SOP for Operation and Calibration of Sieve Shaker : Pharmaguideline

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SOP for Operation and Calibration of Sieve Shaker

Standard operating procedure of Sieve Shaker used to determine the particle size of powder.

1.0 OBJECTIVE

To describe the procedure for operation and calibration of sieve shaker.

2.0 SCOPE

This SOP is applicable for operation and calibration of sieve shaker.

3.0 RESPONSIBILITY

Officer/ Executive - Quality Control

4.0 ACCOUNTABILITY

Manager - Quality Control

5.0 PROCEDURE

5.1 Operation of the instrument

5.1.1 Ensure that the working bench and instrument is clean.
5.1.2 Switch ON the instrument
5.1.3 Display indicates 
ELECTROMAGNETIC
SIEVE SHAKER EMS-8
5.1.4 Setup the instrument
5.1.5 All the sieve diameter and pore size should be as per IP standard. Received certificate keep in an appropriate place.
5.1.6 Set the sieve on the instrument, shaker ensures that the value of the amplitude is set at the lowest.
5.1.7 Set the desired time (0.0 to 99 minute) by pressing the ▲▼ time key provided below the TIME display.
5.1.8 Set the desired amplitude (power level 5 to 20 ) by pressing the ▲▼ power key provided below the POWER LEVEL display

5.2 Mode of Operation

5.2.1 There is two type mode:
A] Continuous mode
B] Intermittent mode

5.3 Control of Continuous Operation

5.3.1 Select continuous mode by pressing “CONTINUOUS” key.
5.3.2 Start the vibration by pressing the “START” key.
5.3.3 The shifter operates during the time and with the power level programmed.

5.4 Control of Intermittent Operation

5.4.1 To start the sifter in intermittent mode, select continuous mode by pressing “INTERMITTENT” key.5.4.2 Start the vibration by pressing the “START” key.
5.4.3 Observe the sifter will start to vibrate during the time and power programmed, at an interval of 0.5 second.

5.5 Cleaning of the Sieve

5.5.1 Dismantle all the sieve and wash with water one by one.
5.5.2 Wash only soap and tap water with soft sponge material to clean the sieve, finally rinse with purified water.
5.5.3 Dry it in the oven at 105 ºC for 1 hour, Keep at an appropriate place.

5.6 Calibration

5.6.1 Calibration frequency: Monthly and after every maintenance.
5.6.2 Check the time with calibrated and certified clock at 10 min, 20 min., 50 min, 70 min and 90 min. The tolerance should be ± 1 minute.
5.6.3 After completing the calibration make an entry in the calibration record of sieve shaker.

6.0 ABBREVIATIONS

6.1 SOP - Standard Operating Procedure
6.2 I.D No - Identification Number
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