SOP for operation of Air borne particle counter.

  • Objective:
  • To lay down a procedure for operation of air borne particle counter.
  • Scope
  • This SOP is applicable for operation of air borne particle counter.
  • Responsibility
  • Officers or above (Production) shall be responsible for the operation of air borne particle counter.
  • Accountability
  • Production-Head shall be accountable for the compliance of the SOP.
  • Abbreviations
  • SOP  : Standard Operating Procedure.
  • EU GMP : European Good Manufacturing Practices 
  • Procedure
  • Intitial set up :
  • No. of locations and location Nos for particle count are identified and tabulated below:
Area Location No
Vial Filling room
On In feed turn table 01
Below  Vial filling Machine LAF 02
On Out feed Turn Table 03
Cooling Room
Adjacent Autoclave door 04
Adjacent dynamic pass box IDNo PIDPB – 01 05
Adjacent garment cubicle 06
Adjacent dynamic pass box IDNo PIDPB – 02 07
Sampling Room
Under sampling Booth LAF 08
Sterile Passage       
Adjacent entry door of vial filling room 09
Adjacent Entry buffer room 10
Adjacent Exit Buffer room 11
  • Wipe the outer surface of the instrument with 20% virosil pharma.
  • Switch on the instrument from On/Off switch on front panel
  • Ensure the internal battery of the instrument is charged by checking the battery indicator on the touch screen
  • Press CFG on touchscreen and from the Menu press Location.
  • Enter the Locations given in the table above by pressing edit button.Press back to return to Menu.
  • Press Channel and tick on the channels for which particle count is required.
  • Press Sample on touchscreen and in Volume enter 1m3 ,similarly enter Delay & Hold
  • Press Clock and set the time & date to current.
  •  Press Alarm and enter maximum allowable concentration of particle through different channels(According to the standard followed).Press check button to enable or disable particle alarm
  • Press SETUP to enable or disable different options available for printer.
  • On the MAIN screen, press the REPORTS button. On the Reports screen select the standard on which we want to take the particle count.Example Press EC GMP button. From Setup choose the current room area, class level, air flow and room status. Press the BACK button to bring the user back to the Reports screen. Note the No. of Minimum. Locations and No. of Minimum sample as shown on the right hand side of the screen.
  • In the CFG screen, press the settings and make sure that the count mode is auto. Particle display is set to cumulative or differential and raw. Verify that the ft³ or m³ icon is pressed. Go back to the Main screen.
  • Operation:
  • Bring the Particle counter to the sampling location. Remove the Purging filter and connect the sampling port to the instrument.
  • Select the Location by pressing the location button on the main screen .scroll up and down to select the location as per the point of sampling.
  • Choose the location where we want to take the sample of air.
  • To start the particle count, press the “START” button on the main screen. While sampling “COUNTING” will appear on the touch screen.
  • Once the first cycle is over then after “HOLDING” word appears. During this period take the particle counter to next location.
  • When the cycle is finished, the word “FINISHED” will appear. If the instrument is stopped due any reason, the word “STOPPED” will appear.
  • If the particle count for a particular channel exceed the specified limit, an asterisk symbol (*) appears against that channel. To acknowledge, press anywhere on the main screen.
  • Take the particle count of ≥ 0.5 µ and ≥ 5.0 µ particles of all the locations.
  • Check the particle count of all the locations is within the limit as per EU GMP guide lines given in table below:
 

Grade

Counts/m³ static condition Counts/m³ Dynamic condition
≥ 0.5 µ ≥ 5.0 µ ≥ 0.5 µ ≥ 5.0 µ
A 3500 0 3500 0
B 3500 0 350000 2000
C 350000 2000 3500000 20000
  • If the non-viable particle count of any location is exceeding the limits, then take necessary action as per SOP on action to be taken in case of environmental monitoring system failure.
  • Note the readings in the format Particle count Monitoring Record, Annexure No. PISP021/A01.Check and sign the print outs of non viable particle count and attach the photocopy of the same in Batch Manufacturing Record.
  • Take the particle counts in static conditions, and on the day of filling take the particle counts in static as well as dynamic conditions.
  • Non-Viable Particle counts under dynamic condition in aseptic Area shall be taken at 6 inches above working height.
  • Calibration Frequency of particle counter is once every year.
  • Shut down
  • To shut down the particle counter, press ON/OFF switch.
  • Connect the purge filter while the instrument is not is use.

Annexure-1

Particle count Monitoring Record 

Date:

Instrument ID No:                                                                   Area Conditions :Static/Dynamic

AREA LOCATION No PARTICLE COUNT TIME DONE BY CHECKED BY
0.5 µ 5.0 µ      
VIAL FILLING ROOM
On In feed turn table 01
Below  Vial filling Machine LAF 02
On Out feed Turn Table 03
COOLING ROOM
Adjacent Autoclave door 04
Adjacent dynamic pass box IDNo PIDPB – 01 05
Adjacent garment cubicle 06
Adjacent dynamic pass box IDNo PIDPB – 02 07
SAMPLING ROOM
Under sampling Booth LAF 08
STERILE PASSAGE    
Adjacent entry door of vial filling room 09
Adjacent Entry buffer room 10
Adjacent Exit Buffer room 11
  • Distribution
  • Master copy –  Quality Assurance
  • Controlled copies- Quality Assurance, Production, Quality Control
  • History
    Date Revision Number
    Reason for Revision
    00 New SOP
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