In Parker Bioscience’s webinar entitled Protect The Process, Protect The Patient, the concern that biopharmaceutical manufacturers have regarding the impact of human error on their processes was all too evident.
When asked "what do you see as the biggest cause of operational errors?" 71.4 percent of participants cited "human error", compared to 14.3 percent who cited "consumables failure" and 7.1 percent who named "equipment failure" as the main culprit.
The risk of human error and the subsequent damage this can cause to a process — product batches, delivery to market and ultimately, patient health — is clear.
But what can be done to mitigate this risk?
One option is to use automation. Let’s look at the main benefits that automation can provide within the single-use sector.
A fully manual process is very labour and operator intensive and involves a high level of manual data acquisition, manual analysis and manning of workstations. Indeed, sometimes many operators are required simply to look after one single process step.
Timings and end points can be subjective, and variation can be caused by human error.
In a world of standardization, manual processing is not the ideal scenario. On the other hand, if we look at automation within the single-use sector, it can offer a huge number of improvements to biopharma process:
Even with clear batch records and SOPs, it is possible there are differences in the way that different teams perform tasks, and there is also the potential for transcription and other human errors which can produce some variation in process controls, systems and quality documentation.
Also, when processes are transferred between facilities, there may be differences in the way processing steps are conducted in order to achieve facility fit. As much standardisation as possible surrounding this area would be an ideal scenario as it allows for faster implementation and validation.
Automation can help in all of these scenarios and is able to detect and reduce variation within processing parameters which would be impossible to perform manually.