SOP Guide for Pharma

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

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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.

See also  Elixir Department: SOP for Sequential Batch Manufacturing - V 2.0

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

  1. 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

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

    5.3 Post-Use Cleaning

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

    5.4 Calibration and Maintenance

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

    5.5 Safety and Precautions

    1. Handle chemicals using gloves and avoid spilling corrosive substances on the pan.
    2. Use anti-static devices when weighing hygroscopic or electrostatic materials.
    3. 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

    1. Weighing Balance Calibration Log (Annexure-1)
    2. Weighing Logbook
    3. 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
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