The key to state-of-the-art secondary processing in the pharmaceutical industry is flexibility - new drugs, personalized formulations and new dosage forms drive the need for processing equipment that can deliver the desired quality and output with minimum downtimes and versatile production options. Modular plants and production lines that can be individually combined for a given product are one answer to this. Another is continuous manufacturing, which helps reduce lead times while reducing equipment footprint. To successfully manage the growing complexity of lines and systems, meet the requirements for quality inspection and documentation as well as speed up release of finished products, we provide a set of aligned systems and solutions that help you win the race for flexibility and performance in secondary processing.
The key factors driving costs and efficiency in secondary processing are making all processing units work together - from preparation to formulation to finishing to packaging, many different types of processes need to be smoothly coordinated, products and data must be transferred safely and reliably, and the final product must come with the required batch report that ensures it is ready for shipping. With our integrated set of systems and advanced digital solutions, you can eliminate lag times and costly procedures, implement quality by design concepts in your lines, pave the way for continuous manufacturing, and optimally operate flexible and modular manufacturing units.
Raw materials and excipients need to be weighed in and all ingredients prepared for formulation. Depending on the operator exposure level of the active ingredient, the weighing and dispensing is performed in contained areas or isolators. This area is characterized by manual operations guided by an interactive workflow (on paper or electronically). The operator follows the steps which are described in the work instructions. Digital solutions for recipe execution and recording can greatly facilitate the operations, reduce errors and improve operational efficiency.
During formulation, all ingredients are added in the right quantities, mixed and processed to obtain the right homogeneous product in bulk. By combining suitable automation solutions with process analytical technology and electronic batch recording systems, you can automatically track product quality and process performance, streamlining batch review and enabling real-time release of products.
The product is filled or formed in the primary dosage form (vial, bottle, capsule, tablet, transdermal patch, etc.) and inspected for conformity with product specifications. Advanced manufacturing systems combining state-of-the-art automaton and drive technology with manufacturing IT make sure your process operates at optimum efficiency, avoid off-spec products, streamline product and process changes, and improve operational efficiency.
The released dosage form is packaged with leaflets, insert, labeled and prepared for shipment and delivery. By integrating the various modules in your packaging line into a consistent information architecture, you can ensure optimum efficiency and transparency in this process. Modular manufacturing execution systems (MES) help increase production performance and flexibility.
Almost as essential as the production equipment are the systems to ensure a controlled environment in clean rooms, containments and warehouses. Additionally, your production relies on an uninterrupted supply with process media, power, and typically, various types of water with different quality requirements. As these systems are often vital for product quality and safety, integrating utility systems with production is essential for ensuring optimum production performance.
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