborne Particle Counter in Quality Control Department.
2.0 SCOPE
2.1 This procedure is applicable for Operation of Automatic Particle Counter
3.0 RESPONSIBILITY
3.1 Microbiologist.
4.0 ACCOUNTABILITY
QC Manager
5.0 PROCEDURE
5.1 Logging in: Switch ON the main power, enter ‘Counter Navigation’ then enter ‘Factory’.
5.1.1 There are two methods to login, depending on weather the 3400 has first been turned on.
5.1.2 To login after the Model 3400 is initialized, touch the screen. When password protection is enabled, users
must log in to proceed.
5.1.3 To login to the unit with another user already logged in, touch the Lock icon to log out the previous user,
then touch the Lock icon again to login
5.1.4 A login screen appears like the one. Touch the Name field to enter the username and a keyboard entry
screen appears.
5.1.5 Enter the username by touching the screen.
5.1.6 When the name is entered, touch the enter button on the screen.
5.1.7 Touch the Password field to invoke the keyboard screen and enter the password via the touch screen.
5.1.8 Press Enter.
5.1.9 If login is successful, the main screen should appear, similar to the one. If the login is unsuccessful, a Login
Failed message appears and the password should be re-entered.
5.2 Taking Counts:
Always remove the protective cap from the inlet tube before performing counts or damage to the counter will
occur.
5.2.1 If still in place, remove the protective cap from the inlet tube ( on top of counter).
5.2.2 Make sure the main screen display ‘counter navigation’. Press ‘Sample’ on the screen.
5.2.3 To start counting particles, press the run icon, on the touchscreen.
Particle counting begins:
The run icon becomes a stop icon until the count is completed.
The display indicates the counts and any other parameters measured.
5.2.4 The count stops automatically. To manually stop counts, press the stop icon. When the count is complete the
total number of particles counted during the count time displays as well as the value for any other parameter
measure (relative humidity, temp., air velocity). Refer to adjust the setting, such as alarm limits, units of
measurements, time and date.
6.0 ABBREVIATIONS
| Abbreviation | Extended Form |
| QC | Quality Control |
| SOP | Standard Operating Procedure |
7.0 ATTACHMENT
Annexure-1 : Airborne Particle Counter usage record.
8.0 REFERENCE
| Sr. No. | Reference Title |
| 01. | In House Specification. |
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