Articles

In the radiation terminal sterilization sector, three primary methods are employed: E-Beam, X-Ray, and Gamma. . Ionizing radiation is the second most prevalent method in the industrial sterilization market, accounting for nearly 45%. While E-Beam and Gamma have been the traditional choices, X-Ray is a more recent addition. Similarities All three technologies ensure sterility and adhere to the ISO 11137 standard. The same dosimetry system can be utilized, and practically, 25 kGy delivered by an Electron Beam accelerator or an X-Ray machine is equivalent to 25 kGy delivered by Gamma radiation. Differences  E-Beam Radiation: This method involves machine-generated high-energy electrons....

  The pharmaceutical landscape is evolving rapidly, driven by the increasing use of complex compounded and manufactured drugs. Biologics, biosimilars, gene therapies, and mRNA vaccines are at the forefront, presenting both opportunities and challenges for pharmaceutical companies. 1. Primary Packaging Performance and Fill-and-Finish Operations: Under the Spotlight The performance of primary packaging and the effectiveness of fill-and-finish operations are critical. These processes directly impact drug safety, efficacy, and overall quality. Managing high-value, small-batch drug products require a flexible production strategy. Variables affecting the manufacturing process—such as vial breakage and particle contamination—must be carefully considered. Vial breakage leads to product wastage...

The medical and pharmacological industries utilize parenteral drug preparations to aid millions of individuals annually in achieving better health and improved quality of life. Parenteral drug preparations encompass solutions, suspensions, emulsions for injection or infusion, powders for injection or infusion, as well as gels for injection. Regardless of the form these preparations take, they are inherently sterile. Given their direct administration into patients’ bloodstreams, it is imperative that these preparations are meticulously protected to safeguard patients’ lives.   Enter the intravenous (IV) bag, a ubiquitous drug delivery format employed daily to deliver parenteral solutions for a myriad of patient healthcare...

The partnership integrates sterile compounding testing into MediZap's Four Pillar Service to meet the ever-tightening USP <797>, and cGMP guidelines for sterile compounding assurance. SAN DIEGO, CA - MediZap, North America’s leading turn-key service provider of E-Beam | X-Ray terminal sterilization for compounded pharmaceuticals announces an exciting partnership with Eagle Analytical to offer sterile compounding testing services: including ISO microbiology sterilization validations, analytical chemistry, and environmental monitoring. The partnership adds another layer of value to the MediZap Program by expanding its services to include USP <797>, USP <800>, and cGMP FDA compliance expertise and testing solutions for compounded pharmaceuticals. Eagle...