White Papers for Pharmaceutical and Biopharmaceutical Manufacturing

  • Application of Low-Frequency (LF) Raman Spectroscopy to an Isoenergetic Polymorph StudyBy

    The importance of polymorphism in the pharmaceutical industry is well established. Much literature exists describing the effect of polymorphs on efficacy, the phenomenon of polymorphism, and the analytical tools available to study polymorphism in active pharmaceutical ingredients and drug...
  • Water hammer can and must be eliminatedBy

    Water hammer can be so damaging to machinery and dangerous to human health that every effort should be taken to prevent the hazard. Also known as hydraulic shock, water hammer sounds like a mechani- cal noise and is sometimes perceived to be a valve slamming closed. In reality, it is a...
  • Are Sterile Bioprocess Containers A Source Of Particulate Contamination?By

    We suggest that containers which are not produced to a recognized standard of cleanliness are a potential source of contamination.’ This article discusses why this is a problem for biopharmaceutical and vaccine manufacturers, the nature and source of possible contaminants, and a readily...
  • Making it clear – the water quality standards of NSF/ANSI 61 and 372By

    To make the products safe for water distribution there must be protective barrier material, joining, and sealing materials. These materials will ensure that the water remains free from any contaminates that may be present on or in the metal, paint, gaskets, lubricants, etc. NSF/ANSI has...
  • Aseptic Isolation - The Time is NowBy

    For many companies, especially those that have existing clean room implementations, the opportunity cost and associated risks to integrate an aseptic isolation system were simply too high. But — if we can go out on a limb to say it — the time has come to kill off the clean room.
  • Investing in automated visual inspection and sorting machines: costs, risks and performance evaluatiBy

    This document provides a brief and objective overview on how to choose the optimal inspection equipment by following the steps below: 1. Carefully consider all of the costs, risks and performances, which defne your return on investment. 2. Try before you buy. 3. Select the solution with...
  • Dec Group Offers Customized DPI Manufacturing SolutionsBy

    A dry-powder inhaler (DPI) is a device that delivers medication such as corticosteroids to the lungs through inhalation. DPIs are commonly used to treat respiratory diseases such as asthma and chronic obstructive pulmonary disease. The powdered substances used for this purpose need to have a...
  • Data Logger vs DAQBy

    Key Differences Between Data Logging and Data Acquisition What is the difference between a Data Logger vs DAQ System? A data logger is a type of data acquisition system, but a data acquisition system is not necessarily a datalogger. There are several key functional differences in how the market...
  • The story behind Ocean Optics - How we did it!By

    Ocean Optics went from a 4' x 6' humble beginning to a premier developer and supplier of the "World's First Miniature Spectrometer" Innovative engineering and equally innovative marketing are part of the "How we did it" story.
  • SCALE-UP AND TECHNICAL TRANSFER FOR LYOPHILIZED PRODUCTSBy

    Formulation and process development for injectable products are typically conducted at laboratory-scale. There are few challenges when increasing the scale of production for a solution formulation, but the challenges drastically increase when the formulation is intended for lyophilization. The...
  • Russell Compact Sieve® provides solution to high-capacity containment sievingBy

    Engineering house combines high containment isolator with hygienic and efficient pharmaceutical sieving solution to provide customized unit.
  • Liquid Filling Machine Brings Scalability to Bio Downstream Fill Finish ProcessBy

    Automating a hand filling process to increase capacity, improve accuracy and reliability. A custom configuration of Intellitech's standard modules - the i-FILL® for unmatched precision liquid filling with single-use fluid path and the i-CAP® for servo-driven cap torque.
  • 6 Strategies To Stretch Your Limited Drug Supply For Clinical StudiesBy

    A clinical packaging strategy that can successfully manage the supply of your expensive drug product throughout the duration of clinical testing is critical to the success of sponsor companies. This paper explores six strategies that can be used to maximize a short drug supply for your...
  • Analysis of Two API Products Using the Opt-Diss 410 UV FIber Optics with Multi-Component AnalysisBy

    This white paper explains the theory behind the MCA algorithm methodology. Then, used in tandem with in-situ fiber optics, the accuracy of the technique is demonstrated by recovering the concentration of two APIs in known mixed solutions. Finally, an example is given of accurately monitoring...
  • TECHNOLOGY OVERVIEW AND APPLICATIONS IN THE PHARMACEUTICAL AND BIOTECHNOLOGY INDUSTRYBy

    In this article Dr Richard Johnson, Founding Director of Upperton Ltd, describes some of the basic principles of spray drying and how spray drying is typically being used in the pharmaceutical and biotechnology industry. Particular attention is focussed on four key applications, namely the...
  • Beyond the Basics: The Benefits of an ERP Solution for Small and Mid-Sized Nutraceutical ManufactureBy

    An ERP solution developed for small to mid-sized nutraceutical companies that use batch process manufacturing needs to go beyond the basics of an accounting and Microsoft Excel-based system, or even a one-size-fits-all ERP solution. An industry-specific ERP will provide you with a higher level...
  • The FDA expects organizations to have full visibility and control over their processesBy

    Expectations include: • Understanding products and processes in order to implement Quality by Design (QbD) into product development • Delivery of quality metrics for risk-based inspection schedules as proposed by a new quality metrics program • Shared responsibility for products manufactured...
  • Determining Extractables and Leachables in Polymeric MaterialsBy

    Jordi Labs determines extractables and leachables in polymeric materials.
  • 4 ways for Serialization SuccessBy

    As the Drug Quality and Security Act’s (DQSA’s) Novem- ber 2017 deadline approaches for serializing saleable units of prescription pharmaceuticals, many pharmaceu- tical companies, particularly small to mid-size organiza- tions, are just embarking on the serialization journey. There are four...
  • ‘Winged’ PACKAGE DESIGN RESULTS IN COST SAVINGSBy

    A SINGLE UNIT DOSE NASAL SPRAYER CARTON FOR FLU VACCINE PROVIDES A MORE COMPACT AND LOWER COST ALTERNATIVE TO BLISTER PACKAGING
  • Impact of the Design of Spray Guns on a Pharmaceutical Film Coating ProcessBy

    This study is to evaluate the impact of the design of spray guns on a pharmaceutical film coating process.
  • Why Do I Need a Cleanroom?By

    The electronic, high-tech, semiconductor, pharmaceutical, aero space, medical and many other industries depend on cleanroom technology. As products such as cell phone circuit boards become smaller, the chance of contamination in manufacturing becomes higher. For pharmaceutical companies, clean,...
  • Taking the Mystery Out of Moisture AnalysisBy

    Learn how to get the most accurate results from your moisture analyzer.
  • Taking the Mystery Out of Moisture AnalysisBy

    Learn how to get the most accurate results from your moisture analyzer.
  • Recent Technical Advancements in Blow-Fill-Seal TechnologyBy

    Blow-fill-seal technology, originally developed in Europe in the 1930s and introduced in the US in the 1960s, has emerged as a preferred method for aseptic packaging of pharmaceutical and healthcare products due to unrivalled flexibility in container design, overall product quality, product...