“How Dry I Am”
Solutions for the Pharmaceutical Industry To Meet
the new NC Water Restrictions
Speaker: Martin E. Rock, P.E., J.D., LEED-AP
Title: President & Senior Principal
Affiliation: OMNI Professional Environmental
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Chapter
1
Water Conservation
A Few Basics . . .
OMNI
Martin E. Rock, P.E., J.D., LEED-AP
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OMNI Professional Environmental
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Chapter
Research
2
Triangle Park, NC
The Eskimo
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The Apple Pie
Xs and Os
3
Thank You Sponsors!
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4
Thank You Sponsors!
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Chapter
5
Four Types of Drought
1.Meteorological
2.Agricultural
3.Hydrological
4.SocioEconomic
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Can we blame
La Niña?
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Agricultural Drought
Easley Asks for Federal Help
for North Carolina farmers.
"Early indications are that more than 90 counties may
meet the criteria for federal disaster assistance," Easley
said.
Criteria: At least one covered crop that is yielding 30
percent or more below normal.
October 25, 2007
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Hydrologic Drought
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Hydrologic Cycle
WATER CARMA: WHAT GOES AROUND – COMES AROUND
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Rainfall Data 1961-1990
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SocioEconomic
Drought
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Types of “Water”
•
•
•
•
Gray Water
Reused Water
Reclaimed Water
Pharmaceutical Water Types (FDA-ITG)
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8 Types of Water
Used in Drug Manufacture
• Non-Potable
• Potable (Drinkable)
Water
• USP purified water
• USP water for
injection (WFI)
• USP sterile water for
injection
• USP sterile water for
inhalation
• USP bacteriostatic
water for injection
• USP sterile water for
irrigation
The latter 4 are “finished” products that are packaged and
labeled as such.
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Water for Pharmaceutical Use
• USP = subject of an official monograph of the US
PHARMACOPEIA with various specifications.
• USP purified water and USP WFI water are
components or “ingredient materials”, intended to
be used in drug production.
• Potable water is defined by EPA standards. (May
not be used for USP dosage form drugs or for
laboratory reagents to test solutions.)
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United States Pharmacopeia 23
Standards
USP 23 Pharmaceutical Grade Water
Purified Water (topical
solutions and
cosmetics)
Water for Injection
Organics
<0.5ppm TOC
<0.5ppm TOC
Conductivity
<1.3 µg/cm at 25°C
inline measurement
<1.3 µg/cm at 25°C
inline measurement
Endotoxin by LAL
No specification
<0.25 EU/mL
Bacteria
100 cfu/mL
10 cfu/100 mL
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“Reclaimed Water” – California
(May Mean: Aquifer Storage & Retrieval)
So, may actually be cleaner than normal tap water. . .
A few hundred yards to a few miles
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(Sewage Plant Effluent)
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Biological Health Risks of
Reclaimed Water
• Aerosol transmission of pathogens in
cooling water
• Possible cross connection of potable and
reclaimed water lines
• Possible spill/leak of cooling tower,
release of pathogens into groundwater
supply
• Microbial contamination of oral liquid and
topical drug products
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Johnson & Johnson Pharmaceutical
Research & Development, L.L.C.
La Jolla, CA
The site implemented use of reclaimed water for landscape irrigation
and cooling tower water in 2006. The total volume
of reclaimed water used in 2006 was 14,182,080 gallons.
In 2007, the site experienced corrosion of the cooling towers
caused by use of reclaimed water.
The site will continue to use reclaimed water for landscape irrigation,
and is in the process of evaluating whether reclaimed water can be
used in cooling towers.
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Gray Water
The North Carolina Plumbing Code defines gray water as
“waste discharged from lavatories, bathtubs, showers,
clothes washers and laundry sinks.” This type of wastewater
may contain disease-producing organisms and should not be
used to water plants such as trees, vegetable gardens or
flowers. By law, this wastewater must be disposed of through
a permitted treatment system, either a public owned
treatment plant or a permitted septic tank system.
North Carolina State Building Code - 2006 Plumbing
Code: Current version Code 301.3 requires all plumbing
fixtures, drains and appliances that receive or discharge
liquid wastes or sewage to discharge to the sanitary
drainage system of the structure – unless it discharges to an
approved
water recycling
system.
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Chapter
Cooling Towers
101
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A small increase
in the Concentration
Ratio may result
in major water use
Reduction.
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Cooling Towers 101:
Screens & Drift Eliminators
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Cooling Tower O&M Issues
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Major Constituents (> 5 mg/L)
• Calcium
• Magnesium
• Sodium
• Bicarbonate
• Chloride
• Sulphate
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•
•
•
•
•
pH
Alkalinity
TDS
Conductivity
Total Hardness
• Silicon
• Carbonic Acid
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Collins Diagram
120
Concentration (meq/L)
Na++K+
Mg2+
100
Ca2+
Cl-
80
SO42HCO3-+CO32-
60
40
20
0
Sample
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1
Sample 2
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Sample 333
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Membrane Technology
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North Carolina
Water Allocation Study
•
•
•
•
Priorities & Rationing Decisions
Water Conservation Strategies & Incentives
Public Input & Stakeholder Meetings
Report expected during Fall 2008
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Points to Remember
– Observe strict regulations &
requirements pertaining to gray
water reuse and reclaimed water
– Keep good records to protect
water allocation
– Beware of corrosion, scaling &
biological contamination from
reclaimed and reused waters.
– Clearly label potable and nonpotable water lines
– Save water the easy ways (Look
for “low hanging fruit”.)
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