URS Workshop

Storage and Distribution System

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 User Requirement Specification

► What is a URS?
A URS is a detailed document used to specify the
requirements of the user for individual aspects of the facility,
equipment , utility and system in terms of function,
operation, document and applicable qualifications need.

Ref.: ISPE Confidential

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 Design Phase of the New Project

V-Model ”Direct Impact” Systems

PQ Test
URS PQ
Plan

OQ Test
FDS OQ
Plan
Design
(incl. FAT)
Development
DDS
IQ Test IQ
Plan SAT
Impact assessment

Implementation

ISPE Baseline Guides– Volume 5: Commissioning and Qualification – March 2001

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 Design Phase of the New Project

V-Model ”Indirect Impact” Systems

Commissioning PQ
URS
Plan

FDS Incl FAT OQ

Plan
Design
Development
Incl PDI
DDS IQ
Plan SAT
Impact assessment

Implementation

ISPE Baseline Guides– Volume 5: Commissioning and Qualification – March 2001

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Hot Storage and Distribution system

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Cold Storage and Distribution System

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User Requirement Specification

► What is to be included in the URS document for

Storage and Distribution Purified water system ?
 Purpose or Scope
 Area application
 Responsibilities
 Requirement
 Regulatory requirement
 Material Requirement for Storage and distribution
system
 Storage Vessel requirement
 Requirement for Water distribution pipe work
 Sanitation and Bioburden control
 Instrument and control
 Testing and Documentation
 General Requirement

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Regulatory Requirement

► Guidelines Regulation
 Current United State Pharmacopeia (USP)
 Current ASME BPE
 ISPE Good Practice Guidelines
 WHO Drinking Water Guidelines
 European Pharmacopeia
 Etc

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Regulatory Requirement

► Specific Requirement water quality

USP Pharmacopeia 36

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Material Requirement for Storage and Distribution
System

► Compatibility (temperature and chemical )

► Corrosion resistance (316 L )
► Smooth internal finish < 0.8
► Jointing
► Design of flange or unions
► Documentation
► Material ( 316 L, polypropylene, polivinylidene
difluoride and perfluoroalkoxy)

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Storage Vessel Requirement

► Capacity : Simulation sizing required

► Spray ball device
► Design nozzle to avoid dead zone
► Vent filter ( Bacteria retentive, Hydrophobic, able
for in-situ integrity Test, Electric heater )
► Pressure –relief and bursting discs

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Requirement for water distribution pipe work
► Temperature Control and Heat Exchanger
 Cold system
 Hot System

► Circulation Pump
 Circulation pump as a sanitary design with appropriate seal that
prevent contamination of the system
► Bio-contamination control technique
 Maintenance of continues turbulent flow
 Dead-legs in the pipe work installation L/D =2 (ASME BPE 2009)
 Membrane Pressure gauge
 Diaphragm valve should be used
 Pipe work slope or drain ability (1-2 % ASME BPE 2009)
 The growth of microorganisms can be inhibited by
 Ultraviolet radiation in pipe work
 Maintaining the system heated ( 70 -80 deg C)
 Sanitizing the system periodically ( > 70 deg C Hot)
 Sanitizing the system periodically ( Ozone or Chemical Cold Process)
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Sanitation and Bioburden Control

► Hot Sanitation
 System that operate and maintained at elevated
temperature in the range of 70 – 80 deg C

► Ozone sanitation or other suitable chemical agent

 System that

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Instrument and Control

► All measuring equipment should be calibrated

► Instrument installed in a way to reduce the
potential for contamination
► Clearly indicated which instrument are critical and
which are not critical

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Function Design Specification

► Point of Use Consumption (PUC)

► Operating condition
 Temperature
 Pressure
► Purified Water generation system
 Flow rate
 Quality
► Sanitation System
► Process Control
► HMI Layout
► Electronic data storage and system security

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Sample Point of Use Consumption

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Detail Design Specification

► Material used
► Size of pipe, pump, heat exchanger, storage tank,
critical instrument and other field device
specification
► Correct or incorrect installation of the equipment
► Automation configuration
► Electrical drawing
► Documentation requirements

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Impact Assessment

► System level impact assessment

 Direct impact system
 Indirect impact system
 No impact system
► Component Level impact assessment
 Critical component impact system
 Non critical component impact system
► Critical attribute and critical process operating parameters

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Design Qualification
A documented review of the design at an appropriate stage in a
project for conformance to operation and regulatory expectations

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Study Case

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Study Case 1

► Please make user requirement review that showed

at least 2 direct impact assessment

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Hot Water Distribution

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Study Case 2

► Please make user requirement review that showed

at least 2 direct impact assessment

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Cold Water Distribution

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