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Containment of Potent Compounds - The New Paradigm

Developing a containment strategy has become a moving target as the exposure limits for new drug compounds become increasingly low. Exposure limits of 10 micrograms were the exception five years ago, but today it is not uncommon for new drug compounds to have exposure limits in the low nanogram range. 'Exposure limit' is a term used to describe the quantity of drug a healthy individual can absorb without suffering a physical or mental effect. Exposure limits are set by the pharmaceutical manufacturing companies based on the information gathered during the development of the compound.

The exposure limit is based on both laboratory data and feedback gathered during clinical trials. The goal is to determine a 'no effect' level, or the maximum amount of the drug a person can be exposed to without seeing a measurable effect. Once a 'no effect' level is determined, a safety factor is selected based on the impact of exposure to the drug.

Most pharmaceutical companies use three categories in selecting safety factors. The three levels are: low impact, defined as not having a long-term effect and easily corrected; serious but not life threatening; and finally an effect which is either irreversible or life threatening. Typically, the quantity of drug creating the 'no effect' level will receive a safety factor of 10 times for low impact, 100 times for serious impact and 1,000 times for non-reversible or life threatening impacts.


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By Henry Rahe, Director of Technology at Containment Technologies Group, Inc. Henry Rahe is the Director of Technology at Containment Technologies Group, Inc. Henry has over 30 years' experience in the pharmaceutical industry as well as four years in academia. He has experience in both management and technical assignments, including facilities support of all phases of pharmaceutical operation, from discovery to final packaging. He also has an excellent working knowledge of current Good Manufacturing Practices (cGMP).
Henry gained a BSIM and an MSE from Purdue University, US. He previously worked for Eli Lilly and Company and has worked for extended periods in Puerto Rico, England, France, Germany and Italy. Henry is a recognised expert in the area of containment of potent compounds and advanced aseptic processing. He has extensive experience in the application of barrier/isolation technology in all facets of pharmaceutical operations.

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