Process analytical technology: A strategy for keeping manufacturing viable in Australia

Process analytical technology (PAT) is the current keyword in the pharmaceutical industry. It represents a dynamic area of manufacturing interest and is certain to become the major focus of most, if not all, pharmaceutical manufacturers worldwide in the next 5 years.Although it has been around for some time in one form or another, it has gained momentum in recent times due to two contributing factors. The first reason is the development of more robust and rapid spectroscopic analysers and the second reason is due to increased computing power and data storage capacity. When correctly driven to obtain maximum results PAT will yield major benefits to the processing efficiency of any Pharmaceuticals manufacturer.When combined with statistical process control (SPC), right first time (RFT) and the current Six Sigma (6σ) initiatives, full accountability can be assured for every batch tested, providing more understanding of many processing issues through timely spectroscopic measurements of key manufacturing points. PAT can form a major part of any manufacturers continuous improvement programs and the benefits will include the ability to increase volume into the sites, whilst at the same time, maintaining high output, thereby helping to keep manufacturing facilities viable in Australia.This paper provides the authors perspective regarding the future of the PAT initiative in Australia. It is a summary of the key issues discussed in a presentation given at the recent ACOVS6 conference concerning the techniques investigated and employed by the Sigma Pharmaceuticals near infrared (NIR) spectroscopy group for reducing cycle times and further understanding key processing issues.