White Papers

  1. Planning And Executing Cycle Development For The Vapor Hydrogen Peroxide Decontamination Of A Filling Line Isolator
    4/6/2017

    The cycle development approach described in this document is fairly universal and should not be dependant on individual isolator systems. The terminology used may be slightly different depending on the technology, but the general principles, process descriptions, and process and execution steps can still be applied across various isolator systems.

  2. How To Reduce Costly Scale-Up Problems in Solid Dose Manufacturing
    4/4/2017

    When scaling a new drug formulation from the development side of R&D into manufacturing, there is often a reality check with respect to process scaleup and performance of the formulation at production levels. Problems with capping/lamination and sticking/ picking are often first realized when a formulation is introduced to a level of compression required to supply market demand.

  3. Validation, Verification And Monitoring For Product Inspection Equipment
    3/16/2017

    This white paper gives guidance on the essential processes of validation, verification, and routine performance monitoring for in-line product inspection equipment in food making facilities.

  4. Integrate Pharmaceutical Development For Commercialization Of Novel Therapeutics
    3/13/2017

    Cost reduction initiatives in R&D organizations frequently focus on the potential benefits of process improvements such as enhanced monitoring and improved QC of raw materials but often overlook the impact of better data management. Those that do typically focus on achieving efficiency gains by transitioning from paper to electronic systems but while such a transition has been demonstrated to save time3, efficiency gains are only beneficial if any time saved is used productively.

  5. How Broadening The Analysis Of Compound Factors Allows For Predictive Solubility Solutions
    3/2/2017

    The Biopharmaceutics Classification System (BCS), developed by the U.S. Food and Drug Administration to simplify and accelerate the drug development process. The system has evolved to classify low-soluble drugs according to their permeability (BCS Class II or IV). A compound’s classification (I through IV) is indicative of its potential bioavailability.

  6. Security Of Pharmaceuticals: A Comparison Of EU And US Standards
    2/27/2017

    With 840 million inhabitants, and two-thirds of global pharmaceutical sales, the US and Europe are also a lucrative target for drug crime. New sales channels such as the internet as well as global and more complex manufacturing and distribution channels make it increasingly easier for pharmaceutical counterfeiters to market counterfeits directly or to infiltrate the supply chain.

  7. Optimize Your Critical Cleaning Process And Ensure Results
    2/2/2017

    Getting the best results from any cleaner requires proper mixing and cleaning procedures. This article includes mixing directions for aqueous cleaning detergent and methods for monitoring performance.

  8. Cleaning Validation For Medical Device Manufacturing
    2/2/2017

    Cleaning validation or verification is a necessary regulatory compliance step in medical device manufacturing and reprocessing. Support from the cleaner manufacturer can save time and money.

  9. Pharma Manufacturers Should Get Cleaning Validation Support From Supplier
    2/2/2017

    Cleaning validation is a necessary and time-consuming part of manufacturing pharmaceuticals. The validation process can be expedited and cost reduced if the cleaner supplier can provide support.

  10. Streamlining Change Control In Today’s Complex Life Sciences Organizations
    1/11/2017

    Change control is collaborative, iterative and labor-intensive. For any specific change event, multiple users are required to follow a prescribed set of tasks and processes, which need to be carried out in a defined sequence and are subject to multiple stages of review and approval. It’s very easy to lose track of where you are in the process, what actions need to be completed next, who owns them, and when they are due. Yet the consequences of such lapses can be very costly. This paper examines why it is absolutely vital for organizations to take a comprehensive, closed-loop approach to automating change management, spanning all areas of the organization and extending throughout the product lifecycle.