GMP Supplementary Water

Project co-financed by European Union
Project co- financed by Asean
WATER FOR COSMETIC USED

Prepared by : Haryanto Susilo - Indonesia Surachai Piyayodilokchai - Thailand Stephanie Wong Choong Moy - Malaysia Approved by : Asean Cosmetic GMP Team
GMP SUPPLEMENTARY TRAINING MODULE
European Committee for Standardization Implementing Agency
Supplementary Module GMP Workshop Kuala Lumpur 14-16 Nov 2005
CONTENT OF PRESENTATION
Introduction Water contaminants Sources of water Water treatment Water purification engineering Water testing Inspection of water treatment plants References
INTRODUCTION
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.
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 drinkingwater Systems must be properly maintained to avoid contaminants Specifications and periodic testing is required Monitoring record is needed
WATER TYPE
Types of water used in cosmetic processes are as follows: For product:
1. 2.
Tap water conforming to national standard Purified water (deionized, reverse osmosis) for cosmetic production Softened water Water for final Rinse Steam
For cleaning:
1.
For rinsing: same quality as for the product

1.
For sanitation:
1.
WATER CONTAMINANTS
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 Phosphates Copper Aluminium Heavy metals Nitrates
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
TURBIDITY
Turbidity may come from:
1. Silt, clay, and suspended materials 2. Small particles include "colloids"
10
WATER HARDNESS
Water hardness classification
Soft Moderate Hard Very hard
mg/L or ppm as CaCO3

0-60 61-120 121-180 > 180
11
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
12
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
13
STORAGE OF WATER
14
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
15
THE WATER TREATMENTS
16
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
17
PRE-TREATMENT GUIDANCE
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)
18
CHLORINE REMOVAL
Activated-Carbon (AC) Filtration or Bisulphite
float operated valve excess water recycled from deioniser air filter activated carbon filter
sand filter
to water softener & DI plant Water is kept circulating
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
raw water in
spray ball
break tank
air break to drain
centrifugal pump
cartridge filter 5 micrometers
S trap to sewer 19
WATER SOFTENER
by pass valve brine and salt tank
"soft" water to deioniser
brine
zeolite water softener -exchanges -Ca and Mg for Na
"hard" water in
drain
20
WATER TREATMENT COMPLEX
Water treatment room External raw water storage
21
WATER PURIFICATION ENGINEERING
Reverse osmosis system

22
OBJECTIVES
To examine the basic technology and requirements for: 1. Water treatment systems 2. Storage requirements 3. Sampling and testing 4. Microbial limits, disinfection
23
WATER SYSTEM DESIGN

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)
24
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
25
WATER SYSTEM DESIGN (1)

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
<2D
Sanitary Valve Water scours deadleg

26
WATER SYSTEM DESIGN (2)
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
27
DE-IONIZER SCHEMATIC
from water softener HCl NaOH 6 5 4 3 2 1
6
5 4 3 2 1
Water must be UV light kept circulating
Cationic column
Anionic column
Cartridge filter 5 m
Cartridge filter 1 m Ozone generator
Eluates to neutralization plant Hygienic pump Return to de-ioniser
Outlets or storage.
Drain line Air break to sewer
28
DE-IONIZER OPERATION
Carbon Filter Valve Position Filter position Services / Operation Backwash Rinsing Opened valves 1,4 2,3 1,5 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
Anion Filter Valve Position Filter position Services / Operation Backwash Anion filter regeneration Backwash Rinsing 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
REVERSE OSMOSIS THEORY

High pressure Low pressure
Feed water under pressure
Reverse osmosis may be used to: purified water feeding of distillation units or ultra-filtration units water for final rinse
Semi-permeable membrane
raw water
Purified water
drain or recycle
Reject water
Permeate water 30
RO SCHEMATIC DIAGRAM
DRINE TANK
31
2-STAGES RO SCHEMATIC
Water from softener or de-ioniser Second stage reject water goes back to first stage buffer tank
Branch
First stage RO cartridge

