automated microbiology tools to support find and fix ...2. field microbiology and find and fix under...
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Automated Microbiology Tools to Support “Find and Fix” Approach Under the RTCRDr. Peter Gallant, VP Regulatory Affairs
ENDETEC / Veolia Water Solutions & Technologies
CA-NV AWWA Annual Conference
October, 2013
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Agenda
1. Automated Micro Methods: From the Lab to the Field
2. Field Microbiology RTCR “Find and Fix” Approach: Pathways and Process
3. Micro at the Plant: Monitoring Multi-Barrier Treatment Processes
4. Field Microbiology and Compliance: Developing a Framework for Certification Outside the Lab
5. Summary and Key Take-Aways
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1. Automated Micro Methods: From the Lab to the Field
All current EPA-approved Total Coliform Rule analytical methods (40 CFR 141) for E. coli and Total Coliform are manual methods requiring visual interpretation of results.
In the next several years, a number of promising technologies will yield new analytical methods that will be highly automated, rapid and sensitive – capable of on-site deployment.
Micro will be able to move from the Lab to the Field – new tools to support “find and fix” approach under the RTCR.
New treatment process diagnostic tool (recent field trial data).
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1. Moving Microbiology from the Lab to the Field
ENDETEC TECTA B-16 Unit and Test Cartridges
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Patented in the US and 13 European countries
Additional patents pending
1. Automated Micro Methods: From the Lab to the Field (ENDETEC TECTA technology)
Polymer sensor extracts fluorescent product from water, facilitating rapid detection either visually or with simple instrument.
Under UV light, positive (top) and negative (bottom)
results
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Detection of E.coli in Surface Water
0
20
40
60
80
100
120
0 2 4 6 8 10 12 14 16 18
Time (hr)
Sig
nal
(%)
300 cells
100 cells
30 cells
10 cells
Threshold for
“Positive”
Detection of E.coli in Surface Water
0
20
40
60
80
100
120
0 2 4 6 8 10 12 14 16 18
Time (hr)
Sig
nal
(%)
300 cells
100 cells
30 cells
10 cells
Threshold for
“Positive”
Continuous sample monitoring by instrument throughout incubation phase for real-time alerting.
Can see the ‘enzyme expression / growth’ curves.
Underlying micro count (CFU/ml) directly related to time-to-result (hh:mm).
1. Automated Micro Methods: From the Lab to the Field (ENDETEC TECTA technology)
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1. Automated Micro Methods: From the Lab to the Field (other automated methods)
qPCR – increasing use for recreational water monitoring (BEACH Act, 2012).
Optical systems (MALS, multi-spectral analysis, zero-angle particle scattering).
Numerous groups working on Biochips using combination of selective binding (ligands, antigens) and optical or electronic detection.
Source: Bashir, Electronic Micro-fluidic Biochips for Detection of Bacteria
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1. Why Automate Micro?
Provide 24/7 availability of micro testing capability –encourage operational monitoring.
Provide same level of testing capability for routine micro for small, remote systems as for larger systems.
Appropriately-trained operators are perfectly capable of effectively running this type of automated microbiology method in the field.
“We know our water quality from 8:30am to 4:30pm, Monday to Thursday…”
Anonymous System Operator
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2. Field Microbiology and “Find and Fix” Under the RTCR in the Distribution System
RTCR – Distribution System monitoring results will trigger assessments (Level 1 and Level 2).
Trigger for a Level 1 Assessment:
Exceed 5.0 % total coliform positive samples for a month
Have ≥ 2 positive samples for total coliform in one month (for systems collecting ‹ 40 samples each month)
Trigger for a Level 2 Assessment:
E.coli MCL violation
Second Level 1 assessment in a rolling 12-month period, or 2 consecutive years, without correcting any problems
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2. Field Microbiology and “Find and Fix” Under the RTCR in the Distribution System
RTCR focus is on “Pathways, not Pathogens” (Burlingame ASDWA Presentation, 2010)
“The proposed RTCR aims to increase public health protection through the reduction of potential pathways of entry for fecal contamination into the distribution system. Since these potential pathways represent vulnerabilities in the distribution system whereby fecal contamination and/or waterborne pathogens, including bacteria, viruses and parasitic protozoa could possibly enter the system, the reduction of these pathways in general should lead to reduced exposure and associated risk from these contaminants.” (40928)
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2. Field Microbiology and “Find and Fix” Under the RTCR in the Distribution System
Automated microbiological testing systems could play a major role in Level 1 (self-assessment) and Level 2 (external assessment) sanitary surveys.
Deploy system rapidly after initial adverse results.
Acquire samples at multiple sample points around source of adverse, including upstream/downstream, storage tanks, etc. –allow for a daily “micro snapshot” of system as part of survey.
Use rapid results and on-site capability to rapidly pinpoint source of sanitary defect.
