Cleaning Verification Tools. Joe Cardamone, General Manager Cell Biosciences Pty Ltd

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Cleaning Verification Tools Joe Cardamone, General Manager Cell Biosciences Pty Ltd

Welcome and Introduction Why is Cleaning and Cleaning Verification important? Risk Food Standards Code Definitions Tools Microbial Detection ATP Protein Detection Allergens Detection

Why is Cleaning and Cleaning Verification important?

Why is Cleaning and Cleaning Verification important? Microorganisms are everywhere

How do we define Clean? How do we define Sanitised? How do we define Sterile?

How do we define Clean? How do we define Sanitised? How do we define Sterile? Cleaning is the process of removing food and other types of soil from a surface.

How do we define Clean? How do we define Sanitised? How do we define Sterile? Correct Cleaning Agents are important

How do we define Clean? How do we define Sanitised? How do we define Sterile? Sanitising is the process of reducing the number of microorganisms that are on a properly cleaned surface to a safe level.

How do we define Clean? How do we define Sanitised? How do we define Sterile? 99.999% reduction Heat, Radiation or chemicals

How do we define Clean? How do we define Sanitised? How do we define Sterile? Sterilising is eliminating all microorganisms and their spores from a surface

How do we define Clean? How do we define Sanitised? How do we define Sterile? Most food contact surfaces do not need to be sterile, however surgical equipment do. Related to risk.

Risks People may die People may be permanently harmed Food Poisoning Outbreak Product Recalls Litigation

What are Biofilms? Plaque on teeth is a bacterial biofilm Pond-scum, or the film in your drains

What are Biofilms? Bacterial colonies encased in a protective polysaccharide shell

Food Safety Standard Legal Requirement Australian legislation Safe Food Australia Guide Plain English

Division 5 Cleaning, sanitising and maintenance 19 Cleanliness The intended outcome is that food premises, fixtures, fittings and equipment, as well as those parts of vehicles that are used to transport food, are maintained to an acceptable standard of cleanliness.

19 Cleanliness 19(1) A food business must maintain food premises to a standard of cleanliness where there is no accumulation of: (a) garbage, except in garbage containers; (b) recycled matter, except in containers; (c) food waste; (d) dirt; (e) grease; or (f) other visible matter.

Division 5 Cleaning, sanitising and maintenance 20 Cleaning and sanitising of specific equipment The intended outcome is that specific equipment is cleaned and sanitised to minimise the transmission of infectious disease and to protect food from contamination.

20 Cleaning and sanitising of specific equipment Cleaning and sanitising are different processes, and both are needed to reduce the risks of foodborne illness. Cleaning involves the removal of dirt, grease and food debris. Sanitising is a process that destroys pathogenic microorganisms and sanitising should be done after cleaning. Even if equipment looks clean it could still be contaminated if it has not been sanitised.

20 Cleaning and sanitising of specific equipment 20(1) A food business must ensure the following equipment is in a clean and sanitary condition in the circumstances set out below: (a) eating and drinking utensils immediately before each use; and (b) the food contact surfaces of equipment whenever food that will come into contact with the surface is likely to be contaminated.

20 Cleaning and sanitising of specific equipment 20(2) In subclause (1), a clean and sanitary condition means, in relation to a surface or utensil, the condition of a surface or utensil where it: (a) is clean; and (b) has had applied to it heat or chemicals, heat and chemicals, or other processes, so that the number of microorganisms on the surface or utensil has been reduced to a level that: (i) does not compromise the safety of the food with which it may come into contact; and (ii) does not permit the transmission of infectious disease.

So how do we know if a surface has been cleaned? Visual inspection

So how do we know if a surface has been cleaned? Visual inspection

So how do we know if a surface has been cleaned? Microbial Swabs

So how do we know if a surface has been cleaned? Microbial Swabs

So how do we know if a surface has been cleaned? ATP

So how do we know if a surface has been cleaned? ATP

So how do we know if a surface has been cleaned? Protein

So how do we know if a surface has been cleaned? Protein PASS MARGINAL FAIL

So how do we know if a surface has been cleaned? Allergen Detection

So how do we know if a surface has been cleaned? Allergen Detection

Microbial Swabs Estimating bacterial count per 100cm 2 can be used as an indication of cleanliness, to gauge improvement by comparing bacterial levels over time, or to compare standards in similar businesses. Allows for the total microbial load counts or counts for specific organisms Total Counts E.coli / Coliforms Yeast and Moulds

ATP / Protein vs. Plate Counts Both have value but provide different information. Bioluminescence Checks for microbial and residual contamination Results in less than 1 minute Simple to use, no technical expertise required Allows you to check cleaning practices before production, avoiding costly contamination problems Provides speedy results required by HACCP Plate Counts Checks only for the specific bacteria that can grow in the selected medium. Results in 24 to 48 hours Requires technical lab support Often requires you to throw away product after contamination results come back Do not provide the speed and simplicity of feedback required by modern HACCP demands

Microbial Swabs Sample the same area each time to enable comparison of results over time Transport swab to the laboratory, typically using a commercial swab that may include transport media Microbiologist streaks onto culture media to detect specific organisms Counts per area sampled

Detection of ATP ATP is the energy molecule found in all living things. Bacteria, Yeast and Moulds, as well as food residue contain ATP. The less ATP there is on a surface the cleaner the surface is.

