VIEWS: 0 PAGES: 7 POSTED ON: 6/10/2013
In the USA, the Food and Drug Administration has had a zero tolerance policy for Salmonella since 2010, which is why various extrusion industries have experienced a dramatic increase in recalls over the past two years.
Digital Re-print - May | June 2013 ‘Kill step’ validation of low-moisture extrusion Grain & Feed Milling Technology is published six times a year by Perendale Publishers Ltd of the United Kingdom. All data is published in good faith, based on information received, and while every care is taken to prevent inaccuracies, the publishers accept no liability for any errors or omissions or for the consequences of action taken on the basis of information published. ©Copyright 2013 Perendale Publishers Ltd. All rights reserved. No part of this publication may be reproduced in any form or by any means without prior permission of the copyright owner. Printed by Perendale Publishers Ltd. ISSN: 1466-3872 www.gfmt.co.uk Innovative extrusion processes without limits. Bühler is the global technology partner for companies producing breakfast cereals, snack foods, or food in- gredients on a commercial scale. With its extensive extrusion know-how and its passion for customized solutions, Bühler is always in a position to generate added value and success for any product idea. Bühler offers an integral range of products and services for all process stages – from correct raw material handling, cooking and shaping through extrusion to drying of the extruded products. And this for all market segments – from breakfast cereals and snack foods to modified flours and starches, texturized proteins, or vitaminized rice. In short: extrusion processes without limits. firstname.lastname@example.org, www.buhlergroup.com/extrusion Innovations for a better world. FEATURE ‘Kill step’ validation of low-moisture extrusion by Will Henry, research & development, Extru-Tech Inc., USA Figure: 3 E525 extrusion system I n the USA, the Food and Drug production scale Extru-Tech E525 extrusion Administration has had a zero tolerance system. As a result, Extru-Tech now offers policy for Salmonella since 2010, the industry’s first scientific validation study Key considerations used in which is why various extrusion industries of a food/feed extrusion system that kills the study have experienced a dramatic increase in Salmonella at levels higher than normally For the development stage of this recalls over the past two years. found in most facilities. process, key operational parameters In an effort to target an industry with the were analyzed to scientifically validate a In many of these recalls, Salmonella was highest exposure, Extru-Tech chose to first typical extruded pet food process. found in the plant (commonly found in raw address specific issues within the pet food materials) and even though very few cases industry by tailoring their validation protocol Equipment scale - production led to sickness, the manufacturer decided to to an adult canine specification. However, rates recall all batches produced at that time. It’s due to the equipment design duplicity, this Impartial and internal studies have prov- better to be safe than sorry, but these recalls same architecture and protocol provides en the agnostic relationship between undermine consumer confidence, damage credibility to multiple extrusion markets. laboratory scale equipment and pro- brands and impact the entire industry. “Extru-tech is using actual equipment duction scale equipment While every manufacturer strives for that you would find in most pet food plants Equipment configuration - barrel screw products that are 100 percent pathogen in a bio-hazard laboratory or a pilot plant,” stack-up, preconditioner paddle con- free, applicable and validated scientific stud- says Dr Jim Marsden, regents distinguished figuration ies to support properly designed extrusion professor, Kansas State University. “Raw Impartial and internal studies have food safety systems weren’t possible…until materials can be inoculated with Salmonella shown that even the slightest change in now. or other pathogens and the effect of the equipment setup will impact the proc- extrusion process can be exactly quantified. ess’s pathogenic efficacy Kill step validation This process is a breakthrough for the pet To mimic how products are contami- food industry.” Formulation nated under real-world production facil- Impartial and internal studies provide ity conditions, Extru-Tech built a BSL (Bio- Production scale vs traditional excellent insight into the variations Safety Level) 2 pilot plant outfitted with a testing methods inherent within individual ingredient Food/feed manufactur- components and how they interact ers have relied on tradi- differently within a processing environ- tional lab studies based on ment (i.e. thermal energy efficiency, testing equipment ranging water absorption, energy of gelatiniza- from beakers and pressure tion) pots to table-top