10 October, 2023 |
In the ever-evolving pharmaceutical landscape, innovation is a driving force to help manufacturers achieve efficiencies while maintaining safety and regulatory compliance.
For many, their current focus centres on delivering targeted medicines to patients worldwide, with a key component to their development being highly potent active pharmaceutical ingredients (HPAPIs). With the HPAPI market predicted to reach a staggering $34.97 billion by 2028, it’s clear that the rising demand for these ingredients necessitates flexible and cost-effective manufacturing solutions that not only streamline processes but also ensure the containment of drug powder materials across pharmaceutical lines.
However, protecting the containment of these drug powders poses challenges to manufacturers, requiring strict adherence to processes and ensuring that cleanrooms have the necessary equipment and capacity for varying batch sizes of drug product transfer.
One solution lies in harnessing single-use technologies (SUTs), with valves and bags offering significant efficiencies when it comes to ensuring uncompromised containment. These technologies not only help to reduce water use, the need for cleaning chemicals and production costs but also protect workers from various health risks associated with exposure to such potent materials.
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While these innovative technologies offer great potential, choosing an unsuitable SUT can inadvertently exacerbate waste generation and lead to issues that hinder processes and reduce efficiencies.
Below, we examine the critical issues manufacturers must consider when selecting the right SUTs to streamline their powder transfers and minimise risks.
When selecting the right single-use bag or valve, the accuracy and robustness of the component play a pivotal role in reducing spillage.
A lack of integrity or poor accuracy during the filling and transfer process can result in powder escape, risking not only material loss but also increasing the potential for contamination risks.
By choosing a component robust enough for safe use, you can ensure that you not only mitigate these concerns but also safeguard the integrity of the manufacturing process.
The single-use component you choose should be designed to not only fit within your existing production lines but also facilitate the smooth transfer and retrieval of all powder.
For example, when using single-use bags or containers, unwanted static charge can build up within the bags, resulting in “stickiness,” making it difficult to retrieve the full powder amount.
Conversely, inadequately designed bags can cause hang-ups, making it difficult for operators to fully extract contents without significant manipulation, posing the risk of rupturing bags.
The right bag will be designed with materials and a geometry that preserves the materials and optimises yield.
Consistency is of paramount importance to quality control during powder transfers, with recipe accuracy often being difficult to maintain across each process.
Selecting an inappropriate single-use component for this process, such as bags with materials that interact with the drug product, can lead to the leaching of unwanted substances into the final product.
This can significantly compromise recipe accuracy and lead to poor reproducibility throughout the chain. It is therefore essential to select the right bag that is qualified to safeguard the integrity of the end product.
As you navigate these pivotal considerations, working closely with an experienced and trusted supplier for your single-use components is key.
These experts can address your concerns by taking your project’s unique needs into account and providing you with the documentation you need to prove its safety and efficacy. Ultimately, this support will help ensure the efficiency and quality of your powder transfers as you advance along your manufacturing journey.
Get in touch with our experts to discuss your unique needs and discover how we can help you choose the right single-use components that streamline your current and future projects.