Newsletter | July 23, 2020

07.23.20 -- System Risk Structures: A New Framework For Avoiding Disaster

Featured Editorial
Industry Insights
Avoiding Hemolysis Blood Sample Collection Processing

Erythrocytes have significant value in specific types of research. If your objective is biobanking these cells in an intact state, then it is equally important that hemolysis and the need for a redraw is avoided. This paper explains how hemolysis can be prevented during specimen collection and handling.

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.

Global Air Cargo Trends Reshaping Pharmaceutical Transport

As we welcome the new decade and the exciting advances it is expected to unleash, many of the forces that shaped the past decade for transporting pharmaceuticals will continue. Price pressures, alternatives to air freight, and increasing automation are just a few. However, there are emerging trends that make 2020 unique. As we look forward, these are the air cargo trends expected to shape the transport of pharmaceuticals in 2020 and beyond.

Optimize Manufacturing Using Comprehensive Powder Characterization

Understanding the range of powder behavior characteristics through measurement of the most appropriate properties is essential for efficient processing and consistently high-quality finished products.

Are You Prepared For The Complexity Of Pediatric Drug Development?

Pediatric drug development requires a formulation designed to fit the specific needs of that patient population. Not considering these requirements early enough could add significant delays.

Quality Metrics: How To Add Value And Meet The FDA's Expectations

Quality metrics have been widely used in the pharma industry to monitor quality systems and operational processes, and to promote continuous improvement initiatives in drug manufacturing. 

Closed And Semi-Automated Processing Of CAR T Cells

This application note describes the details of a robust CAR T-cell manufacturing workflow that can be adapted for cGMP compliance in commercial production of CAR T cells.

Lovis 2000 M/ME For Low-Volume Applications

This application note demonstrates how the Lovis 2000 M/ME is the perfect solution for precise viscosity measurements requiring only small amounts of sample. Dynamic and kinematic viscosities as well as polymer parameters such as intrinsic viscosity are gained from sample volumes as low as 100 μL.

Quality Stability Testing: Oxygen Monitoring During Shelf Life

A manufacturer of a syringe product received complaints about discolored product that was nearing the end of shelf life. A root cause investigation was started, and product syringes were put on stability. The headspace oxygen levels were monitored over time. The laser-based headspace analysis proved to be a useful tool to check package integrity and for the presence of reactive headspace gases that can degrade the formulation.

Glovebox Design Encloses Milling Processes

A manufacturer required a glovebox that would enclose milling processes done by either a Fitzmill L1A or a Quadro Comil. Read how the design features allowed the operator the access and flexibility that they needed while achieving the containment requirements that were required.

Pharmaceutical Manufacturer Utilizes Checkweighers To Identify Inaccurately Filled Product

In no other industry is the need for product quality and process reliability as critical as in the pharmaceutical industry. Sanofi-Aventis is the global leader in core medical areas, such as diabetes/metabolism, the cardiovascular system, thrombosis, the central nervous system, internal medicine, oncology, and prevention through progressive vaccines. Checkweighers check vital insulin; in the injectables area, where liquid drugs such as different types of insulin or drugs for emergency medicine are produced, the packaged medical compounds are subjected to final checks using a dynamic checkweigher.

The Basics Of Biosafety Cabinets
The role of a biosafety cabinet, while critical, might seem passive. A biosafety cabinet (BSC) does not perform any one direct function, but rather it prevents adverse conditions from occurring.
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