White Papers & eBooks

on 'Unit Operations'

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  • eBook: State of Pharmaceutical Manufacturing 2015

    If behavior often speaks volumes, then the pharmaceutical industry is saying a lot lately in the way that it is responding to the social and economic forces that affect its markets and the potential commercial success of the drugs they develop and deliver around the world.

  • eBook: Pharmaceutical Equipment & Manufacturing Trends

    The pharmaceutical manufacturing landscape has changed notably over the past decade and is continuing to evolve rapidly. Pharmaceutical manufacturers have begun to wield some new tools, nailing down new efficiencies and better drugs in the process.

  • eBook: Advancing Solid Dose Manufacturing

    Pharmaceutical manufacturers are looking to advance the efficiency and quality of manufacturing solid dose products that are often increasingly complex.

  • Biopharmaceutical Process Scale Up: Get It Right

    Scaling up any biopharmaceutical process requires a clear understanding of both "real world" and laboratory conditions. Success ultimately depends on close process monitoring, and sensitive and accurate sensors.

    Hamilton Company
  • Examining the Role of TOC Analyzers in the Pharmaceutical Laboratory

    Total Organic Carbon (TOC) analyzers serve a vital role in the pharmaceutical lab, in both the drug development and manufacturing processes. Presented here is an overview, as well as application examples showcasing TOC for Cleaning Validation and to address such guidelines as USP .

    Shimadzu Scientific Instruments
  • The Safest Way to Calibrate: An Introduction to Intrinsically Safe Calibration

    Intrinsically safe calibrators are not only the safest possible calibration equipment—used even for Zone 0 environments—but also provide the functionality and performance of regular industrial calibration devices. This paper provides a primer on the meaning and benefits of intrinsically safe calibration, as well as details on Beamex multifunction calibrators.

  • Turning Data Into Information: Making Sense of an Avalanche of Supply Chain and Production Data

    Biomanufacturing and operations research experts describe how to deal with staggering volumes of production and supply chain data. Learn how to convert this data into actionable information, which will be of value to the whole organization. Read about consolidating data from disparate sources, paramaterizing and visualizing data, building models for analysis and better decision making and a "complete systems" based approach to data consolidation, visualization and analysis.

  • Zeta Plus Activated Carbon Cartridges Evaluation & Scale-Up for Pharmaceutical Applications

    This Technical Brief describes how the Zeta Plus Activated Carbon Cartridge series is evaluated for use in pharmaceutical applications and how the optimal carbon type and media grade are chosen for a given application. In addition, the brief describes how a process is scaled-up in order to determine the requisite Zeta Plus Activated Carbon filter area for manufacturing and production of an active pharmaceutical ingredient.

    3M Purification Inc.
  • Increasing Tablet Press Productivity Using Segmented Turret Technology

    Surveys of tablet press users reveal that machines with segmented turrets increase output and reduce set-up and cleaning time over conventional presses and previous turret technologies. This paper will discuss survey data from drug manufacturers using the technology and quantify some of the benefits over conventional press technologies.

    Fette America
  • Complying With U.S. FDA Title 21 CFR Part 11 for the Life Sciences Industry

    The purpose of this document is to describe the functions and features of SAP ERP that demonstrate technical compliance with U.S. FDA 21 CFR Part 11 Electronic Records; Electronic Signatures Final Rule and several international good manufacturing practice (GMP) guidelines having similar requirements. This document provides background information about the regulation, discusses how SAP ERP complies with this rule, and provides examples of electronic records and signatures within SAP ERP.

  • Reduce Contamination Risk with Advanced Local User Notification Indicators for Remote Particle Counters

    During continuous particle monitoring of a cleanroom environment, a meaningful user notification system near the point of sampling is an important factor in successful intervention and root cause analysis of particle events. Though many remote optical air particle counter suppliers feature a built-in LED indicator in their particle counters, MET ONE 6000 and 7000 series remote particle counters by Hach Ultra provide the most comprehensive set of user notifications through a built-in multi-color LED.

    Hach Ultra
  • Single, Straight-Tube Coriolis Sensors: Installation Best Practices for Cleavability and Drainability

    Biopharmaceutical manufacturing is performed in a highly sterile environment. Bioreactions take place over an extended period of time. For example, it can take 6-8 weeks to complete a single bioreactor batch. Given the time that is committed to manufacturing biopharmaceuticals and their market value, eliminating chemical and biological contamination sources is a top priority for biopharmaceutical manufacturers.

    Micro Motion, a division of Emerson Process Management
  • AstraZeneca Decided for Paperless Solution

    AstraZeneca opted for a paperless solution that would allow for data trending and a centralized, accessible calibration data base. It is cost effective.

    Anders Anlind
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