9/24/20 Leaderboard Pharma

White Papers for Pharmaceutical and Biopharmaceutical Manufacturing

  • Contained Tablet Coating Success Story By

    A customer contacted Freund-Vector asking for a requirement to coat tablets on a LDCS-Pro Hi Coater (150L batches) and needed contained loading, sampling and unloading of their tablets.
  • How to Achieve Data Integrity in the Laboratory By

    Lack of data integrity is the main reason for most FDA warning letters. For laboratories that must comply with GLP, GMP and GAMP regulations it is important to have records or documented evidence of all relevant analyses that can be checked by a second person and are also readily available...
  • Check valve sizing is more important than you think - Proper sizing can avoid costly problems By

    It is surprisingly common for check valve sizing to be an afterthought in the flow control/fluid process industries. Often marketed together with gate and globe valves, check valves are such a small part of the gate, globe, and check valve market that many engineers in the field don’t even think...
  • Application of Low-Frequency (LF) Raman Spectroscopy to an Isoenergetic Polymorph Study By

    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...
  • 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 372 By

    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 Now By

    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 evaluati By

    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 Solutions By

    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 DAQ By

    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 PRODUCTS By

    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 sieving By

    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 Process By

    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 Studies By

    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 Analysis By

    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 INDUSTRY By

    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 Manufacture By

    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 processes By

    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...
  • 4 ways for Serialization Success By

    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 SAVINGS By

    A SINGLE UNIT DOSE NASAL SPRAYER CARTON FOR FLU VACCINE PROVIDES A MORE COMPACT AND LOWER COST ALTERNATIVE TO BLISTER PACKAGING
  • 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 Analysis By

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

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

    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...