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An overview of FDA 21CFR Part 11, its origins and how Version 5 software with the ER/ES features enabled helps users to comply.
A tour of Malvern's Version 3 software for the Mastersizer S, X, Micro and Microplus.
Sprays characterization provides some unique challenges for particle sizing systems in terms of the spray concentration, geometry and speed of actuation of the systems which must be studied. In this seminar, we will present the capabilities of the Malvern Spraytec laser diffraction system in characterizing spray systems, starting with an introduction to how the technique of laser diffraction is applied. Practical examples of the use of the Spraytec in the characterization of systems such as coatings sprays, fuel injectors systems, pesticide sprays and personal products will be provided. These will show how the real-time, high-concentration measurements provided by the system can aid researchers in understanding how spray formation occurs and can be controlled.
Introduction to the use of the Malvern Spraytec in characterizing the output of atomizers used in the agrochemical industry.
This presentation deals with the need to measure and control both rheology and particle size from a quality control and a production perspective.
This web seminar covers all the functions of the new Spraytec - how it works, its major applications and its exciting new features.
In 2003 the FDA issued its most recent draft guidance describing the process by which bioavailability and bioequivalence can be determined for nasal pump spray formulations. Within this, they outlined a series of in vivo tests which should be used to predict bioavailability, including the use of laser diffraction for particle sizing as well as over methods for plume geometry and pattern analysis. In this presentation the process of nasal spray pump characterisation will be discussed with reference to the FDA's guidance. Specific examples will be given, providing guidance regarding how users may assess performance differences between different pumps. The importance of using automated pump actuation stations to control the pump actuation profile will also be stressed, along with the need to ensure that the actuation profile selected for testing is realistic.
This introductory seminar deals with the fundamental statistical descriptors of particle size. In this session we will deal with what different techniques of particle sizing actually measure.
Basisprincipe laserdiffractie: de betekenis en interpretatie van de meet resultaten van laserdiffractie deeltjesgrootte meetapparatuur
The full range of Batch 2 Quality Audit Standards has now been introduced and pass/fail criteria and measurement protocols have been established. This presentation details the progress that has been made.