GMP Supplementary Water

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
European Union

by Asean
CONTENT OF PRESENTATION
Introduction
Water contaminants
Sources of water
Water treatment
Water purification engineering
Water testing
Inspection of water treatment plants
References
European Committee
for Standardization
Implementing Agency
Supplementary
European Union

by Asean
INTRODUCTION
European Committee
for Standardization
Implementing Agency
Supplementary
European Union

by Asean
OBJECTIVE
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
for Standardization
Implementing Agency
Supplementary
European Union
BASIC PRINCIPLES
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
drinking-water
Systems must be properly maintained to
avoid contaminants
Specifications and periodic testing is
required
Monitoring record is needed
European Committee
for Standardization
Implementing Agency
Supplementary

by Asean
European Union

by Asean
WATER TYPE
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
for Standardization
Implementing Agency
Supplementary
European Union

by Asean
WATER
CONTAMINANTS
European Committee
for Standardization
Implementing Agency
Supplementary
European Union
WATER CONTAMINANTS (1)

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
Phosphates
Copper
Aluminium
Heavy metals
Nitrates

by Asean
European Union
WATER CONTAMINANTS (2)

Treatment depends on waters
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

by Asean
European Union

by Asean
TURBIDITY
Turbidity may come from:
1. Silt, clay, and suspended materials
2. Small particles include "colloids"
European Committee
for Standardization
Implementing Agency
Supplementary
10
European Union
WATER HARDNESS
Water
hardness
classification
Soft
Moderate
Hard
0-60
61-120
121-180
Very hard
European Committee
for Standardization
Implementing Agency
mg/L or ppm
as CaCO3
Supplementary
> 180
11

by Asean
European Union
WATER SOURCES
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
for Standardization
Implementing Agency
Supplementary
12

by Asean
European Union

by Asean
WELL WATER
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
for Standardization
Implementing Agency
Supplementary
13
European Union

by Asean
STORAGE
OF WATER
European Committee
for Standardization
Implementing Agency
Supplementary
14
European Union
RAW WATER STORAGES

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
for Standardization
Implementing Agency
Supplementary
15

by Asean
European Union

by Asean
THE WATER TREATMENTS
European Committee
for Standardization
Implementing Agency
Supplementary
16
European Union

by Asean
WATER TREATMENT GUIDANCE

The following should be monitored :
Sources of water
Treatment procedures
Water treatment equipment
Monitoring records required
European Committee
for Standardization
Implementing Agency
Water treatment guidance

All water-treatment systems should be
subject to:
planned maintenance
verified
monitoring
Maintenance work should be
documented
17
Supplementary
European Union
PRE-TREATMENT GUIDANCE

by Asean
1. Disinfection ( i.e. chlorination )

2. Flocculation/coagulation (i.e. by alum)
3. Filtration through multi-media filter
(gravel-sand-carbon) to 10 micron
4. Filtration through filter size of 1 micron
5. Re-disinfection (i.e. chlorination to
eliminate germs)
European Committee
for Standardization
Implementing Agency
Supplementary
18
European Union

by Asean
CHLORINE REMOVAL
Activated-Carbon (AC) Filtration or Bisulphite
float
excess water recycled
operated
from deioniser
valve
air filter
sand
filter
NOTE :
spray ball
1. AC removes
chlorine but
bacteria can then
break tank
grow
2. AC filtration can
remove organic
impurities
3. Bisulphite leaves
air
centrifugal pump
sulphate residues
break to
but is antidrain
microbial
raw water in
activated
carbon
filter
Water is
kept
circulating
cartridge
filter
5 micrometers
S trap to sewer
European Committee
for Standardization
Implementing Agency
Supplementary
to water
softener
& DI plant
19
European Union
WATER SOFTENER
by pass valve

