on 'Unit Operations'

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  • Management of Change: Every Plant for Itself!

    In the absence of FDA guidance, each company or facility must develop its own approaches to change management. Fortunately, OSHA offers a model.

    John Rohrer, JPS and The Interlock Group
  • Cause for Alarm?

    Alarm systems are often the first indication of whether underlying processes are understood and in control. Nuisance alarms must be eliminated and alarms categorized and prioritized so that their connection to product quality is clearly understood.

    Joseph Alford, Ph.D., P.E., CAP, ISA Fellow
  • Improving Control of the Extrusion Spheronization Process

    Extrusion spheronization can be an efficient route to pellet dosage forms, but close control of temperature and speed is critical.

    Rakesh P. Patel, M.M. Patel, J.K. Patel, N.A. Patel and D.M. Patel, Ganpat University, Kherva, Gujarat, India
  • Prioritizing Goals by Applying Options Thinking

    Applying systematic methods can improve results and increase value, whether on the corporate or on the local operational level.

    Brian W. Hagen, Ph.D., Raymond L. Manganelli, Ph.D., and Thomas L. McGurk, Practice Director, Tunnell Consulting
  • How Early Communication with FDA Sped Up One RMM Implementation

    Rapid Microbial Methods (RMMs) offer another tool that can facilitate Lean Manufacturing in biologics and pharmaceutical manufacturing, and taking the industry a few steps closer to parametric product release. Proactive communication with FDA reviewers was instrumental in getting approval for one RMM implementation project at a major pharma company. Rich Boehler discusses how his team at a previous (unnamed) employer went about the implementation.

    Agnes Shanley, Editor in Chief
  • Visualizing the Dynamics of Fluid-Bed Dryers

    A team at the University of Saskatchewan is applying tomography to the study of fluid bed dryers in a bid to make proper operation of the equipment easier and clearer.

  • Controlled Release Moves Beyond Patent Extension

    Prized for benefits that include reduced toxicity, controlled release — and the “manufacturability” issues it raises — is being considered much earlier in drug development process.

    Angelo De Palma, Ph.D., Contributing Editor
  • Rapid Microbiological Methods for a New Generation

    These are exciting times, as 19th-century microbiological methods make way for rapid detection, quantification and characterization technologies.

    Michael J. Miller, Ph.D., Senior Research Fellow, Eli Lilly and Co.
  • Putting WFI to Work in Juncos

    Amgen process engineers share Water-for-Injection expertise from the ever-expanding facilities in Juncos.

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