STP1260: Commissioning Major Pharmaceutical Manufacturing Facilities

    Fay, ST
    Senior Engineer, Performance Solutions, Inc., Indianapolis, IN

    Howard, TP
    Senior Engineer, Performance Solutions, Inc., Durham, NC

    Stevens, WT
    President, Performance Solutions, Inc., Prospect, KY

    Pages: 11    Published: Jan 1996


    Abstract

    Commissioning is the planning, coordination, management, and execution of activities that form the bridge between the construction phase and the operation and maintenance phase of a facility life-cycle. Commissioning helps demonstrate the facility works properly and establishes systems for reliable operations and maintenance. Validation is a major part of the overall commissioning process. Substantial savings are possible in terms of costs and schedule through more effective coordination of commissioning activities. Benefits of a coordinated approach include: • Increased confidence that facility meets intended requirements (e.g., GMP, safety, environment, production capacity,) • Eliminating waste through duplication • Providing for consistent and efficient commissioning • Quicker achievement of successful initial operations

    Keywords:

    Validation, commissioning, scheduling, startup, testing, planning


    Paper ID: STP14705S

    Committee/Subcommittee: E48.03

    DOI: 10.1520/STP14705S


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