Project co-financed by
European Union
Project co- financed
by Asean
GMP SUPPLEMENTARY TRAINING MODULE
WATER FOR COSMETIC USED
Prepared by :
Haryanto Susilo
- Indonesia
Surachai Piyayodilokchai
- Thailand
Stephanie Wong Choong Moy - Malaysia
Approved by :
Asean Cosmetic GMP Team
European Committee
for Standardization
Implementing Agency
Supplementary Module
GMP Workshop Kuala Lumpur 14-16 Nov 2005
1
Project co-financed by
European Union
CONTENT OF PRESENTATION
Project co- financed
by Asean
Introduction
Water contaminants
Sources of water
Water treatment
Water purification engineering
Water testing
Inspection of water treatment plants
References
European Committee
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Implementing Agency
Supplementary Module
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Project co-financed by
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Project co- financed
by Asean
INTRODUCTION
European Committee
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Supplementary Module
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3
Project co-financed by
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OBJECTIVE
Project co- financed
by Asean
To define the type of water used as
the main component of the
cosmetic formula with the right
quality with respect to the chemical
and microbiological content to
prevent cross contamination.
European Committee
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Supplementary Module
GMP Workshop Kuala Lumpur 14-16 Nov 2005
4
Project co-financed by
European Union
BASIC PRINCIPLES





Project co- financed
by Asean
Like any starting material, water must conform
to Good Manufacturing Practice
It must be “potable” and minimally comply with
the quality of the national standard of drinkingwater
Systems must be properly maintained to avoid
contaminants
Specifications and periodic testing is required
Monitoring record is needed
European Committee
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Supplementary Module
GMP Workshop Kuala Lumpur 14-16 Nov 2005
5
Project co-financed by
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WATER TYPE
Project co- financed
by Asean
Types of water used in cosmetic processes are as follows:
For product:
1.
Tap water conforming to national standard
2.
Purified water (deionized, reverse osmosis) for cosmetic
production
For cleaning:
1.
Softened water
For rinsing: same quality as for the product
1.
Water for final Rinse
For sanitation:
1.
Steam
European Committee
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Supplementary Module
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6
Project co-financed by
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Project co- financed
by Asean
WATER
CONTAMINANTS
European Committee
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Implementing Agency
Supplementary Module
GMP Workshop Kuala Lumpur 14-16 Nov 2005
7
Project co-financed by
European Union
WATER CONTAMINANTS (1)
Project co- financed
by Asean
No water is free from contaminants

Contaminant groups:
 Chemical compounds
 Physical compounds
 Solids
 Gases
 Micro-organisms (algae, protozoa, bacteria)

Mineral contaminants :
 Calcium and magnesium
 Iron and manganese
 Silicates
 Carbon dioxide
 Hydrogen sulfide
European Committee
for Standardization
Implementing Agency





