Pollution Prevention, Management,

1 Pages 261 Words

This presentation focuses on evaluation and implementation of pollution prevention during the process development phase for a new drug. Pollution prevention initiatives are best incorporated during the process development phase, in which a process is scaled form the laboratory to the pilot plant. Evaluation of pollution prevention initiatives is iterative, and part of the process evolution. Many process changes driven primarily by yield or productivity gains can also lead to reduced potential pollution (although such changers are not "pollution prevention initiatives", per se), which provides added incentive to successfully implement these process changes.

For any drug process, pollution prevention initiatives should be evaluated during each development phase, and, if appropriate, incorporated into the process. The first phase involves analysis of the Biological and chemical pathways to the final drug. The original, demonstrated process and any alternative undemonstrated processes must be examined. The second phase involved many months of laboratory and pilot development of the processes. During this time, a number of process changes are typically made, most of which may improve the environmental profile of the process. These changes can result in a significantly decreased prospective waste solvent load.

Finally, a computer-aided process simulation, used to generate overall process material balances is an invaluable tool in these efforts. As a case study, we will look at Eli Lilly, which is currently building an insulin manufacturing facility in Prince William County, Virginia. We will look at the corporate environmental policy of the company and the impact of this policy as it may be applied to the design and construction of the facility....