EMS MICROSCOPY ACADEMY PHARMACEUTICAL MICROSCOPY WORKSHOP

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Beatrice Allison Dorsey
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Examples of the Microscopy of Pharmaceuticals PLM

microscopy. Crossed polars with lambda waveplate.

optical crystallographic properties of polymorphs.

Teflon is used in pharmaceutical manufacturing and

1 Examples of the Microscopy of Pharmaceuticals PLM image of anthroquinone cooled after thermal microscopy. Crossed polars with lambda waveplate. Uniaxial interference pattern used to determine optical crystallographic properties of polymorphs. SEM image of Teflon tape. Teflon is used in pharmaceutical manufacturing and is a source of contamination. Energy dispersive x-ray chemical map of a sectioned multivitamin tablet.

Fluorescence microscopy image of a sectioned multivitamin tablet.

2 Fluorescence microscopy image of a sectioned multivitamin tablet. Different imaging techniques can be correlated to better understand drug performance. Differential interference contrast (DIC) image of liquid drops on interior of parenteral glass vial. DIC is used to examine parenteral glass vials. SEM image of primary drug particle. Particle morphology can help understand pharmaceutical performance in some dosage forms. SEM image of interior glass surface showing evidence of parenteral glass vial corrosion (delamination).

3 Details January 22-26, 2018 Monday - Thursday, 8:00 a.m. - 4:30 p.m. Friday, 8:00 a.m. - 12:00 p.m. Hatfield, Pennsylvania, USA Targeted Participants This course is intended for beginning and intermediate level analysts who need to gain familiarity and skill in the use of microscopy as applied to pharmaceutical development. Scope of Class This workshop is designed to introduce the major applications of microscopy in pharmaceutical development: polymorphism, particle size analysis, contaminant identification, and glass corrosion. The workshop is conducted over 4-1/2 days with a mixture of theory, demonstrations, and hands-on work. The course is designed to prepare the student to apply microscopy to solve solid-state pharmaceutical issues. The emphasis is on the practical use of the microscope. The EMS Microscopy Academy Located in Hatfield, Pennsylvania, the Academy provides electron microscopy classes, workshops and training sessions for all fields of microscopy, including materials science and biological science. Format Lecture, demonstration, and hands-on practice, as well as round table tips and tricks discussions. Participants are encouraged to bring their own samples, if possible. Laboratory exercises are designed to teach the student how to collect the appropriate information to aid drug development. Numerous case studies are presented to further the student s ability to accurately interpret data and merge microscopy data with that from other instruments. Instruments Available Polarizing Light Microscope Hitachi S3500 SEM Image Analysis Software Linkam Thermal Microscope Bruker (ESD) Raman Microscope

4 Main Curriculum Polymorphism: using polarized light and thermal microscopy, along with IR and Raman micro-spectroscopy Size and shape analysis using light microscopy, SEM/EDS with image analysis Chemical imaging using SEM, fluorescence microscopy and micro-spectroscopy with image analysis Glass vial corrosion (delamination) using light microscopy and SEM Contamination identification using polarized light microscopy, scanning electron microscopy, EDS, and micro-spectroscopy Faculty Robert Carlton Robert worked for nearly 40 years in the research and development of fiberglass insulation, orthopedics, and pharmaceuticals. His specialty is solid-state analysis with a particular interest in microscopy. Robert retired from full-time employment in early He is now teaching microscopy and consulting on solid-state analysis in pharmaceutical development. Robert s education is in chemistry, with a Ph.D. from Lehigh University. He has taken numerous courses at McCrone Research Institute on microscopy from Skip Palenik and Walter McCrone. Robert worked for pharmaceutical companies Rhone-Poulenc Rorer (Aventis, Sanofi), Elan (Nanocrystal), and GlaxoSmithKline in microscopy and solid-state analysis for 24 years. He published a book on Pharmaceutical Microscopy in 2011 with Springer. Michael Kostrna was the program director of the Electron Microscopy Technician program at Madison Area Technical College and has more than more than 35 years in EM technical education and research experience. He has been training EM students for 30 years and has developed curricula and lab exercises for TEM, SEM, OLM, lab safety, introductory and advanced biological EM, EM, maintenance, and x-ray microanalysis. He has worked with companies such as SC Johnson Polymer, Dow Chemicals, Io Genetics, Virent Technologies, ABS Global, NanoOnocology, and Microscopy Innovations, and in the process gained insight to the various applications of EM. Al Coritz has been working in the Electron Microscopy field for 39 years, beginning at the Yale School of Medicine and ending up on the commercial side with several key EM companies. His specialty is Cryo-techniques and Thin Film Technology: i.e. Freeze Fracture/Rotary Shadowing, High Pressure Freezing, and more He is currently with Electron Microscopy Sciences where he has been the Technical Director for over 20 years.

