Institute for International Research

Wednesday May 2, 2007

Maintain Temperature Control for Product Integrity & Stability

With the growth of biologics, there is a greater need to distribute and store these complex products. There must be 100% assurance in maintaining the stability of your product with proper temperature control. It is imperative to proactively assess gaps in the supply chain, monitor the mechanisms of transport, be on top of the most effective technology and know emerging regulations.

Once the product enters the broader supply chain, it experiences a "complex systems of hand offs." Hence the manufacturer has less control and oversight for the later stages of the drug distribution process. This workshop is divided into sections to provide best practices and solutions to ensure cold chain compliance for product safety and stability. Discussion time is built in for shared learning.

9:00
Current Regulatory Guidelines on Cold Chain Shipping and Distribution
There are emerging laws coming out in reference to temperature protection, and product stability during transportation.

• International harmonization of good cold chain management practices (PCCDG) working with C3 (cold chain committee) in Europe.
• Improve your grasp on FDA views on cold chain logistics for improved regulatory compliance
• What is the current landscape in product protection?
• How to optimize and live with the regulations?
• Integrate cold chain into the new pedigree laws

Eric Sheinin, VP, Pharmaceutical Ingredient Verification Program, United States Pharmacopeia

10:00
Ensure Stability in Cold Chain Transportation for Product Integrity

• How do you transport a product and ensure that it's stable?
• Critical steps to minimize risk and ensure stability of temperature sensitive products
• What are the wholesalers doing to keep it cold?
• Gain confidence that your wholesaler is adhering to temperature regulations

Karen L. Oliver, Global Account Manager, World Courier Inc.

11:00
30 Minute Networking and Refreshment Break

11:30
Key Decision Points in Cold Chain Package Design

• Available options to help thermally regulate the product
• Design and engineer of packaging solutions for cold chain
• Qualification of packaging through lab testing
• Examples of reliable and cost effective thermal packaging

Richard Azaroff, PhD, Senior Packaging Engineer, Genzyme

12:30
Luncheon for Speakers and Symposium Attendees

1:45
What is Realistically Needed to Ensure Patient Safety in Cold Chain Products?

Recently, passive RFID technology has been discussed as a technology to replace 1D barcode for pharmaceutical industry supply chain. This approach may work for pharmaceutical industry. However, there are many there any many unknown issues related to this approach when it comes to the issues related to patient care. We have been developing a cost effective approach of using 2D barcode and active RFID to reduce medication errors beyond what 1D or passive RFID technology may provide. We will discuss some of our development and implementation issues.

• Review of existing barcode enabled point of care systems
• Potential issues with 1D barcode and passive RFID tags
• Advantages of 2D barcode & active RFID
• Implementation strategy

In K. Mun, PhD, VP, Research & Technology, Hospital Corporation of America (HCA)

2:45
15 Minute Refreshment Break

3:00
Interactive Cold Chain Q&A
The symposium concludes with an interactive panel discussion with presenters to address questions and share and exchange ideas.

Claudia Okeke, Scientific Fellow, United States Pharmacopeia

Symposium Concludes