The use of automation in running complex single-use systems has many benefits such as process control and consistency, increased speed, reduced labour costs and operational flexibility.
While implementation of automation is on the rise, perceived challenges around its adoption mean that its efficiencies remain untapped by some biopharmaceutical manufacturers.
Our recent webinar Single-Use Technologies, What is Next? provided an in-depth insight into the challenges faced by biopharmaceutical manufacturers when implementing single-use technologies.
Here we look at the points raised around introducing automation into single-use processes and focus on some of the perceived barriers to its implementation.
In a poll taken during the webinar delivered by Graeme Proctor, Parker domnick hunter product manager for single-use technologies, 48% of respondents cited cost as being the main restriction to implementing automation. Though the initial outlay may appear costly, automation can provide rapid return on investment—in some cases as early as within one year—due to savings in labour cost and investment in facilities. In addition to the financial benefits, other efficiencies can also be achieved through automation.
Variation in a process implies that the product can no longer be assumed to be the same as that tested during clinical trials. This is where automation really comes into its own, adding great value and robustness to processes.
Four sources of process variation in biopharmaceutical manufacturing are biological, raw materials and consumables, operational input and environment (namely temperature and contamination). Automation can help by increasing process consistency and eliminating variation derived from operational and environmental inputs.
Automation can offer a huge number of improvements to single-use processes. It can free up the operator, allowing safe and effective multitasking while ensuring the safety of processes and products.
Processes such as normal flow filtration (NFF), tangential-flow filtration (TFF), bulk final fill and chromatography are all historically labour-intensive, manual operations. In another poll taken during the webinar, 38.5% of respondents thought that final bulk fill is the unit of operation that would benefit most from automation, closely followed by chromatography with 34.6% of the votes.
In addition to providing a faster, safer final bulk filling process which virtually eliminates the chance of cross contamination, automation can provide standardization from start to finish—giving control of pressure, monitoring and feedback on parameters such as conductivity and temperature. Standard, reliable programming can also eliminate human error, ensuring a reliable and robust process.
Data acquisition and analysis can be automated and transcription error-free reports generated automatically, which in today’s fast-flowing market, is essential to ensuring compliance with 21 CFR Part 11 and GMP Standards.
Additionally, automation is also able to detect and reduce variation within processes and parameters which would be impossible to perform manually.
While Parker domnick hunter acknowledges that cost can be a stumbling block, automation can provide a complete solution, ensuring both the integrity and quality of the product while also significantly reducing the opportunity for errors and failures.
Automation can offer:
- Rapid ROI
- Time savings
- Reduced complexity
- Improved process security
- Reduction in training requirements
- Reduction in QA oversight
All of this adds up to a reliable and repeatable process that can simplify scheduling to enable a greater throughput with a lower cost of goods.
What are the barriers to implementing automation in your single-use process? Let us know in the comments section below.
This post was contributed by Graeme Proctor, product manager - single-use technologies, Parker Bioscience Division, United Kingdom.
Parker Bioscience 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