MNL20-2ND

    Chapter 80-Pharmaceutical

    Published: Jan 2005

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    Abstract

    IN THE PHARMACEUTICAL INDUSTRY, a number of business factors exist that tend to discourage a consistent approach to technical issues such as corrosion testing. Some of the major issues are as follows: 1. In many processes the volumes are small and very expensive, creating an economic justification for testing of all processes that is difficult to support. This leads to equipment that is flexible and can handle varied process conditions and chemistries. 2. Being first on the market with a pharmaceutical product is of major business importance. Because speed is a major issue, many technical issues (i.e., corrosion) are frequently “over engineered” from the standpoint of good engineering practices. This allows flexible equipment to be capable of handling varied conditions and chemistries to support rapid product development. This then limits the need for corrosion testing of all processes. 3. Many reactions are multi-step syntheses, frequently requiring varied chemicals and reaction conditions. Many of the reaction components are proprietary and uncommon to traditional corrosion engineering data sources. Attempting to simulate these varied uncommon chemicals and chemical environments is difficult at best. 4. In many cases the chemistry of the process is still being modified well into development, and some even into production. Successful corrosion control depends on teamwork in which all parties of the project team are aware of process changes being considered and can develop a materials compatibility strategy accordingly. 5. The percentage of products that survive from discovery to production is very small. The time from product decision to production is very small. This also drives the need for flexible equipment, and limits the ability to corrosion testing for a specific process.


    Author Information:

    Dean, SW

    Jensen, DF
    Engineering Consultant, Eli Lilly and Company, Tippecanoe Labs, TL27, Lafayette, IN


    Paper ID: MNL11086M

    Committee/Subcommittee: G01.11

    DOI: 10.1520/MNL11086M


    CrossRef ASTM International is a member of CrossRef.

    ISBN10: 0-8031-2098-2
    ISBN13: 978-0-8031-2098-3