Human error in bioprocessing can have serious consequences for biopharmaceutical manufacturers. Accidents can cause a health hazard for staff involved in bioprocessing operations and human error can affect product quality and lead to batches of expensive products being written off — with financial consequences to the manufacturer. Then of course there is the ultimate effect on patient health.
If any manufacturing deviation occurs in bioprocessing, the current practice is that a report needs to be issued and effective corrective and preventative measures need to be implemented. If a manufacturer fails to undertake and complete this process within a reasonable time frame, the company may come under increased scrutiny from regulatory authorities — potentially leading to regulatory observations and warning letters.
Analysis of the root causes of deviations often determines that human error is responsible. Some surveys put human error as the cause of 50 percent of manufacturing deviations in bioprocessing.
Indeed, in a recent Parker survey entitled Protect the Process, Protect the Patient, we asked respondents, "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 cause.
What can be done to minimize human error?
When an analysis identifies that human error has been the root cause of a deviation, biopharmaceutical manufacturers commonly retrain the operators involved. This often constitutes the main corrective action undertaken.
This training usually entails the staff studying the relevant SOP. Their supervisor or trainer then validates that training by checking that the staff correctly understands the procedure.
This is a straightforward — although potentially time-consuming — remedy. Unfortunately, the approach cannot be relied upon to eradicate the problem and there is a risk that errors could be repeated, at great cost to the biopharmaceutical manufacturer.
Automating and enclosing the process
Parker's SciLog® FD System automates, standardizes and encloses final bulk filtration and dispense operations, removing the variability and potential for human error that is associated with manual processes.
The system enables the automated flushing, integrity testing of filters and dispensing into final bulk product containers.
It eliminates many of the errors associated with human interfacing by utilizing standardized programming to ensure reliability and robustness.
Here are some of the advantages of the SciLog® FD system for human error reductions:
- The process is contained in a closed system, which keeps the product protected from the operator and the operator protected from the product. The environment cannot contaminate the process stream, and the operator will not be exposed to potentially potent drug products.
- Pre-defined recipes for dispensing can be applied eliminating the potential for variation if this was undertaken manually.
- The sampling and product recovery stages are automated, so the risk of human error is removed.
- The SciLog® FD system has interlocks that protect the product and the process
- Calibrated SciLog® SciPres pressure sensors are built into the system to ensure validated limits are not exceeded.
- Human error is reduced in data acquisition and analysis as this is automated.
- The system generates batch records — meaning that these aren't created manually, and so eliminates the risk of transcription errors.
Conclusion
Automation can help to eliminate the risk of human error in bioprocessing. A system such as Parker's SciLog® FD System can help biopharmaceutical manufacturers save time and money, and crucially, protect the health of operators and patients.
You can gain a greater understanding of the benefits of standardizing, enclosing and automating a single-use system at the SciLog® Suite at Parker Bioscience Filtration's site in Birtley, UK. Here you can undertake an interactive demonstration with the SciLog® FD System and run trials to determine how the equipment can be used to optimize your processes.
In addition, you can use the SciLog® Suite for in-depth training of operators and engineers.
Contact us to book into the SciLog® Suite
For more information on the SciLog® FD System, visit our web page
This post was contributed by Graeme Proctor, product manager - single-use technologies at Parker Bioscience Filtration, United Kingdom
Parker Bioscience Filtration specializes in automating and controlling bioprocesses. By integrating sensory and automation technology into a process, a biopharmaceutical manufacturer can control the process more effectively ensuring the quality of the final product.
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