welcome! 3-a ssi and the basics of hygienic design...food processing suppliers association (fpsa)...
TRANSCRIPT
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Welcome!
3-A SSI and the Basics of Hygienic Design
Bloomington, MNMay 1, 2017
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Welcome!Greg Marconnet, Program Chair
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Special Welcome!Student Travel Award Recipients
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Student Travel Award Recipients
Akhil Reddy Bora, Texas Tech University
Diego Casas, Texas Tech University
Yungi Huang, Ohio State University
Ishwar Katawal, Texas Tech University
Subbiah Nagappan, Ohio State University
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Key Topics of Learning Objectives
• 3-A SSI history and overview of current structure
• Basic introduction to food regulatory
• Key Concepts of the Hygienic Design Process
• Hygienic Design Considerations
• Manufacturing Techniques
• 3-A Marketplace Benefits
• Holistic Approach Sanitary Design
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3-A SSI Executive Director Tim Rugh
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Overview of 3-A SSI
Intro to 3-A SSI
The 3-A SSI Consensus Process
3-A Symbol Authorization & Certificates
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Intro to 3-A SSI Not-for-profit 501 (c) (3) corporation
Represents three stakeholder groups with a long history of collaboration
Regulatory Sanitarians Processors (Users) Fabricators
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Brief History of 3-A SSI
1920 First Standard
1944 USPH Participation
1956New Symbol
2002 3-A SSI
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Before 2002After 2002
Standards Writing-Publishing-TPV-SymbolTraining-Education-Harmonization
3-A Sanitary Standards, Inc.
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Who Leads 3-A SSI?
Founding Member Organizations International Dairy Foods Association (IDFA)
Food Processing Suppliers Association (FPSA)
International Association for Food Protection (IAFP)
American Dairy Products Institute (ADPI)
3-A Symbol Administrative Council (dissolved)
Chair of the 3-A Steering Committee
One USDA and one FDA representative
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Role of 3-A SSI
Standards Writing and Publishing
Industry Education and Training
3-A Symbol Licensing & Certificate Programs
Harmonization and Liaison With Other Organizations
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The Consensus Process
3-A SSI is an ANSI-accredited Standards Developer Organization (SDO)
3-A Sanitary Standards
3-A Accepted Practices
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Consensus Process - Overview
3-A Steering Committee
Work Group Work Group Work Group
Canvass Group
Management
Development
Approval
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3-A SSI Voluntary Certificates
Require independent Third Party Verification (TPV) of compliance by an independent credentialedauthority – a Certified Conformance Evaluator (CCE)
TPV certification performed via agreement between CCE and Symbol holder
Scope of TPV program set by 3-A SSI
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Why a TPV Requirement?
TPV brings added assurance that equipment shown on the certificate fully conforms to the applicable 3-A Sanitary Standard or criteria.
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Purpose of TPV Inspection
3-A Symbol licensing for equipment built to 3-A Sanitary Standard.
Other voluntary certificate programs:Replacement Parts & System Component
Qualification Certificate
3-A Process Certification
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What is the 3-A Symbol?
A registered mark used to show the conformity of equipment designed and manufactured to a 3-A Sanitary Standard
Available for use on a voluntary basis subject to licensing requirements of 3-A SSI
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Basics of Hygienic DesignGreg Marconnet
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Holistic Approach to Hygienic Design
Equipment Design
Product
Facility Design
Cleaning &
Sanitizing
Operational Design &
GMP
Quality &
Regulation
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Challenges under FSMA
• Hazard Analysis…identification of biological, chemical, physical
• Preventive Controls
• Corrective Actions
• Accurate Monitoring & Verification
• Operator Qualification
• Sanitary Design and cGMP’s
• Operations, Sanitation & Maintenance implications
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FSMA Hazardsbiological, chemical, physical hazards need to consider…
• Raw materials and other ingredients;
• Formulation of the food;
• Manufacturing/processing procedures;
• Sanitation, including employee hygiene;
• Condition, function, and design of the facility and equipment;
• Transportation practices;
• Packaging and labeling activities;
• Storage and distribution;
• Intended or reasonably foreseeable use; and
• Any other relevant factors, such as the temporal (e.g., weather-related) nature of some hazards (e.g., levels ofsome natural toxins).
