3M Microbiology
3M Food Safety
Ken Davenport, Ph.D.
4"
¾"
Title Slide
Layout Specifications
© 3M 2008. All Rights Reserved.
48 pt. 3M logo.
Space logo one “M”
height from edges.
Outline
ƒ Background of ATP
ƒ ATP products from 3M
ƒ Key Considerations for Selecting ATP Systems
ƒ Identifying Test Points
ƒ Setting Pass Fail Limits
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Important Points from Dr. Holly
1.
2.
You can’t “test-in” quality or safety into a product
End Product sampling 6x per year doesn’t give you enough
frequency to give any measureable security…
3.
Even End Product sampling of every batch is not a
guarantee of quality and safety
– 25g, 125g, or 375 g samples from two tonnes of hamburger
4.
You can not depend on Health Canada, CFIA, FDA, USDA,
WHO to make your products safe…
You must control your processes to control your product.
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Why verify cleaning?
ƒ Control your process…
ƒ Not clean = Not safe
ƒ Just because it looks clean, doesn’t mean it is clean
ƒ
Can’t see microbes and biofilm
ƒ
Can’t see product residue
ƒ
Sanitizer isn’t a “cure-all”
• Hard to sanitize a dirty surface
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Why use ATP?
Visual
assessment
Microbiological
tests
ATP
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X
Objective
X
Sensitive
X
9
9
Detect product
residues
9
X
9
9
9
9
Simple
9
X9
9
Rapid
(Lab required)
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What is ATP?
Adenosine Tri-Phosphate
Phosphates
ƒ Chemical in ALL living cells
ƒ
Microbes
ƒ
Plants
ƒ
Animals
ƒ
Bodily Fluids
ƒ ATP stores energy
Adenosine
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Detecting ATP
In cells, ATP loses one or more phosphates
to release energy
Fire-fly Luciferase harnesses this energy to produce
Light
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Simple Relationship
increase
increasein
inlight
light(RLU)
(RLU)
increase
increasein
inATP
ATPlevels
levels
increase
increasein
inorganisms
organismsor
orproduct
productresidues
residues
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Understanding “RLU”
ƒ RLU = Relative Light Units
10 fmole ATP
ƒ RLU isn’t a Standard International Unit
like meters or liters…
ƒ Each ATP system manufacturer sets
their own value for 1 Light Unit and all
measurements are Relative to that.
ƒ Bigger numbers doesn’t mean more
sensitive
Adapted from study
By CARA Technologies Ltd.
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Advantages of ATP
ƒ ATP indicates biological residues – food, bacteria,
body fluids
ƒ Results are immediately available – no day-long
incubation steps
ƒ ATP tests are fast – as little as 30 seconds.
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The 3M™ Clean-Trace™ ATP System
Powerful ATP-bioluminesence
technology packaged in
easy-to-use devices
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3M™ Clean-Trace™ Surface ATP
All-in-one device for testing surface
hygiene
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Swabbing technique
Hold the swab between the thumb
and forefinger,in such a way that the
swab can be rotated
Do not touch the swab near the swab bud
Apply downward
pressure
Rotate swab during sampling
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Swab to Collect Sample
10cm x 10cm / 4” x 4” on a flat surface
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1
2
3
4
Click to Activate
Return swab to the tube
Press the handle down
to activate
Shake sideto-side for
5 seconds
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Measure
Place the swab immediately into the instrument and MEASURE
SAMPLE
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3M™ Clean-Trace™ Water ATP
(Aqua-Trace)
Same format as CleanTrace Surface, but
designed for water
samples:
•
•
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CIP rinse Water
Rinse water from
hoses, tubing,
equipment
The 3M™ Clean-Trace™ NG Luminometer
Small, Powerful, Simple...
•Measures light from CleanTrace surface and water tests
•Store & Transfer results to
Clean-Trace Data Trending
Software (Biotrack Plus)
•Self-Calibration check at
start-up
•Simple menus, multi-lingual
•Allows Re-Test Measurements
to be linked to Original
Measurements
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NG Docking Station
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Uploading, Storing, Data
3M Clean-Trace Data Trending
Software (Biotrack+)
ƒ Place NG in Docking Station
ƒ Launch Biotrack+
ƒ Click “Collect Results From
Instrument” button
ƒ Choose “Collect”
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3M Microbiology
Selecting An ATP Platform
4"
ATP Evaluation:
Trust Your Results
Use Your Data
Ask Your Questions
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Trust Your Results – Repeatability
Repeatability of a Test is Important
- Measure variability by applying a defined amount of
ATP on multiple swabs and looking for variation
Plot your results and you get a Histogram
Number of Results
-
0
25
50
75
100
125
150
RLU of Result
- Variability is also expressed as Coefficient of
Variation
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CV = 100% x Std. Dev./ Mean
The higher the CV the less repeatable the test
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Trust Your Results – Repeatability
What does this mean to your business?
