Professional Documents
Culture Documents
September 2005
Thai FDAj Presentation 08.04.05
JENOPTIK Group.
M+W Zander
JENOPTIK Group.
M+W Zander
JENOPTIK Group.
U.S. FDA
WHO
PIC/S
M+W Zander
JENOPTIK Group.
pH
5.0 7.0
5.0 7.0
N/A
0 / 100 mL
0 / 100 mL
Conductivity
Total Bioburden
Endotoxin
Coliform Level
Source Water
M+W Zander
JENOPTIK Group.
Turbidity
M+W Zander
JENOPTIK Group.
2. Slope of Pipeworks
M+W Zander
JENOPTIK Group.
Qualification
1. Testing Program
2. Operation Parameters
3. Maintenance Program
1. Microbial
4. Cleaning Parameters
5. Change Control
M+W Zander
JENOPTIK Group.
M+W Zander
JENOPTIK Group.
M+W Zander
JENOPTIK Group.
M+W Zander
JENOPTIK Group.
Ion Removal
Key Components
M+W Zander
JENOPTIK Group.
Key Components
Raw Water Source
PW System
Multimedia Filter
.
Thai FDA Cleanroom Presentation 08.03.05
M+W Zander
JENOPTIK Group.
Key Components
PW
Water
Plant
Raw
Water
(POC)
Source
POS
POU
Multimedia Filter
POE
POD
Return
1. Maintenance at > 80 C in
Distribution Loop and User Points
(POC)
WFI Distillation Plant
POU
POS
POE
POD
POSPoint of supply
PODPoint of delivery
Supply
POC Point of connection
POE Point of entry Storage tank
Loop pump
POUPoint of use
.
Thai FDA Cleanroom Presentation 08.03.05
M+W Zander
JENOPTIK Group.
Source
Water
Pre-Treatment
Key
Tests
during
Source Water Pre-Treatment Step
Multimedia
Filter
Activated
removes
1.
Raw Water
Source:
Total Carbon
Bioburden
Level, Heavy
Heavy Metals, Organics, Turbidity, pH,
Metals andIons
Organic
Compounds
Hardness
to ensure
that the Pre-Treatment Step will not be overloaded.
Multimedia
Filter
2.
After Multimedia
Filter / Water Softener / Anti-Scaling Turbidity, Hardness Ions
(Calcium,
Magnesium), Conductivity, pH, Total Bioburden Level
Water
Softener/Anti-Scaling
3.
After /Biosulfite
and Base Addition pH Level between 8.0 and 8.5 to ensure
Bisulfite
Base Pre-Treatment
complete conversion of Carbon Dioxide to Carbonate for removal by First Pass RO
Pre-RO Treatment Filtration
4. After Pre-RO Treatment Filtration ( 5 Micron) Hardness to ensure no scaling of RO
First
Pass RO:
% Recovery
System
and 75
Conductivity
and Total Bioburden Level
Second Pass RO: 75 % Recovery
Thai FDA Cleanroom Presentation 08.03.05
M+W Zander
JENOPTIK Group.
Key Components
Key Tests during Ion Removal Process
Raw Water Source
1. After First Pass RO = DI Water Conductivity, Hardness, Chloride, pH,
Multimedia
Total Bioburden
Level. Filter
2. After Second Pass RO and/or EDI = PW Water Conductivity, Hardness,
Chloride, Ammonia, Sulfate, Heavy Metal, pH, Total Bioburden Level,
TOC.
M+W Zander
JENOPTIK Group.
WFI System
1. From Distillation Tank Hardness,
Conductivity, TOC
2. Distribution Loop Flow Velocity, Temp.
.
Thai FDA Cleanroom Presentation 08.03.05
JENOPTIK Group.
M+W Zander
JENOPTIK Group.
M+W Zander
JENOPTIK Group.
M+W Zander
JENOPTIK Group.
M+W Zander
JENOPTIK Group.
M+W Zander
JENOPTIK Group.
M+W Zander
JENOPTIK Group.
Educational Background
Ph.D. in Biochemistry and Pharmacology (1997)
University of Pennsylvania School of Medicine Department of Pharmacology
M+W Zander
JENOPTIK Group.