4_06_Storage and Distribution, Ozone and UV_WZ

8/6/2019 4_06_Storage and Distribution, Ozone and UV_WZ

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Storage and Distribution of Pharmaceutical Water

Application of Ozone


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CONTENTS

Storage and Distribution of Pharmaceutical Water

Microbial Control

Comparison of RunningCost

Distribution System

Electrolytic Ozone Generation

Application of Ozone for PW Systems Ozone Measuring Device

Ozone Destruction by UV- Light

Christ Loopo

Ozone Case Studies

Ozone Applications Ozone References


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STORAGE AND DISTRIBUTION

Target:

The water must reach the consumerwithout loss of quality


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Storage Tank: the weak point of a distribution system

p Stagnant conditions and areas of low flow rates

p Poor supply water quality

Possible design rules: Make-up plant as small as possible (p continuous operation)

but water available in sufficient quantity (p peak consumption)

Continuous microbial control


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Distribution System: to bring the water to the point of use

Important design criteria:

Continuous turbulent flow

Proper slope

Avoid dead legs (p 6 D; suggestion 3 D)

Smooth, clean surface for wetted parts

Positive system pressure


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Cold distribution with ozone

Tank UV distribution

Point of use

u 1 m/s (return)

Pump

O3

HEx


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Tank

u 65 C Distribution

Verbraucher

< 1 m/s (return)

Pump

HEx

1...3 m/s

heiss kalt

HEx

(Pump)

Hot distribution with cold user


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MICROBIAL CONTROL

Storage and distribution at u 65C (Hot Systems)

Storage and distribution at 4 - 10C (Cold Systems)

Periodic Chemical Sterilization/Sanitization

UV-radiation Sterile filtration 0.2 Qm

Steam at 121C (saturated steam)

Hot water at 130...140C (under pressure)

or:

Sanitization with

p Ozone (O3)


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MICROBIAL CONTROL

ROCEDURES ADVANTA ES DISADVANTA ES

r i iz i5...85

y chemical

y hi h safety

y accepted

y easily controllable

y operating costs

y costly cooling systems forcold points of use

Sterile filtration y efficient

y can be validated( ntegrity Test)

y no protection forthe wholesystem as this is a finalfiltration

y investment costs

y critical change of cartridges

UV-Units y no chemicals

y Installation andoperating costs

y no absolute security

y no waternetwor protection

y not efficient in vessels andtanks


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MICROBIAL CONTROL

ROCEDURES ADVANTA ES DISADVANTA ES

ectrolyticgeneratedzone

y permanent protectionof storage tank

y periodic sterilization /sanitization

y low maintenance costs

y no contamination

y protection of the waternetwork

y removal of pyrogensand TOC

y investment costs

y material requirements

y acceptance

ydestruction of the ozonemay be necessary


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COMPARISON OF RUNNING COST

Sanitization at 80C versus Ozone

Ozone: 0.1mg/l (100 ppb) = 10 g

The production of 4 g ozone requires approx. 1.5 kW

Energy requirement approx. 4 kW/dCost: 1 CHF/d

Sanitization and Cooling:

Heating from 20 to 0 C

Energy requirement approx. 7000 kW/d

Cooling from 0 to 20 C

Energy requirement approx. 7000 kW/d

Cost: 1750 CHF/d

for 100 m Purified Water / Day:


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DISTRIBUTION SYSTEM

Rules of system / point of use design

ISPE Baseline Guide Vol 4 Water and Steam Systems 2001:

A correct system design needs the characterisation of all user points:

- Flow rates

- Volumes- Pressures

- Temperatures

- Simultaneous uses


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DISTRIBUTION SYSTEM

Point of use design / sampling

FDA guide to inspections of high

purity water systems 1993:

The sampling procedure for point of use

sampling should reflect how the water isto be drawn, e.g. if a hose is usually

attached then the sample is taken at the

end of the hose. If the SOP calls for the

line to be flushed before use of the

water from that point, then the sample istaken after the flush.

Loop

Valve

Spool piece

Flexible

Hose

Throttle

Valve or

fitting

TechnicalArea

Process

Area

Sample

Point


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DISTRIBUTION SYSTEM

About FutureConnections

Triclamped

spool piece in

main loop

Use of spool piece allows subsequent extension of loop,

or installation of sub loops

Already installed ZDL valves avoid loop system requalifi-cation after extension ( production stop)

Installation of Zero

Deadleg (ZDL) stylevalves


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ELECTROLYTICOZONE PRODUCTION

protection against

minimum flow

Electrolytic ozone

production (cell)Bypassinstallation


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H2

O

H2O + O2 +O3

H2 + ( H2O )

Cathode

AnodeMembrane


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The advantages of this process are convincing:

Ozone is produced directly from Purified Water and dissolved in it

Production of low ozone quantities in a high concentration No chemicals such as chlorine or equivalent are necessary

Fully automatic and maintenance-free operation

Reduction of TOC and other undesired water components is possible

No contamination by ionic water components


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APPLICATION OF OZONE FOR PW SYSTEMS