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Risk Analysis with HARPC/HACCP review for equipment
• Biological• Parasites, pathogens• Spoilage organisms• Pests
• Chemical • Allergens, gluten• Unapproved additives such as sanitizers, lubricants• Materials of construction, odors
• Physical • Extrinsic: wood, plastic, metal, glass, stones, cloth, packaging, hypodermic
needles, golf balls• Intrinsic: seeds, bones, shells, over processed product• Material compatibility – ingredients, chemicals• Equipment parts, damage or debris during maintenance
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Key Steps in Hygienic Design Process
• Define Intended Uses & Risks
• Define Product Zones
• Define Cleaning Method
• Select Approved Materials of Construction
• Provide Accessibility to Clean and Inspect
• Design and Build to Meet Hygienic Criteria
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Define Intended Uses & Risks
RiskLevel
Intended Use and Products
Process Type Customer
HighInjectable DrugsInfant FormulaRTE Foods
Post ThermalTreatment
InfantElderlyPregnantImmune Deficient
Medium Low Acid FoodsFresh
Pre- ThermalTreatment
Healthy Children
LowHigh Acid FoodsRaw Foods to be Cooked
In package Healthy Adults
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Microbiology 101 for Hygienic Designers
• Only Five Things to Remember About Microorganisms
• Incredibly Small
• Multiple Extremely Fast
• Very Dangerous or Destructive
• Easy to destroy with sanitizers
• Need Food, Water, and Shelter
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“How Big is” – Molds-Bacteria – Viruses
• While we walk through “How Big is” Presentation think about• Surface finish of materials
• Cracks, crevices and pit in materials and welds
• Bolted joint
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*•PIN • 1x *
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2x
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4x
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6x
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8x
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*10x *
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•HAIR • 20x
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40x
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•DUST MITE• 60x
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80x
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*100x *
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200x
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400x
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600x
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•RAGWEED POLLEN • 800x
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* 1000x *
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•LYMPHOCYTE • 2000x
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•RED BLOOD CELL • 4000x
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•BAKER’S YEAST • 6000x
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•E. COLI • 8000x
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*10,000 X *
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•STAPHYLOCCOUS • 20,000 X
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40,000 X
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60,000 X
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• EBOLA • 80,000 X
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*100,000 X*
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200,000 X
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400,000 X
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•RHINOVIRUS • 600,000 X
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800,000 X
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*1,000,000 X*
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Equipment Cleaning
6
0
Cleaning needs to be at a Microbiological Level!
Right now there
are 64!!!
When was there
just 1?
