Nuances and Pitfalls of vial heat transfer

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SP Scientific

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Each product has a maximum temperature below which it must be maintained to avoid collapse or melt back during primary drying step of freeze-drying. The actual product temperature in a vial during primary drying is explicitly controlled by the balance between the heat input and the sublimation rate. At any combination of shelf temperature and chamber pressure, the amount of heat transferred to the product, and therefore the product temperature, can be determined using the vial heat transfer coefficient (Kv). Determination of an accurate vial heat transfer coefficient provides the data to develop a design space and can improve scale up from a laboratory scale to a manufacturing scale. In this work, several factors that can affect the determination of Kv were explored. Best practices in Kv measurement were identified. There is no one correct way of measuring Kv. Selection of the measurement technique will depend on the purpose of the Kv value.

Presented by: Pooja Sane