If you have a pass/fail limit of 100 RLU,
Number of Results
And have a relatively clean surface that should pass at 75 RLU:
0
25
50
75
100
125
150
RLU of Result
Results Curve
With CV=38%
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Results Curve
With CV=8%
~15% FALSE POSITIVE RATE
If your test has poor repeatability
(CV >38%)
Trust Your Results – Repeatability
What does this mean to your business?
If you have a pass/fail limit of 100 RLU,
And have a relatively dirty surface that should fail at 150 RLU:
0
50
Results Curve
With CV=38%
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100
150
Results Curve
With CV=8%
200
250
300
350
~15% FALSE NEGATIVE RATE
If your test has poor repeatability
(CV >38%)
Trust Your Data – Repeatability
ƒ Repeatability is ESSENTIAL for effective cleaning
verification
ƒ Poor Repeatability results in:
ƒ
ƒ
Re-Cleaning when you don’t need to
Wasted Time, Money, Production Capacity
Not Re-Cleaning when you should
Risk to Product Quality and Safety
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Trust Your Results - Sensitivity
ƒ For ATP systems, Sensitivity = femtomoles ATP
ƒ 1 fmole ~ 0.5 picograms
ƒ Essentially all ATP systems on the market are
~0.5-2 fmoles ATP Sensitivity
ƒ Food applications require ~5-10 fmole sensitivity
• You will never get to zero fmole ATP
• All systems on the market have enough
sensitivity based on PURE ATP
• Environmental samples are NOT PURE ATP
ƒ Beware of making decisions based on sensitivity
studies using pure ATP…
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milli
10-3
micro
10-6
nano
10-9
pico
10-12
femto
10-15
atto
10-18
Trust Your Results – “Practical Sensitivity”
ƒ What do you want to measure in the plant?
ƒ
Pure ATP?
ƒ
Biofilms & Microbes?
ƒ
Product Residue?
3M
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Adapted from study
By CARA Technologies Ltd.
© 3M 2008. All Rights Reserved.
3M
3M
3M
3M
3M
Use Your Data
You are collecting ATP data anyway
Pass
Caution
Get more value from your ATP data:
Fail
7.14%
28.57%
ƒ Create Reports to Present Your
Data
ƒ Assess Efficiency of the Sanitation
Team
ƒ
Results after first cleaning
Sample P lan: A ll Selected Sample P lans
Site ID: A ll Selected Site ID's
To tal Test P o int(s) used = 2 : To tal P lan(s) used = 2 : To tal Sites(s) used = 2
Pass
Caution
Fail
0.00%
Get it right the first time
ƒ Assess Effectiveness of the
Sanitation Team
ƒ
64.29%
100.00%
Results after final cleaning
Sample P lan: A ll Selected Sample P lans
Site ID: A ll Selected Site ID's
To tal Test P o int(s) used = 2 : To tal P lan(s) used = 2 : To tal Sites(s) used = 2
Get it right before production
ƒ Track Impact – Positive and
Negative – of Factors Influencing
How Well Equipment is Cleaned
Trend Analysis for Each Test Point
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Ask Your Questions
No matter what system you choose, there are going to be
questions and problems at some point. It is important to
know that you will have competent support to help answer
your questions.
3M Prides itself in having qualified, competent sales and support
for its customers:
ƒ Sales: Caroline Pellerin, Nancy Metcalf,
ƒ Tech Support: Raquel Lenati
ƒ St. Paul Global Tech Support: 4 + dozens in the department +
1500 CRL/CARL
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© 3M 2008. All Rights Reserved.
3M Microbiology
Selecting An ATP Platform
4"
ATP Evaluation:
Trust Your Results
Use Your Data
Ask Your Questions
© 3M 2008. All Rights Reserved.
Setting Up an ATP Testing System
ƒ Hygiene Management Guide
ƒ
Test Point Identification
ƒ
Gather Data
ƒ
Set Pass/Fail Limits
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2007. All Rights Reserved.
Identify Test Points
HACCP Model
ƒ
Risk Analysis
• What’s most critical?
• What’s most likely?
Unlikely Possible
Low Impact
Moderate Impact
Significant Impact
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Probable
Identify Test Points
Use Common Sense!!!
ƒ
This is not rocket science –
ƒ Look at the equipment or process and use common
sense:
ƒ
What parts are critical to the safety of the food?
ƒ
Which areas are most likely to be cleaned poorly?
