Siemens is working with most of the top ten pharma companies piloting continuous manufacturing in their process development and is involved in one of the first pilots for commercial production. But Ivo Backx, the firm’s manager of business and project development for the pharmaceutical industry, points out that integration of all process automation architectures is essential if continuous manufacturing is to be rolled out successfully.
Integration is a challenge for the industry. Many equipment manufacturers have only one piece of the jigsaw, but for continuous manufacturing you need to have all the pieces interact, not just fitting together. Tablet manufacturing, the process where many pharmaceutical companies are choosing to pilot continuous manufacturing, provides a good example. In a traditional batch approach, tablet manufacturing is really a series of disconnected single-unit operations, installed in separate rooms, with intermediate product waiting to be released to the next process step in another room. The equipment automation solutions are often so-called ‘islands of automation’.
With continuous manufacturing of tablets, in-line/online quality measurement using process analytical technology (PAT) controls the critical process parameters. In turn this determines the ‘critical-to-quality’ attributes that allow automatic release for the product to move from one process step to the next. The in-line quality controls enable the equipment to interconnect completely hardware-wise but requires that there is one user interface to operate the equipment as one line.
With a single operator able to operate the line, a unified look and feel, uniform alarming concepts and central recipe management are a must. But many equipment manufacturers only focus on one aspect of the process. They might, for example, have a solution for continuous coating or for tablet pressing but they don’t design it in a way that allows easy integration in a line topology, to manufacture powder in, coated tablet out.
The separate devices need to be integrated, the interdependencies and material flows between them understood and controlled. Siemens process analytical technology (SIPAT) and supervisory control and data acquisition (SCADA) systems provide an integrated and data-driven control platform that can cover all of the requirements for continuous manufacturing. The SIPAT data management integrates all the PAT tools necessary for continuous manufacturing into one overall platform. This allows companies to orchestrate feed-forward, feedbackward controls over the different unit operations across the whole line. In addition, as well as the SIPAT software, Siemens can provide much of the equipment processautomation hardware and integrate this into the Siemens SCADA system to track the material mass flows over the complete manufacturing line.
Company benefits
The company has developed considerable experience of utilising these systems in a variety of continuous manufacturing development environments with different pharmaceutical and OEM partners. Commenting on its continuous manufacturing pilot plant project partnership with Siemens, one leading pharmaceutical company observed: "The Siemens technology has improved tremendously within the past three years. Today it is the most integrated solution on the market and we are impressed by the completeness of the technology."
Facilities are less costly to build and 100% of capacity is utilised when they are in operation. A major saving comes from not having to take batches to the laboratory for analysis, which can shrink the time taken getting the product to the patient from hundreds of days to something in the order of less than ten days, while all relevant quality data become available for Q-review electronically in one platform.
As well as saving time and costs, continuous manufacturing can dramatically reduce building, energy and carbon footprints. An oral solid-dose continuous manufacturing unit developed by Siemens with a leading pharma company occupies a space that is just a tenth of that needed for traditional batch equipment.