The consequences of failure during downstream processing are severe. Following the Affinity Chromatography stage, the value of the product increases significantly at every step. A failure at the final bulk filling stage, therefore, could lead to the waste of millions of dollars’ worth of drug product.
It’s vital, therefore, to safeguard the bulk filling process. But traditional methods of conducting bulk fill operations have several disadvantages including:
1. Manual handling
This introduces the possibility of human error to the bulk filling process. It is also labour intensive, meaning that process operators need to divert their resources into this task.
2. Operator training
When bulk filling is carried out manually, investment must be made in operator training. This can be costly, both financially and in terms of the time dedicated to it by personnel.
3. Supply chain complexity
By using a range of components from several different suppliers in the bulk filling process, there is more potential for variation – and more time must be spent on sourcing and ordering suitable components.
4. Laminar air flow (LAF) maintenance and validation
In traditional bulk fill operations, laminar air flow must be maintained and validated to protect the products from contamination. This requires time and resources.
5. Shipping issues
At the shipping stage, poor handling of bottles – and the use of unsuitable containers – can lead to damage to products before they even arrive at their destination.
6. Non-standard operations and process variability
Traditional methods of bulk filling introduce variability into the process. If bulk filling operations aren’t standardized, they can be subject to a number of factors which can impact the final product. Factors such as different flow rates applied by different operators come into play.
Automating and enclosing bulk fill operations can address the challenges detailed above and increase safety for operators. Parker Bioscience Filtration has developed the SciLog® SciPure FD system as an automated and integrated single-use system for final bulk filtration, filter integrity testing and dispensing into final bulk product containers.
Here are some of the benefits:
This reduces the risk of human error from manual handling and allows operators’ resources to be spent on other tasks.
Standardizing operations means that training can be simplified and variations in the process can be eliminated.
Enclosing the process allows operators to process highly potent molecules and protects both the operators and the process. And, as the flow path is completely enclosed, both filtration and dispensing can be performed in areas of lower classification, eliminating the requirement for vertical laminar flow cabinets.
The SciLog® SciPure FD system
The SciLog® SciPure FD system benefits from innovative component selection based around material science studies, improved filling accuracy (+/-1%), and greater flexibility in the scale of filling (from 50ml samples to 20L).
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 product and process.
A validated shipping solution
To reduce the risk of damage to the product when shipping, Parker Bioscience Filtration has designed a fully validated shipping solution to complement and extend the capabilities of the SciLog® SciPure FD System. Parker Bioscience Filtration has created a unique bottle design that offers manufacturers the confidence that bulk drug products will arrive at their final destinations without contamination.
Parker Bioscience Filtration drew on its extensive material science knowledge during the development of the bottle and material selection was based on an FMEA study. The bottle integrity has been validated down to -89˚C.
Parker Bioscience has also developed an anti-foaming device that eliminates foam and enables a higher filling speed.
The development of the SciLog® SciPure FD System is an example of the change in the vendor/end user relationship: by using a vendor such as Parker Bioscience Filtration, which can provide a complete solution, end users can increase their productivity and gain greater control and protection over their processes.
This post was contributed by Graeme Proctor, product manager (single-use technologies), 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.