Branch
1st stage buffer tank
1st stage reject concentrate
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
Cartridge filter 1 m
Hygienic pump
Water returns to 1st stage buffer tank Outlets or storage
32
COMBINED TREATMENT (1)
Note : Fm : Flow rate sensor with LCD display FL : Flow indicator (rotametor) European Committee for Standardization Implementing Agency
33
V2 2" SIDE VIEW WATER OUTLET V4 2" V5 2"
FRONT VIEW
2"
12" " "

2" " 2"X" 2" V3
2"X" 12"
12" 1" 1.270 m
DR
A MIX
FRONT VIEW
FRONT VIEW
FRONT VIEW
SIDE VIEW
SIDE VIEW
SIDE VIEW
CUT VIEW
V2
CUT VIEW
2" 2"
1.515 m
V1
WATER INLET
TOP VIEW
TOP VIEW
12"
2"
2"
T VIEW
SIDE VIEW
WATER OUTLET 2"
CUT VIEW
CUT VIEW
V4
2" V5
12"
"
"
12"
"
"
" "
12"
12"
12"
"
2"
2"
"
DISTRIBUTOR TUBE DISTRIBUTOR TUBE

DISTRIBUTOR TUBE
2"X"
"
" 2"X"
ZINC COATING ZINC COATING
12" 12"
ZINC COATING
"
2"X" 2"
V 3
DRAIN 1" 1.270 m AIR MIXED
2" V3 V1
1.515 m
V1 2" 2" V 2" 2

V 4
1.515 m
WATER INLET
V3
1.515 m
2" 2" V2 2"
WATER WATER INLET INLET
ANTHRACITE
820 L.
ANTHRACITE 820 L.
ANTHRACITE 820 L.
TOP VIEW
2"
V4 2"
12" PVC STRAINER SAND & GRAVEL No. 1&2 136 L. SAND & GRAVEL No. 3&4 136 SAND & GRAVEL No. 1&2 136L. L. SAND & GRAVEL No. 1&2 136 L. SAND & GRAVEL No. 5&8 136 L.
BOTTOM VIEW
BOTTOM VIEW
2"
TER LET
WATER OUTLET 2"
V4 2" V5
V5 2"
""
12" 12"
12"
PVC STRAINER PVC STRAINER
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.
2"X" 2"X" DRAIN

AIR MIXED
"
12" 12"
12"
12"
DRAIN DRAIN AIR AIR MIXED MIXED
1"
1"
1.270 m 1.270 m
BOTTOM VIEW
VIEW
TOP VIEW TOP VIEW
Multi media column ~ detailed views

BOTTOM VIEW VIEW BOTTOM
? ? ?? ??? ??
Extention DI System
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? ?? ? ?
Supplementary Module Extention ? ? ?? ??? ?? ?.? .? . DI System ? ?? ??? ?? Extention DI System GMP Workshop Kuala Lumpur 14-16 Nov22/12/2003 2005
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? ? ? ? ?? ?
Not to Scale
34
? ? ???? ? ?
? ?? ? ?
? ??? ?? ? ???? ? ? ? ? ? ? ?? ? ? ? ? ? ???? ? ? ? ?? ? ? ? ??? ?? ? ???? ? ? ? ? ? ? ?? ? ? ?
Reservoir of incoming water
Reverse osmosis system
De-ionized water treatment

Treated Water in the storage tank
35
WATER STORAGE & DISTRIBUTION

Typical water storage and distribution schematic diagram
Feed Water from DI or RO
Hydrophobic air filter & burst disc Cartridge filter 1 m
Spray ball
Water must be kept circulating

Outlets
Optional in-line filter 0,2 m UV light
Heat Exchanger
Ozone Generator Hygienic pump Air break to drain
36
DISINFECTION
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
37
WATER TESTING
38
WATER SAMPLING

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 Module GMP Workshop Kuala Lumpur 14-16 Nov 2005 39
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
40
WATER SPECIFICATIONS
DESCRIPTION Color Clarity & consistency Odor pH Cl SO 4 NH 4 Ca / Mg Nitrates Nitrites Conductivity (S/cm)* Oxidizable subs Solid (ppm) TOC (ppb)
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
JP
* For cosmetic used 5-7

