Latest Articles

  • How Much Sterility Assurance is Enough? The Regulatory Quandary of Aseptic Processing

    How is it possible that multiple generations of aseptic manufacturing are simultaneously cGMP? The simple answer is they cannot be. For any technology there is at any point in time where a pinnacle of performance can be identified by looking at the data. read more

  • Packaging Is Tough

    The lesson here isn’t that packaging is bad. It’s that packaging is where all the science, formulation work, and quality control finally meets a real person standing in a real kitchen. If the patient can’t get the product out in one piece, all of that great work ends up in crumbs on the counter. read more

  • Aligning Environmental Monitoring Expectations with Scientific Realities

    Considering the advances in aseptic processing and their effectiveness in eliminating the primary sources of contamination (i.e., human activity), it is not our intent to entirely disparage the value of monitoring. Environmental monitoring has some value in trend analysis within an overall contamination control strategy. However, it is not a control mechanism. read more

  • Beyond the Plate: Where Biofluorescent Particle Counting Can Reduce Errors and Strengthen Contamination Control

    The goal is not to eliminate plates. It is to reduce the number of reasons to open or intervene in the isolator. By supplementing traditional environmental monitoring with real-time BFPC, manufacturers can preserve the value of growth-based methods while reducing avoidable interventions—and, consequently, the number of investigations triggered by the monitoring process itself. read more

  • Featured Documentary: A Solid Dosage Future

    While biopharmaceuticals continue to grab much of the limelight in the pharmaceutical industry, the fact is solid dosage products (tablets, capsules, pills, etc.) still account for the majority of medicinal products made worldwide. The reasons for this market share are abundantly clear: patients are familiar with the dosage form and are comfortable using it. In addition, the industry has many decades of experience designing, formulating, testing, manufacturing and packaging solid dosage products. The knowledge base is extensive. read more

  • Watch Video: The Clean Facility of the Future - Advanced Microbiology Techniques for Cleaner Facilities and Purer Products

    Learn about the tools, techniques, services and best practices being used to manufacture high quality products while minimizing contamination and error in the Clean Facility of the Future Documentary. read more
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