Pharmaceutical facilities have control needs that are both unique and complex. Control-system providers must pay special attention to detail throughout design and installation and conform to quality-assurance requirements that are far more stringent than those they are likely to encounter on other projects. For those who master the requirements, the rewards are many, as drug makers recognize the value a competent controls contractor brings to a project and usually reward such individuals with repeat business.


  1. ISPE. (2001). Commissioning and qualification baseline guide. Tampa, FL: International Society for Pharmaceutical Engineering.

  2. ISPE. (2001). The good automated manufacturing practice (GAMP) guide for validation of automated systems in pharmaceutical manufacture. Tampa, FL: International Society for Pharmaceutical Engineering.

  3. ISPE. (2003). Validation of process control systems. Tampa, FL: International Society for Pharmaceutical Engineering.

The founder and principal of Facility Diagnostics Inc., an engineering-services provider specializing in mission-sensitive ventilation systems and their controls, Ken Kolkebeck has more than 30 years of experience in the controls field. He holds patents for airflow-measuring and fume-hood-control devices and is past chairman of Air Movement and Control Association (AMCA) International Inc.'s Airflow Measurement Station Division and the co-author of ANSI/AMCA Standard 610, Methods of Testing Airflow Measurement Stations for Rating.

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