Complete Pharma Solution
Calibration procedure for halogen moisture analyzer
OBJECTIVE
To lay down the procedure for calibration of the Halogen moisture analyzer,
SCOPE
This SOP shall provide the calibration procedure of the Halogen moisture analyzer in the in-process quality assurance department and quality control department.
RESPONSIBILITY
Officer/ Executive – Quality Control/Quality Assurance.
ACCOUNTABILITY
Head QC/QA
PROCEDURE
Precautions:
Make Metler – Toledo.
The weight taken should be more than 0.5g and less than 20g.
After drying as the pan and sample may still be hot, let these cool off before removing the pan from the sample holder.
The air bubble level of the indicator should be in the center or else be adjusted by the screws provided at the bottom of the balance.
Before starting the operation check for the area cleanliness and instrument cleanliness.
Operate the instrument
The Instrument is calibrated for the following parameters
a) Balance Calibration
b) Moisture Content repeatability with five replicates
c) Temperature
Balance Calibration:
Press the “MENU” key and select calibration mode by pressing the “ / ” 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. The 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 display “DONE”.
The 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 recording the reading.
The weight observed should fall within the tolerance limit of 50.000 ± 0.01 g.
Moisture Content Repeatability Test:
Operate the instrument.
Add 2 g Chemical substance “Disodium tartrate dihydrate” by distributing it 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, and 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 an external agency at 100°C and 160°C using a 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” inform the service engineer and tag the instrument with “UNDER MAINTENANCE”.
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 is done by an external agency for 100°C ± 2°C and 160± 2°C | Yearly and after any maintenance job |
Forms and Records (Annexures)
Calibration format for Halogen Moisture Analyzer – Annexure-1
Distribution
Master copy – Quality Assurance
Controlled copies- Quality Assurance, Production, Quality Control, engineering
History
| Date | Revision Number | Reason for Revision |
| – | 00 | New SOP |
Annexure-1
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 |
| 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 |
| 1 | MEAN VALUE: | 15.66 ± 0.5 % RSD: NMT 0.3% |
||
| 2 | ||||
| 3 | STD.DEV: | |||
| 4 | ||||
| 5 | RSD: |
Temperature Calibration (by an external agency):
Temperature adjustment device ref.No :
| SNo. | Set Temperature | Observed Temperature | Limit | |
| Instrument | Temp. adjust. device | |||
| 1. | 100°C | 98 – 102°C | ||
| 2. | 160°C | 158 – 162°C | ||