CALIBRATION PROCEDURE FOR HALOGEN MOISTURE ANALYSER

CALIBRATION PROCEDURE FOR HALOGEN MOISTURE ANALYSER

OBJECTIVE:  To lay down the Halogen moisture analyzer’s calibration procedure, Make-  Metler – Toledo.

SCOPE:  This SOP shall provide the calibration procedure of the Halogen moisture analyzer in the in-process quality assurance and control departments.

RESPONSIBILITY :

Officer/ Executive – Quality Control/Quality Assurance.

ACCOUNTABILITY:

Head QC/QA

PROCEDURE:

Precautions:

• Before starting the operation check for the area cleanliness and instrument cleanliness.
• The air bubble level of the indicator should be in the center or else is adjusted by the screws provided at the bottom of the balance.
• After drying as the pan and sample may still be hot, let these cool off before removing the pan from the sample holder.
• Weight taken should be more than 0.5g and less than 20g.
• Operate the instrument as per sop.

The Instrument is calibrated for following parameters) Balance Calibration

1. Balance Calibration
2. Moisture Content repeatability with five replicates
3. Temperature

Balance Calibration:

Press “MENU” key and select calibration mode by pressing “ / ” keys.

Press the <<Accept entry >> key (8 ) to start the balance calibration.

The display flashes “50.000” g requesting to place 50.000g standard weight on the weighing pan.

Place the 50.000g standard certified weight in the middle of the weighing pan. Instrument automatically calibrates itself and flashes 0.000 gm on display, indicating that the balance has been calibrated.

The instrument stores the determined weight value and the display prompts to lift off the standard weight from the weighing pan.

Remove the standard weight from the weighing pan and the displays “DONE”.

Display returns back to the main screen.

Now the balance is internally calibrated with external standard weight.

Verify the calibration by placing the 50.0 g weight again on the pan and record the reading.

The weight observed should fall with in the tolerance limit of 50.000 ± 0.01 g.

Moisture Content Repeatability Test:

• Operate the instrument as per sop.
• Add 2 g Chemical substance “Disodium tartrate dihydrate” by distributing as evenly as possible on the sample pan.
• Press the temperature adjusting key. Set the temperature to 130.0°C by using the  /  keys.
• Set the time key to “3”, the factory setting.
  
• Close the heating module, the status displays which indicates the drying of the sample and the system will automatically start the drying and measuring process.
• Record the moisture content observed.
• The test is carried out for five replicates and the RSD is calculated.
• Temperature Calibration:
• Temperature Calibration of the instrument is carried out by external agency at 100°C and 160°C using temperature  adjustment set.
• After usage of the instrument, maintain the record in the user logbook.
• If the instrument does not meet the acceptance criteria, tag the instrument as “OUT OF CALIBRATION” and inform the service engineer and tag the instrument with “UNDER MAINTAINENCE”.

Acceptance Criteria:

Calibration Parameter	Acceptance Criteria	Frequency
Balance Calibration	50.000g  ± 0.01g	Monthly and after any maintenance job
Moisture Content repeatability with five replicates.	Moisture Content = 15.66 ± 0.5 % RSD: NMT 0.3%	Monthly and after any maintenance job
Temperature	Two point calibration done by external agency for 100°C ± 2°C and 160± 2°C	Yearly and after any maintenance job

Forms and Records

calibration format for Halogen Moisture Analyzer-Annexure-1

Distribution

• Master Copy – Documentation Cell (Quality Assurance)
• Controlled Copies – Quality Control, Production, Quality Assurance.

History

Date	Revision Number	Reason for Revision
	00	New SOP

 

Annexure -I

Calibration format for Halogen Moisture Analyzer

Make

:

Instrument No.

:

Model

:

Calibration Date

:

Reference SOP No.

:

Next due date

:

Cleanliness of equipment / instrument before calibration:

1 . BALANCE CALIBRATION: Standard weight box ref.no:

S.No

Check weight

Standard Mass value

Displayed wt.

Limit

Remarks

1

50.000 g ± 0.01 g

2

2. MOISTURE CONTENT REPEATABILITY:  Standard Di Sodium Tartrate used ( B. No. / Lot No._______________________ )

S.No

Sample replicate number

Observed Moisture content

Results

Limit

Remarks

1

MEAN VALUE:

15.66 ± 0.5 % RSD: NMT 0.3%

2

3

STD.DEV:

4

5

RSD:

Temperature Calibration (by external agency):                                 Temperature adjustment device ref. No  :

S.No

Set Temperature

Observed Temperature

Limit

Remarks

Instrument

Temp. adjust. device

1

100°C

98 – 102°C

2

160°C

158 – 162°C

CALIBRATION STATUS: COMPLIES / DOES NOT COMPLIES Calibrated by:                           Checked by:                                           Approved by  : Date      :                                     Date       :                                                       Date               :

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