Air Borne Particle Counter; Purpose
To describe a standard operation, Cleaning & Calibration procedure of Air Borne Particle Counter.
Air Borne Particle Counter; Scope
Procedure is applicable to Air Borne Particle Counter of at XX Pharmaceuticals Limited.
Definition/Abbreviation:
Particle counter: An analytical device to count non-viable particles of specific sizes.
IPA : Isopropyl Alcohol.
Responsibilities:
The roles and responsibility is as follows:
Microbiologist
[] Follow the instructions of this procedure correctly.
Asst. Manager, Microbiology/QC
[] Ensure that SOP is technically sound & reflects the required working practices.
[] Confirm this procedure is kept up to date
Head of Quality Assurance
[] Take initiative to Approval of SOP.
Procedure
Instructions
[] Never use IPA on the display to wash it.
[] Don’t let the verification filter to be moistened.
[] Use your finger dab directly, don’t uses your nail on touch screen.
Operation
- Turn on power switch.
- Press “CONFIG” for “DATA SETUP”.
- Select particle size with pressing “PARTICLE” option.
- Select the particle size for another date setup then Press” BACK “option
- Press ” SAMPLE” option for delay time, sampling time, sampling volume and no. of cycle setup then pressing “ENTER” for saving input.
- To go to main display, Press ” BACK” option.
- For manual mode or automatic mode, Press “SETTING”
- For counting the particle, Press the “START” option.
- Depending on room size, calculate number of sample.
- Go to main the display
- Press “CONFIG “
- Pressing” LOCATION” option, Select Location.
- Press” EDIT “option, if required to add new location.
- To go to main display, Press the “BACK” option.
Set Location & Recipe
- Go to the main display
- Select the “CONFIG” option
- Select the “RECIPE” option
- Select the location
- Write location name
- Select the particle size
- Select sampling time & sampling volume
- Write down desired volume.
- Select delay & set delay time (Initial one is 05 second by default).
- Enable print average if needed
- Select Auto print (if needed)
- To go to main display Press “BACK” option.
- Top count the particle, Press the “START”.
- Completion of counting cycle is stopped automatically.
- Then press “START” option for another cycle & counting the particle.
- Take Print When Auto print option is disable
- Go to the Main Display.
- Press “DATA” option
- Press” RANGE” option
- Pressing “MAIN” option, Go to main display
Verification Test( Zero Count Test)
- Go to the Main Display
- Click on the Sampling Button
- Select the location (Location should be 5)
- Write Zero count test
- Select time (1minute)
- Select Unit( Ft ³ )
- Select the Zero count test
- Select the Sample
Cleaning
[] Clean Air Borne Particle Counter with & pipe with a piece of clean cloth
[] Use 70% sterile IPA damped cloth to clean it.
[] Clean the Display only with a clean sterile dry cloth.
Calibration Procedure
[] Contact with the supplier to the equipment to calibrate as per schedule.
[] Perform the calibration yearly or as per supplier instructions.
Download Annexure Here
Annexure I Air borne particle Counter Logbook