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How Fast Do Microorganisms Multiple
10 Years 1 Year
1,048,576
Cells
10 Hours
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Infective Dose - FDA Bad Bug Book
• Listeria monocytogenes – less than 1,000 cells• E. Coli O157:H7 -- as few as 10 cells• Bacillus Cereus – 106 cells/gram• Perfringens – 108 cells• Staphylococcus – 100,000 cells/gram• Salmonella --15 to 20 cells• Campylobacter – 400-500 cells• Shigella -- as few as 10 cells• Hepatitis A – 10 to 100 virus particles
62
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Easy to Destroy
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Necessities of Life of a Microorganism
1 cell + Food + Water + Shelter + 30 Minutes = 2 cell
=
+ +
+
+
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Key Steps in Hygienic Design Process
• Define Intended Uses & Risks
• Define Product Zones
• Define Cleaning Method
• Select Approved Materials of Construction
• Provide Accessibility to Clean and Inspect
• Design and Build to Meet Hygienic Criteria
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Define Surface Zones
• Product Contact
• Non-Product Contact
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Key Steps in Hygienic Design Process
• Define Intended Uses & Risks
• Define Product Zones
• Define Cleaning Method
• Select Approved Materials of Construction
• Provide Accessibility to Clean and Inspect
• Design and Build to Meet Hygienic Criteria
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Define Cleaning Method
• How are the surfaces being cleaned:• Manually in place
• Disassembled and COP cleaned
• Cleaned without disassembly fully automated CIP system
• Combination of Manual, COP and CIP
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Key Steps in Hygienic Design Process
• Define Intended Uses & Risks
• Define Product Zones
• Define Cleaning Method
• Select Approved Materials of Construction
• Provide Accessibility to Clean and Inspect
• Design and Build to Meet Hygienic Criteria
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Select Approved Materials of Construction
• What is the corrosive issues with product or process?• Low pH – High pH
• Temperature
• What is the Material of Construction?• Metal
• Plastic
• Elastomer
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Material of Construction
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Key Steps in Hygienic Design Process
• Define Intended Uses & Risks
• Define Product Zones
• Define Cleaning Method
• Select Approved Materials of Construction
• Provide Accessibility to Clean and Inspect
• Design and Build to Meet Hygienic Criteria
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Key Steps in Hygienic Design Process
• Define Intended Uses & Risks
• Define Product Zones
• Define Cleaning Method
• Select Approved Materials of Construction
• Provide Accessibility to Clean and Inspect
• Design and Build to Meet Hygienic Criteria
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Key Cleanability Design Considerations
• Material of Constructions
• Surface Finishes
• Joint Design
• No Cracks or Crevices
• Free Draining
• No Dead Legs – Blind Spots - Hollows
• Accessibility to Clean
• Accessibility to Inspect
Let’s look at a series of design failure before we proceed to the next section “Hygienic Design & Fabrication Considerations and Techniques
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Materials of Construction-Corrosion Failure
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Pitting Corrosion
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No Specification Surface Roughness
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Bad Weld Cannot be Clean
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Joint Design – Hygienic Failure
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Bolted Joint
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Plates removed
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Crevice Failure
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Weld joint failure
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Draining Failure
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Hollow Roller Failure
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Access to clean failure
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• Gearbox over product
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Avoid Hygienic Design Failure Follow The Hygienic Design Process
• Define Intended Uses & Risks
• Define Product Zones
• Define Cleaning Method
• Select Approved Materials of Construction
• Provide Accessibility to Clean and Inspect
• Design and Build to Meet Hygienic Criteria
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Hygienic Hazards Contributed during Equipment Design
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Used with permission & based on “A Process for Concurrent Hygienic Design and Risk Assessment” page 26 by Mettler – Toledo, 2016
Design Area Possible Hazard
Cleanable Is the design difficult to clean?
Accessible Are areas difficult to inspect or clean?
Compatible Are the materials incompatible and do they lead to contamination?
No Niches Are niches present that can collect debris, harbor bacteria or allergens?
Pooling, Ponding Are surfaces prone to collect liquid and/or debris?
Durable Are surfaces resistant to damage in normal use, that result in niches, cracks, warping, etc.?
Sealed Are there internal cavities that create harborage sites?
Enclosures Do enclosures and similar hardware contribute to non-hygienic condition?
Operationally Safe Do operational functions contribute to non-hygienic conditions? e.g., reaching over a product area, control touch panels,
Foreign Objects Are there parts that can come loose or fall off? How are glass, stones, metal fragments handled?
Installation Can equipment be improperly installed resulting in a hazard?
Maintenance When and how to perform, when is a part worn out?
Lubrication Type, where used, when used? (is equipment designed to protect from lubrication encroachment?)
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Any Questions Before We Move on to
“Hygienic Design & Fabrication Considerations and Techniques”
???