Chargepoint’s senior product manager Ben Wylie explains why single-use technology might be key for complex manufacturing environments.
Complex environment
With the growing demand for medicines that have complex manufacturing requirements, pharmaceutical companies must introduce aseptic and high potency manufacturing processes into their operations. Effective containment during high potency manufacturing is important to protect the safety of operators, while aseptic processing measures must protect the drug product from contamination. Any contamination during the manufacturing process can have a substantial financial impact, not to mention possible implications within the supply chain.
In response, pharmaceutical manufacturing environments are evolving with new technologies, including SMART monitoring capabilities which give manufacturers an automatic / reliable method of understanding the health status of process and transfer devices to better control risk and ensure consistent integrity throughout the life-cycle of the system and its critical components.
2019 is no exception with the rise of hybrid, single use technology now being adopted within pharmaceutical manufacturing processes.
Whilst single-use technologies need to deliver the same level of performance as some of the more traditional stainless-steel solutions, the reality is that this is often not the case. A new hybrid solution now includes disposable versions of Split Butterfly Valve (SBV) technology, which enables high performance contained and sterile transfer of pharmaceutical powders.
Responding to the challenges of today and tomorrow, pharmaceutical manufacturers also need solutions that are pre-validated, ready to use and deliver repeatable and reliable performance levels. They must also be easily integrated into existing processes and perform to the highest level of containment and sterility assurance.
Hybrid single use SBV systems are lightweight and cost effective, delivering containment and sterility assurance performance whilst eliminating the time and cost associated with cleaning, maintenance and validation of the disposable half, something that will increase productivity and reduce downtime.
Transfer Solutions
Today, more pharmaceutical companies than ever are utilising multiple manufacturing locations. Consequently, more drug products and APIs are being moved between facilities. Assuring the integrity of these expensive, sensitive powders whilst in transit is a challenge that is currently met with common packaging solutions that, while they meet the needs for transportation, often give facilities a headache when it comes to filling, sealing, handling and emptying in line with containment or sterility requirements. One method that works well for facility A, may not work so well for facility B or vice versa. Together, the SBV and transfer bag form a high performance, single use package for the contained and sterile transfer of pharmaceutical powders between manufacturing process steps or even facilities.
Furthermore, single use options can also reduce the time and investment required to get facilities and process lines up and running. These solutions can be a method for contained powder transfer within facility A (drug supply), but can also be used as a product’s primary packaging and container closure for transportation to facility B (for drug product formulation for example).
A hybrid system, including a single use version of the passive mating half of SBV technology, ensures users can take advantage of the benefits of single use transfer technology without compromising performance or convenience.