Online Pharmaceutical Solutions

The US FDA's process analytical technologies (PAT) initiative has provided the pharmaceutical industry with the opportunity to apply new technologies to understand and control manufacturing processes.

Key to this is the retrieval of real-time data, such as the tracking of particle size and size distribution changes, whist the process is running. Malvern Instrument’s on-line particle characterisation systems provide manufacturers with the ability to follow pharmaceutical milling, classification, spray drying and granulation process, yielding closed loop process control and improved production efficiency and product quality.

Fundamental to pharmaceutical drug development and production is that “Every patient is special”. Strict regulatory requirements and quality control of actives, excipients, intermediates and raw materials exist to ensure that this simple edict is fulfilled. Malvern Process Systems offers particle sizing solutions that allow you to:

• Reduce time to market through improved process understanding using the same analyser from pilot to production
• Improve process reliability through better understanding of unit operation performance in accordance with PAT
• Meet pharmaceutical industry standards and guidelines including PAT, GAMP4, CIP/SIP, 21 CFR Part 11, validation and IS
• Eliminate operator exposure to highly toxic compounds through containment
• Improve startup and shutdown performance to reduce improve yield of batch processes using high value materials