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

“Perfect is the enemy of good” -Voltaire

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? The People Factor and Importance of Training Efficacy of Training

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

Practical Wash System Management: The Whole Picture

Equipment

System Design

Product(s)

People

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?

Closing Points

“Do Not Go Gentle Into That Good Night…” - Dylan Thomas

Be Brave Be Bold