Pre-Conference Workshop Day                  

Verification of Containment Performance

With APIs becoming more and more potent, the importance of proper functioning containment equipment is more significant now than ever before. This workshop will discuss the proper design for a study to evaluate the performance of these devices. It will examine differences between factory and site acceptance testing, the selection of a surrogate dust to use during the study, proper selection of air and surface sampling sites, and how to evaluate the results to determine whether the containment device meets the design specifications. The attendee will leave the course with a better understanding of the importance of each of the above-mentioned aspects of the containment verification process.

Bob Sussman, Managing Director, SafeBridge Consultants

Workshop B: 

Isolator Design for Operator Safety & Filing for Proper URS

Isolator protection scope is wider than just during direct API processing in it - environmental monitoring. Together, we shall develop a generic containment strategy which can be applied to every isolator. In order to fulfill this strategy requirements, the isolator’s design and engineering must be adapted. This strategy can be applied for any isolation purpose and should be required in any isolator’s URS. Following this we shall drill in URS development: Its chapters, Who should write it? What should be written? How to increase project successful certainty? Isolators manufacturers, or plants engineers are experts in metal, plastic and machinery processing/handling however do not recognize your process. They need detailed input about customer’s process requirement.

In this interactive workshop, we will discuss:

  • What are the requirements? Whose function is to define it? How shall we know that nothing is forgotten? URS, MOCKUP

Yossi Shapira, Assoc Director, MS&T S.M.E, Teva

Workshop C: 

Managing Variability in OEL & How to Calculate OEL

You have one API and two different OELs from experts. Why is that? What should you do? Do you really need an expert OEL?

The goal of this workshop is to help you discover the answers to these and other OEL questions such as:

What do I do when one toxicologist says my API is potent, and the other says it isn’t? What does “potent” really mean? What’s contained in that black box toxicologists use to determine OELs? Can I derive one myself? What OELs should I use for molecules that have no toxicological data?

With easy-to-understand language (assuming you know basic organic chemistry), we will collaboratively explain, demonstrate (in real-time on a computer using open-source apps), practice, and evaluate a process used to derive OELs and identify special hazards. By the end of this workshop, you will understand why OELs can vary, you will have your own OEL examples, and you will have a decision matrix so you can decide if you really need an expert at all.

Mark Maier, Managing Partner, BioRisk Sciences