Procedure for Extractable Volume Testing in Parenterals
1) Purpose
The purpose of this SOP is to outline the procedure for determining the extractable volume of parenteral containers using appropriate analytical techniques.
2) Scope
This SOP applies to all parenteral containers within the facility that require extractable volume testing as part of quality control, following pharmacopeial guidelines and internal specifications.
3) Responsibilities
Quality Control (QC) Department: Responsible for performing extractable volume testing and ensuring compliance with this SOP.
Analytical Laboratory: Responsible for conducting analysis using suitable techniques and interpreting results accurately.
4) Procedure
4.1 Apparatus Setup:
4.1.1 Ensure the syringe or suitable measuring device is calibrated according to manufacturer instructions and method validation protocols.
4.1.2 Verify the cleanliness and condition of syringes, pipettes, or other measurement tools.
4.1.3 Prepare any solvent or medium required for extraction, ensuring compatibility with the container material.
4.2 Sample Preparation:
4.2.1 Obtain representative parenteral containers requiring extractable volume testing.
4.2.2 Label containers with batch numbers, dates, and any other relevant information.
4.2.3 Rinse containers thoroughly with extraction solvent to remove potential extractables.
4.3 Extraction Procedure:
4.3.1 Extract the volume of solvent specified by pharmacopeial standards from each container.
4.3.2 Ensure consistent and thorough extraction by shaking, swirling, or other suitable
4.3.3 Transfer the extracted volume into suitable measuring devices for subsequent analysis.
4.4 Measurement:
4.4.1 Measure and record the volume of solvent extracted from each container.
4.4.2 Perform duplicate or triplicate measurements as required to ensure precision.
4.4.3 Calculate the average extractable volume for each container based on measurements.
4.5 Calculation and Documentation:
4.5.1 Calculate and report the average extractable volume per container based on triplicate measurements.
4.5.2 Document all extractable volume testing procedures, instrument settings, and results in the Extractable Volume Testing Report.
4.5.3 Review and approve the documentation by QC Manager before releasing results.
5) Abbreviations, if any
QC: Quality Control
6) Documents, if any
Extractable Volume Testing Report
Method Validation Protocol and Report
Instrument Calibration Records
7) Reference, if any
USP General Chapter <381> – Elastomeric Closures for Injections
Pharmacopeial standards for extractable volume testing in parenteral containers
8) SOP Version
Version 1.0