Twenty years ago, Professor Bernhard Sonnleitner, of the Institute of Chemistry and Biological Chemistry at the Zürich University of Applied Sciences, suggested that the bioprocess industry would benefit from a standard operating procedure and highlighted the opportunities that could be generated from automation, including the enablement of skilled personnel to engage in more useful work.1
There’s no doubt that since Professor Sonnleitner raised the issue in 1997, the use of automation in bioprocessing systems has been on the rise — and that’s for good reason.
Overall, the use of automation in running complex single-use processes has many benefits for engineering managers, such as improving process control and consistency, increasing speed, and reducing human error deviations. It also frees up time for highly skilled scientists to carry out more value-added activities, such as research and development.
Of course, there is a cost implication, and the initial investment may appear high. However, automation can provide rapid return on investment – in some cases as early as within one year – due to savings in labour costs and reduced deviations.
By introducing automation, engineering managers can make a significant positive impact on traditionally labour-intensive operations such as normal flow filtration (NFF), tangential flow filtration (TFF), bulk final filling and chromatography.
In the case of the bulk final filling process, for instance, automation is faster and safer, helping to eliminate the chance of cross contamination. The increased repeatability means that in many implementations the need for direct supervision of this critical step by Quality Assurance (QA) and Quality Control (QC) is reduced or completely eliminated. Data acquisition, analysis and control is automated and transcription, error-free reports are generated automatically – greatly facilitating compliance with 21 Code of Federal Regulations (CFR) Part 11 and Good Manufacturing Practice (GMP) standards.
Parker domnick hunter has worked with an industry leader in the development and production of biopharmaceuticals on the automation of a semi-manual TFF step to eliminate process risk.
The client preferred standard operating procedure (SOP) driven processes with a single operator, or few skilled operators, trained to carry out the processes to ensure repeatability. However, this left operators constantly supervising GMP processes during campaigns – an impractical scenario, especially when considering scale-up.
The Parker domnick hunter SciPure TFF GMP-ready automated single-use tangential flow filtration system successfully delivered an automated solution. We implemented SciLog SciPres® single-use pressure sensors inline for pressure monitoring and interlocks, as well as a 21 CFR Part 11 compliant data historian directly into the client’s semi-manual process.
As the room was very small, the SciPure design was able to eliminate two scales by integrating a WeighStation gravimetric fluid handling platform into the skid to mount the retentate bioprocess container, as well as adding automation to calculate and display the permeate weight without requiring a physical permeate scale.
As our system simplified and standardized the process for the operator, a greater number of staff could be trained to carry out the process step, increasing operational resilience. This was seen as of great value for the business and cemented Parker’s reputation with the customer as a fast, flexible solutions provider, rather than a "take it or leave it" product vendor — so common in the industry.
1. Sonnleitner B. Bioprocess Automation and Bioprocess Design. Journal of Biotechnology 52, 1997: 175-179
This post was contributed by Peter Newell, application scientist at Parker Bioscience Division, United Kingdom.
Parker domnick hunter Process Filtration Division specializes in automating and controlling single-use bioprocesses. By integrating sensory and automation technology into a process, a manufacturer can control the fluid more effectively, ensuring the quality of the final product. Find out more at www.parker.com/bioscience