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
20
European Union

by Asean
WATER TREATMENT COMPLEX
Water treatment room

External raw water
storage
European Committee
for Standardization
Implementing Agency
Supplementary
21
European Union

by Asean
WATER
PURIFICATION
ENGINEERING
Reverse osmosis system

European Committee
for Standardization
Implementing Agency
Supplementary
22
European Union

by Asean
OBJECTIVES
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
23
European Union
WATER SYSTEM DESIGN

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
for Standardization
Implementing Agency
Supplementary
24
European Union

by Asean
WATER PURIFICATION STAGES

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
25
European Union
WATER SYSTEM DESIGN (1)

There should be no dead legs
D
Flow direction arrows
on pipes are important
If D=25mm &
distance X is
greater than
50mm, we
have
a dead leg
that is too
long.
Deadleg section
<2D
Sanitary Valve
Water scours deadleg
European Committee
for Standardization
Implementing Agency
Supplementary
26

by Asean
European Union
WATER SYSTEM DESIGN (2)

by Asean
1. Butterfly valves are better

than Ball valves
2. In Ball valves,
Bacteria can grow
when
3. The water
is valves are closed
the
Stagnant
contaminated as it passes
water
through the valve
inside valve
European Committee
for Standardization
Implementing Agency
Supplementary
27
European Union
DE-IONIZER SCHEMATIC
from water softener
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
Cartridge
filter 1 m
Eluates to
neutralization
plant
Ozone generator
Hygienic pump
Return to de-ioniser
Outlets or storage.
Drain line
Air break to sewer
European Committee
for Standardization
Implementing Agency
Supplementary
28

by Asean
European Union
DE-IONIZER OPERATION
Carbon Filter Valve Position

Filter position
Services / Operation
Backwash
Rinsing
Opened valves
1,4
2,3
1,5
European Committee
for Standardization
Implementing Agency
Closed valves
2,3,5
1,4,5
2,3,4
Cation Filter Valve Position

Filter position
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
Supplementary

by Asean
Anion Filter Valve Position

Filter position
Backwash
Anion filter regeneration
Backwash
Rinsing
29
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
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
Permeate
water
Reject
water
drain or recycle
Purified water
Supplementary

by Asean
30
European Union
RO SCHEMATIC DIAGRAM
DRINE TANK
European Committee
for Standardization
Implementing Agency
Supplementary
31

by Asean
European Union
2-STAGES RO SCHEMATIC
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
for Standardization
Implementing Agency
Cartridge
filter 1 m
Hygienic pump
Water returns to 1st stage buffer tank

Outlets or storage
Supplementary
32

by Asean
European Union
COMBINED TREATMENT (1)

by Asean
HIGH PRESSURE PUMP

Con du c ti v i ty
M e te r
Fm
Fm
Ai r
M ix e d
TO OLD RO UNIT
SDS
1 ST
2
Y
RO FEED PUMP
191
RO Unit
10 m3 /h
PERMEATE LINE
FRESH
WATER
CONCENT
RATE LINE
2 ND
5
FL FL
6
RECYCLE LINE
5 MICRON
CARTRIDGE
FILTER
MULTIMEDIA COLUMN
Dra i n
CLEANING LINE
CIP TANK
Y
Dra i n
LS
LS
To Mixed Bed old unit

12
7
HCl 35%
TO PROCESS
8
10
4
VOLUME 25 M3
Fm
Co n d u c ti v i ty
M e ter
9
5
VENT VAL VE
VOLUME 25 M3
VOLUME 25 M3
P
Ai r
M ix e d
11
MIXED BED COLUMN
RO STORAGE TANK
DRAIN VAL VE
PRESSURE TANK
DI STORAGE TANK
DI FEED PUMP
European Committee
Notice :
for Standardization
Fm = Flow rate sensor wi th LCD display.
FL = Flow indi cator (rotametor).
Implementing
Agency
= Pressure swi tch.
DI SUPPLY PUMP
NaOH 50%
Supplementary
Note :
Fm : Flow rate sensor with LCD??display
FL : Flow indicator (rotametor) ????????
33
ExtentionDI System
???????
??????? ??????????
????????
??????? ??????????
V2
2"
SIDE VIEW
FRONT VIEW
WATER
OUTLET
2"
V4
2"
2"
European Union
"
12"
"
V5

by Asean
2"X" 12"

