Procedure for Specific Gravity Testing of Liquids
1) Purpose
The purpose of this SOP is to outline the procedure for measuring the specific gravity of liquid samples used in pharmaceutical manufacturing to ensure accurate density determination.
2) Scope
This SOP applies to all liquid formulations produced within the manufacturing facility that require specific gravity testing.
3) Responsibilities
Quality Control (QC) Department: Responsible for conducting specific gravity measurements and ensuring compliance with this SOP.
Production Department: Responsible for providing liquid samples and maintaining process parameters.
4) Procedure
4.1 Equipment Preparation:
4.1.1 Calibrate the specific gravity meter using distilled water as per the manufacturer’s instructions.
4.1.2 Ensure the specific gravity meter is clean and free from any residues.
4.1.3 Set up the equipment in a stable environment to minimize vibrations and ensure accurate readings.
4.2 Specific Gravity Measurement Procedure:
4.2.1 Fill the specific gravity meter with the liquid sample up to the specified mark.
4.2.2 Allow the meter to stabilize and record the specific gravity reading displayed.
4.2.3 Repeat the measurement with fresh samples to ensure consistency and accuracy.
4.2.4 Calculate the average specific gravity value from the multiple measurements.
4.3 Calculation and Interpretation:
4.3.1 Compare the measured specific gravity with the specified limits or target
4.3.2 Document any deviations from expected specific gravity values and take appropriate corrective actions if necessary.
4.4 Acceptance Criteria:
4.4.1 The specific gravity of the liquid sample meets the specified range or target value as per product requirements.
4.4.2 Specific gravity meter calibration check is performed at regular intervals and meets acceptance criteria.
4.5 Documentation:
4.5.1 Record all specific gravity measurements, calibration checks, and any corrective actions taken in the Specific Gravity Testing Record.
4.5.2 Review and approve the documentation by QC Manager.
5) Abbreviations, if any
QC: Quality Control
6) Documents, if any
Specific Gravity Testing Record
Calibration Record for Specific Gravity Meter
Sampling Plan Document
7) Reference, if any
USP General Chapter <841> – Specific Gravity
21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
8) SOP Version
Version 1.0