Photostability Chamber Calibration Procedure

Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish the procedures for the calibration of photostability chambers. Proper calibration ensures that the chambers provide accurate and reliable light intensity and environmental conditions for stability studies.

Scope

This SOP applies to all photostability chambers used for stability studies within the facility.

Responsibilities

• Stability Manager: Oversee the calibration process and ensure compliance with this SOP.
• Calibration Technician: Perform the calibration of photostability chambers and document the results.
• Quality Assurance (QA) Team: Review and approve calibration records and reports.

Procedure

1. Preparation:
   • Ensure that the photostability chamber is clean and in good working condition.
   • Gather all necessary calibration equipment, including light meters, UV sensors, temperature and humidity sensors, and calibration standards.
   • Verify that all calibration equipment is within its calibration due date and properly certified.
2. Light Intensity Calibration:
   • Turn on the photostability chamber and allow it to stabilize for at least 30 minutes.
   • Measure the light intensity using a calibrated light meter positioned
     

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     at multiple points within the chamber to ensure uniform exposure.
   • Record the light intensity readings and compare them with the specified light intensity settings (e.g., 1.2 million lux hours for cool white fluorescent light and 200 watt hours/square meter for near-UV light).
   • Adjust the light sources as necessary to achieve the desired light intensity levels.
   • Document the light intensity measurements and any adjustments made.
3. Temperature and Humidity Calibration:
   • Verify that the temperature and humidity control systems are functioning correctly.
   • Place calibrated temperature and humidity sensors at multiple locations within the chamber.
   • Record the temperature and humidity readings and compare them with the chamber’s set points.
   • Adjust the control systems as necessary to achieve the desired temperature and humidity levels.
   • Document the temperature and humidity measurements and any adjustments made.
4. UV Light Calibration:
   • Measure the UV light intensity using a calibrated UV sensor positioned at multiple points within the chamber.
   • Record the UV light intensity readings and compare them with the specified UV light settings (e.g., 200 watt hours/square meter).
   • Adjust the UV light sources as necessary to achieve the desired UV light intensity levels.
   • Document the UV light intensity measurements and any adjustments made.
5. Verification and Documentation:
   • Review all calibration data to ensure accuracy and completeness.
   • Prepare a calibration report that includes:
     • Date of calibration
     • Calibration equipment used
     • Light intensity, temperature, humidity, and UV light measurements
     • Adjustments made (if any)
     • Signatures of the personnel performing and reviewing the calibration
   • Submit the calibration report to the Stability Manager and QA Team for review and approval.
6. Record Keeping:
   • Maintain all calibration records, including reports and certificates of calibration equipment, 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.

Abbreviations Used

• QA: Quality Assurance
• SOP: Standard Operating Procedure
• UV: Ultraviolet

Documents

• Calibration Records
• Calibration Equipment Certificates
• Calibration Reports

References

• ICH Q1B: Photostability Testing of New Drug Substances and Products
• FDA Guidance for Industry: Stability Testing of Drug Substances and Drug Products

SOP Version

Version 1.0 – Effective Date: [Insert Date]