British Standards Institution

Source:: ISO
Committee:: B/505/50 - Water reuse
Categories:: Information management | Standardization. General rules
Comment period start date:: 05/09/2024
Comment period end date:: 27/10/2024

Comment by:

27th Oct

Scope

This document provides design principles for the installation, operation, and performance of reliable purified water (PW) and water for injection (WFI) storage and distribution systems based on membranes. This document covers the following topics: - distribution piping, - associated system components, - point of use (POU), - operating parameters, - piping and accessories for the POU and equipment inlet sanitization. - all distribution loops and sub-loops are included in the scope of this document. This document does not cover the following topics: - detailed specifications for the equipment design, construction, and inspection, - detailed specifications for pipeline installation, slope measurement, cleaning, and passivation, - detailed engineering design, commissioning, and operation of the PW/WFI system , - inspection and Verification / Qualification / Validation requirements, - pretreatment and purification systems that are used to generate PW/WFI (refer to ISO 22519), - hardware that will constitute the control system of a PW/WFI system.

Purpose

The water quality specifications for purified water (PW) and water for injection (WFI) are given in national and international standards and are well defined and understood. The PW/WFI storage and distribution systems need to be in accordance with the company's policy and current good manufacturing practice (cGMP). Properly engineered, constructed, operated and maintained storage and distribution systems must reliability meet PW/WFI quality specifications with low operational costs.

Comment on proposal

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Would you or your organization be prepared to participate in the development of the standard or to comment on the draft when it is available? *

Are you aware of any regulation, existing standards and other good practice information in this area in the UK (e.g. Industry codes of practice; company specifications, international or European Standards)? *

Would the development of a standard(s) in this area have a particular impact/relevance to SME, consumer, environmental or societal interests? *

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Additional comments on the scope or proposal:

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Discard

Please email further comments to: debbie.stead@bsigroup.com

Standard timeline

1. Proposal

Proposal start date:

05/09/2024

Proposal end date:

27/10/2024

2. Draft

3. Public Comments

4. Comment Resolution

5. Approval

6. Publication

Learn more about the standards development process

Standards Development

ISO/NP 25413 Purified water (PW) and water for injection (WFI) storage and distribution systems

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