41
pass test pass test < 0.05 pass test pass test pass test < 10 < 500
BACTERIAL LIMITS
Suggested bacterial limits (CFU /mL)
(no E-coli form bateria,no pathogenic bacteria)
Sampling location
Raw water Post multimedia filter Post softener Post activated carbon filter Feed to RO RO permeate Points of Use
Target
200 100 100 50 20 10 1
Alert
300 300 300 300 200 50 10
Action
500 500 500 500 500 100 100
42
INSPECTION OF WATER TREATMENT PLANTS
43
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
44
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
45
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
Supplementary Module GMP Workshop Kuala Lumpur 14-16 Nov 2005 46
INSPECTION (3)
Check pipes and pumps for hygienic couplings welded pipes hygienic pumps hygienic sampling points acceptable floor slope leaks
47
INSPECTION (4)
Check condition of equipment
Staining on water storage tanks
Corrosion on plates of heat exchangers indicates possible contamination
48
INSPECTION (5)

Check maintenance records Check maintenance of pump seals and O rings
49
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
50
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) 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)
51
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GMP Supplementary Water

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GMP Supplementary Water

Transféré par

Droits d'auteur :

Formats disponibles

Project co-financed by European Union

Project co- financed by Asean

WATER FOR COSMETIC USED

GMP SUPPLEMENTARY TRAINING MODULE

European Committee for Standardization Implementing Agency

Supplementary Module GMP Workshop Kuala Lumpur 14-16 Nov 2005

Project co-financed by European Union

Project co- financed by Asean

Supplementary Module GMP Workshop Kuala Lumpur 14-16 Nov 2005

Project co-financed by European Union

Project co- financed by Asean

European Committee for Standardization Implementing Agency

Supplementary Module GMP Workshop Kuala Lumpur 14-16 Nov 2005

Project co-financed by European Union

Project co- financed by Asean

European Committee for Standardization Implementing Agency

Supplementary Module GMP Workshop Kuala Lumpur 14-16 Nov 2005

Project co-financed by European Union

Project co- financed by Asean

European Committee for Standardization Implementing Agency

Supplementary Module GMP Workshop Kuala Lumpur 14-16 Nov 2005

Project co-financed by European Union

Project co- financed by Asean

For rinsing: same quality as for the product

European Committee for Standardization Implementing Agency

Supplementary Module GMP Workshop Kuala Lumpur 14-16 Nov 2005

Project co-financed by European Union

Project co- financed by Asean

European Committee for Standardization Implementing Agency

Supplementary Module GMP Workshop Kuala Lumpur 14-16 Nov 2005

Project co-financed by European Union

WATER CONTAMINANTS (1)

Project co- financed by Asean

European Committee for Standardization Implementing Agency

Supplementary Module GMP Workshop Kuala Lumpur 14-16 Nov 2005

Project co-financed by European Union

WATER CONTAMINANTS (2)

Project co- financed by Asean

Supplementary Module GMP Workshop Kuala Lumpur 14-16 Nov 2005

Project co-financed by European Union

Project co- financed by Asean

European Committee for Standardization Implementing Agency

Supplementary Module GMP Workshop Kuala Lumpur 14-16 Nov 2005

Project co-financed by European Union

Project co- financed by Asean

mg/L or ppm as CaCO3

Supplementary Module GMP Workshop Kuala Lumpur 14-16 Nov 2005

Project co-financed by European Union

Project co- financed by Asean

European Committee for Standardization Implementing Agency

Supplementary Module GMP Workshop Kuala Lumpur 14-16 Nov 2005

Project co-financed by European Union

Project co- financed by Asean

European Committee for Standardization Implementing Agency

Supplementary Module GMP Workshop Kuala Lumpur 14-16 Nov 2005

Project co-financed by European Union

Project co- financed by Asean

European Committee for Standardization Implementing Agency

Supplementary Module GMP Workshop Kuala Lumpur 14-16 Nov 2005

Project co-financed by European Union

RAW WATER STORAGES

Project co- financed by Asean