Elixir Department: SOP for Digital Weighing Balance Usage – V 2.0

Standard Operating Procedure for Digital Weighing Balance Usage in Elixir Manufacturing

Department	Elixir Department
SOP No.	SOP/ELX/140/2025
Supersedes	SOP/ELX/140/2022
Page No.	Page 1 of 10
Issue Date	11/04/2025
Effective Date	15/04/2025
Review Date	11/04/2026

1. Purpose

To define the procedure for proper usage, calibration verification, and documentation related to digital weighing balances used in the Elixir Department for dispensing raw materials and in-process checks.

2. Scope

This SOP applies to all digital weighing balances (analytical, precision, and platform types) used in dispensing, manufacturing, and quality control areas of the Elixir Department.

3. Responsibilities

Production/QC Operator:
- Perform weighing operations and check balance before each use.
- Record observations in the Weighing Logbook and BMR.
Engineering Department:
- Maintain balances and carry out preventive maintenance and calibration.
QA Officer:
- Verify calibration certificates and cross-check weighing records.

4. Accountability

The Heads of Production, Quality Control, and Engineering are jointly accountable for adherence to this SOP, accuracy in weighing, and equipment performance.

5. Procedure

5.1 Pre-Use Checks

Ensure the balance is labeled “CALIBRATED” with a

valid calibration date.

Verify cleanliness of the balance pan and surrounding area.

Check spirit level and adjust balance feet to center the bubble.

Ensure the balance is placed on a vibration-free and level surface.

Allow the balance to warm up for at least 30 minutes before use (if switched off).

5.2 Operation

Switch on the balance and wait until the self-check is complete.
Place a clean, dry, and tared container on the weighing pan.
Press the “TARE” button to reset the display to zero.
Add the material slowly to the container while monitoring the digital readout.
Once the desired weight is achieved (± allowable tolerance), record the weight.
Do not lean on or disturb the weighing table during measurement.

5.3 Post-Use Cleaning

Remove any spilled material using a clean dry brush or lint-free cloth.
Do not use wet cloths or liquids directly on the pan or display unit.
Cover the balance with its dust cover after use.

5.4 Calibration and Maintenance

Daily calibration check to be performed with certified standard weights before use.
Record calibration verification in the Balance Calibration Log (Annexure-1).
Scheduled calibration by Engineering or external agency to be performed quarterly or as per schedule.
Do not use the balance if the calibration fails or if it is due for calibration.

5.5 Safety and Precautions

Handle chemicals using gloves and avoid spilling corrosive substances on the pan.
Use anti-static devices when weighing hygroscopic or electrostatic materials.
Do not move the balance frequently; relocate only with QA and Engineering approval.

6. Abbreviations

SOP: Standard Operating Procedure
QA: Quality Assurance
BMR: Batch Manufacturing Record
QC: Quality Control

7. Documents

Weighing Balance Calibration Log (Annexure-1)
Weighing Logbook
BMR/Batch Sheet

8. References

21 CFR Part 211 – Current Good Manufacturing Practices
ICH Q7 – GMP for Active Pharmaceutical Ingredients
WHO TRS 1010 – Laboratory Equipment Guidelines

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Weighing Balance Calibration Log

Date	Balance ID	Standard Weight Used	Displayed Weight	Deviation	Status (Pass/Fail)	Checked By
11/04/2025	WB-05	100.00 g	99.98 g	-0.02 g	Pass	Sunita Reddy

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial SOP Release	New SOP	QA Head
11/04/2025	2.0	Added calibration verification and cleaning steps	Compliance Update	QA Head