SOP on Calibration of Halogen Moisture Balance

April 6, 2016September 12, 2024 Pharmaceutical Guidanace

Objective:To lay down the Calibration Procedure for Halogen Moisture Balance.

Scope:This standard operating procedure is applicable for formulation plant of Pharmaceutical company name with location.

Make: Mettler Toledo.

Responsibility
- Trained worker / Operator shall be responsible for operating of the equipment as per this SOP.
- Production Supervisor / Officer shall be responsible for implementation of this SOP.
- Head-Production / designee shall be responsible for compliance of this SOP.
Abbreviations and Definitions

SOP – Standard Operating Procedure

gm – gram

QA – Quality Assurance

Procedure
- Balance Calibration for Halogen moisture Balance
  - Check that the pan is cleaned and dry. Close the balance by pressing ‘’key. Then check the spirit level and adjust to zero level.
  - Switch on the instrument and allow it to stabilize for 2 minutes. When the balance display ‘0.000 gm’. Press ‘menu’ w.cal: No display. Press ‘∆’ key to get ‘yes’ display then press enter key.
  - Display shows w.cal: 50.000 gm and pan comes out automatically. Place 50gm standard weight at the centre of the pan calibration starts automatically. After few seconds, w.cal: 0.000 gm displays remove the weight from the pan again. The instrument displays 0.000 gm.
  - Place 50 gm standard weight at the centre of the pan display shows actual weight.
  - Acceptance criteria for 50 gm standard weight, the measured weight shall be 50.000 ± 0.025 gm.
  - Fill the Calibration Record as per the Annexure-I.
- Temperature Calibration of Halogen Moisture Balance:
  - Temperature of Halogen Moisture balance will calibrate in two steps 1^st point Temperature Calibration and 2^nd point temperature calibration.
    - 1^st Point Temperature Calibration:

5.2.2.1.1 Press Menu Key, Display will show

Temperature Calibration :No.

5.2.2.1.2 Press ^ & v Key for Select Yes. Display will show

Temperature Calibration: Yes.

5.2.2.1.3 Press ‘ Enter ’ Key to start the temperature calibration.

5.2.2.1.4 Remove the sample pan holder from the automatic sample

chamber.

Place the temperature calibration kit for Halogen Moisture Balance in the sample pan chamber.

Press ‘start’ key to start the temperature calibration process.
Temperature of heating module in Halogen Moisture Balance will go to 100°c with in 15 minute.
At the end of this time a continuous audio signal sound shall come and display of temperature calibration kit shall show correct temperature.
Value of temperature shall be recorded in Temperature Calibration Record of Halogen Moisture Balance.

5.2.2.2 2^nd Point Temperature Calibration:

5.2.2.2.1 Press ‘Enter’ key.

5.2.2.2.2 Temperature in Display shall reach up to 160°C.

5.2.2.2.3 Temperature of balance shall reach 160°C with in 15 minute.

Correct temperature of Halogen Moisture Balance shall be checked display of Temperature Calibration Kit.
Value of temperature shall be recorded in Temperature Calibration Record of Balance.

After completion of calibration affix ‘CALIBRATION StATUS’ label duly filled and signed on the instrument.

Frequency: Calibration shall be done once in a month or after every repairing work on it.

Forms and Records
- Balance Calibration Record – Annexure-I
- Temperature Calibration Record – Annexure-II
Distributions
- Master Copy – Documentation Cell (QA)
- Controlled Copies – Production and Quality Assurance
History

Date

Revision

Number

Reason for revision

–

New SOP

Annexure-I

Calibration of Halogen Moisture Balance

Equipment I.D. No.

Date of Calibration: Calibration Due Date:

Duration: Six Month

Actual weight 50.0 gm	Observed weight Limit ±0.025	Status OK/NOT OK	Done By

Calibrated By/Date: Approved by/Date

Annexure-II

TEMPERATURE CALIBRATION RECORD

S.No.

Date

Time

1st Point temperature calibration

Date

Time

2 nd Point temperature calibration

Status
OK/Not OK

Due Date

Done by

Checked by

Set value 100 °C

Observed value 100 ±6°C

Set value 160 °C

Observed value 160 ±6°C

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