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Pre-filled syringes present considerable benefits compared to traditional parenteral sterile drug delivery systems, notably in terms of precision and swift administration of pharmaceutical compounds and their active pharmaceutical ingredients. Compounded/manufactured under controlled conditions, these syringes undergo rigorous testing to ascertain the safety of all materials, processes, and personnel involved. Moreover, the manufacturing phase incorporates exacting sterilization methodologies to curtail contamination risks. This article aims to shed light on the growing demand for pre-filled syringes, delineate their intrinsic benefits, and provide insight into the advanced fill-finish production processes essential for compounded drug syringe filling. Current analyses by Global Market Insights anticipate...

The utilization of ionizing radiation (E-Beam, X-Ray) is the preeminent modality for the terminal sterilization and bioburden elimination of sterile drug compounding within the last decade. This article delineates the distinctions between a validated sterility process and finished drug compound sterility claim.  FDA, ISO, USP, and cGMP regulatory standards dictate the sterilization process validation for compounded pharmaceutical products. Such sterility claims demand a Sterility Assurance Level (SAL) of 10-6 or better, signifying a less than one in one million chances of a non-sterile drug product. Compounders/manufacturers claiming sterility typically combine multiple operational controls to maintain a sterile barrier and drug...

There is a growing emphasis on quality control in healthcare institutions, especially among those that outsource to 503A compounding pharmacies and 503B outsourcing facilities. To safeguard patient health, it is crucial to collaborate with suppliers dedicated to ensuring quality standards. One of the foremost strategies to mitigate drug contamination is incorporating semi-automated or automated equipment, technologies, and robotics. Such advancements can effectively decrease human-induced errors, enhance productivity, and streamline operations. Given these compounding pharmacies' quality assurance challenges, such technological interventions could facilitate regulatory trust and establish confidence among affiliated hospitals and clinics. Recently, the U.S. Food and Drug Administration (FDA)...

This partnership brings on MediZap as the only contract terminal sterilizer by E-Beam | X-Ray built for pharmacy. RXinsider is the leading resource for pharmacy management to learn about the products and services that support pharmacies and patient care. Featured products and services include: View our one-page MediZap ad featured in 20Ways Health Systems Winter Edition 2023 https://publuu.com/flip-book/37174/707212/page/1 Subscribe to RXinsider to stay up-to-date with pharmacy news, product/service announcements, trends, and more at https://get.rxinsider.com/subscribe Download PDF