Batch crystallization represents a ubiquitous unit operation in the manufacture of a wide range of products and materials. The importance of crystallization lies in the ability to control the physical form of a material and hence the inherent physical characteristics. The identification of a preferred crystal polymorph, solvate, hydrate, co-crystal, salt form or solid solution represents only the starting point for key process studies, which investigate optimum processing methodologies to deliver the desired product with the required specifics of purity, form, habit and size distribution.

Pharmaceutical Crystallization

Park Place Research conducts extensive controlled studies to assist in developing understanding and control of active pharmaceutical material manufacture. A range of automated laboratory reactor equipment from 50ml to 50L are used to study crystallization processes in real-time. Initial solubility studies and small scale trails are followed by studies using a Mettler Toledo Multimax™ platform equipped with in-line analytics, controlled dosing, agitation and temperature profiling.

In or at-line studies are conducted using dispersive Raman, ATR-FTIR and laser diffraction techniques to enhance process understanding of key crystallization events. Mixing and control of supersaturation are used to optimise the kinetics of nucleation and growth. In conjunction with key strategic partners we offer a complete service from the development of physical form analytics, polymorph and salt-screening, process research and development, formulation development and cGMP manufacture of clinical trial materials.

In a further enhancement which took place in 2006 Park Place Research entered into a joint venture with the Haden Freeman Group to expedite the transfer and validation of Process Analytical Technologies to full-scale manufacture through optimal development and implementation of process control technologies and systems. HFL-Park Place combines the expertise of both organisations in process validation, technical risk management and construction of pharmaceutical API manufacturing plants.

Park Place Research Research Equipment

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