Ointments: SOP for Testing Ointment Viscosity – V 2.0

Posted on by Comments Off on Ointments: SOP for Testing Ointment Viscosity – V 2.0

SOP for Testing Ointment Viscosity – V 2.0

Procedure for Testing Ointment Viscosity

Department Quality Control (QC)/Quality Assurance (QA)/Production
SOP No. SOP/Ointment/061
Supersedes V 1.0
Page No. Page X of Y
Issue Date [Insert Issue Date]
Effective Date [Insert Effective Date]
Review Date [Insert Review Date]

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish a standardized method for testing the viscosity of ointments. Viscosity is a critical parameter that determines the ease of application, spreadability, and stability of the formulation.

2. Scope

This SOP applies to all personnel in the Quality Control (QC) and Quality Assurance (QA) departments responsible for testing the viscosity of ointments during formulation development, in-process control, and final batch release.

3. Responsibilities

  • Quality Control Analyst: Conducts viscosity testing and records results.
  • Quality Assurance Personnel: Reviews and approves test results.
  • Production Supervisor: Ensures that the ointment batches conform to viscosity requirements.
  • R&D Team (if applicable): Evaluates formulation modifications based on viscosity test results.
See also  Ointments: SOP for Homogeneity Testing at Different Stages - V 2.0

4. Accountability

The QC and QA Managers are accountable for ensuring that viscosity tests are conducted accurately and documented as per regulatory and GMP standards.

5. Procedure

5.1 Equipment and Materials

  • Brookfield Viscometer (or equivalent)
  • Spindle set (as per formulation requirements)
  • Calibrated thermometer
  • Standardized viscosity reference material
  • Calibrated weighing balance
  • Clean sample containers
  • Data recording sheets

5.2 Pre-Test Preparations

  • Ensure the viscometer is calibrated before use.
  • Ensure the sample is free from air bubbles and is at room temperature (25°C ± 2°C) unless otherwise specified.
  • Stir the ointment sample gently to ensure uniformity before testing.
  • Select the appropriate spindle (e.g., Spindle No. 6 for semi-solid formulations).

5.3 Viscosity Measurement

5.3.1 Brookfield Viscometer Method

  • Turn on the viscometer and select the appropriate speed (e.g., 10, 20, or 50 rpm).
  • Lower the spindle into the sample ensuring proper immersion as per instrument guidelines.
  • Allow the viscometer to stabilize for at least 30 seconds.
  • Record the viscosity reading in centipoise (cP) or milliPascal-seconds (mPa·s).
  • Repeat the test three times and take the average of the readings.
See also  Ointments: SOP for Transferring Ointments to Filling Machines - V 2.0

5.3.2 Cone and Plate Viscometer Method (If Applicable)

  • Ensure the sample is evenly spread across the plate.
  • Set the appropriate temperature control (if applicable).
  • Start the test and record the viscosity readings as per instrument guidelines.

5.4 Acceptance Criteria

  • The viscosity should be within the predefined range for the specific ointment formulation.
  • Significant deviations from the standard range may indicate formulation issues requiring further evaluation.

5.5 Documentation

  • Record all viscosity measurements, spindle numbers, and speeds in the Viscosity Test Log.
  • Document observations such as sample homogeneity and instrument stability.
  • QA personnel must review and approve results before batch release.

6. Abbreviations

  • GMP – Good Manufacturing Practices
  • QA – Quality Assurance
  • QC – Quality Control
  • cP – Centipoise
  • mPa·s – MilliPascal-seconds

7. Documents

  • Viscosity Test Log (Annexure-1)
  • Ointment Batch Testing Report (Annexure-2)
See also  Ointments: SOP for Ensuring Consistent Filling Volume - V 2.0

8. References

  • WHO GMP Guidelines for Pharmaceutical Manufacturing
  • USP <912> – Viscosity Determination
  • ICH Q2 (R1) – Validation of Analytical Procedures

9. SOP Version

Version 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Viscosity Test Log

Date Batch Number Spindle Used Speed (RPM) Viscosity (cP) Result Verified By
01/02/2025 OINT-101 No. 6 20 45,000 Pass QA Officer
02/02/2025 OINT-102 No. 6 20 47,500 Pass QA Officer

Annexure-2: Ointment Batch Testing Report

Date Batch Number Test Method Acceptance Criteria Result Final Status Approved By
01/02/2025 OINT-101 Brookfield 40,000 – 50,000 cP 45,000 cP Approved QA Head
02/02/2025 OINT-102 Brookfield 40,000 – 50,000 cP 47,500 cP Approved QA Head

12. Revision History:

Revision Date Revision No. Details of Revision Reason for Revision Approved By
01/01/2024 1.0 Initial Version New SOP QA Head
01/02/2025 2.0 Updated SOP Format Standardization of Document QA Head