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Title: A critical assessment of factors effecting blister pack formation in the pharmaceutical industry
Authors: Allen, Keith W.
Issue Date: 2011
Publisher: © Keith W. Allen
Abstract: Blister packing is a very complex process, incorporating many areas of science and technology. To date there have been many studies carried out evaluating various types of blister materials, sealing and forming processes and heat sealable adhesives. However, there has never been a reported study pulling together all of the critical factors involved in achieving optimised blister packing. There is also very little on this topic in terms of published literature. The aim of this study is to evaluate all critical aspects of blister packing to resolve ongoing machine and material issues by enabling the introduction of alternative materials and processes. Further to a critical evaluation of the available literature and studies on the various types of blister sealing equipment and tool design, the alternative types of materials used to produce the blister packs were also evaluated to identify the critical features and parameters required to achieve a totally sealed hermetic pack. More recent studies have evaluated the seal quality of new and existing Multi-Dose Powder Inhalation (MDPI) lidding and base foils. These novel studies have utilised techniques such as Scanning Electron Microscopy (SEM) and calculated peel strength data using developed test protocols. Moisture ingress determination based upon both theoretical and actual calculations have also been deduced. A further study has also been carried out to determine the heat transfer from the heated sealing tools to the product for platen type blister sealing. This study set out to give an overview of the packaging requirements of the pharmaceutical industry, the purpose being to highlight the critical aspects of a heavily regulated industry and to explain the various stages of the packaging process to identify any areas of development and improvements that could be made as part of any subsequent studies. Once an overview had been undertaken, it was necessary to identify the current and new materials under development that are and will be used for blister packaging in future applications. It has also been neccessary to determine the required protection in terms of moisture vapour, light transmission, seal strength and seal integrity that the products require. Prior to any decisions on the areas to research as part of my studies it was essential to understand the types of blister designs and material construction with the necessary additives such as stabilising agents, stability agents and antiblock agents. The rationale being to avoid repetition of any previous developments and to use those developments and previous studies to further enhance the performance of the current materials, developing totally new concepts and blister structures. Once the materials were identified a study was carried out into two types of blister sealing equipment, namely rotary and platen sealers. This was essential in developing a good understanding of the process and technology available when introducing new materials and alternative blister designs. Furthermore, it was key in understanding the problems associated with blister packs and in resolving ongoing material and equipment issues. Further research was then directed towards other critical aspects of blister sealing, such as dwell time, temperature, pressure and the importance of the adhesive function. After which the types of testing that is carried out on the finished blister to ensure that a good hermetic seal is achieved was identified. This guarantees that the product will be preserved during its shelf-life and the required dose will be administered throughout. The study then focused on a number of operational improvements and introduction of new materials, such as alternative types of lidding and base laminates, new heat seal lacquers and new rotary blister sealing tools.
Description: This thesis is confidential until 1st July 2021. A Doctoral Thesis. Submitted in partial fulfillment of the requirements for the award of Doctor of Philosophy of Loughborough University.
Version: Closed Access
URI: https://dspace.lboro.ac.uk/2134/8509
Appears in Collections:Closed Access PhD Theses (Materials)

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