4 Key Factors To Consider During The Design Process In Aseptic Manufacturing

Bringing a sterile drug or medical device to market involves navigating a complex design process, especially in aseptic manufacturing. Success hinges on more than just filling or assembly; it requires a strategic approach focused on critical objectives. How can you design equipment flexible enough for changing drug properties and container designs? What steps are essential to de-risk core processes, define critical quality attributes, and ensure precise process control?

Building a solid foundation during the design phase is paramount for regulatory approval and commercial viability. Explore the key considerations that shape a successful aseptic manufacturing design strategy in the complete article.