model extruders. Most testing Product specification has been completed on a Parameters such as: size, shape, den- lab table at very low pro- sity, cell structure, moisture and water duction rates of 30 g to a activity 1 kg per hour - not exactly Impartial and internal studies reflect that real world conditions. specific changes in product character- Typically for a pilot istics via process management, equip- scale extrusion lab, the ment configuration or formulation, will Extru-Tech model E325 directly affect the efficiency of microbio- Figure 1: Collection of equipment architecture that would be used. However, logical control. represent models for existing validations the smallest change, from the lab E325 (3.25 in 22 | may - June 2013 Grain &feed millinG technoloGy FEATURE Creating a dry introduced into the ingredient stream better Figure: 2 E925 inoculant test represents how the pathogens are usually high capacity A significant point present within contaminated raw ingredients. extrusion of discovery is how a The obvious pathogen choice was a system (13 to raw material is con- 3-serotype cocktail of Salmonella as it is the 15 t/hr pet taminated or inocu- most opportunistic organism that is preva- food) lated in a factory. lent in the pet food industry and the media. Various preemptive The selected industry generic pet food for- trials, discovered that mula was charged with a tailored inoculant many of the read- that represents typical contamination events ily available and sci- in the manufacturing process. entific methods of Ultimately all three replications of the inoculation are not challenge study resulted in a log reduction of truly representative Salmonella that exceeded the 5-log reduc- of a typical contami- tion requirement of a CCP allocation. nation event that our clients deal with on a Validation 101 daily basis. As any food safety auditor may tell you, For example, some the ability to correlate the assignment of bore) to a production E525 (5.25 in studies have developed thermal survivability critical control points (CCPs) to scientifically bore), translates to a production rate profiles (charts that show death of various validated proof of their effectiveness in the of 200 to 600 pounds per hour for the microbes against time or temperature). control of targeted pathogens is ultimate E325 and upwards of 8,000 pounds per However, these data sets were created with confirmation of effectiveness. hour for the E525 (in terms of typical the microbes suspended in a largely aqueous “All food manufactures are required pet food). The process data translation solution. If Salmonella is in a liquid, heat will under the Food Safety Modernization Act is cumbersome at best and filled with transfer quickly and kill it quickly. However, (FSMA) to develop written food safety non-linearity. this is not a representation of what happens plans,” says Dr Marsden. “For example, if With all this in consideration the in a pet food plant and creates a false set of Salmonella is a hazard that is reasonably likely BSL-2 pilot plant was outfitted with operational parameters that do not control to occur in the process or product, then a a E525 production scale extruder Salmonella. series of interventions are required and they system and the equipment was config- For pet food, food, and feed manu- must be scientifically proven.” ured for the production of an industry facturers, Salmonella is usually introduced Validation is the process of demonstrat- generic low-moisture dry-expanded through dry ingredients. For this reason, we ing that a food safety system (HACCP, pet food. developed a dry inoculant. A dry inoculant CCPs, CLs) as designed can adequately Die and roll re-working machines Pellet Die re-working and unblocking www.oj-hojtryk.dk Phone: +45 75 14 22 55 O&J Højtryk A/S Fax: +45 82 28 91 41 Ørnevej 1, DK-6705 mail: email@example.com Esbjerg Ø CVR.: 73 66 86 11 O&J_AD_QP_190x60.indd 1 11/02/2013 09:09 A SOLID reputation for quality without compromise! Rota Val’s rotary and diverter valves are UK manufactured from our Wiltshire base using only high quality British castings. Receive 5% discount on your first order when you quote MFJUN13. For more information please visit www.rotaval.co.uk or contact our technical sales team on 01249 651138 & firstname.lastname@example.org. Grain &feed millinG technoloGy may - June 2013 | 23 FEATURE Study parameters Possible paths for validation of a typical pet food process were reviewed in order of preference and viability: Pilot plant - most accepted and least risk Configure a pilot plant with representative production-scale equipment models and perform a tailored challenge study with specific formulations, equipment configuration, product specifications and targeted pathogens Pros - correlation becomes moot, no risk Figure 4: Summary data of extrusion validation for all three repetitions Cons – none In-plant surrogate Select non-pathogenic surrogate and inoculate actual