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Reverse Osmosis in Ph. Eur. Monograph Water for Injections
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News about GMP/cGMP

2015-04-27

Reverse Osmosis in Ph. Eur. Monograph Water for Injections

For many years now, discussions have been ongoing as to whether it is possible to include non-distillation technologies as a method for the production of Water for Injections (WFI). Following a number of consultations with its stakeholders, the Ph. Eur. is proposing a revision of the monograph for Water for Injections (0169) to take into account current manufacturing practices which use methods other than distillation to produce water of injectable quality. The draft of the monograph foresees production of WFI also by reverse osmosis, which may be single-pass or double-pass, coupled with other suitable techniques such as deionisation and/or ultrafiltration.

 

The Ph. Eur. Water for Pharmaceutical Use (WAT) Working Party have concluded that there is now evidence to support a revision of the WFI monograph (0169). The monograph has now been revised to include, in addition to distillation, reverse osmosis coupled with suitable techniques (as deionisation and/or ultrafiltration), for the production of WFI; a requirement for regular total organic carbon (TOC) monitoring has been added to emphasise further the specific test controls required in the Production section.

As a result of introducing non-distillation technologies into this monograph, the monograph Water, highly purified (1927) will be made redundant and will be deleted from the Ph. Eur.

The Working Party lists the following data to support this change:

  • consistent performance of non-distillation systems;
  • reverse osmosis no longer used as a final stage of production;
  • recognition that all water-production systems are a series of interdependent unit processes which rely on the optimum function of each stage to assure the production of water of an acceptable quality; there is a need to have successive treatments to build step-wise the water quality;
  • advances in the technology and materials used for membrane production;
  • 20 years of experience in non-distillation technologies;
  • system design improvements to avoid dead legs and allow drainage and sanitisation;
  • advances in process controls and in-line monitoring of specification parameters;
  • improvements in rapid microbial methods reducing time to result;
  • evidence supplied that systems are constantly meeting WFI specifications.

The draft has been published on 01 April 2015. The deadline for comments is: 30 June 2015 (after registration under Pharmeuropa Online - where also the draft can be viewed).

Source:

EDQM: News
EDQM: Background document for revision of monograph Water for Injections (0169)

Comments
Depyrogenation of RO system how it would be possible? WHAT IS ITS METHODS? I think by RO system WFI cant possible to produce.
sanket shah 2015-05-15
 
The microbilogical safety can be assured by ultrafiltration. The ultrafiltration should be combined with regular sanitisation with hot water and the recirculation should be done via ultrafiltration. Accurate control of the production process is necessary, especially the monitoring of pressure to prevent the ultrafiltration from harm.
Maas & Peither GMP Publishing 2015-05-20