Micro/Clean Design

Clean Design Principles

‘Do/Don’ts’ for Water Systems Design
 - .

Micro/Clean Design Principles

Water Systems Design

Water System Design Requirements
 “Do’s” & “Don’ts” —very difficult to ID good and bad examples
without looking in detail at the water systems.
 Review other “Do’s & Don’ts” first prior to review of the
water systems
 Surface Finishes
 Piping
 Tanks
 Pumps
 Filters/Strainers
 Pressure Relief
 Valves
 CIP/SIP
 Micro/Clean Design Principles

Clean Design Specs for Water Systems

 Process Overview
 Water System Design
 Design Requirements:
 Water system: Process Overview
 Color codes (Green; Red; Blue)
 Pre-treatment
 Core Treatment and Purification:
 Storage (Preservation) and Distribution
 Materials of construction (MOC)
 Conditions that increase microbial risk
 Common Design Features
 Branch System Designs
 Water Velocity Requirements
 Pipe Connections
 CIP/SIP
 Micro/Clean Design Principles

Water Systems Design

“Do”

Deionization Not always needed

Storage
Feed
Pretreatment Polishing &
Water Distribution

RO

Pre-Treatment Purification Storage & Distribution

Raw Water Process Water Purified Water
Protected Unprotected Protected
(Chlorine) (Ozone or Heat)
High Risk
Micro/Clean Design Principles

Water Systems Design

 Green is chlorine protected water
 Controls microbial growth
 Red is dechlorinated unprotected water
 High microbial risk
 Requires frequent sanitization
 Blue is protected water
 Heat (> 820C/1800F)
Actively kills microorganisms
 Ozone

Color Coding
Micro/Clean Design Principles

Water Systems Design

“Do”

Pre-Treatment Purification Storage & Distribution

Raw Water Process Water Purified Water
Protected Unprotected Protected
(Chlorine) (Ozone or Heat)
High Risk
Pre-treatment: Chlorine either inside or outside site
Core Treatment and Purification: RO System to reduce micro activity
Storage (Preservation) and Distribution: Maintaining water quality (either ozone or heat treatment
(82 0C(180 0F))

Typical Purified Water System

Micro/Clean Design Principles
Pretreatment Purification Storage & Distribution
Water Protected by Chlorine Water Unprotected Water Protected by Ozone
City
Water High Risk
Cleaning & Sanitization
Flow Paths for RO & CDI
UV has to
with High Risk, be turned
Unprotected Water off
SIP/CIP periodically
SIP/CIP Connection to sanitize
Connection Ozonated the
Raw
Water distribution
Water Tank RO loop.
CDI Tank
RO
MMF Softener Prefilter
SIP/CIP
RO
Connection
Feed
Pump
Ensure there are
CIP isolation valves within Ozone

Connection 3 pipe diameters of Generator

UV
SBS Injection Detail
CIP connection to
isolate circuit from Ozone
Low Micro Risk if other equipment and Distribution
Recirc
Raw Concentration is ensure no dead legs - Pump
Water turbulence sweeps Pump
10% or Higher branches clean.
Pump
SBS
CIP
Feed
Turbulence
CIP Turbulence
Feed

CDI
<3d RO Feed
Pump

<3d

Typical Purified Water System

 Micro/Clean Design Principles

Water Systems: Materials of Construction

Pre-Treatment
(=standard for new equipment)
Given Pre-treatment systems are
chlorine protected, material
selection can be FRP, PVC, or carbon
steel lined. Water softener tank
similar as MMF Tank.
Surface finish to mill standard.
Core Treatment & Purification Storage & Distribution
(all RO machines to use full fit membranes)
Exceptions to be approved by Micro/QA
Purification: RO and RO/CDI use316L SS 316L SS. No PVC; No FRP.
tubing with 316L SS piping for portions of 304SS not recommended due
reject line to drain. to corrosive impact of Fe to
finished water.
Ra 0.8-1.0μm (32-42μinch) Ra 0.8-1.0μm (32-42μinch)

Non-sanitary connections and piping
through all the Pre-treatment
sections. Avoid ball valves.
Exceptions have to be approved by
GMDO.
After chlorine removal; piping to be 316L All piping prior and existing
SS. Sanitary tri-clamps; no internal storage system 316L SS
threads; No PVC; No ball valves--only sanitary tubing meeting
approved sanitary butterfly, piston or Design and Construction
diaphragm valves. For high pressure RO Standard 15371. Sanitary
applications (feed and/or reject lines), tri-clamps; no internal
ball valves may be required, must be threads; No PVC; No ball
approved by GMDO. valves--only approved sanitary
butterfly, piston or diaphragm
valves.

