Automating a traditionally manual process can introduce a variety of advantages to the procedure. In an application that is benefited from repeatable performance and a 24-hour schedule, automating the processes associated with a device can significantly enhance the quality of the product as well as the product’s bottom line.In recent years, there has been increasing pressure within pharma to streamline the drug discovery and development process and reduce time-to-market. Pulmonary drug development, manufacturing, and testing is just one area of focus. However, with stringent regulatory requirements, the continual evolution of inhaler device design and the amount of analytical testing required for each new design brought to the market, this is no simple feat. Many of the regulatory tests for pulmonary drug delivery devices, such as particle size determination and dose content uniformity or emitted dose testing, are manual tests which are labor intensive and time consuming, and thus not easily “streamlined.” As the industry has recognized these limitations and bottlenecks, so have equipment providers. Specifically, those with extensive automation expertise have been working towards the provision of automated alternatives that can improve the cost and time efficiency of the drug development and testing process.
In order to meet this demand, Astech Projects has launched the X-range, a series of next generation products for automated drug delivery testing for both R&D and manufacturing quality control. The X-range has been developed as a collection of unique solutions for complex applications that had previously not been automated. The Xelair is a series of products for testing the dose content uniformity of the emitted dose; the Xelize is an advanced range for particle size determination in conjunction with the Andersen cascade impactor; and the Xelox is a next generation series of products for particle size determination with the next generation impactor.
The Xelair, Xelize, and Xelox have been designed to address some of the key issues or bottlenecks in the development process. These include increasing throughput and extending operational activity over a 24-hour period, improving process and data reproducibility, and reducing health and safety risks associated with manual operations. With the X-range, a device can be picked from the product line and immediately tested using sophisticated control software and advanced handling systems. Any anomalies or batch inconsistencies could be detected and rectified straight away before the entire batch is produced, thus vastly reducing manufacturing downtime and improving profitability.
Automating a Manual ProcessOne of the main drivers has been to develop platforms or automation modules that could efficiently automate time-consuming and labor-intensive processes. This would also vastly reduce experimental variability, eliminate the risk of human error from fatigue, and mitigate associated health and safety risks from repetitive strain injury. A key example of this is the pressurized metered dose inhaler manual preparation shake, where it is accepted that results can vary according to the technique and skill of the analyst. For example, the shaking and firing of a device may vary due to physical strength or shaking methods. However, an automated equivalent with intelligent control and sensory feedback can use standardized, fixed parameters for the device shaking and actuation so that every sample is treated identically, eliminating variability within the sample preparation phase of the testing process.
It is not just data consistency, however, that can vastly benefit from automation. To optimize the manufacturing and testing process, companies must maximize throughput and overall productivity. As tests are generally carried out manually, they are not high throughput and their timing is often dictated by the hours of the standard working day. Conversely, as is the case with Astech’s automated Andersen product, the Xelize, an automated alternative can not only significantly increase throughput (ten fold compared to manual Andersen cascade impactor tests) but can work over a 24-hour period. In turn, the analyst can be relieved of repetitive tasks and apply their skill-set to more technicallyand intellectuallydemanding work and core research. This is of great benefit to the individual and the organization as a whole.
A Modular ApproachRapid advancements in device design mean that device handling robotics can quickly become obsolete. However, by incorporating modules to accommodate changing device designs a system can be adapted as needed. Astech has established that modularity is paramount for long term cost-efficiency, ensuring maximum return on investment for the organization concerned. The company’s platforms enable the device actuation module to be interchanged and the testing of multiple device designs on the same system. Additionally, as automation can often be considered costly, the provision of a modular system can allow the incorporation of automation on a step-by-step basis. Astech’s X-range also has a simple upgrade path in place so modules can be added to form a full integrated system as budget and requirements change.
ConclusionIncreasing pressures have stimulated change within the pharmaceutical manufacturing and testing environment. It is now well accepted that the benefits of automation are significant and highly valued. In addition to improving workflow efficiency through the reduction of manual operation, automation has without question improved the reliability of the tests performed and thus the repeatability and consistency of the resultant data. Today, the common questions asked by pharma are not “How can we, or should we, automate this process?” but rather “Who is the best company to do this?” “Who can help us maximize our ROI?” and “Who can provide a reliable, long-term solution?” Where stringent regulatory requirements dictate most aspects of this process, the key to success is the integration of robust, high quality automation that can withstand the test of time and adapt to the changing needs of the industry.
OnlineFor additional information on the technologies and products discussed in this article, visit Astech Projects at www.astechprojects.com.
Anthony Moran is the sales and marketing director for Astech Projects. He can be reached at 01928-571797 or firstname.lastname@example.org.