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Water2 0506
Water2 0506
Slide 1 of 25
WHO - EDM
Water treatment systems Storage requirements Sampling and testing Different types of water used in pharmaceuticals Microbial limits, disinfection
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WHO - EDM
Pipes sloped so water does not pool and can drain easily
Sanitary fittings & connections Constructed of suitable materials such as stainless steel Circulate the water Incorporate non-return valves (NRV)
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WHO - EDM
2. 3.
4. 5.
Slide 4 of 25
WHO - EDM
If D=25mm & distance X is greater than 50mm, we have a dead leg that is too long.
<2D
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WHO - EDM
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WHO - EDM
Sanitary pumps Clamps and O rings versus threaded fittings Heat exchangers Side arm level measuring devices are unacceptable
3. 4.
Slide 7 of 25
WHO - EDM
6
5 4 3 2 1
6 5 4 3 2 1
Cationic column
Anionic column
Cartridge filter 5 m
Outlets or storage.
Drain line Air break to sewer
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WHO - EDM
Slide 9 of 25
WHO - EDM
Counter Cation
Styrene Cross linking Agent (DVB) Hydrating Water
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WHO - EDM
Reverse Osmosis
Reverse Osmosis
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WHO - EDM
Semi-permeable membrane
raw water
Purified water
drain or recycle
Reject water
Slide 13 of 25
Permeate water
WHO - EDM
Reverse Osmosis
Feed Water
Permeate
Reject
Slide 14 of 25
WHO - EDM
Second stage reject water goes back to first stage buffer tank
Branch
First stage filtrate feeds second stage RO . excess back to 1st stage buffer tank with Air break to sewer 2nd stage buffer tank
Cartridge filter 1 m
Hygienic pump
Slide 15 of 25
WHO - EDM
Advantages
Disadvantages Many uses
purified water feeding of distillation units or ultra-filtration units Water for Final Rinse
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WHO - EDM
Can be used for WFI or for Water For Final Rinsing for parenteral manufacturing (if permitted) Removes organic contaminants, such as endotoxins
Operation at 80C, and sterilization at 121 C
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WHO - EDM
Ultrafiltration
Ultrafilters are asymetric membranes, sometimes composite Under pressure,small size molecules go through the membrane,whereas molecules larger then the NMWL are retained
100
Slide 18 of 25
WHO - EDM
Single-effect distillation
simple distillation, single effect vapour compression, thermo compression
2.
3.
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WHO - EDM
Spray ball
Heat Exchanger
Ozone Generator Hygienic pump Air break to drain
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WHO - EDM
One of the most reliable methods of disinfection of water systems Produced easily Leaves no residue
Ozone
Slide 21 of 25
WHO - EDM
UV does not sterilize Flow rate critical Post-irradiation recontamination may be an issue
4.
Other chemicals
1.
2.
3.
10-10 Wavelength(m)
10-7
10-6
10-4
10-3
Ultraviolet radiation
Ultra short Short UV-C
100 Wavelength (nm)
Module 2, Part 2: Water purification engineering Slide 23 of 25
WHO - EDM
Medium UV-B
280
200
U. V. Technology
Wavelength (nm)
Germicidal Action
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WHO - EDM
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
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WHO - EDM
Sample container
Sample label Sample storage and transport
4.
5.
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WHO - EDM
Nitrates
Nitrites
< 0,2
-
pass test
pass test
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WHO - EDM
pass test
-
JP
Method verification
Chemical testing Microbiological testing
test method
types of media used incubation time and temperature
International pharmacopoeia requirements for WFI are those for purified water plus it must be free from pyrogens Usually prepared by distillation Storage time should be less than 24 hours Microbial limits must be specified
2. 3. 4.
Slide 33 of 25
WHO - EDM
Water for final rinse must be of the same quality as the water required for pharmaceutical preparation
Slide 34 of 25
WHO - EDM
Any compound injected into mammals which gives rise to fever is a Pyrogen Endotoxins are pyrogenic, come from Gram negative bacterial cell wall fragments Detect endotoxins using a test for lipopolysaccharides (LPS)
rabbit test detects pyrogens LAL test detects endotoxins
4.
Slide 35 of 25
WHO - EDM
Post softener
Post activated carbon filter Feed to RO
100
50 20
300
300 200
500
500 500
RO permeate
Points of Use
10
1
50
10
Slide 36 of 25
WHO - EDM
100
100