2"
"
DR
12"
2"X"
1"
2"
A
MIX
1.270 m
V1
FRONT VIEW
SIDE VIEW
FRONT VIEW
12"
"
"
12"
1.270 m
V3
WATER
WATER
INLET
INLET
2"
2"
ANTHRACITE
ANTHRACITE 820 L.
2"
2"
V4
BOTTOM VIEW
BOTTOM VIEW
SAND & GRAVEL No. 1&2 136 L.
2"
V4
SAND
& GRAVEL
No.
3&4
SAND
& GRAVEL
No.
1&2136
136L.
L.
PVC STRAINER
12"
2"
PVC STRAINER PVC STRAINER
12"
12"
V5
AIR
MIXED
12"
1"
820 L.
ANTHRACITE 820 L.
TOP VIEW
V2
1"
DRAIN
DRAIN
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"X" 2"X"
DRAIN
12"
1.515 m
V1
AIR
MIXED
1"
1.515 m
WATER
INLET
2"
"
DRAIN
12"
ZINC COATING
ZINC COATING
1.515 m
2"
V3
2"
2"
V5
12"
2"X"
ZINC COATING
2"
2"
DISTRIBUTOR TUBE
DISTRIBUTOR TUBE
"
V 3
WATER
OUTLET
2"
V5
"
2"X"
2"
V4
CUT VIEW
DISTRIBUTOR TUBE
2"X"
V 2"
2
CUT VIEW
12"
12"
2"
V 4
2"
2"
CUT VIEW
WATER
OUTLET
2"
TER
LET
""
"
"
V1
TOP VIEW
2"
12"
"
TOP VIEW
V2
"
"
12"
SIDE VIEW
SIDE VIEW
"
"
CUT VIEW
SIDE VIEW
FRONT VIEW
V IEW
WATER
INLET
2"
2"
1.515 m
V3
12" 12"
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
for Standardization
Implementing Agency
??
???
??
Supplementary
??????????
ExtentionDISystem
???????
?????
???
????
??????
??
??????
?????
?? ???
???????
??????????
34
????????
?.?.?. DI System
Extention
???????
?
ISy?stem
22/12/2003 ExtentionD
Not to Scale
???????
?????????????????????????
????????
???????
?????????????????????????
????????
European Union
Reservoir of incoming water
De-ionized water treatment

European Committee
for Standardization
Implementing Agency
Supplementary

by Asean
Reverse osmosis system
Treated Water in the storage

tank
35
European Union

by Asean
WATER STORAGE & DISTRIBUTION

Typical water storage and distribution schematic diagram
Feed Water
from
DI or RO
Water must
be kept
circulating
Hydrophobic air filter

& burst disc
Cartridge
filter 1 m
Spray ball
Optional
in-line filter
0,2 m
UV light
Outlets
Heat Exchanger
Ozone Generator
European Committee
for Standardization
Implementing Agency
Hygienic pump
Supplementary
Air break
to drain
36
European Union
DISINFECTION

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
for Standardization
Implementing Agency
Supplementary
37
European Union

by Asean
WATER TESTING
European Committee
for Standardization
Implementing Agency
Supplementary
38
European Union
WATER SAMPLING
European Committee
for Standardization
Implementing Agency
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
Supplementary
39

by Asean
European Union
THE WATER TESTING

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
for Standardization
Implementing Agency
Supplementary
40

by Asean
European Union
WATER SPECIFICATIONS
DESCRIPTION
Ph.Eur.
USP
JP
Color
Colorless
Clarity & consistency
Clear liquid
Odor
Odorless
pH
5.0 - 7.0
Cl
< 0.5
pass test
SO 4
past test
pass test
NH 4
< 0.2
< 0.05
Ca / Mg
pass test
Nitrates
< 0.2
pass test
Nitrites
pass test
Conductivity (S/cm)*
< 1.3
Oxidizable subs
pass test
pass test
Solid (ppm)
< 10
< 10
TOC (ppb)
< 500
< 500
* For cosmetic used 5-7
European Committee
for Standardization
Implementing Agency
Supplementary
41

by Asean
BACTERIAL LIMITS
European Union

by Asean
Suggested bacterial limits (CFU /mL)

