January 22, 2013 2013 Wash Water Sanitation and Validation
Practical Approaches to Validating Efficacy of Wash Water Management Systems Presented by: Drew McDonald Danaco Solutions
A Practical Approach: The Considerations
• What are we trying to measure?
• How are we trying to measure?
• Who is measuring? • What a practical
approach looks like
Equipment
System Design
Product(s)
People
A Little Background Over-simplification statements: • There really are no clear standards • FDA does not tell you when something is
correct • There are disconnects
– Between wash system designers and operators – Written SOPs and on-floor execution
Produce Wash Systems An Elastic Spectrum
Anything that is used in produce where water comes in contact--directly or indirectly--with edible surfaces of the product or outer surfaces that may be handled by the end-user.
What Are We Trying To Measure? • People do not understand
their sanitizer chemistry • Chlorine is a good disinfectant
under specific conditions • Hypochlorous acid vs.
Hypochlorite – pH
• Cross-contamination control vs. surface log reduction
An Examination Of What You Are Measuring Contemplation Questions: • Why are you measuring where you are
measuring? • What is your CCP level and why? • Did you conduct process capability studies
as part of developing your SOP? • Does your SOP take into account the
differences between products and specific attributes of the different wash systems in your operation?
How Are We Trying to Measure?
Equipment and Methodologies • Perspective: PPM • What is the right tool?
Equipment & Methods Stories What’s wrong with this? Example #1: Equipment Mismatch Anti-microbial readings of 1.5 ppm free chlorine using a piece of equipment that has a standard error of 2 in municipal water source that has 2.5 ppm free chlorine
Equipment & Methods Stories
What’s wrong with this? Example #2: Observer Effect SOP states to check sanitizer level every 30 minutes and hand dose when necessary. The QA team member adds sanitizer because “it is usually necessary anyway” and then checks level.
Equipment & Methods Stories
Case Study: Photometric or Optic-based Instruments • Plastic vials • Intended life span • Condition Cloudiness and scratches
influence produce erroneous results
Equipment & Methods Stories Case Study: Dilutions • Many people use dilutions • Hach Colorimeter- high and low levels
– The low range reads 0-2 ppm at 0.00 sensitivity and the high range reads 0-8 ppm at 0.0 sensitivity.
– Depending on what your target is, if you are looking for 1 ppm at the high range you will always see some level.
• What is the chlorine level of your source?
Equipment & Methods Stories
Case Study: Zero-ing Which is the MOST correct way to zero a sample?
a) Tap/bottle water
c) Wash water sample diluted with “distilled” water
d) Empty sample vial
How are you doing it?
b) Wash water sample diluted with tap/bottle water
Equipment and Methods Stories What’s wrong with this? Example #3: “Perfect Data”
0.01.02.03.04.05.06.07.08.09.0
10.0
1 13 25 37 49 61 73 85 97 109
121
133
145
157
169
181
193
205
217
229
241
253
265
277
289
301
313
325
337
349
Sanitizer Readings
Question your system if you never see readings below your target or minimum level.
Who is Measuring?
Sample Before
training 1st
training 2nd
training 1 0.31 0.11 0.03 2 0.22 0.10 0.02 3 0.21 0.11 0.01 4 0.18 0.13 0.03 5 0.33 0.09 0.04 6 0.36 0.11 0.02 7 0.39 0.08 0.06 8 0.19 0.11 0.03 9 0.23 0.13 0.05
10 0.27 0.12 0.02 11 0.03 0.01 12 0.11 0.02 13 0.13 0.04 14 0.25 0.02 15 0.11 0.01
Average 0.27 0.11 0.03 St Dev 0.07 0.05 0.01
After training the average drops from 0.27 to 0.1 to .03 Standard deviation gets tighter from .07 down to .01
Training is the foundation
What Does A “Practical Approach” Look Like?
1. Prerequisite programs 2. Awareness of “the problem” 3. Comprehensive analysis and knowledge
of the process Data SOPs Training and expertise
Awareness of “The Problem” • There is a low level of
contamination that can be expected to come in from the field
• It can’t reliably be found by testing • It can be made much worse
through downstream handling and washing
• Processes must be in place to prevent/reverse such cross-contamination
Too Fresh!
The fundamental problem with ready-to-eat fresh produce is that it is ready to eat fresh produce.
Knowledge of the Process: What the SOPs Must Contain Moving Forward Identifying Key Control Points: Beyond pH and Sanitizer QA Checks • System design optimization- counter-flow/multi-stage • Water to product volume and ratios • Contact time • Agitation • Submersion • Product through-put rate • Uniformity of sanitizer dispersal • Monitoring sensor or method response time and
thresholds of detection
Knowledge of the Process: What Kind of Training and Expertise is Needed Moving Forward?
• Understanding of water chemistry and how it interacts with your antimicrobial of choice
• Intimate knowledge of the variables that impact safe operation of your wash system
• Math and statistics skills to be able to evaluate the performance of your wash system
Compare training between wash system monitors and packaging machine operators
System Management: Beyond Basic
Training
Conclusions: Validate vs. Verify • YES, the end goal is to validate the
process • BUT, the challenge lies in first
addressing the basic verification methods – Process design – Equipment and measurement
limitations – Training and knowledge
Conclusions: Consistent Implementation vs. Perfect Intervention
• What are our wash line systems capabilities? • Do those capabilities meet the minimum
required food safety goals? • How to improve our wash lines systems
capabilities to meet food safety goals? • How do we ensure control of key parameters to
meet our wash lines food safety goals? • How do we validate and verify that we are in
control and meeting our wash lines food safety goals?