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1.0 OBJECTIVE
To lay down a procedure for operation of particle counter.
2.0 SCOPE
The procedure is applicable for operation of particle counter Met one 3400.
3.0 RESPONSIBILITY
Officer/ Executive - Quality Control
4.0 ACCOUNTABILITY
Manager - Quality Control
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 whether the 3400 has first been turned on or if another user
is already logged in.
To log in after the Model 3400 is initialized, touch the screen. When password protection is enabled, users must
log in to proceed.
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.
5.1.2 A login screen appears like the one. Touch the Name field to enter the user name and a keyboard entry
screen appears.
5.1.3 Enter the user name by touching the screen.
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5.1.4 When the name is entered, touch the Enter button on the screen.
5.1.5 Touch the Password field to invoke the keyboard screen and enter the password via the touch screen.
5.1.6 Press Enter
5.1.7 If login is successful, the Main screen should appear, similar to the one. If 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 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 touch screen.
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.
Note: - Count or environmental alarms will be indicated by red color and flashing text at the bottom of the touch
screen, as well as an audible alarm if one was set as described in Sounds Tab.
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 values for values for any other
parameter measured (relative humidity, temperature, air velocity).
Refer to adjust the settings, such as alarm limits, units of measurements, and time and date.
6.0 ABBREVIATIONS
6.1 SOP - Standard Operating Procedure
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Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of
Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email
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Email: info@pharmaguideline.com.
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Further Readings: ,
1. Qualification Procedure for Vial Washing Machine
2. Computer System Validation in Pharmaceuticals
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