HEL's LaserTRACK, a near-absolute particle sizing probe from, advances crystallisation and formulation studies. When combined with a reactor and integrated software, the PAT concept in accordance with the FDA guidance for QbD (Quality by Design) is readily realized. The heart of the PAT is the data quality from the particle sizing probe. In this example, the data from two probes, the LaserTRACK and FBRM is compared. The sample is a quartz based material with a specified mean size of 10µm and 95% of particles are below 34µm; this was confirmed by electron microscope. The probe agrees closely with the specification while the FBRM reports both a significantly higher mean size and also a very different (much wider) distribution. Such discrepancies have been found in many side-by-side trials with different materials. HEL Ltd 9-10 Capital Business Park Manor Way, Borehamwood, Hertfordshire WD6 1GW. UK Phone: +44 (0) 20 8736 0640 Fax: +44 (0) 20 8736 0641www.helgroup.com
Michelle LongoAsst. Managing Editor
Striving Toward Secondary GoalsLate last month, Republican presidential candidate Newt Gingrich stunned most everyone when he declared his promise that "by the end of my second term, we will have the first permanent base on the moon." While I don’t fault Gingrich for dreaming and trying to set high standards and goals, I can’t help but think of the enormous amount of known and unknown variables that significantly deter this accomplishment...continue