The Science behind it all.. The bioluminescent reaction that produces light. The substrate/enzyme complex combines with ATP to produce light. Luciferin/Luciferase + ATP Light Luciferin Luciferase The Firefly Reaction ATP

Simple Relationship - More ATP = More Light increase in light (RLU) increase in ATP levels increase in microbes or product residues

AccuPoint Advanced Components Monitor, Luminometer Consumable Samplers PC Software

Consumables Surface Sampler Ideal for Flat Surfaces The shaft does not bend Able to sample biofilms also Access Sampler For filler heads Flocked Swab Water Sampler Absorbs 100ul of liquid More consistent results Surface Access Water

Consumables Engineered from the ground up to be better!

Consumables More consistent Designed to break open and expose BIOFILMS. Use Surface Samplers for FLAT surfaces. Use Access Samplers for Filler heads, etc. Use Water samplers for rinses.

Activate sampler by pressing it all of the way down into the housing compartment Mix gently twice Place immediately into sampler compartment on reader Open compartment by pressing eject button on the side of the reader Close the top door so that the reader and begin An icon will appear and a progress indicator bar

Traffic Light System

Traffic Light System 20 60 1256

Data Manager

ATP Results at California Hospital over 3 month period Australian Distributor:

Limitation of ATP Testing The correlation of detectable ATP as an indicator of live cells has been proven in numerous studies, however the following conditions impact the accuracy of ATP testing. Dirt or soils which obscure sampled surfaces. Biofilm made by colonized bacteria which shield cells from acquisition by swabbing. Bacteria on surfaces that are not sampled by the swab. Swab contact with live human cells from hands, or body fluids. Presence of beneficial bacteria found in food production. 48

Protein Detection Rapid test from 10 seconds to 10 minutes Limited of detection down to 10ug / sample No equipment or capital purchase required Results are read manually and open to interpretation Require a manual system for record keeping

Protein Detection Sample the same area each time to enable comparison of results over time Insert samples into device and depress Read results after 10 seconds in the base of the device

What are Food Allergens? Naturally occurring proteins Heat and processing resistant Resistant to extremes in ph Usually major proteins in food Foods can have 1 or many allergens No known cure strict avoidance

Food Allergens Food Allergy : An allergic reaction causes the release of histamine with the body (i.e. watering eyes, runny nose, scratchy throat, etc) Food Intolerance: Sensitivity to certain food caused by a deficiency (i.e. bloating, headaches, cough, stomach ache) Lactose intolerance, Celiac Disease

Food Allergens Concern Peanuts Soy Milk Eggs Fish Shellfish Tree Nuts Wheat And many others

Food Allergens Up to 8% of children, and up to 3% of adults in US have a food allergy Researchers estimate 50,000 emergency room visits, and 150-200 deaths per year from food-induced anaphylaxis Trace amounts (ppm) of the offending food will trigger reactions

Hidden Risks Recycled CIP and COP rinses Oils re-contaminated after refining Rework Labeling terms i.e. non-dairy creamer Many others

Allergen vs. ATP Testing An allergenic protein can exist on a surface up to 100x the level of concern, but be below the level of detection of any ATP system. Unknown as to how much ATP is from allergenic protein, as opposed to something else. Best to use an antibody specific test to confirm when assessing the presence or absence of allergens.

Neogen Solutions Laboratory Testing In-House Testing Combination of Both

Laboratory Testing Quantitative results using Neogen s Veratox Systems ELISA Technology to give a number Unless otherwise specified Results: Standard within 2 days of receipt Rush within 1 day of receipt

In-house testing Kit Specifications Screening tests at 5 ppm No equipment required Ideal for testing environmental swabs and CIP rinses Test a line when changing between products Less than 10 minutes total time to result

Reveal 3-D Kit Components Components provided: Extraction buffer sachet Swab Sample tube & cap Reveal 3-D test device Swab wetting buffer provided with some kits

Reveal 3-D Test Schematic

Reveal 3-D Procedure 5 minutes.

Reveal for Multi-Treenut

Validation of Neogen Test Kits Cross reactivity Limit of detection Inter and Intra Assay Variability Recovery Stability Food trials (various processed conditions) Alpha and Beta testing

Thank You