Aseptic processing

Aseptic processing
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 – 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.
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.
Flexibility and cost-effectiveness for advanced aseptic production
The use of robotics and automation in the industry is not new. For several decades now, many assembly lines have utilized production robots in different functions to increase productivity. Although human operators result in a potentially risky activity in sterile areas, pharma manufacturing remains heavily human. This article discusses how to apply current isolation technologies with robotic systems to reduce the risk of microbial contamination in aseptic processes caused by human intervention.
Author: Mauri, Sergio.
Emerging Gloveless Robotic Technologies in Aseptic Manufacturing for Personalized Cytotoxic Drugs
This article discusses trends for the pharmaceutical manufacturing industry in the following years. A robotic solution for the next generation of drugs is introduced and its main advantages are presented. The concepts integrated into this innovative solution are explained and technical details are provided.
Author: Mauri, Sergio.
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.
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.
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.
ISO 14644 - Revision to Parts 1 and 2
Actions and implications of the changes in the International cleanroom standard.
Author: Sandle, Tim.

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