production process flow Pros - matched equipment and process model Cons - lack of applicable (correlation) challenge study data In-plant pathogenic Inoculate actual production process flow with pathogenic microbe Pros - correlation becomes moot. Cons - risk of future events and liability thereof Laboratory validation Secure a BSL-2 laboratory to perform ‘bench-top validation Pros - specific pathogen, surrogate correlation, tailored formulation Cons - does not replicate equipment scale, configuration or the manufacturing process Scientific literature - least accepted Figure 5: XX Extru-Tech Inc. pilot plant control system screenshot and most risk depicting CCP verification Search for existing scientific data that best represents your manufacturing model control (5-log reduction) the identified are reduced or killed through the Pros - least cost hazards to produce a safe product. As the lethality conditions of the CCP. Cons - difficult to find a single United States Department of Agriculture “The best way to see how effective an study that will be even minimally indicates there are two distinct elements intervention is against certain pathogens is representative of a pet food of validation: to actually inoculate a food product with extrusion process • The scientific justification or Salmonella,” says Dr Marsden. “We then documented basis for the system apply that intervention under conditions design requires scientific and technical that ideally replicate a real-world food plant documentation that demonstrates to measure the reductions associated with eters that are required to deactivate the designed process can control the that treatment. As a result, we know exactly Salmonella in the extrusion process,” says identified hazard. The practical and how effective an intervention is in controlling Dr Marsden. “There are other production scientific demonstration must prove specific pathogens.” steps that follow where Salmonella could the system can perform as expected. Basing a food safety system on impractical re-contaminate the product. Extru-tech is This consists of keeping records to data is not safe! By selecting a sub-standard looking at those additional steps to identify demonstrate the plan in operation food safety model, you forfeit all leverage to interventions that could be applied down- and that the HACCP plan achieves mitigate the risk of a food safety event. stream to prevent recontamination.” expectations. • Conducting multiple repetitions in a Validating your extrusion food real-time processing environment using safety system full- scale production equipment and Until now, an extrusion kill step validation More inforMation: actual production formulations that has not been available in the food industry. Tel: +1 785 284 4133 have been inoculated with designated Extru-Tech now offers scientific validation Website: www.extru-techinc.com high levels of specific (non-man made) focused on the extruded foods that exceed Newsletter: http://eforms.kmpsgroup. microorganisms. The process also must FSMA requirements. com/wattpub/forms/extr_subscribe.htm prove that high levels of microorganisms “Extru-tech is documenting the param- 24 | may - June 2013 Grain &feed millinG technoloGy This digital Re-print is part of the May | June 2013 edition of Grain & Feed Milling Technology magazine. Content from the magazine is available to view free-of-charge, both as a full LINKS online magazine on our website, and as an archive of individual features on the docstoc website. Please click here to view our other publications on www.docstoc.com. May - June 2013 first published in 1891 • See the full issue • Visit the GFMT website In this issue: • Adding value to feed milling with profit-oriented feed • Additives for flour formulation standardisation Part II: Additives other than enzymes • Contact the GFMT Team • ‘Kill step’ • High efficiency validation of elevator low-moisture buckets: extrusion modern vs traditional design • Feed focus • Pest control Poultry • Subscribe to GFMT across the supply chain • Assessing nutritional value with NIR INCORPORATING PORTS, DISTRIBUTION AND FORMULATION A subscription magazine for the global flour & feed milling industries - first published in 1891 To purchase a paper copy of the magazine, or to subscribe to the paper edi- tion please contact our Circulation and Subscriptions Manager on the link adove. INFORMATION FOR ADVERTISERS - CLICK HERE Article reprints All Grain & Feed Milling Tecchnology feature articles can be re-printed as a 4 or 8 page booklets (these have been used as point of sale materials, promotional materials for shows and exhibitions etc). If you are interested in getting this article re-printed please contact the GFMT team for more informa- tion on - Tel: +44 1242 267707 - Email: email@example.com or visit www.gfmt.co.uk/reprints www.gfmt.co.uk
Pages to are hidden for
"‘Kill step’ validation of low-moisture extrusion"Please download to view full document