Sop for Operation of Airborne Particle Counter


Sop for Operation of Airborne Particle Counter


1.1 To lay down a Procedure for Operation of Airborne Particle Counter in Quality Control Department.


2.1 This procedure is applicable for Operation of Automatic Particle Counter


3.1 Microbiologist.

QC Manager

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
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.


 Abbreviation Extended Form
QC Quality Control
SOP Standard Operating Procedure

Annexure-1 : Airborne Particle Counter usage record.


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 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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