With operational efficiency and flexibility being the current norm in production facilities, biopharmaceutical manufacturers are working on concepts that will facilitate this with ease. The move towards employing single-use systems (SUS) is a case in point. However, this poses several challenges, be it technical, logistical or any other. Some factors that need to be considered while designing such systems to prevent operational bottlenecks are mentioned in this article...
Single-use technologies are making new inroads into the development of flexible production facilities to manufacture active pharmaceutical ingredients for the purpose of clinical trials. At present, nearly all large biopharmaceutical manufacturers are exploring ways to ensure more efficient operation of such facilities. Some special requirements need to be taken into account while designing such systems.
New Requirements for Biopharmaceutical Production
If conventional requirements for setting up a production system are closely examined with respect to the current needs, substantial differences can be identified. So far, most systems have been developed for large volume production. This is why stainless steel systems have been engineered and built, as these have few physical limitations pertaining to temperature, pressure or volume. However, the considerable degree of hard-piped stainless steel construction in these systems results in limited flexibility when it comes to changing volumes or adapting them to specific process needs.
Another aspect that limits flexible adaptation is that once the design specifications of such a reusable system have been defined and the system has been built, it can be reconfigured only at a relatively high cost involving labor-intensive and time consuming revalidation.
However, market requirements over the past years have been increasingly following the trend towards smaller manufacturing capacity that affords a high degree of flexibility. In this case, the approach taken focuses more strongly on functionality and hence, has inevitably led to systems that consist of both stainless steel and plastic, called hybrid systems. Such designs offer a plethora of options not only with respect to adapting the volume, but also changing the product and modifying the process itself. As a result, such combination systems respond to emerging challenges posed by the market.
Tips for Successful Implementation
Implementing a single-use project requires a supplier, who has the experience of dealing with conventional stainless steel systems, to change both organizational and process transaction structures. This is because classic project workflows can be used or adapted to single-use projects only to a limited extent. For the benefit of manufacturers and users alike, here is some handy information that will enable successful implementation of single-use or hybrid projects.
The terms ‘requirement profile’, ‘factory acceptance testing (FAT)’ and ‘site acceptance testing (SAT)’, as understood in the classical sense, take on different meanings when it comes to SUS and processes. Unlike conventional projects, SUS projects involve stainless steel equipment employed as the frame and support structure to enable use of disposables, and of the product-contact plastic surfaces.
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