Abstract

The production of pharmaceutical ingredients, intermediates and final products strongly depends on the utilization of water. Water is also required for the purification and preparation of reagents. Each specific application determines the respective water quality. In the European Union, the European Pharmacopeia (Ph. Eur.) contains the official standards that assure quality control of pharmaceutical products during their life cycle. According to this, the production of water for pharmaceutical use is mainly based on multi-stage distillation and membrane processes, especially, reverse osmosis. Membrane distillation (MD) could be an alternative process to these classical methods. It offers advantages in terms of energy demand and a compact apparatus design. In the following study, the preparation of pharmaceutical-grade water from tap water in a one-step process using MD is presented. Special emphasis is placed on the performance of two different module designs and on the selection of optimum process parameters.

Highlights

  • The forecast of the European pharmaceutical market predicts a 3.9% growth between2019 and 2024, while the global market is expected to rise by about 4.2% in the same period [1]

  • The investigations were carried out using a test plant that was especially designed by Wilhelm Werner GmbH (Figure 1). It allows the operation of both air-gap membrane distillation (AGMD) and vacuum membrane distillation (VMD) configurations, which were chosen for the experimental investigations due to their advantages, i.e., little conductive heat losses and relatively high permeate flux

  • Similar to what observed for AGMD, the feed temperature TF had the greatest influence on the transmembrane distillate flux during VMD, followed by the feed volume flow FF and the cooling water volume flow FK

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Summary

Introduction

The forecast of the European pharmaceutical market predicts a 3.9% growth between. 2019 and 2024, while the global market is expected to rise by about 4.2% in the same period [1]. Membrane distillation (MD) may be an alternative process for the generation of pharma-grade water. MD is a thermal separation process based on vapor pressure differences between the feed and the distillate sides of porous, hydrophobic membranes [4]. Xu et al [7] reported about graphene oxide (GO) nanolayers that were deposited on the permeate side of PVDF membranes These membranes show an advantage for membrane distillation because of their unique water channels. Application in direct-contact membrane distillation enhanced the desalination performance due to a decrease of the vapor pressure at the permeate side. Alternative configurations with low energy consumption and improved flux have been developed [14] Both sides of the membrane are in contact with a liquid.

Test Plant and Modules
Conductivity
Quality Parameters
Experimental Investigations
Investigation of Influencing Parameters by Factor Variation
Long-Term Investigations
Hygienic Safety
Chemical Resistance of the Membranes against H2 O2
Results
40 Feed volume
Distillate flux flux as aa function function of temperature during
Long-Term
Microbiological
Material Stability
Parameter Variation
Microbiological Investigations
Conclusions and Outlook
Full Text
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