1. Importance of Verification and Regulatory Basis

As a core equipment for conducting accelerated tests and long-term stability studies in the pharmaceutical, chemical and other industries, the temperature uniformity of the stability test chamber directly affects the accuracy of drug shelf-life evaluation. According to the requirements of Good Manufacturing Practice (GMP), the stability test chamber must be verified regularly to ensure that the temperature deviation at each point in the working space does not exceed ±2℃ and the uniformity is ≤2℃. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q1 guideline further specifies that long-term stability tests should be carried out under the conditions of 25℃±2℃/60%RH±5%RH, and temperature uniformity is a key indicator of data reliability.

2. Strategies for Solving Common Problems

• Problem 1: Slow recovery after door opening
• Possible cause: Aging of door seals
• Solution: Replace the silicone rubber sealing strips, and keep the compression amount at 2-3mm

• Problem 2: Local temperature exceeding the standard
• Possible cause: Blocked air duct
• Solution: Adjust the placement of samples, leaving an air duct gap of ≥150mm

• Problem 3: Data drift
• Possible cause: Sensor aging
• Solution: Calibrate with a standard thermometer, and replace it in time when the deviation exceeds ±0.3℃

The Labonce pharmaceutical stability test chamber from GlobalEquipX can easily deal with the problem of temperature uniformity. Equipped with high-quality accessories and supporting precise calibration, it lays a solid foundation for your drug stability research, making the tests more reliable and efficient.

Through systematic verification and refined maintenance, the temperature uniformity of the stability test chamber can be controlled within ±1℃ for a long time, providing reliable data support for drug stability research. It is recommended to establish a closed-loop management system of "verification - maintenance - re-verification" in conjunction with the requirements of "JJF (Jin) 111 - 2025 Calibration Specification for Pharmaceutical Stability Test Chambers".