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Mixer
Probe
Scraper
Drain
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Dairy Holding Tank
Swab Inside tank
Swab inside tank
Swab door gasket
Swab sanitary
fittings
AQT the CIP
Rinse water
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Meat slicer
Tray
Weight
Blade
Collection pan
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Ribbon Blender
Underside of braces
Walls
Ribbon Blades
Shaft
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Close-up of sanitary connectors
Swab sanitary
connections
Use the 3M CleanTrace Water ATP
Tests for rinse water
through the hoses
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3M Microbiology
Setting Pass/Fail Limits
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Pass/Fail Limits for ATP
ƒ Government does not set limits
ƒ
Not like microbial counts or pathogens
ƒ No one “limit” is applicable for everyone
ƒ
ƒ
ƒ
Slaughterhouse/rendering plant
Ready to eat packaging
Neutraceuticals, beverages, etc.
ƒ Use ATP to:
ƒ
ƒ
ƒ
Identify abnormal cleaning events
Track improvements
Identify patterns
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What to do with Pass, Caution, and Fail
Pass
ƒ No action required – continue with production
Caution
ƒ Low Risk area – continue with production, but monitor more
closely in the future
ƒ High Risk area – re-rinse and re-test
Fail
ƒ Re-Clean and Re-Test
ƒ Note: Caution zone isn’t necessary, just set one limit if
preferred
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Collect Reference Data
1) Pre-Cleaning
ƒ
What do the “dirty” numbers look like?
2) Post-Cleaning
ƒ
What do the “clean” numbers typically look like?
3) Deep-Cleaning
ƒ
What “clean” numbers are possible to achieve?
Interpretation of Data:
2-1 tells us how well we can differentiate clean from dirty
3-2 tells us how much room for improvement there is in the
current process
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Collect Data
Soiled
Clean
Deep Clean
Day 1
14204
Day 2
Day 3
Day 4
Day 5
204
352
105
197
245
321
First Analysis:
-Can I tell Clean from Dirty?
-Is there room for improvement?
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Setting Pass/Fail Limits
ƒ Typically round P/F limits to the nearest 25, 50, or
100.
ƒ Historically, the Fail is 2x of the Pass
ƒ We can tailor the P/F limits to suit the direction the
customer wants to go…
ƒ
Option 1 - status quo
ƒ
Option 2 – improve over the status quo
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Example 1
Clean:
350
404
383
310
Option 1 – reflect current cleaning
Pass <500; Caution 500-1000; Fail >1000
Option 2 – improve cleaning
Pass <400; Caution 400-800; Fail >800
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405
Example 1
Clean:
350
404
383
310
405
Alternatively, use a more statistical approach:
Set the pass at the Mean (370)
– Only best 50% of cleaning will Pass
Set the fail at 3 Sigma above the mean (492)
- Worst 16% of cleanings will fail
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Note: IF you opt for statistical methods, gather a
LOT more data first…(30 measurements)…and
review frequently
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Example 2
Clean:
194
151
104
Option 1: Pass <200; Fail >400
Option 2: Pass <150; Fail >300
Mean: 168
SD: 40
Pass <168; Fail >288
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192
197
Example 3
Clean:
950
1104
1867
792
1495
More spread in the data (is 1867 & 1495 a good
cleaning?)
Option 1: Pass <1000; Fail >2000
Option 2: Pass <750; Fail >1500
Mean=1242; SD=436…P<1242; F>2550????
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With more data we would know if the high numbers
are due to bad cleaning, or accurately reflect the
variability…
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Example 4
Clean:
295
394
Option 1?____________
Option 2?____________
Mean= 340; SD=40.
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310
365
335
Example 5
Clean:
406
19450
2064
430
12460
??????
Looks like there’s a problem with consistency
•Training of testers
•Inconsistent cleaning
•Interference of some sort
•Collect more data to identify what “real” results
look like
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Example 6
Clean:
11
36
42
35
48
These numbers are just above the background
level of the Clean-Trace swabs (10-20 RLU)
Set a low standard (ex. 50 pass; 100 fail) and
collect more data.
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Summary – Pass Fail Limits
ƒ Use ATP to identify “unusual” cleaning events
ƒ
Rather than to identify “clean” vs. “dirty”
ƒ Collect data to understand what “clean” and “dirty”
means for your plant
ƒ Set Pass/Fail limits to:
ƒ
ƒ
Identify variations from what is typical
Push cleaning crew to improve their performance
Note: If you don’t have a consistent test platform,
interpreting your data will be very difficult
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Acknowledgement
ƒ Thanks to 3M Canada Team
ƒ
For the invitation to speak
ƒ
For their hospitality
ƒ Thanks to our customers
ƒ
ƒ
For your kind attention
For your business
• If you aren’t successful, we won’t be either!
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Contact Information
Ken Davenport, Ph.D.
Technical Services Global Product Specialist
3M Food Safety Department
Phone: 651-733-5121
Cell: 651-331-8802
E-mail: [email protected]
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