Abstract In this penultimate section the development of the ‘sterilisation’ of isolators used for sterility testing and aseptic processing will be reviewed. This will include the chemical agents used, the equipment to deliver and remove that agent (in a gaseous form), as well as agents used for manual wet processes and also fogging techniques with associated […]
Abstract The discussion in this part of the history of isolator and containment technology reviews the development and use of various devices that permit the aseptic transfer of components such as sterile vials, syringes, bottles and other types of container as well as the actual product itself into and out of the aseptic filling area […]
Abstract This third paper on the history of isolators describes the development and use of non-flexible film isolators including restricted access barrier systems (RABS). By non-flexible is meant that type of unit that has a metal or a rigid plastic structure. These are referred to as conventional isolators. Many of these models have been designed […]
This short article is an introduction to the basic selection of sterilization autoclaves. It defines this type of equipment, summarizes the varieties available and discuss the preliminary problems to cope with in specification and design of sterilization autoclaves.
Presentation overview – A balance must be achieved between the need to maintain a safe, stable and efficacious product while providing sufficient lethality to attain a minimum level of sterility assurance •No sterilization method should be considered exempt •Sterilizing processes should be a compromise between the degradation effect on the materials and destruction of microorganisms […]
Presentation Overview – Terminal Sterilization Fundamentals ■ Steam ■ Radiation ■ Current Best Practices ■ TS processes and approaches that everyone, including regulators can agree on ■ Current processes with a modest twist. Those may that create will likely create some angst ■ Expected Future Developments ■ Thinking outside the current box that might be […]
A case study of hydrogen peroxide penetration through the load packaging: a customer required support for «A Package Integrity Verification» which involved all the samples and consumables inside the Sterility Test Isolator.
One of the most problematic issues of aseptic manufacturing is the involvement of personnel. Human presence generates millions of particles every minute. Some of these particles are biologically active and can generate product contamination. Now, technology can create a revolution by removing human intervention from the aseptic manufacturing process to reduce its impact on product […]