Skip to content
  • Clinical Studies
  • Pharma Tips
  • Pharma GMP
  • Pharma SOP
  • Pharma Books
  • Schedule M
StabilityStudies.in

StabilityStudies.in

Pharma Stability: Insights, Guidelines, and Expertise

SOP for Operation of Lux Meter

Posted on By

Lux Meter Usage Procedure

Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish the procedures for the proper operation of a lux meter. This ensures accurate measurement of light intensity in photostability chambers and other laboratory environments.

Scope

This SOP applies to all personnel using lux meters for measuring light intensity within the facility.

Responsibilities

  • Stability Manager: Ensure compliance with this SOP and oversee the proper use of lux meters.
  • Laboratory Technicians: Operate the lux meter, document measurements, and report any deviations or malfunctions.
  • Quality Assurance (QA) Team: Review and approve light intensity measurement records and reports.

Procedure

  1. Preparation:
    • Ensure that the lux meter is clean and in good working condition.
    • Verify that the lux meter is within its calibration due date and properly certified.
    • Familiarize yourself with the lux meter’s user manual and operational procedures.
  2. Measurement Setup:
    • Turn on the lux meter by pressing the power button.
    • Select the appropriate measurement mode (e.g., lux or foot-candles) as per the study protocol.
    • Ensure that

      “Mastering Drug Stability: Unveiling the Revised Principles and Practices to Ensure Effective Medication Longevity”

      the sensor is clean and free from any obstructions.
  3. Taking Measurements:
    • Position the lux meter’s sensor at the location where the light intensity needs to be measured.
    • Hold the sensor steady and ensure it is facing the light source directly.
    • Allow the lux meter to stabilize and display a consistent reading.
    • Record the light intensity reading in the measurement log.
    • Repeat the measurement at multiple points within the photostability chamber to ensure uniform light exposure.
  4. Data Recording:
    • Document all light intensity readings in a measurement log, including the date, time, and location of each measurement.
    • Record any observations or anomalies noted during the measurements.
    • Ensure the measurement log is complete, accurate, and signed by the personnel performing the measurements.
  5. Post-Measurement:
    • Turn off the lux meter and store it in a clean, dry place.
    • Ensure that the lux meter is stored in a protective case to avoid damage.
    • Report any deviations or malfunctions to the Stability Manager and QA Team.
  6. Maintenance:
    • Perform regular maintenance of the lux meter according to the manufacturer’s recommendations.
    • Calibrate the lux meter periodically to ensure accuracy.
    • Keep maintenance and calibration records up-to-date and accessible for review.
  7. Record Keeping:
    • Maintain all measurement logs and calibration records in a centralized location for easy access and review.
    • Ensure electronic data is backed up regularly and securely stored.
    • Archive records according to the facility’s document retention policy and regulatory requirements.
See also  SOP for Performing Stability Testing for Amorphous Drug Forms

Abbreviations Used

  • QA: Quality Assurance
  • SOP: Standard Operating Procedure

Documents

  • Measurement Logs
  • Calibration Records
  • Maintenance Records

References

  • Lux Meter User Manual
  • Manufacturer’s Calibration Guidelines

SOP Version

Version 1.0 – Effective Date: [Insert Date]

Related Topics:

  • Stability Testing Conditions: A Comprehensive Guide… Stability Testing Conditions: A Comprehensive Guide for Pharmaceutical Product Testing Stability Testing Conditions: Ensuring Reliable and Accurate Pharmaceutical Stability Studies…
  • SOP for Operation of Photostability Chamber Photostability Chamber operation Procedure Purpose The purpose of this Standard Operating Procedure (SOP) is to establish the procedures for the…
  • SOP for Operation of UV Meter UV Meter Usage Procedure Purpose The purpose of this Standard Operating Procedure (SOP) is to establish the procedures for the…
  • The Role of Packaging in Photostability Testing for… The Role of Packaging in Photostability Testing for Light-Sensitive APIs The Role of Packaging in Photostability Testing for Light-Sensitive APIs…
  • Stability Study Design: A Comprehensive Guide for… Stability Study Design: A Comprehensive Guide for Pharmaceutical Product Testing Stability Study Design: Ensuring Pharmaceutical Product Quality and Regulatory Compliance…
  • Stability Testing: A Cornerstone of Pharmaceutical… Overview of Stability Testing in Pharmaceuticals Stability testing is a critical component of pharmaceutical development, ensuring that drugs and medicinal…
Stability Studies SOP Tags:Accelerated stability, Accelerated stability testing, API degradation products,, Biopharmaceutical stability, Combination product stability,, Container closure integrity testing, Degradation pathways, Drug degradation, Drug degradation pathways, Drug formulation stability, Drug product quality, Drug stability, Drug stability studies,, Forced degradation, Forced degradation studies, GMP and stability studies,, ICH guidelines, ICH guidelines for stability, ICH stability guidelines,, Long-term stability, Long-term stability studies, Long-term stability testing, Parenteral dosage form stability, Pharmaceutical industry, Pharmaceutical products, Pharmaceutical stability, Pharmaceutical stability testing,, Photostability testing, Photostability,, Real-time stability, Real-time stability studies, Regulatory compliance, Regulatory guidelines, Regulatory requirements, Regulatory requirements stability studies, Regulatory submissions, Shelf life determination, Shelf life extension, Shelf life,, Short-term stability, Stability analysis, Stability chamber conditions, Stability chambers, Stability data analysis, Stability data interpretation, Stability indicating assays Stability indicating methods, Stability indicating methods, Stability protocol, Stability protocols, Stability studies, Stability study acceptance criteria,, Stability study best practices, Stability study data analysis, Stability study data trending,, Stability study design, Stability study deviations, Stability study documentation,, Stability study guidelines, Stability study photostability,, Stability study procedure,, Stability study protocol, Stability study protocol design, Stability study report,, Stability study sample handling, Stability study SOPs, Stability testing, Stability testing best practices, Stability testing challenges, Stability testing compliance, Stability testing conditions, Stability testing for biologics, Stability testing for drug approval, Stability testing for generic drugs, Stability testing for new drug products,, Stability testing for pharmaceuticals,, Stability testing guidelines, Stability testing innovations, Stability testing methods, Stability testing of APIs,, Stability testing of finished products,, Stability testing parameters, Stability testing protocols,, Stability testing regulations, Stability testing requirements, Stability testing trends, Stability testing validation, Statistical analysis stability, Storage conditions for stability testing,, Temperature and humidity control

Post navigation

Previous Post: SOP for Calibration of Lux Meter
Next Post: SOP for Calibration of Photostability Chamber

Quick Guide

  • Stability Tutorials
  • Stability Testing Types
    • Types of Stability Studies
    • Real-Time and Accelerated Stability Studies
    • Intermediate and Long-Term Stability Testing
    • Freeze-Thaw and Thermal Cycling Studies
    • Photostability and Oxidative Stability Studies
    • Stability Testing for Biopharmaceuticals
  • Stability Studies SOP
  • ‘How to’ – Stability Studies
  • Regulatory Guidelines
  • Shelf Life and Expiry Dating
  • Stability Documentation
  • Stability Studies – API
  • Stability Studies Blog
  • Stability Studies FAQ
  • Packaging – Containers – Closers
Widget Image
  • Maintain Backup Stability Chambers to Prevent Data Loss in Case of Failure

    Understanding the Tip: Why backup chambers are essential: Stability chambers are critical infrastructure in pharmaceutical QA.
    A sudden malfunction—due to power failure, temperature controller breakdown,… Read more

Copyright © 2025 StabilityStudies.in.

Powered by PressBook WordPress theme