Overview of Pure Steam and

Water for Hemodialysis

Module 5

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All rights reserved. USP Pharmaceutical Waters Course – March 2016 COPYRIGHT© 2016. ALL RIGHTS RESERVED.
 The Pharmaceutical Waters Tree

Drinking Water

Water for
Purified Water Water for Injection Pure Steam
Hemodialysis

Bacteriostatic
Sterile Purified Sterile Water for Sterile Water for Sterile Water for
Water for Injection
Water Injection Inhalation Irrigation

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 Agenda of Module 5 – Other Waters

 Pure Steam
 Water for Hemodialysis

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 Pure Steam – What Standards Exist?

 British Health Technical Memorandum

– Part 2: Design Considerations – Sterilizers
– Section 7.29 requires non-condensable gases to be <3.5%
– Section 7.18 through 7.27 describe limitations for dryness, excessive
moisture, superheating
 EN285 – similar requirements
 Focus is on mechanical properties of steam

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 Pure Steam – What is Industry Definition?

 Is it Pure Steam or Clean Steam?

 Pure Steam is pressurized water vapor…
– prepared from Purified Water
– prepared from WFI
– condensate meets requirements for Purified Water
– condensate meets requirements for WFI
 Steam is defined by
– the quality of the condensate?
– the quality of the feedwater?
– by the quality/method of preparation?

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Pure Steam Monograph – USP39 2016-05-01

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Pure Steam Definition

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Pure Steam Usage and Sampling

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Pure Steam Tests

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 Agenda of Module 5 – Other Waters

 Pure Steam
 Water for Hemodialysis

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Water for Hemodialysis – AAMI

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Water for Hemodialysis – AAMI

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Water for Hemodialysis Monograph

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 Water for Hemodialysis

 See 1230 Water for Health Applications for general

information
 Start with drinking water, subjected to further suitable
treatment for chemical and microbiological reduction
 Produced under direction of qualified personnel
 No added antimicrobial agents
 Not for direct injection

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Water for Hemodialysis

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 Water for Hemodialysis Tests

 Meets 61 Microbial limit

 Meets 85 Bacterial Endotoxin
 Meets 645 Water Conductivity
 Meets 643 Total Organic Carbon

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Water for Hemodialysis Tests

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 Module 5 Summary – Other Waters

 Monograph developed for Pure Steam

– Based on condensate of WFI
– Provides test for quality
– Provides [Note] for thermal properties

 Monograph developed for Water for Hemodialysis

– Follows AAMI in some respects

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USP Pharmaceutical Waters Course – March 2016 COPYRIGHT© 2016. ALL RIGHTS RESERVED.