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Documents - Pub PQ and Monitoring Water Systems
Documents - Pub PQ and Monitoring Water Systems
Systems
Dawn Tavalsky
Deputy Director
Cleaning Validation
1
Where to turn for Validation Guidance?
2
Validation of Water Systems
IQ
OQ
PQ
PQ is executed by intensively monitoring the system over a
period of 1 year and is typically structured into 3 phases
phases. Before
starting the PQ, the operational ranges and sanitizing cycles must
be fixed based on the results of the OQ and then verified in the
subsequent PQ.
3
Validation of Water Systems
4
Validation of Water Systems
10
5
Validation of Water Systems
The validation of WFI systems must follow the approach as given in the table above. For PW
and HPW Systems the approach shown above is highly recommended but may be adapted
according to site usage and risk analysis assessment particularly in terms of sampling point
frequencies.
11
12
6
Developing the Sampling Scheme
13
14
7
Sampling Considerations
15
16
8
Example List of Sample Sites
17
18
9
Example Sample Scheme
19
20
10
Sampling Instruction Considerations
21
22
11
Example List of Sample Containers
23
24
12
Example Sample Instructions
25
26
13
Example Testing Specifications
27
Heavy Metals?
USP justifies:
NPDWR specs are very tight
Contemporary water system
construction materials do not leach heavy metals
No failures in previous tests
Washington Post Article:1
Questions veracity of local water authority tests
Old infrastructure in old distribution systems leach lead
European Pharmaceopeia:
Retains heavy metal requirement
Instrumentation
AA or ICP allows for higher sensitivity.
Should at least document absence during
commissioning.
28
14
How long should microbial monitoring continue?
29
Seasonal Variations
Water
W quality
li changes
h with
i h seasons
Affected by temperature
Drought, flood
Wisconsin Cryptosporidium outbreak 1993:
50 people died
4000 people hospitalized
403 000 people became ill
403,000
Ineffective filtration failed to remove oocysts
Turbid feed water slows disinfection
30
15
What is a biofilm?
31
Biofilms
32
16
Biofilms
33
Biofilms
34
17
Biofilms
35
Biofilms
36
18