University of Pavia Consorzion Interuniversitario Nazionale

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University of Pavia
Consorzion Interuniversitario Nazionale
Department of Pharmaceutical Chemistry
TEFARCO Innova     ISO Standards for particle
sizing and surface area measurements Towards a
correct use and interpretation Audiutorium
Shering, Via E. Shering 19-21 Segrate (MI)   27th
February 2003 under the auspices of
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• Objective of the seminar
•  
• Particle sizing and surface area measurements are
  commonly used in many industrial environments
  including pharmaceuticals. Practicability,
  reliability and transferability are mandatory
  characteristics of all analytical methods and
  represent the basis for a correct validation of
  those methods that are used for regulatory
  purposes.
• ISO guidelines, are already available for laser
  diffraction, PCS and surface area measurements by
  BET and similar guidelines are now in preparation
  on porosimetry, image analysis, light interaction
  and gravitational methods.
• In the pharmaceutical field compliance with
  compendia (namely pharmacopoeia) test methods and
  relevant guidelines is also required. Moreover
  compendia methods for particle size and surface
  area measurements are presently the object of
  International Harmonization Procedure.
• All considered, the present seminar is focused on
  the most commonly used techniques for the
  microstructure characterisation of powders,
  namely laser diffraction, surface area
  measurements by BET and porosimetry, with the aim
  of highlighting the critical points and
  elucidating how ISO standards can facilitate a
  correct use of equipments and a safe
  interpretation of experimental data.
• The seminar is directed to the manufacturers of
  bulk materials as well as of finished products,
  to the operators in quality control and quality
  assurance activities and to people involved in
  the preparation of registration dossiers.

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• Scientific committee
• Jun ( Atsushi ) Kimura The association of
  Powder Process Industry and Engineering, JP
• Brian Scarlett - University of Florida, U.S.A.
• Maurice Wedd - Consultant , United Kingdom
• Organizing committee
• Carla M. Caramella - University of Pavia/TEFARCO
  Innova, Italy
• Paolo Colombo - University of Parma / TEFARCO
  Innova, Italy
• Franca Ferrari - University of Pavia, Italy
• Andrea Gazzaniga University of Milano/ TEFARCO
  Innova, Italy
• Alessandro Rigamonti AFI
• Acknowledgements
• Franco Polchi, ALFATEST, Italy
• Orazio Russo, Micromeritics, Italy
• Sandro Venturin, Instrumentation Laboratory,
  Italy
• Information
• Carla M. Caramella

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Preliminary programme   14.30-14.45 Welcome
to the attendees (one representative of the
organizing commettee ) Presentation of
the activities of ISO sub-committee in the field
of particle sizing and
characterisation ( Henk Merkus, University of
Delft, NL )   I Session Laser diffraction (
Chairpersons Carla Caramella, Henk
Merkus) 14.45-15.15 The general principles
of Laser Diffraction How to make error free
measurements (Maurice Wedd,
Consultant, U.K.)   15.15-15.45 The
importance of setting user friendly SOP and
allocate reliable measurement
tolerances (Speaker to be
announced) 15.45-16.15 The importance of
ISO Standards and associated Proficiency Testing
activities. (Brian Miller,
Beckman/Coulter, U.K.)   16.15-16.30
Coffee-break
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Preliminary programme ( cont. ) II Session
Surface area and porosimetry (Chairpersons Carla
Caramella, Henk Merkus ) 16.30-17.00
Application of Gas Adsorption in the
Pharmaceutical/Industrial fields Old/New
ISO Standards for BET Surface Area Analysis
(Matthias Thommes,
Quantachrome, U.S.A.)   17.00-17.30 A turn
point for Mercury Porosimetry in
Pharmaceutical/Industrial
Applications New and Certified Reference
Materials Availability ( Luca Lucarelli,
Thermofinnigan, Italy )  17.30-1740
Conclusions