Check your MOC compatibility with your product & sanitizing agent with CETL !
More details: See P&G Clean Design Standards on cGMP site *Exception where Industrial RO Machines are used
Micro/Clean Design Principles

Water Systems Design

 Conditions that increase microbial risk
 Stagnant conditions and areas of low flow rates
 Where no applications of heat or ozone; ensure turbulent flow
(>1 meter/sec: up to DN 75mm/3” diameter pipe)
 Heat and ozone present; flow rate sufficient to maintain
concentration or temperature
 Temperatures that promote microbial growth (15-550C)
 Poor quality water supply
 High Organic Level
 High Bio-burdens
 In-appropriate use (e.g., hoses permanently connected;
leaks not corrected, etc.)
 Micro/Clean Design Principles

Water Systems Design

General comparison of Ground water versus Surface Water
PARAMETER Ground (Well) Surface Water
Water

Dissolved Solids High Low

Suspended Solids Low High

Organic Content Low High

Microbiological Site specific Seasonal

Activity variability

Water Quality: Incoming Water

Micro/Clean Design Principles

Water Systems Design

“Do”
 Common Design Features:
 Storage at elevated temperature (>820C/180 0F)
 Proper slope
 Smooth, clean surfaces that minimize nutrient accumulation
 Polished tubing; Orbital welding
 Use of sanitary connections/sanitary valves (No ball valves)
 Maintaining positive system pressure; no leaks in system
 Constant Circulation
 Frequent draining, flushing or sanitizing (of non-protected
areas)

Common Design Features consistent with all “Do’s & Don’ts”

Micro/Clean Design Principles

Water Systems Design

“Do”

Purification: Reverse Osmosis: RO System

Micro/Clean Design Principles

Water Systems Design

“Do”
Micro/Clean Design Principles

Water Systems Design

 Recirculating loops are the preferred method for water

distribution systems
 Loops allow continuous flow
 Loops allow simple sanitization strategies
 Branch distribution systems should be avoided!
 Branch systems result in stagnant flow conditions
 Branch systems are extremely difficult to sanitize –
particularly with large systems
 No dead legs
 Dead legs are difficult to clean and make rinsing difficult as
well

Distribution
Micro/Clean Design Principles

Water Systems Design

“Do”
Distribution Loop

Storage
Tank

Distribution: Recirculation Loop (Preferred Design)

Micro/Clean Design Principles

Water Systems Design

“Do”

Distribution: Parallel Loop Configuration

Micro/Clean Design Principles

Water Systems Design

“Do”

Distribution: Sub-Loop Configuration: Issue for the above is the design of the back pressure associated with the sub-loop.
An option is to install stop valves at each sub-loop to avoid back pressure issues. Momentary non-flow cvonditions are
acceptable through the sub-loop. Users need to understand the system hydraulic requirements and control strategy for this
type of application.
Micro/Clean Design Principles

Water Systems Design

“Don’t”

Branch Distribution: Not Clean Design- (Branch systems result in stagnant flow conditions)
Micro/Clean Design Principles

Water Systems Design

“Don’t”

Velocity is too low to keep the pipe flooded

Water Velocity: Why is it Important?

