While single-use equipment has been around for many years, the primary difference between the Facility of the Future and hybrid facilities is that, unlike in the hybrid facility, there is no fixed equipment in the Facility of the Future and as such, the process train can be easily and fully reconfigured.
The “batch of you” philosophy is also rewriting the economies-of-scale rule book that has underpinned pharma for so many years. But in order to make it feasible, pharmaceutical companies must deploy technology leveraging every single capability and nuance of a fully integrated and connected processing and automation system.
Single-use technology helps answer this challenge for many of our customers, but it does have additional demands and challenges over those of traditional manufacturing facilities.
For example, facilities should be multi-product capable, they must use disposable, single-use consumables and they have to deploy an agile, plug-and-play architecture to make changeovers as quick, seamless and economical as possible.
Single-use solutions must focus on the operational capabilities and agility of the hardware to meet the demands of a flexible mobile facility.
Savings in time and effort in batch changeovers are reflected in the ultimate financial performance of the system. Customers require complete mobility of equipment in the Facility of the Future, but this presents further challenges in terms of the physical movement of totes over 500 liters.
Mobility also requires that skids from any vendor can communicate with one another and be easily integrated into a centralized process control system. Indeed, any delay in these practices, through alarms or delayed and ineffective handshaking, will add to the batch run’s costs.
We are also advising our customers that they must consider the increased complexity that their operators face working within a fully mobile facility.
In any one batch, an operator may be required to make up to 900 individual connections. Even if they get this 99% correct, that still leaves nine errors – any one of which may cause a batch to fail. In order to guide the operator through the connections of these single-use tubes, various solutions have been developed that use graphical aids to help operators visualize the work instruction.