The temperature study is required to understand the behavior of the product and packaging withstand. The packaging depends on product compatibility and stability guidelines.
So, FDA has made guidance intended to define the stability data package for a new drug substance or drug product sufficient for a registration application within the European Union (EU), Japan (JP), and the United States(USA).
Temperature stability study of packaging material
The guidance represents the core stability data package for new drug materials and products. Still, it leaves sufficient flexibility to encompass various practical situations that may be encountered due to the evaluated materials’ specific scientific considerations and characteristics. Alternative proposals can be used when there are scientifically justifiable reasons.
Let it directly be said that temperatures cannot strictly be divided into such simple categories as were once conceived, i.e., market and home.
How can we decide the temperature?
We all know that the many pharmaceuticals or medicines will finish up in the kitchen or bedroom invariably. It means that the maximum temperature and humidity may be worse in the home and export conditions. So, the businesses should also perceive that goods transported in the boot or trunk of a representative’s car may infrequently reach temperatures over 60°.
If outdoor arctic or antarctic circumstances are included, then outcomes of packaging stability may be exposed from −60°C to +60°C, depending on the circumstances.
The pharmaceutical industry, therefore, until recently, tended to operate to no particular standard and selected from the following requirements for testing purposes:
• −18°C to −22°C deep freeze conditions (arctic, antarctic conditions)
• freeze-thaw advised for drug substance
• 4°C, i.e., refrigeration 0–8°C
• 10°C
• 15°C (lower temperate)
• 20°C
• 25°C (upper temperate/lower tropical)
• 30°C
• 37°C or 38°C (tropical, body temperature)
• 40°C a preferred condition for specific Japanese tests
• 45°C or 50°C upper maximums for medium-term storage, i.e., 3–6 months
• 55°C, 60°C, and 80°C usually short-term upper challenge conditions
Other than body temperature, the phrases in parentheses have evolved by tradition rather than on any scientific basis and should be interpreted accordingly.
The zone-wise temperature stability condition
Recent investigations based on kinetic mean (km) temperatures have divided the world into four zones:
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Zone I km temperature 21 °C mean RH 45% (lower temperate Europe)
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Zone II km temperature 26°C mean RH 60% (upper peaceful Europe) location.
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Zone III km temperature 31°C represent RH 40% (tropical dry)
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Zone IV km temperature 31°C mean RH 70% (tropical humid)