Micro/Clean Design Principles

Water Systems Design

 “Rules of Thumb” for Velocity in a Water System to

MINIMIZE biofilm formation
 Reynolds Number, NRe is the ratio of the inertial force to the
viscous force
NRe = DVρ/μ
NRe ≤ 2,100 – Laminar Flow
NRe 2,100 – 4,000 – Transition Regine
NRe ≥ 4,000 – Turbulent Flow
 A minimum return velocity is required to maintain the loop in a
flooded condition under positive pressure
 Reynolds Number – Turbulent flow regime

Water Velocity: Objective is to have turbulent flow (Assures pipe is flooded)

Micro/Clean Design Principles

Water Systems Design

Diameter NRe Volumetric Velocity @ Volumetric
 Why not just use the @ 2m/s Flow (m3/hr) NRe 20,000 Flow (m3/hr)
velocity rules (1-2 m/s)? (m/s)

 How does velocity DN 25 50,000 3.5 0.8 1.4

impact the system (~1”)
design and cost?
 Equipment capital DN 80
(~3”)
160,000 36 0.25 4.5

cost
 Operating cost DN 150 250,000 127 0.13 8.3
(~6”)
 Energy
 Maintenance DN 250 500,000 353 0.08 14
(~10”)

Reynolds Number Versus Minimum Velocity

Micro/Clean Design Principles

Pipe Connections & Systems

“Do” “Don’t”

Note: RE: Dead leg design requirements: Always aim to minimize dead leg lengths particularly for large
bore pipe since turbulent flow regime during cleaning is more difficult to achieve
Example: Dead Leg illustration identifying “cleaning” effectiveness
 Micro/Clean Design Principles

Water Systems Design

“Do” & “Don’t”

Cross connection
has dead legs

Water system should have pre-treatment systems

Micro/Clean Design Principles

Water Systems Design

“Don’t”

Example: Dead Leg illustration

Micro/Clean Design Principles

Water Systems Design

“Do”

Water System: Pipe Connections

Micro/Clean Design Principles

Water Systems Design

“Do”

Water System: Pipe Connections

Micro/Clean Design Principles

Water Systems Design

“Don’t”

Bolted connection on a water system NOK

 Micro/Clean Design Principles

Water Systems Design

“Don’t”

Water system should be logical with planned layouts and pipe flow indicator markings
 Micro/Clean Design Principles

Water Systems Design

“Do” or “Don’t”??

Design
Simplicity—
yes or no?

Water system should be logical with planned layouts and pipe flow indicator markings
Micro/Clean Design Principles

Water Systems Design

“Don’t”

Progressive cavity pump selection for RO System

 Micro/Clean Design Principles

Clean Design Specs for CIP/SIP*

 Water System Design:
 Inert Materials
 316L SS (or sufficient recommended metallurgy (based on
system application)
 Fully Drainable
 Surface finish Ra <0.8 microns (32 micro-inches)
 Smooth surfaces
 Avoidance of bio-films
 Prevent product/material accumulation
 Welds polished and good quality
 Clean and dry air
 Protected against contamination from outside environment

*CIP = Clean-in Place; SIP = Sanitize-in-Place Note: Reference CIP/SIP “Do’s” and “Don’ts”
Micro/Clean Design Principles
Water Systems Clean Design Summary
“Do”
• REVIEW OTHER DO/DON’TS PRIOR
TO WATER SYSTEMS CHEC
•REVIEW COLOR CODING
•STORAGE TEMP (>820C)
•PIPE DRAIN-ABILITY
•SMOOTH SURFACES
•POLISHED TUBING/ ORBITAL
WELDING
•SANITARY CONNECTIONS
•MAINTAIN POSITIVE SYSTEM
PRESSURE
•CONSTANT CIRCULATION
•PARALLEL LOOPS/SUB LOOPS
•TURBULENT FLOW
•CIP/SIP ABILITY
“Don’t”
•HAVE DEADLEGS
•STAGNANT WATER/LOW FLOW
CONDITIONS
•IF NECESSARY, TREAT WATER
APPROPRIATELY
•MICROBIAL GROWTH PROMOTION
•TEMPERATURE (15-550C)
•POOR WATER SUPPLY
•HIGH ORGANIC LEVEL
•UNSANITARY USE OF
EQUIPMENT
•PRESSURE LEAKS
•BRANCHED LOOP SYSTEMS