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ISO 14644 - Revision to Parts 1 and 2
Actions and implications of the changes in the International cleanroom standard.
Author: Sandle, Tim.
History of isolator and containment technology: Early containment leading to flexible film isolator
PART 1 Abstract This is the first of five papers that will describe the history and development of containment technology in the field of research, medicine and pharmaceutical applications. The paper commences with the development of containment for various purposes but essentially for experiments to determine if the raising of germ free animals was possible and practical. The paper goes on to describe how the experimental work in the late 1920s led to the development of metal and then flexible film isolators for use in veterinary research, human medicine and surgery. The notable contributions of Philip Trexler, known to everyone as Trex, from the 1930s right through to the 1960s, especially in patient care and treatment, are recorded.
Author: Thorogood, Doug.
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.
Essentials of Steam Sterilization Kinetics
Steam sterilization kinetics is the base for a correct understanding of industrial practice of moist heat sterilization, but is a too often neglected topic. This article by the well known Italian sterilization practitioner Dario Pistolesi and his former assistant Vittorio Mascherpa provides a simple but rigorous introduction to it.
Author: Mascherpa, Vittorio.
Risk Analysis for Aseptic Processing: The Akers-Agalloco Method
Aseptic processing is considered by many in this industry to be among the more difficult activities to execute properly. The number of variables that affect the safety of sterile products manufactured aseptically is substantial. In the design and operation of an aseptic production facility, it is essential that risk to the patient be minimized. This article presents a new approach to risk assessment for aseptic processing that emphasizes the contributions of personnel.
Author: Akers, James. Agalloco, James.
Aseptic Processing Risk Assessment:The Simplified Akers-Agalloco Method
This method is an effort to assess risk in aseptic processing. We believe because we have broadened the perspective of risk relative to aseptic processing that if nothing else we have increased awareness that risk can vary substantially in what are perceived by many to be equivalent (and thus equally acceptable) practices and technologies.
Author: Agalloco, James. Akers, James.
Aseptic Processing – Achieving Sterility by Design
Informal risk mitigation brought about the technology advances seen in aseptic processing. Confidence in aseptic processing is not derived from monitoring or testing; it is the result of attention to detail in aseptic processing design. With newer technologies the emphasis must shift even farther from monitoring & testing.
Author: Agalloco, James.
Current USP Perspectives on Sterilization & Sterility Assurance
Sterilization, Sterility Assurance & Sterility Testing. What’s on the Horizon?
Author: Agalloco, James.
Principles of sterilization - From A to Z
Sterilization is a critical process in the pharmaceutical industry for the control of microbial populations. While most prevalent in the manufacture of sterile products it can be used in a variety of settings where microbes have potential impact on patients or products. Sterilization really isn’t that difficult, but inattention to science through excess criteria and constraints can make it an onerous task.
Author: Agalloco, James.
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.
How does moist heat inactivate microorganisms?
Book chapter - Steam Sterilization: A Practitioner’s Guide (Ch.01)
Author: Moldenhauer, Jeanne.
Chemical Surface Bio- Decontamination Applied to Material Transfer into Sterile Enclosures
Material transfer to sterile suite issue and available technologies; Surface bio-decontamination drivers; QbD and risk assessment and mitigation overview; Surface chemical bio-decontamination cycle; Cycle validation approach;
Author: Mauri, Sergio.
Cycle development
Book chapter - Steam Sterilization: A Practitioner’s Guide (Ch.11)
Author: Korczynski, Michael S. . Moldenhauer, Jeanne.

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