Biopharmaceutical manufacturers have traditionally implemented bulk final filtration and bulk dispensing as two separate unit operations – with multiple operators assigned to carrying them out. However, this approach can be inefficient in a number of ways.
Drug product needs to be transported between the two unit operations. This movement of product and materials not only wastes operators’ resources but also increases the time taken to complete the final stage of the manufacturing process. There is also a risk of product loss and contamination during the transition between two unit operations.
The manual nature of bulk final filtration and bulk dispensing as two separate unit operations also has implications for biopharmaceutical manufacturers.Involving multiple operators in the process increases the potential for variability and human error. This can lead to product losses and in the event of contamination, the loss of entire batches – with the resulting financial losses, reputational damage and market shortages of life-changing drugs.
Human error can also lead to inaccuracies; for example, more product being transferred to a bottle or bag than is required can have a significant impact on production and can be financially damaging too – especially given the high value of the product when it reaches this stage.
There are also cost implications of the man-hours dedicated to the two unit operations – as well as the fact that specialist staff may be more effectively employed elsewhere in a process, rather than being used to manually operate pumps and valves.
Using a separate open process for bulk filling after filtration can expose a sterilized batch to potential contamination and given the product is in its most concentrated and valuable format at this time, the consequences can be grave.
Parker’s SciLog® FD (Filter and Dispense) System automates, standardizes and encloses final bulk filtration and dispense operations. The system brings bulk final filtration and bulk dispense into one unit operation, which is optimized for both functions.
The SciLog® FD System removes the variability and potential for human error that is inherent in manual processes and it allows manufacturers to apply pre-defined recipes for dispensing. Stages such as sampling and product recovery are automated, while in-line pre and post-use filter integrity testing is built into the system.
Gain a greater understanding of the SciLog® Filter and Dispense FD at the SciLog® suite at Parker Bioscience Filtration’s site at Birtley, UK.
You can undertake interactive demonstrations with the SciLog® FD system and run trials to determine how the equipment can be used to optimize your processes. This can also be carried out virtually through a video link.
Contact us to book into the SciLog® suite.
This post was contributed by David Heaney, market development manager, Parker Bioscience Filtration, UK
Parker Bioscience Filtration specializes in automating and controlling 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.