White Papers & eBooks

on 'Aseptic Processing'

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  • Aseptic Processing Trends 2017 eBook

    Modern therapies add emphasis to the industry-wide need to take advantage of new technologies and explore new ways of addressing process control.

    Pharmaceutical Manufacturing
  • Special Report: Addressing Process Contamination Risks

    The high risk involved with biopharmaceuticals means there are high demands placed on the hygienic design of bioprocessing equipment. Instrument connections on equipment -- commonly used to position measurement instruments in the process flow for accurate monitoring -- are a known challenge in preventing process contamination, especially when they aren’t properly installed or maintained.

  • Pharma Packaging Trends 2016 eBook

    Once viewed as a mundane part of the business, primary packaging of pharmaceuticals has morphed into a hotbed of creativity.

  • Pharmaceutical Packaging Trends eBook

    Pharmaceutical packaging plays a critical role in ensuring the efficient distribution and safe consumption of the world’s drug supply.

  • Rotary Tank Cleaning and Cost Savings

    Specific case studies on the benefits of rotary impingement and CIP optimization vs. the standard tank cleaning processes. Benefits include: increased revenue and production with drastic reductions of operating costs pertaining to tank cleaning.

  • Cartridge Filtration in the Production of Pharma Grade Water

    Cartridge filtration can be a reliable, efficient means of producing bulk pharmaceutical grade water. This detailed paper from 3M illustrates its effective use for some of the most critical applications: the removal of particulates that might contaminate water systems, eliminating Pseudomonades and other microorganisms, reducing endotoxins, and protection of storage tanks during draw-down.

  • 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
  • Environmental Monitoring and Certification in Controlled Environments

    Environmental testing and monitoring programs are essential elements in pharmaceutical and medical device manufacturing. Companies must understand industrial sterilization and contamination control procedures to bring products to market on time and on budget. Steven Wieczorek of Microtest Laboratories reviews the key elements of a best-practice environmental testing program, including sterilization standards, FDA requirements, and the critical factors in maintaining controlled environments.

    Microtest Laboratories
  • Where and What to Test: From Purified Bulk Drug Substance to Sterile Liquid Final Drug Product

    This white paper focuses on what many consider the most critical part of a biological drug product’s manufacturing life cycle: going from the purified bulk drug substance (“PBDS”) to the sterile final drug product (“FDP”). Specifically, the white paper discusses establishing the testing “where and when” (and in some instances the “why”) for manufacturing formulation and fill/finish activities and how the approach is also applicable, for the most part, to small molecule drug products formulation and fill/finish.

  • Residual Solvents by HT3 Headspace in Reference to USP 467

    Residual solvents in pharmaceuticals are defined as volatile organic chemicals that are used or produced in the manufacture of drug substances, excipients or in the preparation of drug products. Because residual solvents do not provide therapeutic benefits, they should be removed, to the extent possible. Drug products should contain no higher levels of residual solvents than can be supported by safety data. Looking forward to the implementation of a revised USP 467 method, Teledyne Tekmar evaluated the new protocol, therefore this application will comply with the procedure and criteria changes set forth in the USP30 NF25, Second Supplement (effective December 1, 2007) and the interim revision announcement.

    Teledyne Tekmar
  • Online Reaction Monitoring of Inprocess Manufacturing Samples by UPLC

    Process Analytical Technology (PAT) is a critical component in manufacturing, relied upon to ensure product quality and improve process yields. In this white paper, Waters Corp. discusses the use of novel Waters technology for online reaction monitoring of inprocess manufacturing samples, which allows for simultaneous quantification of APIs and process impurities.

    Waters Corp.
  • Nanoparticles in Pharmaceutical Manufacturing

    The paper explores the rapidly expanding role and significant performance advantages of nanoparticles in pharmaceutical applications. It provides an overview of nanoparticle uses in applications including diagnostic products, product packaging and biomarker discovery, as well as an extensive look at nanoparticle use in drug delivery. The paper also describes the ability to create nanoparticles efficiently and economically with media milling.

    NETZSCH Fine Particle Technology, LLC
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