Standard Operating Procedure for Maintenance of Stability Chambers

1) Purpose

The purpose of this SOP is to establish guidelines for the maintenance and operation of stability chambers in pharmaceutical manufacturing facilities to ensure accurate and reliable stability testing of products.

2) Scope

This SOP applies to all stability chambers used within the facility premises.

3) Responsibilities

The Quality Control Department is responsible for implementing and adhering to this SOP. The Stability Chamber Technician or designated personnel are responsible for the maintenance and operation of stability chambers.

4) Procedure

1. Preventive Maintenance
   1. Develop a preventive maintenance schedule for stability chambers based on manufacturer recommendations and regulatory requirements.
   2. Inspect chamber components such as temperature sensors, humidity control systems, shelves, and door seals regularly for accuracy, calibration, and cleanliness.
2. Cleaning and Calibration
   1. Follow standard operating procedures for cleaning and calibrating stability chambers to maintain temperature and humidity control, and prevent contamination.
   2. Use approved cleaning agents and calibration standards suitable for stability chamber materials and accuracy requirements.
3. Performance Verification
   1. Conduct performance verification tests to ensure stability chambers operate within specified parameters such as temperature uniformity, humidity control, and alarm systems.
   2. Calibrate equipment as per calibration procedures and maintain calibration records.
4. Incubation and Monitoring
   1. Place stability samples in the chambers according to approved protocols.
   2. Monitor chamber conditions and record data at specified intervals.
5. Documentation and Reporting
   1. Maintain accurate records of equipment inspections, maintenance activities, performance tests, calibrations, stability sample incubations, and any adjustments made to the stability chambers.
   2. Document any incidents, deviations, or out-of-specification results.

5) Abbreviations, if any

SOP: Standard Operating Procedure

6) Documents, if any

Preventive Maintenance Schedule, Cleaning and Calibration Procedures, Performance Verification Reports, Stability Sample Records, Calibration Records

7) Reference, if any

Manufacturer’s recommendations for stability chamber maintenance, industry guidelines for stability testing, regulatory requirements for stability chamber cleanliness and performance, and local safety regulations.

8) SOP Version

Version 1.0