Supplementary Module
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Phosphates
Copper
Aluminium
Heavy metals
Nitrates
8
Project co-financed by
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WATER CONTAMINANTS (2)
Project co- financed
by Asean
Treatment depends on water’s chemistry
and contaminants such as:
1. Rainfall
2. Erosion
3. Pollution
4. Dissolution
5. Evaporation
6. Sedimentation
7. Decomposition
European Committee
for Standardization
Implementing Agency
Supplementary Module
GMP Workshop Kuala Lumpur 14-16 Nov 2005
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Project co-financed by
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TURBIDITY
Project co- financed
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Turbidity may come from:
1. Silt, clay, and suspended materials
2. Small particles include "colloids"
European Committee
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Implementing Agency
Supplementary Module
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10
Project co-financed by
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WATER HARDNESS
Water hardness
classification
Soft
mg/L or ppm
as CaCO3
0-60
Moderate
61-120
Hard
121-180
Very hard
European Committee
for Standardization
Implementing Agency
Project co- financed
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> 180
Supplementary Module
GMP Workshop Kuala Lumpur 14-16 Nov 2005
11
Project co-financed by
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WATER SOURCES
Project co- financed
by Asean
Source of raw water
1. Rain water
2. Surface or ground water
3. Well or borehole
4. Municipal or civil – “tap water”
5. Purchased in bulk
European Committee
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Supplementary Module
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Project co-financed by
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WELL WATER
Project co- financed
by Asean
Well construction
1. Inspect exposed parts of the well
2. Depth of well
Check:
1. Nearby septic systems
2. Hazardous materials usage (pesticides,
fertilizers, etc)
3. “Potability”
4. Well maintenance
European Committee
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Supplementary Module
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Project co-financed by
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Project co- financed
by Asean
STORAGE
OF WATER
European Committee
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Supplementary Module
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14
Project co-financed by
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RAW WATER STORAGES
Project co- financed
by Asean
1. May be required prior to pre-treatment
2. Check material of construction
 concrete, steel are acceptable but check
corrosion
 plastics or plastic linings may leach
3. Check cover
 to keep out insects, birds and animals
4. Check disinfection practices
European Committee
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Supplementary Module
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Project co-financed by
European Union
Project co- financed
by Asean
THE WATER TREATMENTS
European Committee
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Implementing Agency
Supplementary Module
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16
Project co-financed by
European Union
Project co- financed
by Asean
WATER TREATMENT GUIDANCE
The following should be monitored :

