Articles

Given recent pressures on the manufacturing supply chain relative to the capacity for terminal sterilization of healthcare products, the challenges facing the sterility assurance community have never been greater. To combat these challenges, new tools and processes are being developed to address these challenges so that new innovations and strategies can be built. Challenges Of Sterility Assurance Sterility is key across many healthcare sectors, including pharmaceuticals, biopharmaceuticals, sterile barrier packaging, and much more. Sterility mechanisms are put in place to control contamination through aseptic processing, terminal sterilization, cleaning, disinfection, and reprocessing. Regulations exist for each sector, and strategies determining quality...

Surprisingly, one of the most significant challenges facing the pharmaceutical industry is getting drugs to patients in the proper packaging. The industry is working every day to innovate in a variety of means, but one that is often overlooked is the packaging. Innovation in packaging is consistently lagging behind innovations being made to eradicate disease and ensure sterile compounds are getting to the public. As new trends begin to shape the pharmaceutical industry's future, it is critical to be prepared and innovative. Eliminating Glass Dependency The COVID-19 pandemic brought out critical innovation needed from drug manufacturers. While the vaccine was...

Ensuring products are contaminant-free is necessary for patient safety and drug efficacy, as contamination causes adverse effects on patient health and outcomes. Additionally, contamination can alter the pharmacology of drugs, with negative effects on efficacy due to the decomposition of ingredients, as well as safety issues due to toxicity. Eliminating Bioburden Through Sterilization For many sterile drugs, microbes are eliminated through a terminal sterilization process, including either heat or radiation. Ensuring the absence of contaminants such as bacteria or fungus requires validation by sterility testing for sterile drugs, and manufacturing process controls are used to ensure consistency. Terminally sterilized drugs...

USP 797 published new proposed guidelines for comment. Many of the new standards change/affect the compounding industry. Medizap / SteriTek have read the USP 797 guidelines to develop a position. The goal is to share this position with you. By being thought leaders, we hope to influence USP 797 guidelines while also building the advocacy and trust of the APC, compounding industry, and all stakeholders affected and defined by this Pharmacopeia regulatory body. Medizap / SteriTek is uniquely positioned to bring a scientific perspective to the newly proposed guidelines and ensure understanding and use of ISO guidelines for all irradiation...