Standard Operating Procedure for Conductivity Testing

1) Purpose

The purpose of this SOP is to establish a standardized procedure for performing conductivity testing on pharmaceutical products to ensure they meet quality standards and regulatory requirements.

2) Scope

This SOP applies to all pharmaceutical products that require conductivity testing within the facility, including water for injection (WFI) and other aqueous solutions.

3) Responsibilities

3.1 Laboratory Analyst
– Conduct conductivity tests as per this SOP.
– Document and report test results accurately.
3.2 Laboratory Supervisor
– Ensure all testing procedures are followed.
– Review and approve conductivity test records.
3.3 Quality Assurance (QA) Personnel
– Validate conductivity testing methods.
– Ensure compliance with regulatory guidelines.

4) Procedure

4.1 Preparation
4.1.1 Clean and disinfect the testing area and equipment.
4.1.2 Prepare the conductivity meter and calibrate it using standard solutions.
4.2 Sampling
4.2.1 Collect samples aseptically to prevent contamination.
4.2.2 Transport samples to the testing area in appropriate containers.
4.3 Testing Methods
4.3.1 Immerse the conductivity electrode in the sample and allow the reading to stabilize.
4.3.2 Record the conductivity value, ensuring the meter is properly calibrated and functioning.
4.4 Monitoring and Documentation
4.4.1 Monitor the conductivity meter’s performance regularly and recalibrate as needed.
4.4.2 Record observations and test results in the Conductivity Test Log.
4.5 Reporting
4.5.1 Compile test results and prepare a conductivity test report.
4.5.2 Submit the report to QA for review and approval.
4.6 Investigation of Failures
4.6.1 Investigate any deviations from acceptable conductivity ranges to determine the cause.
4.6.2 Implement corrective actions to prevent recurrence.

5) Abbreviations, if any

– QA: Quality Assurance
– WFI: Water for Injection

6) Documents, if any

– Conductivity Test Log
– Conductivity Test Reports
– Calibration Records

7) Reference, if any

– United States Pharmacopeia (USP) <645> Water Conductivity
– European Pharmacopoeia (Ph. Eur.) 2.2.38 Conductivity

8) SOP Version

Version 1.0