Validating the Reduction of Salmonella and Other Pathogens ...

1 Validating the Reduction of Salmonella and Other Pathogens in Heat Processed Low-Moisture Foodsbrought to you by:PMMI | 11911 Freedom Drive, Suite 600 | Reston, VA 20190 For more information on this document and Other work from the OpX Leadership Network, please visit is excited to announce that the Alliance for Innovation & Operational Excellence (AIOE) is now the OpX Leadership Network REPRINT Leadership NetworkMoving Operational Excellence ForwardFOR POSITION ONLYDEVELOPED BY THE ALLIANCE FOR INNOVATION & OPERATIONAL EXCELLENCEPRODUCT SAFETY SOLUTIONS GROUPSEPTEMBER 2012 Validating the Reduction of Salmonellaand Other Pathogens in Heat Processed Low-Moisture FoodsBased in Washington, , the Grocery Manufacturers Association (GMA)

2 Is the voice of more than 300 leading food, beverage and consumer product companies that sustain and enhance the quality of life for hundreds of millions of people in the United States and around the in 1908, GMA is an active, vocal advocate for its member companies and a trusted source of information about the industry and the products consumers rely on and enjoy every day. The association and its member companies are committed to meeting the needs of consumers through product innovation, responsible business practices and effective public policy solutions developed through a genuine partnership with policymakers and Other keeping with its founding principles, GMA helps its members produce safe products through a strong and ongoing commitment to scientific research, testing and evaluation and to providing consumers with the products, tools and information they need to achieve a healthy diet and an active food.

3 Beverage and consumer packaged goods industry in the United States generates sales of $ trillion annually,employs 14 million workers and contributes $1 trillion in added value to the economy every year. For more information,please visit document was written by members of the Product Safety Solutions Group (PSSG), a community of practice within theAlliance for Innovation & Operational Excellence (AIOE). PMMI and Charter Partner GMA launched The Allliance in 2011as a forum where operations professionals fro consumer goods companies and their solutions providers can address keyissues nad best practices. The Alliance serves consumer products companies and Other stakeholders through communities of practice established to address key issues and solve critical problems in the areas of Sustainability, ManufacturingExcellence, Operational Reliability and Product members are small, mid & large cap consumer products companies and Other stakeholders including associations,suppliers, scientific and regulatory professionals, technical service providers and academic institutions.

4 Members can collaborate through the Alliance to produce innovations for continuous improvement in performance. Learn more at a trade association of about 600 member companies that manufacture packaging, processing and related convert-ing machinery in the United States or Canada; machinery components and packaging containers and materials. PMMI svision is to be the leading global resource for the packaging and processing supply chain, and its mission is to improve andpromote members abilities to meet the needs of their customers. PMMI organizes the PACK EXPO trade shows: PACK EXPOI nternational, PACK EXPO Las Vegas and EXPO PACK M xico, connecting participants in the packaging and processing supplychain with their customers around the world.

5 Learn more about PMMI and the PACK EXPO trade shows at 2012 by the Alliance for Innovation & Operational Excellence (AIOE), Reston, VACONTENTSEXECUTIVE SUMMARY ..1 Part 1 Introduction ..5 Part 2 Sources of Information for SalmonellaControl ..10 Part 3 Food Safety Plans ..13 Part 4 Methods to Validate Elements of a Food Safety Plan ..15 Part 5 Hazard Analysis ..19 Part 6 The Most Resistant Pathogen of Concern ..20 Part 7 The Level of Pathogen Inactivation Needed ..21 Part 8 Impact of the Food Matrix on Pathogen Survival ..22 Part 9 Validating the Efficacy of the Pasteurization Process .. team .. laboratory assistance.

6 Microbiological methods .. objectives for the validation study .. test plan .. of each product to be validated .. of each process to be validated .. mapping and heat transfer distribution studies . penetration studies .. of product residence time in equipment .. of product moisture/awthroughout the process .. of relative humidity or Other attributes .. data from scientifically valid source documents .. microbiological studies .. and objectives of microbiological studies .. with Pathogens .. based on the pathogen of concern .. preparation .. of the heat resistance of the inoculum .. Method .. in a laboratory or in-plant.

7 Load .. storage conditions .. of the study and sampling times .. product insertion and retrieval .. collection during the process ..57 CONTENTSiValidating the Reduction of Salmonellaand Other Pathogens in Heat Processed Low-Moisture from the test plan .. and estimation of microorganisms .. sensitivity and false negatives .. tests .. Death Time (TDT) study methods .. results of microbiological tests .. considerations .. modeling .. analysis .. validation report .. of previously validated processes ..73 Part 10 Defining Critical Limits, Operating Parameters, Monitoring and Verification74 Part 11 Prevent Product Recontamination After Pasteurization.

8 76 Part 12 Equipment and Facility Design ..79In Conclusion ..80 References ..81 Glossary ..92 APPENDIX I Considerations for PreConditioners, Extruders and Dryers ..94 CONTENTS(cont.)iiValidating the Reduction of Salmonellaand Other Pathogens in Heat Processed Low-Moisture FoodsAuthorsThis document was written by David Anderson of Del Monte Foods and Lisa of The Kellogg Company. The author for correspondence can be reached The authors welcome comments about this document, andare unable to provide specific advice about the validation of individual low-moisturefood cite this document,Anderson, D. G. and L. A. Lucore. 2012. Validating the Reduction ofSalmonellaand Other Pathogens in Heat Processed Low-MoistureFoods.

9 Alliance for Innovation & Operational Excellence, Alexandria, VA. Published online at Accessed [date].AcknowledgmentsWe are grateful for the comments, edits and generous amounts of time given byDerrick Bautista, Glenn Black, Dave Bresnahan, Bala Kottapalli, Craig Reinhart andWarren Stone in comments and edits of the text. Thank you also to Jon colburn , Leon Bruner, Kirk Dolan, George Dunaif, Carrie Ferstl, Mike Hayes, Will henry ,Stephen Perry, Stephen Schlegel, Norm Schmitt, Wilfredo Ocasio the GMA MicroCommittee and the GMA Process and Emerging Technologies Committee for reviewsand of LiabilityImplementation of validation protocols requires expert interpretation and readers areresponsible to ensure that they have the necessary skill and expertise.

10 Where such skilland expertise are lacking, one should consult experts in food microbiology, engineeringand statistics. Any guidelines given here are recommendations only. Owners, operatorsor agents who are in charge of a facility that manufactures, processes, packs or holdslow-moisture foods are encouraged to become familiar with applicable local, state andfederal regulations. Recommendations are not presented as a guarantee that they aresufficient to prevent damage, loss or regulatory action resulting from their use. The authors and sponsors of this document exclude all liability and responsibility forany amount or kind of loss and damage that may result to any party in connectionwith the use of this document.