20 May 2013, BioSpectrum Bureau , BioSpectrum
Singapore: Agilent Technologies launched a new series of verified dissolution components, including molded vessels as well as paddle and basket shafts. Designed to ensure compliance with mechanical qualification guidelines, these components will be available June 1 and offer verification that they conform to exact specifications.
Dissolution is a technique used in the pharmaceutical industry to determine the rate at which pure active pharmaceutical ingredients dissolve. To meet precise tolerances, the new molded vessels are vacuum-formed around a set of Agilent's mandrils, which eliminates the warps and flaws of traditional hand-blown manufacturing.
Mr Allan Little, director, marketing, dissolution systems, Agilen, said that, "To better support the qualification needs of our customers, it was critical for Agilent to offer improved options for component verification and traceability. Not only do we offer these new vessels and shafts, but Agilent is leading the effort to educate pharmaceutical analysts on the importance of compliance with the developing qualification guidelines."
The verified paddle and basket shafts are being introduced to meet a growing demand for verified components. Made with updated manufacturing processes, these shafts are measured to exact specifications and certified for traceability with an individual certificate of conformance.
Qualification of dissolution apparatus in pharmaceutical laboratories involves performance verification testing, enhanced mechanical qualification, or a combination of the two procedures. With evolving guidance on qualification best practices, the adoption of verified components assists with long-term traceability and offers assurance that components meet tolerances set by the United States Pharmacopeia.