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3. Micro at the Plant: Monitoring Multi-Barrier Treatment Processes
RTCR is focused on the distribution system, but what about monitoring the efficacy of the multi-barrier treatment process itself?
Significant interest among operators in areas where “water reclaim” / indirect or direct water re-use is being implemented or considered.
High-frequency (every 6 hr.) sampling by plant operator staff (keyed to water residence time in plant), analysis automated micro unit on-site (field trial starting in November in Ottawa).
Provides a complete “production quality assurance” snapshot of treatment process before water “product” enters the distribution system – like food/beverage industry QA/QC in that sense.
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3. Micro at the Plant: Monitoring Multi-Barrier Treatment Processes
WW reclaim plant, Australia – TECTA used by operator
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3. Micro at the Plant: Monitoring Multi-Barrier Treatment Processes
Detection times in hours – longer times = lower micro count.
‘High count’ source water results in less than 4 hours. Improved reagents now give all results in < 18 hours.
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3. Micro at the Plant: Studies Recently Completed
Multiple Studies of the ENDETEC method:
EPA Alternate Test Procedure study run at Pinellas County Utilities – report submitted to US EPA for consideration as a TCR approved analytical method.
Battelle / Columbus Water – Environmental Technology Verification (ETV) study comparing method performance to Colilert-18 under “in-plant” testing conditions.
Sneak Peek: results in 10-13 hours!
Plus: results from on-site use at Tucson and Las Vegas.
Results of these studies to appear in upcoming conferences...
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4. Field Microbiology and Compliance: Developing a Framework for Certification Outside the Lab
First automated methods are arriving at EPA’s doorstep for approval.
Fostering development of new technologies a key component of EPA Drinking Water Strategy.
Can EPA-approved automated methods be used on-site for compliance purposes?
This would nominally require site-level accreditation / certification – satellite lab sites?
How will regulatory agencies deal with the vast amounts of data that automated sensor networks will produce?
Are adverse results from operational monitoring using these systems reportable (ethically, if not legally)?
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4. Field Microbiology and Compliance: Developing a Framework for Certification Outside the Lab
Could use laboratory certification process to create “mini accredited labs” within even small treatment facilities.
Risk of burden on state accreditation resources.
Complexity of accreditation and costs of maintaining may be a barrier to adoption, particularly for small systems.
Personnel and other requirements for full accreditation (to ISO 17025) is a potential barrier (personnel, etc.)
Could a standardized framework provide an effective standard of care and performance while maintaining accessibility?
What would a framework look like?
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4. Field Microbiology and Compliance: Developing a Framework for Certification Outside the Lab
Approved Methods
Validation / Pilots
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4. Field Microbiology and Compliance: Developing a Framework for Certification Outside the Lab
Operator Training &Certification
Approved Methods
Validation / Pilots
02/10/2013 20
4. Field Microbiology and Compliance: Developing a Framework for Certification Outside the Lab
Accreditation &Auditing
Operator Training &Certification
Approved Methods
Validation / Pilots
02/10/2013 21
4. Field Microbiology and Compliance: Developing a Framework for Certification Outside the Lab
Accreditation &Auditing
QA/QC & System Built-In Test
Operator Training &Certification
Approved Methods
Validation / Pilots
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4. Field Microbiology and Compliance: Developing a Framework for Certification Outside the Lab
Accreditation &Auditing
Reporting & Data Exchange
QA/QC & System Built-In Test
Operator Training &Certification
Approved Methods
Validation / Pilots
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4. Field Microbiology and Compliance: Developing a Framework for Certification Outside the Lab
Accreditation &Auditing
Proficiency TestingReporting &
Data Exchange
QA/QC & System Built-In Test
Operator Training &Certification
Approved Methods
Validation / Pilots
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4. Field Microbiology and Compliance: Developing a Framework for Certification Outside the Lab
Accreditation &Auditing
Proficiency Testing
Other Elements ofComplete Framework?
Reporting & Data Exchange
QA/QC & System Built-In Test
Operator Training &Certification
Approved Methods
Validation / Pilots
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5. Summary and Key Take-Aways
Right Now:
Potential application in taking rapid, repeat “microbial snapshots” of distribution systems for Level 1 and Level 2 assessments under the RTCR. “Find and Fix” is about both pathways and processes.
Ability to monitor each stage of a multi-barrier treatment system to demonstrate efficacy / “microbial takedown”.
Future:
Automated methods for TCR E.coli / Total Coliform testing will soon be available and (hopefully) approved.
Need a regulatory framework (adapted from ISO 17025 / lab cert best practices) to enable compliance reporting of results obtained from automated micro systems – this is the future!
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Contact Information
Dr. Peter Gallant
Vice-President, Regulatory Affairs
ENDETEC – Global Sensor Platform
Veolia Water Solutions & Technologies
www.endetec.com