fulltext_016 - Chapter 17 Quality Management and...

Info icon This preview shows pages 1–3. Sign up to view the full content.

View Full Document Right Arrow Icon
403 Abstract: Good specification of a product’s performance requires adequate char- acterization of relevant properties. Particulate products are usually characterized by some PSD, shape or porosity parameter(s). For proper characterization, adequate sampling, dispersion, and measurement procedures should be available or developed and skilful personnel should use appropriate, well-calibrated/qualified equipment. The characterization should be executed, in agreement with customers, in a well- organized laboratory. All related aspects should be laid down in a quality handbook. The laboratory should provide proof for its capability to perform the characterization of stated products and/or reference materials within stated confidence limits. This can be done either by internal validation and audits or by external GLP accreditation. 17.1 Introduction The quality aspects of particle characterization are or should be directly related to product performance, as already discussed in Chap. 3. In the same chapter, various candidate parameters for characterization are discussed. Of course, both method and technique used should allow adequate characterization. Thus, size measurement Chapter 17 Quality Management and Calibration H.G. Merkus, Particle Size Measurements, DOI 10.1007/978-1-4020-9015-8_17, © Springer Science+Business Media B.V. 2009 Good practice requires: standard operating procedures and protocols adequate education and skills of operators quantitative statements on required measurement quality procedure for instrument qualification / method validation instructions for dealing with out-of-specification qualification results instructions for instrument maintenance documentation of all results and interventions Contents 17.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 403 17.2 Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 404 17.3 Qualification and Validation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 405 17.4 Quality Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 407 17.5 Laboratory Accreditation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 409 17.6 Practical Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 409 17.7 Definitions, Abbreviations and Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 409 Bibliography . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 410
Image of page 1

Info iconThis preview has intentionally blurred sections. Sign up to view the full version.

View Full Document Right Arrow Icon
404 17 Quality Management and Calibration range, precision, bias, resolution, sensitivity, and lower determination limit should be fit for purpose. Usually, requirements for size range and precision are dominant. Sometimes, the lower determination limit for a specific size class is important as well. Moreover, the technique should be capable of measuring at the required con- centration level of the product or the product should allow dispersion/dilution to the required concentration level of the technique. Finally, if traceability is required, then the technique should be capable of providing this. It is important to realize that the measurement technique is usually not the main source of error. In fact, sampling is usually the dominant error source for particulate materials with free-flowing properties (see Chap. 4). A representative sample can only be obtained if each particle in a batch has the same chance of being sampled. Moreo- ver, it should contain a sufficient number of particles to allow the required precision of the relevant size parameter. On the other hand, dispersion is often the dominant error
Image of page 2
Image of page 3
This is the end of the preview. Sign up to access the rest of the document.

{[ snackBarMessage ]}

What students are saying

  • Left Quote Icon

    As a current student on this bumpy collegiate pathway, I stumbled upon Course Hero, where I can find study resources for nearly all my courses, get online help from tutors 24/7, and even share my old projects, papers, and lecture notes with other students.

    Student Picture

    Kiran Temple University Fox School of Business ‘17, Course Hero Intern

  • Left Quote Icon

    I cannot even describe how much Course Hero helped me this summer. It’s truly become something I can always rely on and help me. In the end, I was not only able to survive summer classes, but I was able to thrive thanks to Course Hero.

    Student Picture

    Dana University of Pennsylvania ‘17, Course Hero Intern

  • Left Quote Icon

    The ability to access any university’s resources through Course Hero proved invaluable in my case. I was behind on Tulane coursework and actually used UCLA’s materials to help me move forward and get everything together on time.

    Student Picture

    Jill Tulane University ‘16, Course Hero Intern