SOP Guide for Pharma

Elixir Department: SOP for Conductivity Monitoring – V 2.0

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Elixir Department: SOP for Conductivity Monitoring – V 2.0

Standard Operating Procedure for Conductivity Monitoring in Elixir Manufacturing

Department Elixir Department
SOP No. SOP/ELX/202/2025
Supersedes SOP/ELX/202/2022
Page No. Page 1 of 8
Issue Date 11/04/2025
Effective Date 15/04/2025
Review Date 11/04/2026

1. Purpose

To define a standardized procedure for monitoring conductivity during the elixir manufacturing process, ensuring water and solution quality compliance with pharmacopeial and regulatory specifications.

2. Scope

This SOP applies to all conductivity measurements of purified water, water for injection (WFI), and product solutions at various stages of elixir manufacturing within the Elixir Department.

3. Responsibilities

  • Production Operator:
    • Collect samples and perform basic conductivity checks using portable meters.
  • QC Analyst:
    • Perform conductivity verification on product solutions and water systems.
    • Record data and verify instrument calibration status.
  • QA Officer:
    • Review records and investigate any out-of-specification results.
See also  Elixir Department: SOP for Cleaning of Mixing Vessels Post-Batch - V 2.0

4. Accountability

The QC Head is accountable for the accuracy of results. The Production Head is responsible for sampling compliance. QA Head ensures adherence to SOP and regulatory standards.

5. Procedure

5.1 Equipment and Calibration

  1. Use a calibrated digital conductivity meter with
temperature compensation capability.
  • Verify calibration using certified conductivity standards (e.g., 1.3 μS/cm and 5.0 μS/cm) before testing.
  • Record calibration details in the Instrument Calibration Logbook.

    • 5.2 Sampling Procedure

    1. Use clean and dry conductivity sampling bottles or measure directly from point-of-use when online meters are available.
    2. Collect samples from:
      • Purified water and WFI lines
      • Product solutions post-dissolution
      • Final bulk solution before filtration
    3. Label each sample with date, time, location, and sample point ID.

    5.3 Testing and Measurement

    1. Rinse the probe with the sample before immersing fully for measurement.
    2. Wait until the temperature and conductivity readings stabilize.
    3. Record conductivity value in μS/cm along with temperature.

    5.4 Acceptance Criteria

    1. Purified Water: NMT 1.3 μS/cm (as per IP/BP/USP standards at 25°C).
    2. WFI: NMT 1.1 μS/cm at 25°C.
    3. Elixir product solution: As specified in the BMR (typically ≤ 10 μS/cm unless product-specific).

    5.5 Action for Out-of-Specification Results

    1. Repeat testing using fresh sample.
    2. If OOS is confirmed, inform QA and initiate investigation.
    3. Hold product batch and water line until issue is resolved.

    5.6 Documentation

    1. Enter all data in the Conductivity Monitoring Logbook (Annexure-1).
    2. Attach calibration certificates and instrument printouts (if available).
    3. Ensure QA sign-off before batch release or water use approval.

    6. Abbreviations

    • SOP: Standard Operating Procedure
    • QA: Quality Assurance
    • QC: Quality Control
    • BMR: Batch Manufacturing Record
    • WFI: Water for Injection

    7. Documents

    1. Conductivity Monitoring Logbook (Annexure-1)
    2. Instrument Calibration Logbook
    3. Batch Manufacturing Record (BMR)

    8. References

    • USP <645> – Water Conductivity
    • BP Monograph – Purified Water and WFI
    • 21 CFR Part 211.160 – Laboratory Controls

    9. SOP Version

    Version: 2.0

    10. Approval Section

    Prepared By Checked By Approved By
    Signature
    Date
    Name
    Designation
    Department

    11. Annexures

    Annexure-1: Conductivity Monitoring Logbook

    Date Sample Point Batch No. Conductivity (μS/cm) Temperature (°C) Result Tested By QA Verified
    11/04/2025 WFI Line ELX-0425-021 0.95 25.1 Pass Rajesh Kumar Sunita Reddy

    Revision History:

    Revision Date Revision No. Revision Details Reason for Revision Approved By
    01/01/2024 1.0 Initial Release New SOP QA Head
    11/04/2025 2.0 Included WFI and process solution sampling scope Regulatory Alignment QA Head
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