Sources of water

Treatment procedures

Water treatment equipment

Monitoring records required
Water treatment guidance
 All water-treatment systems should be
subject to:
 planned maintenance
 verified
 monitoring
 Maintenance work should be documented
European Committee
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Implementing Agency
Supplementary Module
GMP Workshop Kuala Lumpur 14-16 Nov 2005
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Project co-financed by
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PRE-TREATMENT GUIDANCE
Project co- financed
by Asean
1. Disinfection ( i.e. chlorination )
2. Flocculation/coagulation (i.e. by alum)
3. Filtration through multi-media filter (gravelsand-carbon) to 10 micron
4. Filtration through filter size of 1 micron
5. Re-disinfection (i.e. chlorination to eliminate
germs)
European Committee
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Supplementary Module
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Project co-financed by
European Union
Project co- financed
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CHLORINE REMOVAL
Activated-Carbon (AC) Filtration or Bisulphite
float
operated
valve
excess water recycled
from deioniser
air filter
NOTE :
1. AC removes chlorine
but bacteria can
then grow
2. AC filtration can
remove organic
impurities
3. Bisulphite leaves
sulphate residues
but is anti-microbial
spray ball
to water
softener &
DI plant
Water is kept
circulating
break tank
air break
to drain
raw water in
European Committee
for Standardization
Implementing Agency
sand
filter
activated
carbon
filter
centrifugal pump
cartridge
filter
5 micrometers
« S” trap to sewer
Supplementary Module
GMP Workshop Kuala Lumpur 14-16 Nov 2005
19
Project co-financed by
European Union
WATER SOFTENER
by pass valve
Project co- financed
by Asean
"soft" water to deioniser
brine and salt tank
brine
zeolite water softener
-exchanges
-Ca and Mg for Na
"hard" water
in
drain
European Committee
for Standardization
Implementing Agency
Supplementary Module
GMP Workshop Kuala Lumpur 14-16 Nov 2005
20
Project co-financed by
European Union
WATER TREATMENT COMPLEX
Project co- financed
by Asean
Water treatment room
External raw water storage
European Committee
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Implementing Agency
Supplementary Module
GMP Workshop Kuala Lumpur 14-16 Nov 2005
21
Project co-financed by
European Union
Project co- financed
by Asean
WATER
PURIFICATION
ENGINEERING
Reverse osmosis system
European Committee
for Standardization
Implementing Agency
Supplementary Module
GMP Workshop Kuala Lumpur 14-16 Nov 2005
22
Project co-financed by
European Union
OBJECTIVES
Project co- financed
by Asean
To examine the basic technology and
requirements for:
1. Water treatment systems
2. Storage requirements
3. Sampling and testing
4. Microbial limits, disinfection
European Committee
for Standardization
Implementing Agency
Supplementary Module
GMP Workshop Kuala Lumpur 14-16 Nov 2005
23
Project co-financed by
European Union
WATER SYSTEM DESIGN
Project co- financed
by Asean
There should be:
 proper pipe slope to avoid stagnation and
can be drained easily;
 Proper fittings & connections that can be
easily cleaned and sanitized;
 constructed of suitable materials such as
polyethylene material, stainless steel, etc.
 water circulation
 non-return valves (NRV)
European Committee
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Implementing Agency
Supplementary Module
GMP Workshop Kuala Lumpur 14-16 Nov 2005
24
Project co-financed by
European Union
WATER PURIFICATION STAGES
Project co- financed
by Asean
Further water treatment purification stages
downstream of the pre-treatment system :
 Pre - disinfection - flocculation
 Filtration
 Softening column
 Disinfection
 De-ionization System
 Reverse osmosis plus deionization
 UV system
 Looping of water
European Committee
for Standardization
Implementing Agency
Supplementary Module
GMP Workshop Kuala Lumpur 14-16 Nov 2005
25
Project co-financed by
European Union
WATER SYSTEM DESIGN (1)
Project co- financed
by Asean
There should be no dead legs
D
If D=25mm &
distance X is
greater than
50mm, we have
a dead leg that
is too long.
Flow direction arrows
on pipes are important
Deadleg section
X
<2D
Sanitary Valve
Water scours deadleg
European Committee
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Implementing Agency
Supplementary Module
GMP Workshop Kuala Lumpur 14-16 Nov 2005
26
Project co-financed by
European Union
WATER SYSTEM DESIGN (2)
Project co- financed
by Asean
1. Butterfly valves are better than
Ball valves
2. In Ball valves, Bacteria
can grow when
the valves are closed
3. The water is contaminated
Stagnant water
as it passes through the valve
inside valve
European Committee
for Standardization
Implementing Agency
Supplementary Module
GMP Workshop Kuala Lumpur 14-16 Nov 2005
27
Project co-financed by
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DE-IONIZER SCHEMATIC
from water softener
Water
must be
UV light
kept
circulating
HCl
Project co- financed
by Asean
NaOH
6
6
5
4
3
2
1
5
4
3
2
1
Cationic column
Anionic column
Cartridge
filter 5 µm
Eluates to
neutralization
plant
Cartridge
filter 1 µm
Ozone generator
Hygienic pump
Return to de-ioniser
Outlets or storage.
Drain line
Air break to sewer
European Committee
for Standardization
Implementing Agency
Supplementary Module
GMP Workshop Kuala Lumpur 14-16 Nov 2005
28
Project co-financed by
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DE-IONIZER OPERATION
Carbon Filter Valve Position
Filter position
Services / Operation
Backwash
Rinsing
Opened valves
1,4
2,3
1,5
European Committee
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Closed valves
2,3,5
1,4,5
2,3,4
Cation Filter Valve Position
Filter position
Services / Operation
Backwash
Cation filter regeneration
Backwash
Rinsing
Opened valves
6,9,10
7,8,10
7,12,13,14
7,8,10
6,11
Closed valves
7,8,11,12,13,14
6,9,11,12,13,14
6,8,9,10,11
6,11,12,13,14