5 Schedule Monday, January 22, 2018 EMS MICROSCOPY ACADEMY 8:00-8:30 Introductions of staff and participants 8:30-9:00 Introduction to microscopy in pharmaceutical development 9:00-10:30 Polymorphism theory 10:30-11:00 Coffee break 11:00-12:00 Lab exercises in solid-state form discovery using polarized light microscopy 12:30-2:30 Lab exercises in solid-state form discovery using thermal microscopy 2:30-4:30 Lab exercises in solid-state form discovery using IR and Raman spectroscopy 6:30 Hosted dinner Tuesday, January 23, :30-10:00 Form selection principles, thermodynamic principles of polymorphism 10:00-10:30 Coffee break 10:30-12:00 Lab Exercises using microscopy in developing form understanding 12:30-2:30 Methods of determining the stable form at ambient conditions 2:30-4:30 Lab exercises in form stability studies Wednesday, January 24, :30-10:00 Image analysis principles, particle size and shape analysis, sample preparation, image analysis routines 10:00-10:30 Coffee break 10:30-12:00 Lab exercises in sample preparation and image analysis: optical microscopy 12:30-2:30 Lab exercises in sample preparation and image analysis: SEM 2:30-4:30 Counting statistics, error analysis, laser diffraction, size analysis, correlation, and regulatory considerations Thursday, January 25, :30-9:30 Chemical imaging in drug development: methods and uses 9:30-10:30 Lab exercises in chemical imaging, tablet sample preparation, SEM/EDS 10:30-11:00 Coffee break 11:00-12:00 Lab exercises in chemical imaging, fluorescence microscopy, and Raman microspectroscopy 12:30-2:30 Glass vial corrosion (delamination) theory and characterization 2:30-4:30 Lab exercises in glass vial corrosion analysis using optical microscopy and SEM

6 Friday, January 26, 2018 Principles of contaminant identification, microscopy methods used with contaminants 8:30-9:00 Contaminant identification principles 9:00-11:30 Lab exercises in contaminant identification using light microscopy and SEM/EDS 11:30-12:00 Workshop summary, recommendations for further study, and assessment feedback on workshop Registration Fee: $1, Includes Workshop syllabus All supplies Reagents and solutions Lunches Coffee Tea Dinner on the first evening of the workshop Lodging Participants are responsible for making their own hotel reservations. The following hotel has been designated as the host hotel: Homewood Suites 1200 Pennbrook Parkway Lansdale, PA Phone: The special rate is $ per night (plus tax) which includes a hot breakfast and a light dinner in the evening. Please make your reservations and mention you are participating in the EMS Workshop. GROUP CODE: EMS WORKSHOP Everyone should plan to arrive the evening of January 21sth. Enrollment Note Registration will be limited to a maximum of 15 participants. EMS will provide samples to those who prefer not to bring their own.

7 Printable Registration Form EMS MICROSCOPY ACADEMY M / F Name / Title Institution Department Mailing address City / Zip Country Telephone / Fax Will you bring your own specimens? Yes / No (See note on prior page) What Samples are you bringing and most interested in? All registrations must include payment. Rate $1, per Person Number of Participants Total $ Pay by check: make payable to EMS and reference Pharmaceutical Microscopy Jan18. Pay by credit card: Credit Card Type Credit Card Number Expiration Date 3 Digit Code Signature / Date Return your registration to: Stacie Kirsch 1560 Industry Road Hatfield, PA USA Phone: sgkcck@aol.com or Fax: TO REGISTER ONLINE, CLICK HERE.

EMS MICROSCOPY ACADEMY MATERIALS ULTRAMICROTOMY WORKSHOP

EMS MICROSCOPY ACADEMY MATERIALS ULTRAMICROTOMY WORKSHOP Examples of the endless possibilities when doing materials microtomy High Impact Polystyrene. Claudia Maymofer, TU Graz GaAs-AlGaAs nanowires grown