Global Event Calendar and Registration

Selection and Utilization of Glass Containers in Pharmaceutical Packaging

Location: Washington, DC
Date: June 7, 2012
Duration: 1 Day
Time: 8:30 a.m. - 4:00 p.m.

Program Highlights

“Edward Smith and Roger Asselta have presented the topic Selection and Utilization of Glass Containers in Pharmaceutical Packaging in a very refreshing manner, combining both deep theoretical insight and long term practical experience.  The content of this course will be of great value to my company.”

Stefan Hagen, Syntese A/S, Ferring Pharmaceuticals

The objective of this course is to give the attendee a broad overview of the advantages and disadvantages of glass containers based on the interaction of glass with drug products.  Attendees will learn to appreciate the methods that both glass suppliers and pharmaceuticals utilize to increase the compatibility of glass with drugs and reduce glass container defects.

The course curriculum will consist of both lecture and class discussion of case studies pertaining to the compatibility of glass with drug products, glass standards and regulatory requirements.  The student will also learn how to write specifications for glass components in order to obtain consistent high quality parts and learn how to identify points in their process that can impact quality.

Who Should Attend

Packaging Engineers; Formulators of Injectable Drug Products; Quality Assurance & Control Professionals; Chemical Analysts; Regulatory Professionals; Manufacturers of Glass & Glass Containers; Scientists responsible for Stability Studies and/or Extractables & Leachables Studies.

Prerequisites

There are no prerequisites, but some experience with parenteral packaging systems (vials, syringes, ampoules) will be useful in understanding the concepts and examples discussed.

Upon completion of this course, you will be able to:

  • Discuss the composition, structure, and advantages/disadvantages of glass containers for pharmaceuticals
  • Summarize the manufacturing processes of glass and glass components such as vials, syringes, and ampoules
  • Describe the handling of glass components in the pharmaceutical manufacturing processes such as storing, washing, depyrogenation, sterilization, filling, and packaging
  • Identify locations in their process that contribute to Impact Damage, Frictive Damage, Thermal Stress, and Mechanical Stress
  • Interpret the existing standards (ISO, ASTM, GPI) and compendial requirements (USP, PhEur, JP) of glass containers
  • Explain the ways in which glass can interact with drug products (DP) and methods of reducing glass-DP interactions (e.g., glass delamination, pH change, adsorption)
  • Explain how to conduct an extractables and leachables assessment of glass components
  • List the factors that impact glass strength and describe a typical Fracture Analysis study

Edward J. Smith, Principal Consultant, Packaging Science Resources
Roger Asselta, Vice President, Technical Affairs, Genesis Packaging Technologies

Standard
Government / Health Authority / Academic
Member Non-Member Member Non-Member
Price on or before April 20, 2012
 $895 $1,165 $600 $700
Price after April 20, 2012
 $995 $1,295 $600 $700

All rates in US dollars.

Class Schedule

All lecture courses begin at 8:30 a.m. and end at 4:00 p.m. unless otherwise noted on the confirmation letter or in course information posted on the website or in the course brochures. Courses that are listed with a half day will begin at 8:30 a.m. and end at noon on the last day.
Please arrive at your course location approximately thirty minutes before the start of the course to register and receive your course materials. Please be sure to bring your confirmation letter as proof of registration during check-in. TRI will not allow persons to attend a course without payment, or guarantee of payment.

A continental breakfast will be served before class beginning 7:30 a.m. Lunch will be provided from 12:00 – 1:00 p.m. Snacks will be provided during the morning break from 10:00 – 10:15 a.m. and the afternoon break from 2:30 – 2:45 p.m.

Location

Renaissance Hotel
999 9th Street, NW
Washington, D.C. 20001
+1 (202) 898-9000

Contact

For more information, please contact:

Stephanie Ko
Senior Manager, Lecture Education
Tel: +1 (301) 656-5900 ext. 151
Email: ko@pda.org

For registration inquiries please call: +1 (301) 656-5900 ext. 115

Description: ACPEThe PDA Training and Research Institute is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Education Units (CEUs) following the successful completion of an accredited course and submission of the provided evaluation forms. Statements of Credit for CEUs earned will be mailed within four to six weeks of the event.

PDA #284 | ACPE #0116-0000-11-284-L04-P | 0.6 CEUs
Type of Activity: Knowledge, Application

From: 
Email:  
To: 
Email:  
Subject: 
Message: