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Could hydrogen peroxide decontamination affect the results of a sterility test?
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.
Author: Bernuzzi, Maria Luisa.
ISO 14644 - Revision to Parts 1 and 2
Actions and implications of the changes in the International cleanroom standard.
Author: Sandle, Tim.
Lowering the risk of personnel induced contamination: The use of robotics in aseptic processing
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 sterility. Stainless steel GMP robotic arms have been introduced to handle fill finish operations within a gloveless isolator. The advantage of this process, apart from sterility improvement, is the possibility of handling Highly Potent Active Pharmaceutical Ingredients (HPAPIs) like cytotoxic drugs in a flexible and cost-effective way. This article goes through all the main features of the gloveless robotic solution and describes a cluster tool concept for an advanced aseptic production facility.
Author: Mauri, Sergio.
What is a sterilization autoclave?
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.
Author: Mascherpa, Vittorio.
Importance of risk assessment for aseptic transfer in pharmaceutical compounding
Aseptic transfer is a critical contamination control issue, carried out over a series of stages. If any stage is performed in an uncontrolled manner then microbial contamination of a product can occur. Contamination risks can arise from a number of sources, including incoming materials, air and personnel. To address these risks appropriate controls include controlled environments, personnel gowning and behaviour, and the use of disinfectants. This article considers the key risks and risk mitigation strategies using a case study of aseptic transfer within a pharmacy unit for the purpose of preparation or compounding of a medicinal drug product.
Author: Sandle, Tim.
Moist Heat Terminal Sterilization for Controlled Release Materials
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 part of our future.
Author: Agalloco, James.
Non-heat terminal sterilization of controlled released material
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 •A sterilization process that destroys all microorganisms, but renders the item being sterilized unfit for use is of no value •The sterilization process and the specific product, formulation and container must all be suited to each other • There are few universal answers, and some of those that appear to be broadly applicable may be wrong.
Author: Agalloco, James.

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