A History of Isolator and Containment Technology, Part 5: Development and use of sterilising agents with associated devices

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 […]

author: Thorogood Doug

A history of isolator and containment technology Part 4: Transfer devices

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 […]

author: Thorogood Doug

A history of isolator and containment technology Part 3: Non-flexible film isolators including RABS

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 […]

author: Thorogood Doug

A history of isolator and containment technology Part 2: Flexible film isolators

Abstract This is the second of five papers that will describe the history and development of isolator and containment technology in the fields of research, medicine and pharmaceutical applications. The paper commences with the development of flexible film isolators based on designs similar to Trexler’s later models and the expansion of the use of such […]

author: Thorogood Doug

Importance of risk assessment for aseptic transfer in pharmaceutical compounding

Abstract 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 […]

author: Sandle Tim

A history of isolator and containment technology, Part 6: Development of the validation of isolators

Abstract This final section is devoted to the development of various validation methods conforming to GMP when applied to isolators and also a review of the methods in relation to validating the processes used in preparing for aseptic processing and sterility testing. There are brief comments on what the regulators expect. Early aspects Validation, as far […]

author: Thorogood Doug

Practical experiences in particle deposition monitoring

Abstract The rate of deposition of airborne particles determines the risk of product contamination and demonstrates the operational quality of a cleanroom. The particle deposition rate at a particular location and time depends on the deposition velocity and the concentration of articles. The concentration of particles larger than 10 μm cannot be measured easily; therefore […]

author: Koos Agricola

EMA Annex 1 Draft Revision Comments from Industry Experts

Submission of comments on Revision of ‘Annex 1: Manufacture of Sterile Medicinal Products’ Jim Agalloco, Russ Madsen and Jim Akers developed a comprehensive set of comments to the draft revision of Annex 1. The authors believe it is essential that the EMA receive comments that outline the difficulties that the draft presents. Their more than […]

author: Agalloco James and Akers James

ISO 14644 – Revision to Parts 1 and 2

Actions and implications of the changes in the International cleanroom standard. ISO 14644 ISO 14644 International cleanroom standard Part 1 in 1999 12 part standard Electronics, healthcare, biotechnology, pharmaceuticals Replaced FS 209E in 2001 Accepted by EU GMP in 2003 for classification but not monitoring FDA aseptic filling guide in 2004. ISO 14644 – parts […]

author: Sandle Tim

History of isolator and containment technology Part 1: Early containment leading to flexible film isolator

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. […]

author: Thorogood Doug

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