Articles

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...

As of Nov. 1st, 2022, USP 797, “Pharmaceutical Compounding - Sterile Preparations,” was published, and one year later, on Nov. 1st, 2023, compliance with these new regulations was enforced. Upon extensive review of new guidelines, the industry and subject matter experts across regulatory consulting were left with some open questions. Two of the most salient and common areas that colleagues within the 503A compounding pharmacy industry focused on were Beyond-Use Dates (BUDs) and Lot size restrictions. MediZap has been at the forefront of addressing these concerns and has worked to understand further and provide context and recommendations around these areas...

Extractables and leachables (E&L) studies constitute a pivotal element of regulatory submissions aimed at validating product safety. The complexity of E&L investigations varies depending on the container-closure system and drug product under scrutiny. Selecting a Contract Research Organization (CRO) endowed with expertise is imperative for the meticulous generation of reliable E&L data. The ISO certification for contract research labs that conduct microbiology and analytical chemistry testing on pharmaceutical products is ISO/IEC 17025. This standard specifies the general requirements for the competence, impartiality, and consistent operation of laboratories. It applies to all organizations performing laboratory activities, regardless of the number of...

Several emerging methods of terminal sterilization hold promise to become established techniques that adhere to pharmaceutical drug products over time. These technologies encompass X-Rays, ultrasonication, supercritical gases, ultraviolet light, pulsed light, microwaves, infrared radiation, and plasma. This article specifically examines X-Rays. Emerging sterilization technologies must satisfy several criteria to be considered suitable for product sterilization: The technology must achieve a Sterility Assurance Level of 10-6 or higher. Products must withstand the terminal sterilization conditions. Terminal sterilization within the final packaging must be attainable. Chemical residues as by-products of sterilization must not be produced.  Additionally, terminal sterilization technologies must:  Be sufficiently...