7,8,9,10,11,12,13,14
Project co- financed
by Asean
Anion Filter Valve Position
Filter position
Services / Operation
Backwash
Anion filter regeneration
Backwash
Rinsing
Supplementary Module
GMP Workshop Kuala Lumpur 14-16 Nov 2005
Opened valves
15,18,19
16,17,19
16,21,22,23
16,17,19
15,20
Closed valves
16,17,20,21,22,23
15,18,20,21,22,23
16,17,18,19
15,20,21,22,23
16,17,18,19,21,22,23
29
Project co-financed by
European Union
REVERSE OSMOSIS THEORY
Low pressure
High pressure
under
pressure
raw water
Semi-permeable
membrane
Feed
water
European Committee
for Standardization
Implementing Agency
Reverse osmosis may be used to:
 purified water
 feeding of distillation units or
ultra-filtration units
 water for final rinse
Purified water
Permeate
water
Reject
water
drain or recycle
Project co- financed
by Asean
Supplementary Module
GMP Workshop Kuala Lumpur 14-16 Nov 2005
30
Project co-financed by
European Union
RO SCHEMATIC DIAGRAM
Project co- financed
by Asean
DRINE TANK
European Committee
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Implementing Agency
Supplementary Module
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Project co-financed by
European Union
2-STAGES RO SCHEMATIC
Project co- financed
by Asean
Water from softener or de-ioniser
Second stage reject water goes back to first stage buffer tank
1st stage reject concentrate
1st stage buffer tank
First stage RO cartridge
Branch
Branch
First stage filtrate feeds second stage RO
. excess back to 1st stage buffer tank
with
Air break
to sewer
2nd stage buffer tank
Second stage RO cartridge
High pressure
pump
Second stage RO water
meets Pharmacopoeia
standards
European Committee
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Implementing Agency
Cartridge
filter 1 µm
Hygienic pump
Water returns to 1st stage buffer tank
Outlets or storage
Supplementary Module
GMP Workshop Kuala Lumpur 14-16 Nov 2005
32
Project co-financed by
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COMBINED TREATMENT (1)
Project co- financed
by Asean
Note :
Fm : Flow rate sensor with LCD display
FL : Flow indicator (rotametor)
European Committee
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Supplementary Module
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33
V2
2"
2"
SIDE VIEW
FRONT VIEW
V4
WATER
OUTLET
2"
2"
Project co-financed by
European Union
¾"
12"
¾"
V5
COMBINED TREATMENT (2)
Project co- financed
by Asean
2"X½" 12"
2"
¾"
DR
12"
2"X½"
A
MIX
1"
2"
1.270 m
V1
FRONT VIEW
SIDE VIEW
FRONT VIEW
¾"
¾"
WATER
OUTLET
2"
12"
ZINC COATING
2"
2"
V4
BOTTOM VIEW
BOTTOM VIEW
SAND & GRAVEL No. 1&2 136 L.
2"
V4
SAND & GRAVEL No. 5&8 136 L.
PVC STRAINER PVC STRAINER
12"
12"
AIR
MIXED
12"
1"
SAND
& GRAVEL
No.
3&4
SAND
& GRAVEL
No.
1&2136
136L.
L.
SAND & GRAVEL No. 1&2 136 L.
PVC STRAINER
12"
2"
V5
"
820 L.
ANTHRACITE 820 L.
TOP VIEW
2"
1"
SAND
SAND & GRAVEL No. 3&4
136&L.GRAVEL No. 3&4 136 L.
SAND
SAND & GRAVEL No. 5&8
136&L.GRAVEL No. 5&8 136 L.
12"
2"X½" 2"X½"
DRAIN
12"
ANTHRACITE
ANTHRACITE 820 L.
V2
2"
V5
1.515 m
2"
2"
2"
WATER
OUTLET
1.270 m
WATER
WATER
INLET
INLET
1.515 m
2"
2"
AIR
MIXED
1"
V3
1.515 m
WATER
INLET
V1
m
DRAIN
12"
2"
V3
V 2"
2
12"
2"X½"
ZINC COATING
ZINC COATING
2"
V 3
""
DISTRIBUTOR TUBE
DISTRIBUTOR TUBE
¾"
2"X½"
TER
LET
2"
V5
¾"
2"X½"
V 4
V4
CUT VIEW
12"
12"
2"
V1
2"
2"
CUT VIEW
CUT VIEW
DISTRIBUTOR TUBE
¾"
"
TOP VIEW
2"
12"
"
TOP VIEW
V2
¾"
¾"
12"
SIDE VIEW
SIDE VIEW
¾"
12"
¾"
CUT VIEW
SIDE VIEW
FRONT VIEW
T VIEW
WATER
INLET
2"
2"
1.515 m
V3
12" 12"
DRAIN
DRAIN
AIR
AIR
MIXED
MIXED
1.270 m1.270 m
VIEW
BOTTOM VIEW
TOP VIEW
TOP VIEW
Multi media column ~ detailed views
BOTTOM
VIEW VIEW
BOTTOM
? ? ?? ??? ??
? ?? ? ?
European Committee
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Implementing Agency
Extention DI System
? ??? ?? ? ????? ? ? ? ? ? ?? ? ? ?
? ? ???? ? ?
Supplementary Module Extention
? ? ?? ??? ??
?.? .? . DI System
??
Extention? ??DI???System
GMP Workshop Kuala Lumpur 14-16 Nov22/12/2003
2005
? ? ?? ??? ??
? ? ? ? ?? ?
? ??? ? ? ? ??? ? ???? ?
34
Not to Scale
? ?? ? ?
? ??? ?? ? ????? ? ? ? ? ? ?? ? ? ?
? ? ???? ? ?
? ?? ? ?
? ??? ?? ? ????? ? ? ? ? ? ?? ? ? ?
? ? ???? ? ?
Project co-financed by
European Union
COMBINED TREATMENT (3)
Reservoir of incoming water
De-ionized water treatment
European Committee
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Implementing Agency
Project co- financed
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Reverse osmosis system
Treated Water in the storage
tank
Supplementary Module
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Project co-financed by
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Project co- financed
by Asean
WATER STORAGE & DISTRIBUTION
Typical water storage and distribution schematic diagram
Feed Water
from
DI or RO
Hydrophobic air filter
& burst disc
Cartridge
filter 1 µm
Spray ball
Optional
in-line filter
0,2 µm
Water must
be kept
circulating
UV light
Outlets
Heat Exchanger
Ozone Generator
European Committee
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Hygienic pump
Supplementary Module
GMP Workshop Kuala Lumpur 14-16 Nov 2005
Air break
to drain
36
Project co-financed by
European Union
DISINFECTION
Project co- financed
by Asean
Heat
• One of the most reliable methods of
disinfection of water systems
Ozone
• Produced easily
• Leaves no residue
UV
• UV does not “sterilize”
• Flow rate critical
• Post-irradiation recontamination may be
an issue
• Lamps have short life
Other chemicals
• Sodium Hypo-chlorite solution
European Committee
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Supplementary Module
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Project co-financed by
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Project co- financed
by Asean
WATER TESTING
European Committee
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Implementing Agency
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Project co-financed by
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WATER SAMPLING










