Friday, 26 July 2019

Purified water and water for injection standard update


The ISO standard for Purified water and water for injection has been update. This document specifies design, materials selection, construction and operation of Purified Water (PW) and Water for Injection (WFI) pretreatment and membrane-based production systems.

"ISO 22519:2019 - Purified water and water for injection pretreatment and production systems."

According to ISO, the document:
  • Allows users to specify water systems that fit specific needs without being experts in the water system field;
  • Allows users to decide whether the offered systems are safe, efficient and sustainable;
  • Enables national governments, state authorities and regulatory bodies to perform professional audits;
  • Provides auditors a standard check list to harmonize equipment and systems in the water industry;
  • Sets a high benchmark for suppliers of water systems all over the world, to be used as a point of reference for their systems and;
  • Will improve reliability of the water generation process methods and water product while reducing downtime needed for scheduled and non-scheduled maintenance.
Furthermore, as many different types of feed water are possible, different components and configurations are presented. The guidance provides a decision matrix is provided to give guidance for the different types of feed water.

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

3 comments:

  1. Dear Sir,Have a nice day.Purified water and water for injection standard as per BP/UKMHRA guide line, it will have any change like production,documentation or regulatory rule after Brexit UK Leave from EU?
    Regards
    Emran Hossain
    Head of QA
    Team Pharmaceuticals Ltd.
    Rajshahi, Bangladesh.

    ReplyDelete
  2. The ISO-standard as it turned out is one of the biggest threats to pharma industry there is. If used it would mean >99% of the existing water production plants would be OOS. Imagine the drug shortage if >99% of world pharma closed down.

    ReplyDelete

Pharmaceutical Microbiology

Special offers