| Abstrakt: |
This article provides an overview of the latest trends and challenges in manufacturing equipment for the pharmaceutical industry. It emphasizes the need for flexibility in equipment to accommodate different manufacturing scales and the importance of containment for potent drugs and complex biologics. Regulatory guidance, such as the European Commission's revised Annex 1 and the FDA's guidance on continuous manufacturing, is also discussed. The article explores specific trends in oral solid dosage production, tablet manufacturing, and liquid filling and assembly. Challenges faced by the industry include balancing flexibility with compliance, ensuring product quality and process efficiency, scaling up production, and addressing skilled labor shortages. The article highlights the importance of process reliability, product safety, and compliance with regulatory requirements. Advancements in isolator technology, robotic automation, continuous manufacturing, digitalization, and artificial intelligence are being utilized to improve safety, efficiency, and quality control. The development of equipment that can easily scale up production and address challenges such as small batch sizes and labor shortages is also a focus. [Extracted from the article] |
