
In our previous blog post, ‘4 Factors to Consider During the Design Process in Aseptic Manufacturing’, we discussed the objectives that the design process should set out to achieve for new aseptic manufacturing challenges. For our third blog post, we will be discussing the importance of developing flexible solutions that can support next-generation formulations, accommodate different filling environments and fulfil changes in production volumes for years to come.
Pharmaceutical manufacturers are becoming increasingly active in the search for evolving technologies that can provide flexible, future-proof aseptic solutions. Although flexible systems may cost more initially and take longer to develop, they have the ability to support the total life-cycle from early-stage manufacturing to commercial production and handle challenging drug properties to eliminate the need to purchase new technologies. As with any automation investment, the goal should also be to ensure improved labour productivity and safety, manufacturing reliability, product quality and, where required, faster throughout to achieve the overall goal of shortening product development lead times. This makes for a cost-effective and robust investment.
The increasing complexity of new drugs
The increasing complexity of manufacturing new drugs has stimulated a growing demand for flexible solutions. Many traditional filling systems are unable to handle changing drug properties, which impacts the accuracy of doses. As mentioned in our previous blog, it is highly important to specify and design flexible equipment that can accommodate changing properties of the drug quickly (e.g. viscosity of liquids, powder flow properties etc). This agility and flexibility will, for example, be a major enabler for low dose and potent drug handling to support next-generation powders and formulations of the future. This includes the ability to fill very low dose weights of pure API or higher concentrations of...