Within the pharmaceutical industry there is increasing emphasis on processing efficiency and more effectively controlled manufacture.
In production, it is impossible to eliminate all the possible sources of variability, but it is feasible to compensate for
them and control their impact. This relies on identifying, measuring, and controlling those parameters that define processing
efficiency and the quality of the finished product.
In solid-dosage manufacture, achieving this goal requires a relevant and sensitive powder testing toolkit capable of reliably
generating parameters that can be directly correlated with process performance. Key to this is the ability of a technique
to effectively simulate the specific processing environment, which, as an analysis of tableting reveals, can vary considerably.
Instruments that combine established techniques, such as shear and bulk property testing, with newer methodologies, such as
dynamic testing, can be valuable. The user can then tailor testing to the specific application, and access the most complete
information for process design, optimization, and control.
Tim Freeman* is managing director and Jamie Clayton is operations manager at Freeman Technology, 1 Miller Court, Severn Drive, Tewkesbury, Gloucestershire, GL20 8DN, United Kingdom,
tel. +44(0)1684.851.551, fax. +44(0)1684.851.552, firstname.lastname@example.org
*To whom all correspondence should be addressed.
1. M. Glodek et al., "Process Robustness: PQRI White Paper," online,
http://www.pqri.org/, Oct., 2005.
2. G. Carlson and B. Hancock, AAPS Annual Meeting and Exposition (Atlanta, GA, 2008).
3. R. Freeman, Powder Technol.
174 (1–2) 25-33 (2007).