• The Keys To Superior Containment In Compounding Applications

    This paper reviews why very bad things happen when either quantity or purity of Highly Potent Active Pharmaceuticals is not properly maintained during the compounding process. 

  • Overcoming Encapsulation Issues Caused By Sticky Formulations

    This guide provides a best-practices approach to troubleshooting capsule-filling problems when handling a sticky product formulation.

  • Developing A Scalable Process For Adenovirus Manufacturing

    To address the growing need for speed and efficiency in viral vector manufacturing, GE developed a process for adenovirus manufacturing that not only meets regulatory requirements but is also scalable.

  • Considerations When Cleaning Your Tablet Presses & Tablet Tooling

    Implementing a cleaning procedure is essential to maintaining your tablet tooling and presses. Dirty tools cause tableting and product quality-related problems, such as sticking & picking. Keeping tools clean also decreases premature tool, turret and cam wear, and reduces the risk of product cross-contamination. While most cleaning methods can achieve similar results, utilizing an automated cleaning system, such as an ultrasonic wash with rinse and dryer, can ensure tooling is properly cleaned and dried consistently with limited handling and potential for damage. A warm air-drying process is ideal for preventing moisture and corrosion by pushing warm air through areas, such as key slots, punch cups, and die bores, that may not be dried properly with a traditional towel or cloth.

  • Water Activity Determination Of Oral Solid Dosage Products Using Frequency Modulation Spectroscopy

    Controlling water content in oral solid dosage (OSD) products, and dry pharmaceutical products in general, is essential to maintaining efficacy and safety. Measuring the water activity at multiple time points during the product life-cycle will correlate to changes in critical quality attributes such as degradation of the active ingredient, changes in the dissolution or disintegration rate, and changes in physical properties such as hardness or friability.




Process validation is one of the most commonly cited 483 Inspectional Observations issued by the FDA. This ebook is a compilation of various statistically based techniques to help determine risk-based sample sizes to support process validation activities.

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