Primary single vials

The various techniques available to monitor the primary drying can be roughly divided into three groups as they can be used to monitor single vials, a group of vials or the whole batch (Barresi et al, 2009a) these techniques will be discussed and compared in the following sections. 

The computer must determine the rate at which this step develops from the heat of sublimation of the ice in the sample and the uncrystallized water present in the interstitial region. Also, it should take into account the heat transfer coefficient of the sample container — in the case of a vial, not just a single container, but the frequency distribution of an entire lot of containers. From this statistical information, the computer can then determine the highest shelf-surface temperature where, based on knowledge of the batch size, the chances that the heat transfer coefficient of a container would result in a product temperature exceeding the collapse temperature and yielding a defective product are minimal. The frequency distribution of the heat transfer coefficients of the containers would also provide the computer with the information needed to extend the primary... 

Vials and small primary packing that contain a single dose and upon which it would be impossible to mention all the information laid down in the above sections shall contain ... 

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