In a world where we measure on-time delivery, is 98 percent really acceptable? It sounds good but in the supply chain of the pharmaceutical industry, what is the impact on the 2 percent of patients who experience a delay in the supply of vital medicines?
During downstream processing, the value of a biopharmaceutical product increases at every step, as the purity of the product increases. Therefore, if there is product loss at the bulk filling stage, this could prove very costly indeed for a manufacturer and have serious consequences for patients further down the supply chain.
The only acceptable loss in terms of product and time, therefore, is zero. But how can that be achieved?
Automating and enclosing bulk fill operations can reduce the risk of human error in the bulk filling process. There is no open manual manipulation of tube sets – a very real potential source of product loss – and by standardizing the process and simplifying training, variations in the process are eliminated.
The introduction of enclosure processing protects the product, as well as having a significant benefit for the safety of operators. As the process is enclosed, dispensing can be performed in areas of lower classification, potentially eliminating the requirement for vertical laminar flow cabinets and/or isolators to be installed, validated and maintained.
Parker Bioscience Filtration has developed The SciLog® FD System as an automated integrated single-use system for final bulk filtration. The system enables the automated flushing, integrity testing of filters and dispensing into final bulk product containers - bags or bottles.
The system features include a barcode reader for manifold tracking, reverse flow and purge options to maximize product recovery and fully programmable alarms and interlocks to protect the product and the process. All of this is delivered in a package that is cGMP ready.
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Tubing selection is also important: wall thickness, brittleness and the material itself must all be considered, especially when storage will be at ultra-low temperatures. TPE and silicone both have different qualities and a one size fits all approach needs to be avoided.
After dispense it is crucial that the substance being shipped remains in an optimum condition as it completes the journey from production to the filling site. A poor bottling solution can lead to product loss, even if bulk fill has been successfully completed. Common problems include the tubing from the bottle breaking under impact once frozen, the bottle cap seal leaking and variable torque on the bottle cap allowing ingress of air during thawing of the frozen bulk.
It is critical to validate each step within the shipping process and implement solutions to alleviate the risk of product loss.
At Parker Bioscience Filtration, we’ve created an end-to-end automated packaging solution that creates a platform for bulk shipping. We have validated this solution with a focus on bottle filling, bottle integrity and liquid ingression, across the full range of temperatures found in a typical supply chain.
Eliminating the risk of human error at the bulk dispense stage through automation can play a key part in minimizing the risk of product loss – and reaching that 100% on-time delivery figure. But it’s also vital to consider what often gets overlooked: bottle integrity and protection during shipment. Parker Bioscience Filtration, by taking a holistic approach to this often-overlooked process step, has created a solution: the SciLog® FD. This solution protects the product being filled and the operator running the process but also enables the reliable, on-time delivery of critical pharmaceutical products.
To learn more about the SciLog® FD system can protect your product, visit our webpage or contact your local Parker Representative.
This post was contributed by Guy Matthews, division marketing manager, Parker Bioscience Filtration, United Kingdom.
Parker Bioscience Filtration 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. Visit www.parker.com/bioscience to find out more.