Articles

With the advent of terminal sterilization by X-Ray irradiation, compounding pharmacists are being presented an option for IV Bags that solves for the deficiencies provided in the use of terminal sterilization via autoclave. X-Ray terminal sterilization is important for the security of patients and does not grant an inconsequential mistake. Sterility is the absolute criterion of an injectable product. Pathogenic components are counteracted predominantly through direct exposure to warmth. Let’s review the perils of Autoclaving. The lack of proficiency of polymers that devise the bags or ports can cause rupture, or deformed bags, damage to the twist-off, or produce a...

In 2013, the Drug High Quality and Security Act (DQSA) was enacted as retort to instances of infections like the contamination of steroid injections produced by New England Compounding Facility in Framingham, Massachusetts, which included 64 fatalities and more than 700 injuries. The DQSA has enhanced monitoring and traceability of manufacturing and disbursement of compounded drugs along with supply chain logistics and increased the overall quality of compounding procedures with the Compounding Quality Act (CQA). The CQA offers the FDA more oversight authority over compounding drug facilities, specifically establishing the 503B classification of the Federal Food, Drug, and Cosmetics Act...

It is estimated that the pharmaceutical product packaging market will experience a growth rate at a compounded annual rate of 6.1% throughout the forecast period of 2020-2027. This growth comes with technological demands and market needs that are driving enhancements for development. There are 9 megatrends that define and affect the pharmaceutical product packaging market. These data vectors are the increase in chronic conditions and an aging populace, fast development in generics, improved medical care provisions, growing metropolitan populations as well as middle class, rising healthcare costs, stricter regulatory requirements, more biosimilars and biologics, self-medication, in addition to personalized medication,...

The science of sterilization has come a long way in the last century, with multiple evolved methods still in use today. However, electron beam (E-Beam) processing has emerged as one of the most efficient and effective methods. Here, we take a closer look at the technology behind this sterilization method. Using a high-energy electron beam accelerator (also known as a linear accelerator or linac for short), the velocity of ions or subatomic particles is increased by using a sequence of oscillating electric field potentials along a linear beamline. In doing so, electron emission takes place, when electrons are accelerated via a high voltage emitter, and then...