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Water
for Pharmaceutical
Good Manufacturing
Practice
Use
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WHO - EDM
2.
Storage requirements
3.
4.
5.
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WHO - EDM
2.
3.
4.
5.
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WHO - EDM
Filtration
2.
Disinfection
3.
4.
Distillation or ultra-filtration
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WHO - EDM
<2D
Sanitary Valve
Water scours deadleg
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WHO - EDM
Stagnant
water
inside valve
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WHO - EDM
Sanitary pumps
2.
3.
Heat exchangers
4.
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WHO - EDM
Water
must be
UV light
kept
circulatin
g
HCl
NaOH
5
4
3
2
1
5
4
3
2
1
Cationic column
Anionic column
Cartridge
filter 5 m
Eluates to
neutralization
plant
Cartridge
filter 1 m
Ozone generator
Hygienic pump
Return to de-ioniser
Outlets or storage.
Drain line
Air break to sewer
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WHO - EDM
UPFLOW:
Channeling
but lower
risk of
clogging
Used in
Pretreatment
Module 2, Part 2: Water purification engineering
DOWNFLOW :
No channeling
and better ion
capture,
but higher
risk of
clogging
Used in
Polishing
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WHO - EDM
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WHO - EDM
Reverse Osmosis
Osmosis
Osmotic
pressure
1
Feed water
Purified water
Reverse osmosis
membrane (RO)
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WHO - EDM
High pressure
under
pressure
raw water
Semi-permeable
membrane
Feed
water
Permeate
water
Reject
water
drain or recycle
Purified water
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WHO - EDM
Reverse Osmosis
Feed Water
Reject
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WHO - EDM
Second stage reject water goes back to first stage buffer tank
1st stage reject concentrate
Branch
Branch
High pressure
pump
Second stage RO water
meets Pharmacopoeia
standards
Cartridge
filter 1 m
Hygienic pump
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WHO - EDM
Advantages
Disadvantages
Many uses
purified water
feeding of distillation units or ultra-filtration
units
Water for Final Rinse
Water for Injections (if permissible)
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WHO - EDM
Ultrafiltration
100
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WHO - EDM
Single-effect distillation
simple distillation, single effect
vapour compression, thermo compression
2.
3.
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WHO - EDM
Water must
be kept
circulating
Cartridge
filter 1 m
Spray ball
Optional
in-line filter
0,2 m
UV light
Outlets
Heat Exchanger
Ozone Generator
Hygienic pump
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Air break
to drain
WHO - EDM
Ozone
Produced easily
Leaves no residue
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WHO - EDM
3.
4.
1.
Other chemicals
1.
XO2
2.
Halogen
Formaldehyde
3.
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WHO - EDM
UV Technology :
Electromagnetic Spectrum
Gamma rays
Infrared
10-10
Wavelength(m)
X Rays
U.V.
Visible
10-7 10-6
10-4
10-3
Ultraviolet radiation
Ultra short
Short
Long wave
UV-A
100
200
Wavelength (nm)
280
Medium
UV-C
UV-B
315
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WHO - EDM
400
U. V. Technology
Wavelength
(nm)
185
254
313
Emission of a low pressure mercury lamp.
Module 2, Part 2: Water purification engineering
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WHO - EDM
Germicidal Action
60%
40%
20%
0%
24
0
26
0
28
0
30 320
0
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WHO - EDM
UV Technology
(185 + 254 nm)
Conversion of traces of
organic contaminants to
charged species and
ultimately CO2 (185 +
254)
Limited destruction of
micro-organisms and
viruses (254)
Easy to operate
Polishing technique
only: may be
overwhelmed if
organics
concentration in feed
water is too high.
Organics are
converted, not
removed.
Limited effect on
other contaminants
Good design required
for optimum
performance.
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WHO - EDM
Contaminants Removal
STILL
DI
RO
UF
MF
AC
IONS
ORGANICS
PARTICLES
COLLOIDS
BACTERIA
VIRUSES
GASES
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WHO - EDM
2.
3.
Sampler training
4.
Sample point
5.
Sample size
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Sample container
2.
Sample label
3.
4.
5.
Start of test
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WHO - EDM
JP
USP
pH
5.0-7.0
5.0-7.0
Cl
< 0.5
pass test
pass test
SO4
pass test
pass test
pass test
NH4
< 0.2
< 0.05
pass test
Ca/Mg
pass test
pass test
Nitrates
< 0,2
pass test
pass test
Nitrites
pass test
5.0-7.0
Int. Ph.
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WHO - EDM
pass test
JP
-
USP
< 1.3
Int. Ph
-
Oxidizable subs.
pass test
pass test
pass test
Solids (ppm)
< 10
< 10
nmt(*) 10
TOC (ppm)
< 0.5
< 0.5
Heavy metals
pass test
CO2
pass test
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WHO - EDM
Method verification
2.
Chemical testing
3.
Microbiological testing
test method
types of media used
incubation time and temperature
objectionable and indicator organisms
manufacturer must set specifications
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2.
3.
4.
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2.
3.
4.
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WHO - EDM
(CFU /mL)
Target
200
Alert
Action
300
500
100
300
500
100
300
500
Post activated
carbon
Feed tofilter
RO
50
300
500
20
200
500
RO permeate
10
50
100
Points of Use
10
100
Raw water
Post multimedia
filter
Post softener
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WHO - EDM