Tim Freeman Series On The Powder Testing Toolkit
The pharmaceutical industry is currently undergoing a seismic shift in terms of manufacturing practice. The advent of Quality by Design and the Process Analytical Technology (PAT) initiative invite the adoption of smarter ways of manufacturing, and the engineering of more efficient processes that consistently produce materials of the necessary quality. Continuous manufacture and real time release are strong themes of the current landscape. Against this backdrop Tim Freeman takes a look at the existing powder testing toolkit, especially those techniques detailed in the standards and the pharmacopoeias, to see how well it supports the attainment of today's manufacturing goals. In the past, it's fair to say that production has been a lower priority than it is now. Much progress has been made in various analytical areas, but for powder processing many are still using simple techniques that evolved several decades ago. Establishing better powder handling expertise is a core requirement for the sector so we really need to think about the best powder testing techniques to support it.
Powder Testing Tools For A New Manufacturing Model
In this new series of editorials I'm going to ask the question "How well does the powder testing toolkit used by the pharmaceutical industry meet its current needs?" In seeking answers, I'm going to start by looking at what the industry asks of its powder characterization techniques, what information it requires, and why. Taking challenges that the pharmaceutical industry faces into account helps to set a specification against which to judge different instrumentation and techniques.
Overcoming Powder Testing Limitations
Flowability – the ease with which a powder flows – is arguably the most important characteristic of powder behavior. For pharmaceutical manufacturers, engineering the right flow properties has always been the key to many processes, one important example being the successful production of quality tablets at the required rate. Today though, the increasing emphasis on more efficient manufacture and continuous processing intensifies the need for reliable, relevant, and precise flowability measurement. This changing climate makes it timely to review traditional flowability test methods, examining both their value and limitations.
Reproducible Powder Testing
Reproducibility, measurement sensitivity, and the usefulness of an analysis are inextricably linked. If a technique or instrument exhibits poor reproducibility, then measurements are ‘noisy' and only gross trends or differences can be detected. As the pharmaceutical industry strives for greater knowledge of its processes and products, this becomes increasingly limiting. In the area of powder testing, achieving the required level of reproducibility is especially challenging, but is now essential.
Evaluating The Powder Testing Toolkit: Tapped Density
In earlier editorials, I've examined modern industrial requirements for powder characterization and assessed how well different test methods answer to the resulting brief. In this editorial, I want to focus on tapped density methods and their advantages and limitations when it comes to investigating powder flow properties.
Evaluating The Powder Testing Toolkit: Shear Testing
In this series of editorials, I'm looking at how well the traditional powder testing toolkit meets the requirements of today's powder processors. In the last editorial, I put tapped-density methods under the spotlight, and now it's time to consider shear testing.
Powder Characterization For Modern Manufacturing
In this series, I've been looking at traditional powder testing techniques, such as tapped density methods and shear analysis, to see how they fit with today's powder processing needs. Greater efficiency is the goal now dominating pretty much every area of production, so I really do feel it's appropriate to question whether we have the right powder characterization tools for modern applications.
About Tim Freeman
Tim Freeman, Director of Operations at Freeman Technology, has created a series of articles relating to the Quality by Design initiative implemented by the company. Tim Freeman has a degree in Mechatronics from the University of Sussex in the UK and has worked for Freeman Technology since the mid 1990s. Since Freeman Technology's launch of the FT4 Powder Rheometer, he has been responsible for application and method development and works closely with customers in the pharmaceutical and powder processing industries.
About Freeman Technology
Freeman Technology was founded in 1988 by Reg Freeman. The company is a specialist company that has pioneered the measurement and understanding of powders and their flow properties. Effective powder processing underpins almost all pharmaceutical manufacture.