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Limitations of Control Banding
 

Limitations of Control Banding

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Limitations of control banding in the pharmaceutical industry. Presented by Dean M. Calhoun, CIH, President and CEO of Affygility Solutions, LLC.

Limitations of control banding in the pharmaceutical industry. Presented by Dean M. Calhoun, CIH, President and CEO of Affygility Solutions, LLC.

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    Limitations of Control Banding Limitations of Control Banding Presentation Transcript

    • Four Limitations of Control Banding. By Dean M. Calhoun, CIH President and CEO Affygility Solutions, LLC Affygility Solutions ■ 303-884-3028
    • 1970’s What is control banding? Copyright 2009 Affygility Solutions
      • “ Control banding is a process of assigning a compound to a hazard category that corresponds to a range of airborne concentrations – and the engineering controls, administrative controls, and personal protective equipment – needed to ensure safety handling.“
      • Naumann, B.D., Ph.D., DABT
      • Merck and Co., Inc.
      • Control Banding in the Pharmaceutical Industry
      Copyright 2009 Affygility Solutions
    • Limitations Copyright 2009 Affygility Solutions
    • Placement into a band is based on a whole picture approach NOT just the OEL Copyright 2009 Affygility Solutions
      • Companies often make the mistake of just determining a numerical OEL and placing the compound into the band based solely on the number. There are at least 16 factors involved in placing compounds into a control band, with the numerical OEL only being one of them.
      Copyright 2009 Affygility Solutions
    • Control banding is NOT a replacement for sound professional judgment and experience. Copyright 2009 Affygility Solutions
      • Knowing what you can reliably control and handle based on professional judgment and site-specific experience is invaluable. Remember that poor work practices and administrative controls can invalidate even the most sophisticated engineering control.
      Copyright 2009 Affygility Solutions
    • Control banding is NOT a replacement for industrial hygiene monitoring. Copyright 2009 Affygility Solutions
      • Engineering controls and administrative practices still need to be validated. Industrial hygiene monitoring is necessary to ensure that the controls and practices are working as designed. Improper installation or maintenance, or poor work practices can be identified through I.H. monitoring.
      Copyright 2009 Affygility Solutions
    • Control banding is ultimately about what you CAN control and contain. Copyright 2009 Affygility Solutions
      • You can come up with ridiculously low OELs and as many bands as you like, but it’s ultimately about what you can control. If you can’t control it, you’re wasting time, money, and putting people at risk.
      Copyright 2009 Affygility Solutions
    • For more information Dean M. Calhoun, CIH Affygility Solutions, LLC http://affygility.com 303-664-0545 Copyright 2009 Affygility Solutions