When implementing a single-use bioprocessing solution, various levels of automation are available from completely manual steps, through semi-automated to completely automated unit operations. The level of automation specified will depend on the step in question and the cost of implementation and ownership versus the technology transfer and operational improvements achievable.
Based on our experience working with both commercial and contract manufacturers in the biopharmaceutical industry, we present what we believe are the 10 most important considerations when automating a bioprocess step and invite you to use our quick and easy questionnaire to assess the automation needs of your bioprocess.
1. Location of equipment
As we scale-up from process development, which will be operated with a necessary degree of flexibility, through pilot-scale to GMP (good manufacturing practices) manufacturing where the process is clearly defined, automation becomes more beneficial.
2. Type of manufacturing facility
In a facility manufacturing a single product with a fixed process, automation is typically simpler to implement than in a multi-product facility; however, automation can be used to create a template unit operation used for multiple processes.
3. Frequency of process transfers into the facility
A facility receiving few process transfers from development-scale will benefit from full automation; however, automating bioprocess steps at a facility receiving a higher number of process transfers, such as a CMO (contract manufacturing organization), can facilitate right-first-time manufacturing.
4. Proportion of processes that would fit a standard
Automating a single-use processing step is indicated if a large number of the processes to be operated within the facility will fit within a standard. Where processes are highly diverse and require significant modifications to steps, implementing single-use automation becomes more of a challenge.
5. Number of processing parameters to be controlled
Single-use automation is particularly useful when there are a large number of process parameters to be monitored and controlled. In operations where there are fewer of these parameters to be controlled the drive toward automation is often not as strong.
6. Frequency of need for manual interventions
Where manual interventions are infrequently required, single-use automation is likely to be very beneficial for the process. Some processes require frequent manual interventions in order for the step to be completed effectively. This typically requires a high degree of operator skill and it would be a significant undertaking to automate. An example might be the laboratory-scale cultivation of pre-seed inoculums.
7. Number of manufacturing deviations attributed to ‘operator error’
If deviations are frequently attributed to operator error then automation can play a valuable role in eliminating these. Manual errors can come from lapses in concentration associated with repetitive activities or from the operator becoming overloaded with information while performing technically difficult and infrequently performed actions.
8. Number of operators able to perform the operation
By automating a processing operation we can reduce the need for skilled manual operations that are required for it to be successfully performed. More operators will be able to successfully perform the step leading to a reduction in scheduling conflicts that occur during operations.
9. Level of skill required to perform the operation
Where a high degree of skill is needed to execute a step, automation may provide significant benefits by reducing errors and increasing process consistency. If a step requires little or no skill then investment in full automation may not be warranted.
10. Frequency of process changes
If the nature of process changes can be anticipated with a degree of confidence, then flexibility can be built into the design of single-use systems, particularly where full automation is not required. If a process is changing very frequently and substantially then automation can become more of a challenge.
Parker domnick hunter Process Filtration Division specializes in automating and controlling single-use bioprocesses. By integrating automation and sensory technology into a process, a manufacturer can control the fluid more effectively, ensuring the quality of the final product. Find out more about our bioprocessing solutions.