Will WFI from membrane-based technologies now become an alternative for Europe?

In an EDQM paper published in March 2015 the topic production of WFI by means of membrane-based technologies is discussed again and not excluded any more. Read more about WFI from membrane-based technologies.


In an EDQM paper published in Pharmeuropa in March 2015 the topic production of WFI (water for injections) by means of membrane technologies (reverse osmosis coupled with other suitable techniques) is discussed again and not excluded any more. So far distillation is the only permitted procedure for the production of WFI in Europe. It was already pointed out in the paper on the revision of Annex 1 published in February that alternative procedures for the manufacture of WFI might become possible.

The first part of the new document describes the history of the long lasting discussion of the question whether other procedures than distillation should be allowed for the production of WFI. In the end this led to the creation of a new monograph of highly purified water (HPW). This is water with WFI quality produced by means of membrane-based technologies. But its possible applications were very restricted.

Now it looks as though the Ph. Eur. Water for Pharmaceutical Use (WAT) Working Party has concluded that there is evidence to support a revision of the WFI monograph in the European Pharmacopoeia (0169). As reasons for this change are indicated for example advances in the “non-distillation technology” and improvements in the design of the water-production systems as well as an advanced process control. But it is acknowledged that the design and maintenance of any water-production system plays an important role in ensuring  the security of the produced water. The manufacturer is responsible for compliance with GMP requirements. Presumably, existing guidance documents must be complemented for this by the appropriate stakeholders. Furthermore, quality assurance and monitoring should extend to storage and distribution processes for WFI.

As a result the highly purified water monograph (1927) would be made redundant and be deleted. Furthermore, the inclusion of water for dialysis in the WFI monograph could also be contemplated.

The draft monograph is available on the EDQM webpage for free, after registration. The main change reads:

WFI is produced either by [..destillation, . ].or
by reverse osmosis, which may be single-pass or double-pass, coupled with other suitable techniques such as deionisation and/or ultrafiltration.
Correct operation monitoring and maintenance of the system are essential.

The EDQM already organised a special webinar on April 22nd where this topic has been discussed.

The original document mentioned above discusses the alternative production methods for WFI.



DR ANTHONY MELVIN CRASTO, Born in Mumbai in 1964 and graduated from Mumbai University, Completed his Ph.D from ICT, 1991,Matunga, Mumbai, India, in Organic Chemistry, The thesis topic was Synthesis of Novel Pyrethroid Analogues, Currently he is working with GLENMARK PHARMACEUTICALS LTD, Research Centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India. Total Industry exp 30 plus yrs, Prior to joining Glenmark, he has worked with major multinationals like Hoechst Marion Roussel, now Sanofi, Searle India Ltd, now RPG lifesciences, etc. He has worked with notable scientists like Dr K Nagarajan, Dr Ralph Stapel, Prof S Seshadri, Dr T.V. Radhakrishnan and Dr B. K. Kulkarni, etc, He did custom synthesis for major multinationals in his career like BASF, Novartis, Sanofi, etc., He has worked in Discovery, Natural products, Bulk drugs, Generics, Intermediates, Fine chemicals, Neutraceuticals, GMP, Scaleups, etc, he is now helping millions, has 9 million plus hits on Google on all Organic chemistry websites. His friends call him Open superstar worlddrugtracker. His New Drug Approvals, Green Chemistry International, All about drugs, Eurekamoments, Organic spectroscopy international, etc in organic chemistry are some most read blogs He has hands on experience in initiation and developing novel routes for drug molecules and implementation them on commercial scale over a 30 year tenure till date Dec 2017, Around 35 plus products in his career. He has good knowledge of IPM, GMP, Regulatory aspects, he has several International patents published worldwide . He has good proficiency in Technology transfer, Spectroscopy, Stereochemistry, Synthesis, Polymorphism etc., He suffered a paralytic stroke/ Acute Transverse mylitis in Dec 2007 and is 90 %Paralysed, He is bound to a wheelchair, this seems to have injected feul in him to help chemists all around the world, he is more active than before and is pushing boundaries, He has 9 million plus hits on Google, 2.5 lakh plus connections on all networking sites, 50 Lakh plus views on dozen plus blogs, He makes himself available to all, contact him on +91 9323115463, email amcrasto@gmail.com, Twitter, @amcrasto , He lives and will die for his family, 90% paralysis cannot kill his soul., Notably he has 19 lakh plus views on New Drug Approvals Blog in 216 countries......http://newdrugapprovals.wordpress.com/ , He appreciates the help he gets from one and all, Friends, Family, Glenmark, Readers, Wellwishers, Doctors, Drug authorities, His Contacts, Physiotherapist, etc

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