SOP Guide for Pharma

Elixir Department: SOP for Online Viscosity Measurement – V 2.0

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Elixir Department: SOP for Online Viscosity Measurement – V 2.0

Standard Operating Procedure for Online Viscosity Measurement in Elixir Manufacturing

Department Elixir Department
SOP No. SOP/ELX/137/2025
Supersedes SOP/ELX/137/2022
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 a standardized procedure for the operation, monitoring, and documentation of online viscosity measurements during the manufacturing of elixirs to ensure product consistency, quality, and regulatory compliance.

2. Scope

This SOP applies to all online viscosity sensors or meters integrated into process tanks, recirculation loops, or transfer lines during the formulation of sugar-based, alcohol-based, or aqueous elixir products in the Elixir Department.

3. Responsibilities

  • Production Operator:
    • Operate and monitor the online viscosity meter during batch processing.
    • Log readings at specified intervals in the Batch Manufacturing Record (BMR).
  • Production Supervisor:
    • Ensure the instrument is calibrated and functioning correctly before batch initiation.
  • Engineering Department:
    • Calibrate and maintain the instrument as per schedule.
  • QA Officer:
    • Review viscosity records and validate against batch specifications.
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4. Accountability

The Production Head is accountable for the implementation of this SOP. The Engineering Head is responsible for calibration and preventive maintenance of the online

viscosity measurement system.

5. Procedure

5.1 Pre-Operation Checks

  1. Ensure the online viscosity sensor is labeled “CALIBRATED” and calibration is within due date.
  2. Check for any physical damage, loose fittings, or sensor malfunctions.
  3. Ensure the system is properly cleaned (CIP/SIP completed) and the sensor is immersed correctly in the process stream.

5.2 Startup and Monitoring

  1. Turn on the control panel/display unit and confirm the baseline reading.
  2. Begin batch processing and ensure consistent flow around the sensor for real-time viscosity monitoring.
  3. Record viscosity values at designated intervals (e.g., every 10–15 minutes) in the BMR and Online Viscosity Log (Annexure-1).
  4. Viscosity should remain within the acceptable range defined in the Master Formula Record (e.g., 45–60 cP at 25°C).
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5.3 Deviations and Troubleshooting

  1. If viscosity goes out of range:
    • Pause the addition of excipients or sugar syrup.
    • Check for agitation uniformity or formulation imbalance.
    • Inform supervisor and QA for investigation and approval of corrective action.
  2. If sensor shows erratic or no reading:
    • Inspect for air bubbles, fouling, or disconnection.
    • Do not tap or hit the sensor; inform Engineering for evaluation.

5.4 Post-Batch Procedure

  1. Stop the system and clean the sensor in place as per CIP procedure.
  2. Record final reading and note any observations or anomalies.
  3. Shut down the system and update calibration tracker if next batch is not due.

5.5 Safety and Precautions

  1. Do not disconnect the sensor while under pressure or during active flow.
  2. Always wear gloves and goggles during monitoring or cleaning steps.
  3. Do not expose the sensor to temperature or pH outside its specified range.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • BMR: Batch Manufacturing Record
  • QA: Quality Assurance
  • cP: Centipoise (viscosity unit)
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7. Documents

  1. Online Viscosity Log (Annexure-1)
  2. BMR of respective batch
  3. Calibration Certificate

8. References

  • 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
  • WHO TRS 986 – GMP Equipment Guidelines
  • ICH Q8 – Pharmaceutical Development

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Online Viscosity Log

Date Batch No. Sensor ID Reading Time Viscosity (cP) Temperature (°C) Operator Remarks
11/04/2025 ELX-1065 VISC-07 09:20 48.7 25.1 Rajesh Kumar Within Range

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 deviation handling and log table format Process Enhancement QA Head
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