European Committee
for Standardization
Implementing Agency
Project co- financed
by Asean
There must be a sampling procedure
Sample integrity must be assured
Sampler training
Sample point
Sample size
Sample container
Sample label
Sample storage and transport
Arrival at the laboratory
Test record
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Project co-financed by
European Union
THE WATER TESTING
Project co- financed
by Asean
Basic principle of water testing are as follows:
 Method verification
 Chemical testing
 Microbiological testing
 test method
 types of media used
 incubation time and temperature
 objectionable and indicator organisms
 manufacturer must set specifications
European Committee
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Project co-financed by
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WATER SPECIFICATIONS
DESCRIPTION
Color
Clarity & consistency
Odor
pH
Cl
SO 4
NH 4
Ca / Mg
Nitrates
Nitrites
Conductivity (µS/cm)*
Oxidizable subs
Solid (ppm)
TOC (ppb)
European Committee
for Standardization
Implementing Agency
Ph.Eur.
5.0 - 7.0
< 0.5
past test
< 0.2
pass test
< 0.2
pass test
< 10
USP
Colorless
Clear liquid
Odorless
< 1.3
< 500
Project co- financed
by Asean
JP
pass test
pass test
< 0.05
pass test
pass test
pass test
< 10
< 500
* For cosmetic used 5-7
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BACTERIAL LIMITS
Project co-financed by
European Union
Project co- financed
by Asean
Suggested bacterial limits (CFU /mL)
(no E-coli form bateria,no pathogenic bacteria)
Sampling location
Target
Alert
Action
Raw water
200
300
500
Post multimedia filter
100
300
500
Post softener
100
300
500
Post activated carbon
filter
Feed to RO
50
300
500
20
200
500
RO permeate
10
50
100
Points of Use
1
10
100
European Committee
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Implementing Agency
Supplementary Module
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Project co-financed by
European Union
Project co- financed
by Asean
INSPECTION
OF
WATER TREATMENT
PLANTS
European Committee
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Implementing Agency
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Project co-financed by
European Union
CLEANING & SANITATION
Project co- financed
by Asean
Procedure for cleaning and sanitization of
water treatment system should be available
and with defined written procedure which
may consist of the following:
frequency
cleaning agent
sanitizing agent
acceptance criteria
documentation
European Committee
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Implementing Agency
Supplementary Module
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Project co-financed by
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INSPECTION (1)
Project co- financed
by Asean
Conducting the inspection
 Take the schematic diagram and walk around the
entire system
 Check:
 dead legs
 pumps
 filter
 UV lights
 pipes and fittings
 sample points
 DI
 RO
 storage tanks
 non return valves
 by-pass lines
 heat exchangers
European Committee
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Project co-financed by
European Union
INSPECTION (2)
Project co- financed
by Asean
Check:






