Articles

MediZap proudly announces new exclusive partnership as contract terminal sterilizer by E-Beam | X-Ray irradiation with Complete Group Services | Newsletter | Issue 12 | 2023

MediZap proudly announces new exclusive partnership as contract terminal sterilizer by E-Beam | X-Ray irradiation with Complete Group Services | Newsletter | Issue 12 | 2023

Complete Group Services (CGS) is the pioneering GSO that is exclusively designed to cater to the needs of the compounding and manufacturing industry. A Group Service Organization (GSO) is dedicated to providing tailored support and services to a specific market, such as Compounding. The primary focus of a GSO is to leverage its relationships with leading vendors in the market to assist its members in expanding their businesses and enhancing profitability. CGS offers its members the following benefits: Consolidated Point of Contact: CGS simplifies the process of obtaining quality FDP CofA reports by centralizing multiple points of contact into one....

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Testing Container Closure Integrity in Compounded Parenteral Drug Products | Newsletter | Issue 12 | 2023

Testing Container Closure Integrity in Compounded Parenteral Drug Products | Newsletter | Issue 12 | 2023

Container Closure Integrity (CCI) is a critical aspect that requires assessment during the drug product development phase. CCI refers to the package's capacity to prevent product loss, the entry of microorganisms, and the infiltration of harmful gases or substances throughout its shelf life, ensuring compliance with safety and quality standards. This term is interchangeable with package integrity. Failures in CCI for packaging and delivery systems include leakage, product loss, elevated product concentration, contamination, sterility failure, critical headspace loss, over-pressurization, or pressure loss. The United States Pharmacopeia (USP) also dedicates a chapter to address CCI. USP <1207> Package Integrity Evaluation –...

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Start at the End: Success with Secondary Packaging of Compounded Drugs | Newsletter | Issue 12 | 2023

Start at the End: Success with Secondary Packaging of Compounded Drugs | Newsletter | Issue 12 | 2023

When compounders introduce a new sterile drug product, they often fail to consider vital aspects such as primary and secondary packaging, leading to complications in drug product sterilization processability, presentation, cost, and time-to-market. To address this challenge, it is crucial to establish a robust and transparent primary and secondary packaging strategy early in the product development process. The following five success factors are essential for this endeavor: Begin with primary packaging: Decisions regarding primary packaging significantly impact the requirements for secondary packaging. Therefore, a secondary packaging strategy is best when deciding on primary packaging. For instance, if your product is...

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The X-Ray Factor: The Advantages of X-Ray Terminal Sterilization on Sterile Drug Products | Newsletter | Issue 12 | 2023

The X-Ray Factor: The Advantages of X-Ray Terminal Sterilization on Sterile Drug Products | Newsletter | Issue 12 | 2023

Using ionizing radiation for sterile compounded drug irradiation includes Gamma, X-Rays, and electron beams (E-Beams). Gamma-Rays and X-Rays were discovered in the 1890s, and subsequent research has shown that these types of irradiations can effectively kill bacteria. While X-Ray technology has been available for several years, the first commercial facility designed explicitly for sterilization was not opened until 2010. More and more X-Ray irradiators are being installed to sterilize healthcare products. X-Ray sterilization combines the best features of E-Beam and Gamma techniques, offering speedy turnaround times, good processing flexibility, pallet setup processing, and relatively low dose ratios. The international recognition...

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