(no E-coli form bateria,no pathogenic bacteria)
Sampling
location
Target
Alert
Action
200
300
500
100
300
500
100
300
500
Post activated carbon

filter
Feed to RO
50
300
500
20
200
500
RO permeate
10
50
100
Points of Use
10
100
Raw water
Post multimedia
filter
Post softener
European Committee
for Standardization
Implementing Agency
Supplementary
42
European Union

by Asean
INSPECTION
OF
WATER TREATMENT
PLANTS
European Committee
for Standardization
Implementing Agency
Supplementary
43
European Union
CLEANING & SANITATION

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
for Standardization
Implementing Agency
Supplementary
44

by Asean
European Union

by Asean
INSPECTION (1)
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
for Standardization
Implementing Agency
Supplementary
45
European Union

by Asean
INSPECTION (2)
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
for Standardization
Implementing Agency
Supplementary
46
European Union

by Asean
INSPECTION (3)
Check pipes and pumps for

hygienic couplings
welded pipes
hygienic pumps
hygienic
sampling points
acceptable floor slope
leaks
European Committee
for Standardization
Implementing Agency
Supplementary
47
European Union

by Asean
INSPECTION (4)
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
48
European Union

by Asean
INSPECTION (5)
Check maintenance records

Check maintenance of pump seals and O
rings
European Committee
for Standardization
Implementing Agency
Supplementary
49
European Union

by Asean
INSPECTION (6)
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
50
European Union

by Asean
REFERENCES
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)
edition, volume 2, (1996)
edition, Volume 3; (1997)
edition, Addendum to Volume 1 & 2 (1998)
European Committee
for Standardization
Implementing Agency
Supplementary
51
European Union
European Committee
for Standardization
Implementing Agency

by Asean
Supplementary
52

GMP Supplementary Water

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Project co-financed by

Project co- financed

GMP SUPPLEMENTARY TRAINING

WATER FOR COSMETIC

Project co- financed

Project co- financed

Project co- financed

Like any starting material, water must

Project co- financed

Project co- financed

Tap water conforming to national standard

Purified water (deionized, reverse osmosis) for

For rinsing: same quality as for the product

Water for final Rinse

Project co- financed

WATER CONTAMINANTS (1)

Micro-organisms (algae, protozoa, bacteria)

Calcium and magnesium

Iron and manganese

Project co- financed

WATER CONTAMINANTS (2)

Project co- financed

Project co- financed

Project co- financed

Project co- financed

Project co- financed

Project co- financed

RAW WATER STORAGES

May be required prior to pre-treatment

Check material of construction

Check disinfection practices

Project co- financed

Project co- financed

THE WATER TREATMENTS

Project co- financed

WATER TREATMENT GUIDANCE

Water treatment guidance

Project co- financed

1. Disinfection ( i.e. chlorination )

Project co- financed

Project co- financed

"soft" water to deioniser

brine and salt tank

zeolite water softener

Project co- financed

WATER TREATMENT COMPLEX

Water treatment room

Project co- financed

Reverse osmosis system

Project co- financed

WATER SYSTEM DESIGN

Project co- financed

There should be:

proper pipe slope to avoid stagnation and

Proper fittings & connections that can be

constructed of suitable materials such as

non-return valves (NRV)

Project co- financed

WATER PURIFICATION STAGES

WATER SYSTEM DESIGN (1)

Project co- financed

WATER SYSTEM DESIGN (2)

Project co- financed