All wetted parts must be ozone resistant (e.g. gaskets, filters)

No need of a spray ball inside the storage tank

Velocity is of less importance

Biofilm formation is restrained

The volume of the storage tank is not critical

Temperature > 20 C is less critical (but should not exceed 30C)

Sanitary connections are not an absolute necessity

Design of tank allows to reduce costs (pressure, safety devices etc.)

insulation is typically not necessary PVDF as distribution system is acceptable


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APPLICATION OF OZONE FOR PW SYSTEMS

Growth likely

Growth possible

No Growth

0 0.004 0.00 0.012 0.016 0.020

Ozone concentration mg/l (ppm)

Hoffmann-La Roche (Swiss Pharma 1983)


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OZONE MEASURING DEVICE

Display and Alarm

O

Sensor

Absence and presence of Ozone should be proven


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OZONE DESTRUCTION BY UV- LIGHT


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CHRIST LOOPO

The Solution:

Compact skid- mounted system with:

Variable speed-drive pump(s) for distribution system

Electrolytic Ozone generator with following benefits

- Permanent protection of storage tank- Periodic sanitization of distribution system

UV unit for Ozone destruction at loop inlet

Control cabinet

Measurement of quality relevant parameters

(Flow, Conductivity, Temperature, Ozone and

TOC [optional])

Heat exchanger for cooling [optional]


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CUSTOMER SPECIFIC REQUIREMENTS

- Preferred supplier list of customer can be integrated (Pump, Ozone

measuring.)

- Operation mode with 1 Pump or 2 pumps (2x100%) with automatic

change

- Pump can be flow- or pressure-controlled

- Management of user points with interlocking function (it is not

allowed that 2 big user points are open at the same time)

- Piping in stainless steel or PVDF

- Stainless steel with lower surface roughness or ferrite

specification

- Interface with facility management


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OZONE CASE STUDIES

Effect of Ozone on Biofilm Removal

Biofilm in an old PVC distribution system (development building):

Counts 10...20,000 CFU/ml

Chemical disinfection: no effect

Mechanical cleaning with air and NaOH 2% rinsing: no effect

Introduction of ozone:

after one week results below 100 CFU/ml (constantly)

The plant is in operation since 1987 !


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OZONE CASE STUDIES

Effect of Ozone on Biofilm Removal

Dialysis water system (SS 316 L) in a hospital:

Problems:

- Germs and EU: out of spec. (OOS)

- Distribution system over dimensioned (velocity < 20 cm/sec.)- Endotoxines: > 1 EU/ml

- Germs: 200...1000 CFU/ml (no correlation with EU)

Solution: Sanitization with Ozone every night:

No OOS since more than 10 years !


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OZONE CASE STUDIES

Effect of Ozone on TOC

Plant 1 (IX) :

Raw water: 300 - 500 ppb

Ion exchanger : peaks up to 850 ppb

UV 185 nm: no effect !

Loop with ozone: < 400 ppb

Plant 2 (RO-RO):

Raw water: 820 ppb*

after1st stage RO: 60 ppb*

after 2nd stage RO: 40 ppb*

After ozonization: < 10 ppb

Plant 3 (RO-EDI):

Raw water: 820 ppb*

After treatment: 18 ppb

Loop (PVDF): < 5 ppb

*) average values


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OZONE CASE STUDIES

Summary for TOC reduction:

Ozone has an impact on reduction of the TOC level in a system.

However,Ozone should not be used as TOC removal unit.

Ozone is an agent to maintain the TOC

on a low level in a system


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OZONE CASE STUDIES

Effect of Ozone on Endotoxines

Plant 1 (IX):

Feed into the tank: 0.41 EU/ml*

Distribution system: < 0.06 EU/ml (Reduction rate > 85%)

Concentration of O3: 0.02 mg/l (20 ppb)

Plant 2 (RO-RO):

Feed into the tank: 0.08 EU/ml*

Distribution system: < 0.025 EU/ml (Reduction rate > 70%)

Concentration of O3: 0.08 mg/l (80 ppb)

*) average values


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OZONE CASE STUDIES

Summary for endotoxine units (EU) reduction :

Ozone has an impact on reduction of EU level in a system.

However,Ozone should not be used as EU removal unit.

Ozone is an agent to maintain the EU content

on a low level in a system


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OZONE APPLICATIONS

Purified Water (PW) yes

Highly Purified Water (HPW; low endotoxine) yes

Purified Water for haemodialysis yes

Purified Water in cosmetics,

biotechnology and health care applications yes

Purified Water for general hygienic applications yes

Water for Injection (WFI) (no)


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OZONE REFERENCES

More than 200 plants in Europe, South and North America,

Asia, Africa

Results:

no problems with compendial water quality

no problems with acceptance of authorities (EU, USA)

more than 20 plants FDA inspected in Switzerland


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Thank you very much for your attention.

Any Questions ?


4_06_Storage and Distribution, Ozone and UV_WZ

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