SOP for METONE Laser Particle Counter : Pharmaguideline

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SOP for METONE Laser Particle Counter

Standard operating procedure for laser particle counter in pharmaceutical.

1.0 Objective

To clearly define the operation of equipment for better and error-free use.


This procedure is applicable to check non-viable air particle count in (Classified Area).

3.0 Responsibility

3.1 Doing: Technical Assistant/Executive
3.2 Checking: Executive /Manager

4.0 Accountability

Head of the Department

5.0 Procedure

5.1 Collect all the required attachments & accessories for the instrument.
5.2 Locate the counter in clean environment and assemble the attachments
5.3 From clean classified area environment transfer the counter to a specific area.
5.4 Plug the counter to the main supply.
5.5 Switch ‘ON’ the mains & switch ‘ON” the instrument.
5.6 Attach the suction path standard purge filter assembly to the sensor inlet tube and perform zero counting to verify that the particles have not contaminated the counter.
5.7 If the count is zero, the counter suction path is clear then go for the Actual count.
5.8 The display will show the size of particles & number of particles as well as flow rate when the instrument is switch ‘ON’.
5.9 Press ‘F1’ to enter in the system set up. So the display will show.
Location            000
Count Cycle      000
Screen mode     OFF
RUN mode        AUTO
COUNT mode   CUM
BUFFER           0000
Group              01

5.10 Set the location with the help of arrow keys (up-Down arrow key). 
5.11 Press the “PROG” key to enter programme mode. So the Location will blink.
5.12 Set the required Location with the help of arrow key and press “ENTER” key.
5.13 Then come to count cycle & press “PROG”, So count cycle will display.
5.14 Set the required cycle & press “ENTER” key.
5.15 Keep Screen mode ‘OFF’. (No change to be done in factory setting during Operation)
5.16 Keep RUN mode on ‘AUTO’ & count mode on ‘CUM’.
5.17 Keep Buffer 0000.

5.18 Set the group as required with the help of arrow keys & press ‘Enter’.
N:B: GROUP è indicate Room. I. D. No. of Location
5.19 Then press ‘F2’ key for clock set up.
5.20 So the display will show
Set period 1 min with the help of “PROG” & arrow keys & press “ENTER”.
5.21 Come to hold with the help of arrow key & set 5 seconds with the help of “PROG” & arrow keys & then press “ENTER”.
5.22 The Time will show current time, Month, Date and Year.
5.23 Then press ‘F4’ to return the programme.
5.24 Again press ‘F4’ for status.
5.25 Press ‘F1’, the display will show system set up & print set up.
5.26 Again press ‘F1’ to “ENTER” in print set up.
5.27 So the display will show
Printer OFF
Statistic 209 E
Print mode ALL
Keep the data as it is & press ‘F4’ to return.
5.28 Locate the isokinetic probe at required Location & attach it to the sensor inlet tube. Now press ‘RUN’ to run the cycle.
5.29 After completion of counting cycle, Press ‘F1’ to Enter in the system set up.
5.30 Again press ‘F1’ for print set up.
5.31 With the help of arrow keys & “PROG” keys select ‘ON’ of the printer & press “ENTER”.
5.32 Then press ‘F2’ to take out print.
5.33 After completion of print, Press ‘F4’ to return
5.34 Switch ‘OFF’ the Instrument. Switch ‘OFF’ the mains.
5.35 Disconnect all attachments

Note : (1) There is a facility for measuring Air velocity & Relative Humidity/Temp in the Instrument. To attach the sensor probes to the instrument whenever it is required.
Precautions :
1. Do not look into counter inlet while the counter is on. It will cause eye injury.
2. Do not attempt to sample reactive like hydrogen or oxygen with the particle counter to prevent the hazards in the counter.


RH = Relative Humidity
CUM = Cumulative
ID.No = Identification No.
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