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4 - 06 - Storage and Distribution, Ozone and UV - WZ

The document discusses using ozone for microbial control in pharmaceutical water storage and distribution systems, noting that ozone can provide permanent protection of storage tanks and periodic sanitization of distribution systems in a cost-effective manner without the use of chemicals.

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101 views28 pages

4 - 06 - Storage and Distribution, Ozone and UV - WZ

The document discusses using ozone for microbial control in pharmaceutical water storage and distribution systems, noting that ozone can provide permanent protection of storage tanks and periodic sanitization of distribution systems in a cost-effective manner without the use of chemicals.

Uploaded by

decio ventura rodrigues mira
Copyright
© Attribution Non-Commercial (BY-NC)
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PPT, PDF, TXT or read online on Scribd
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Storage and Distribution of Pharmaceutical Water

Application of Ozone

30.03.2005, Wz
CHRIST PHARMA & LIFE SCIENCE LTD, SWITZERLAND
30.03.2005, Wz
STORAGE AND DISTRIBUTION

Target:
The water must reach the consumer
without loss of quality

30.03.2005, Wz
STORAGE AND DISTRIBUTION

Storage Tank: the weak point of a distribution system


 Stagnant conditions and areas of low flow rates
 Poor supply water quality

Possible design rules:


• Make-up plant as small as possible ( continuous operation)
but water available in sufficient quantity ( peak consumption)
• Continuous microbial control

30.03.2005, Wz
STORAGE AND DISTRIBUTION

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


Important design criteria:
• Continuous turbulent flow
• Proper slope
• Avoid dead legs ( ≤ “6 D”; suggestion ≤ “3 D”)
• Smooth, clean surface for wetted parts
• Positive system pressure

30.03.2005, Wz
Cold distribution with ozone

 1 m/s (return)
HEx

O3

Tank Pump UV distribution

Point of use
30.03.2005, Wz
Hot distribution with cold user

< 1 m/s (return)


HEx

Tank 1...3 m/s


 65 °C Pump Distribution

(Pump)

HEx

30.03.2005, Wz
Verbraucher heiss kalt
MICROBIAL CONTROL

• Storage and distribution at  65°C (“Hot” Systems)


• Storage and distribution at 4 - 10°C (“Cold” Systems)
• Periodic Chemical Sterilization/Sanitization
• UV-radiation
• Sterile filtration 0.2 m
• Steam at 121°C (saturated steam)
• Hot water at 130...140°C (under pressure)
or:

Sanitization with
 Ozone (O3)
30.03.2005, Wz
MICROBIAL CONTROL

PROCEDURES ADVANTAGES DISADVANTAGES

Periodic Sterilization /  “no chemicals”  installation costs


Sanitization with Steam at  safety  production stop
121°C  well-proven and  emptying of the systems
accepted necessary
 controllable by  sloped erection of the
temperature distribution system
 work-intensive
 no permanent protection

Periodic Sterilization /  efficient  chemicals


Sanitization with  simple handling  rinsing must be supervised
Chemicals:  low investment costs  production stop
 Peracetic acid  no permanent protection
 Hydrogen peroxide  time-intensive
 Sodium Hypochlorite  damages to membranes /
 Formaldehyde resins
30.03.2005, Wz
MICROBIAL CONTROL

PROCEDURES ADVANTAGES DISADVANTAGES

Permanent sanitization  “no chemicals”  operating costs


at 65...85 °C
 high safety  costly cooling systems for
 accepted cold points of use
 easily controllable

Sterile filtration  efficient  no protection for the whole


 can be validated system as this is a final
(Integrity Test) filtration
 investment costs
 critical change of cartridges

UV-Units  no chemicals  no absolute security


 Installation and  no water network protection
operating costs  not efficient in vessels and
tanks

30.03.2005, Wz
MICROBIAL CONTROL

PROCEDURES ADVANTAGES DISADVANTAGES

Electrolytic generated  permanent protection  investment costs


Ozone of storage tank  material requirements
 periodic sterilization /  acceptance
sanitization
 destruction of the ozone
 low maintenance costs may be necessary
 no contamination
 protection of the water
network
 removal of pyrogens
and TOC

30.03.2005, Wz
COMPARISON OF RUNNING COST

 for 100 m³ Purified Water / Day:

Sanitization at 80°C 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/d
Cost: 1 CHF/d

Sanitization and Cooling:


Heating from 20 to 80 °C
 Energy requirement approx. 7000 kW/d
Cooling from 80 to 20 °C
 Energy requirement approx. 7000 kW/d
Cost: 1750 CHF/d

30.03.2005, Wz
ELECTROLYTIC OZONE PRODUCTION

protection against
minimum flow

Electrolytic ozone
Bypass
production (cell)
installation

30.03.2005, Wz
ELECTROLYTIC OZONE PRODUCTION

H2O + O2 + O3 H2 + ( H 2 O )

Membrane
Anode

Cathode

30.03.2005, Wz
H 2O
ELECTROLYTIC OZONE PRODUCTION

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

30.03.2005, Wz
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 30°C)
• 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

30.03.2005, Wz
APPLICATION OF OZONE FOR PW SYSTEMS

Growth likely

Growth possible

No Growth

0 0.004 0.008 0.012 0.016 0.020

Ozone concentration mg/l (ppm)

Hoffmann-La Roche (Swiss Pharma 1983)

30.03.2005, Wz
OZONE MEASURING DEVICE

Absence and presence of Ozone should be proven

O Sensor
Display and Alarm

30.03.2005, Wz
OZONE DESTRUCTION BY UV- LIGHT

30.03.2005, Wz
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]

30.03.2005, Wz
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

30.03.2005, Wz
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 !

30.03.2005, Wz
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

30.03.2005, Wz
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

30.03.2005, Wz
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

30.03.2005, Wz
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)

30.03.2005, Wz
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

30.03.2005, Wz
STORAGE AND DISTRIBUTION

Thank you very much for your attention.

Any Questions ?

30.03.2005, Wz

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