Parenteral Particulate Matter Testing and Identification of Particles
Foreign and Particulate Matter is a Universal Test required as per USP Injections and Implanted Drug Products (Parenterals). This presentation highlights USP requirements and guidelines with respect to particulate matter in parenteral products. The following QC test methods will be addressed: · Visual examination · Particle counting by light obscuration · Microscopic particle counting In the event that visible particles or high levels of sub-visible particles are encountered, identification of these particles is required to determine the source such that process improvements can be implemented and regulatory compliance can be maintained. Common analytical techniques used to identify particulate matter will be presented. Several Case Studies will be presented to illustrate the approach taken to identify various parenteral particles and the information obtained from the various analytical techniques. Presenter Bryan Wickson is the Manager of Materials Sciences within the Health Sciences Division of Exova. The Material Sciences team focuses on physical characterization of pharmaceuticals, medical devices and polymeric products by using techniques such as FTIR spectroscopy, x-ray diffraction, particle counting and sizing, thermal analysis, molecular weight determination, mechanical testing, light microscopy and scanning electron microscopy. These projects range from QC testing, to method development/optimization to failure analysis and medical device 510K programs. In addition to material characterization and testing, Bryan has been involved with projects related to the development of novel medical devices and drug containing parenteral devices. Prior to joining Exova, Bryan’s research activities related to surface modification of polymeric biomaterials and the evaluation of these materials’ ability to selectively adsorb specific proteins when brought into contract with blood. He received an engineering degree in the field of biomaterials engineering from the University of Guelph. Sponsored Raffle: Calling all SF 49er fans. If you register by 05APR19, you will get a chance to win 2 SF 49er tickets for the opening game of the 2019 season ($300 value). Tickets donated by TAF Group LLC (firstname.lastname@example.org). Agenda: 6:00 PM Registration/Networking* 7:00 PM Complementary Buffet Dinner 7:45 PM Announcements 8:00 PM Presentation/Q&A 9:00 PM Closing Annual Sponsor: FAQs How can I contact the organizer with any questions? You can contact the event organizer sending an email to email@example.com, please allows few days for the respons. Is my registration fee or ticket transferrable? Yes, thicket is not reboundable, however you can transfer it to whoever would like to attend in your behalf My company would like to become a WCC PDA Sponsor, do you have a sponsorship program? Yes, our WCC PDA Sponsorship Program offers a unique opportunity for companies that want to strengthen brand image, increase visibility, and gain access to leaders of the San Francisco Bay Life-Science Community What is the dressing code? Business casual *Cash Bar Cancellation Policy: Dinner seating is confirmed and reserved in advance. We regret that no refunds can be offered for non-attendance. If a registrant cannot attend, substitutions are welcome. The chapter reserves the right to cancel a dinner meeting if the minimum number of attendees is not met by Monday prior to the event.
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