Calibration of Moisture Analyzer, Purpose :
Calibration of Moisture Analyzer, The purpose of this SOP (Standard Operating Procedure) is to describe the operation, calibration and cleaning of Moisture Analyzer.
Calibration of Moisture Analyzer, Scope :
This procedure is applicable for Moisture Analyzer (Model: METTLER TOLEDO, MJ33) used in the Product Development of XX Pharmaceuticals Limited.
Definitions / Abbreviation:
N/A
Responsibilities:
The roles and responsibility is as follows:
Operator / Supervisor, Product Development
[][]To ensure that this procedure is followed.
[][]To maintain the records properly as per SOP.
Executive / Senior Executive, Product Development
[][]To ensure that this procedure is kept up to date.
[][]To arrange training on the SOP to all concerned personnel.
[][]To ensure implementation of the SOP after training.
Manager, Quality Assurance
[][]Approval of the SOP.
Procedure:
Precaution(s):
[][]Keep sufficient free space around the instrument to avoid heat accumulation and over- heating.
[][]Never cover, plugged, taped over or tampered with any way the vent over the sample.
[][]Do not place any combustible material on, under or next to the instrument during operation.
[][]Be very careful to touch sample, sampling pan, sampling pan holder and heating module just after the operation.
Operating Procedure:
[][]Switch on the main power. Instrument shows “OFF” in display.
[][]Press the “ON/OFF” key to switch the instrument on.
[][]The instrument performs a self-test. Wait until the display shown 0.000 g.
Temperature setting
[][]Press the temperature setting key
[][]In display temperature reading shall be blinking.
[][]Select the desire temperature by pressing scroll button
[][]Press enter key to conform the temperature.
[][]Open the heating module (Top lid) for tare and close the heating module.
[][]Again open the heating module and put the sample on sample pan as mentioned in BMR or test procedure.
[][]Close the heating module and wait for buzzed.
[][]Record the moisture content from the display.
[][]Press the “ON/OFF” key to switch off the instrument.
[][]Wait sufficient time to cool down the instrument in ambient temperature before cleaning.
Calibration Procedure:
Balance calibration
[][]Ensure that the sample pan is in position.
[][]Switch ON the power supply. The display shows “OFF”.
[][]Press the “ON/OFF” key to start the instrument.
[][]The instrument performs a self-test. Wait until the display shown 0.000 g.
[][]Select standard weight of 1g, 5g and 10 g for calibration.
[][]Open the heating chamber and place 1g standard weight on the balance pan at center position.
[][]Repeat previous step no.for 5g. & 10 g.
[][]Record the observations in the calibration report (Annexure–II)
Temperature calibration
[][]Press menu key twice. Display shows “Temperature adj.”
[][]Select “Yes” using scroll keys.
[][]Press “enter” key to start process. Display shows “Remove pan holder”
[][]Open the heating chamber and Remove the sample pan holder from the sample chamber.
[][]Display shows “Insert adjustment kit”. Place the temperature adjustment kit (standard thermometer) in the sample chamber.
[][]Close the heating module to start heating to temperature 100deg. C. The display shows the temperature.
[][]Wait 15 minutes, instrument gives audio signal sound.
[][]Note down the actual temperature on standard thermometer in calibration report (Annexure-II)
[][]Press enter key. The heating module automatically starts calibration at 160deg. C.
[][]Again wait for 15 minutes, instrument gives audio signal sound.
Acceptance Criteria
[][]For balance calibration ± 0.1 % & for temperature calibration ± 30 C.
[][]After completion of calibration switch “OFF” the main supply.
[][]After completion of the calibration activity, affix the duly filled and signed calibration status label on the instrument.
[][]Calibration Frequency
[][]Every six month ± 10 days of due date and after maintenance job.
Cleaning Procedure:
[][]Disconnect the instrument from the power supply before cleaning.
[][]Open the heating module and remove the sampling pan by sampling pan holder.
[][]Clean the sampling pan with soft brush.
[][]Clean exteriors of the instrument by clean dry cloth.
[][]Set the parts of weighing pan carefully and close the heating module
Annexure:
Annexure-I: Log Book Of Moisture Analyzer.
Annexure-II: Calibration Report of Moisture Analyzer.