stainless steel, PE, PP pipelines are
appropriate outside the storage tanks
and mixing room.
storage tanks and mixing room,the
pipelines should be appropriate and
stable material i.e.stainless steel
welding quality (right welding material)
hygienic couplings (stainless steel)
passivation
air breaks or “Tundish”
European Committee
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Implementing Agency
Supplementary Module
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Project co-financed by
European Union
INSPECTION (3)

Project co- financed
by Asean
Check pipes and pumps for
 hygienic couplings
 welded pipes
 hygienic pumps
 hygienic
sampling points
 acceptable floor slope
 leaks
European Committee
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Implementing Agency
Supplementary Module
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Project co-financed by
European Union
INSPECTION (4)
Project co- financed
by Asean
Check condition of equipment
Staining on
water storage
tanks
Corrosion on plates of heat
exchangers indicates possible
contamination
European Committee
for Standardization
Implementing Agency
Supplementary Module
GMP Workshop Kuala Lumpur 14-16 Nov 2005
48
Project co-financed by
European Union
INSPECTION (5)


Project co- financed
by Asean
Check maintenance records
Check maintenance of pump seals and O rings
European Committee
for Standardization
Implementing Agency
Supplementary Module
GMP Workshop Kuala Lumpur 14-16 Nov 2005
49
Project co-financed by
European Union
INSPECTION (6)
Project co- financed
by Asean
More points to check (Contd.)
1. UV light – monitoring performance and lamp
life and intensity
2. Validating ozone dosage
3. Specifications for acids, alkalis for DI system
and sodium chloride for water softener
4. “Normally open” and “normally closed”
valves
European Committee
for Standardization
Implementing Agency
Supplementary Module
GMP Workshop Kuala Lumpur 14-16 Nov 2005
50
Project co-financed by
European Union
REFERENCES
Project co- financed
by Asean
1. ASEAN Guidelines for Cosmetic GMP (2003)
2. WHO EDM, Supplementary Training Modules on
Good Manufacturing Practice, Water for Pharmaceutical
Use, Part 1,2, and 3. (2001)
3. WHO, Guidelines for drinking-water quality, 2nd edition,
volume 1 (1993)
4. WHO, Guidelines for drinking-water quality, 2nd edition,
volume 2, (1996)
5. WHO, Guidelines for drinking-water quality, 2nd edition,
Volume 3; (1997)
6. WHO, Guidelines for drinking-water quality, 2nd edition,
Addendum to Volume 1 & 2 (1998)
European Committee
for Standardization
Implementing Agency
Supplementary Module
GMP Workshop Kuala Lumpur 14-16 Nov 2005
51
Project co-financed by
European Union
European Committee
for Standardization
Implementing Agency
Project co- financed
by Asean
Supplementary Module
GMP Workshop Kuala Lumpur 14-16 Nov 2005
52