MICROBIOLOGYOPRPs as a Control for Product VectorsSince the control of significant product vectors is especiallycritical to product safety, these controls could be described asOPRPs. An OPRP requires the establishment of operating limits(or control limits), monitoring activities, corrective actionsfor when a control limit is not met, verification activities andrecord-keeping procedures.Table 3 describes the controls associated with the theoreticalmilk spraying nozzle removal and reinsertion procedure describedin Table 2. The hazard is that Salmonella could be takeninto the dryer on the nozzle and supporting wand, and via theair surrounding the top of the dryer. The nozzle and wandcould be cross-contaminated from the operative’s hands andclothing and from the tools used. Control measures could includechanging into clean clothing at the point of nozzle removaland reinsertion, using dedicated tools and cleaningequipment, decontaminating wands and nozzles and all surfacestouched prior to reinsertion and tamperproof tagging ofthe wands so that they cannot be unintentionally removed. Bymicrobiologically filtering environmental air surrounding thedryer, contamination from the air at routine dryer interventionswould be controlled.ATP testing prior to entry could apply an operating limit toan assessment of the cleanliness of the wands, nozzles andProcess step or process activityObservationLikely hazardContamination event vector(s)Product vector risk analysis without controlsPotential presence of hazard on vector: LHMFrequency of event: LMHSeverity of hazard: LMHRisk scoreSubsequent control step?Current or intended vector controlsProduct vector risk analysis with controlsPotential presence on vector: LHMFrequency of vector: LMHSeverity of hazard: LMHMilk spray dryingGuillotines or spray covers areinserted into the dryer toseparate the dryer from the baghouse during CIP cleaningof the dryerSalmonellaContamination on the reverseside of the guillotine enteringthe dryer on guillotineremoval after CIPMediumHighHigh18Prior to start-up, the dryersurfaces are subjected to hot airat up to 205 °C/400 °F for 2 hoursNot necessary due to subsequentcontrol steptools, and verification of cleanliness could be periodically undertakenby microbiological sampling. During the nozzle removalprocedure, observations could be made to ensure theprocedure was being done correctly and that there were no extrinsicfactors that could act as additional cross-contaminationvectors. Records would be kept of all interventions into thedryer, whether removal and reinstallation procedures had beencorrectly followed, ATP and microbiological counts and tamperprooftag numbers. Corrective actions would review thetraining of the staff against removal and reinstallation proceduresand the effectiveness and validation of the tools andcleaning equipment decontamination programs.In the same manner as CCP records, the records of anOPRP should be incorporated into a food safety plan to ensureall essential conditions were met during the manufacture of aproduct. If a deviation in an OPRP were to occur, then the affectedproduct should be placed on hold while a cross-functionalteam is assembled to review the associated risk and makea decision on product disposition.The management strategy described above for OPRPs is essentiallythe same as for CCPs as defined under HACCP. Sothen what is the difference between a CCP and an OPRP?CCPs are generally described for specific steps in the manufacturingprocess to eliminate or reduce a significant hazard to anMilk spray dryingApproximately once per shift, milkinjectors are removed from thedryer, cleaned and reinstalledSalmonellaDryer nozzles touch hands,clothing and tools prior to entryRisk score99Table 2: Theoretical observational record of potential cross-contamination vectors associated with two spray dryer intervention procedures.HighHighHigh27NoneGloves are worn and nozzlesand tools are decontaminatedwith alcohol prior to dryer entryLowHighHighMilk spray dryingApproximately once per shift, milkinjectors are removed from thedryer, cleaned and reinstalledSalmonellaAir can enter the dryer duringthe nozzle removal andinstallation processLowHighHigh9NoneNoneLowHighHigh60 F O O D S A F E T Y M A G A Z I N E
MICROBIOLOGYProcess step or areaLikely hazardSource or contaminationevent/vector(s)Control measure(s)Operating limit(s)Control measure(s)Control verification(s)Corrective action(s)RecordsMilk spray dryingSalmonellaRemoval, cleaning and reinsertion ofmilk spraying nozzles• Dryer processing area air filtered to 95% removal of 1.0-µm particles• Gloves are worn by operative to remove nozzles• Nozzles and support wand removed and replaced by alcoholdecontaminatedblanking plate• Nozzles cleaned and kept in QAC until reuse• Glove and sleeve change by operative at point of insertion• Nozzle wand CIP process• ATP assessments of wand and/or nozzle cleanliness• Use of dedicated tools• Alcohol decontamination of gloves, blanking plate and wand• Blanking plate removal and nozzle insertion• Tamperproof tag installedATP < 150 RLUVisual assessment of the removal and reinsertion operationATP assessment of the cleaned wand and nozzleOccasional microbiological verification of wand and nozzle cleaning• Put on hold any potentially affected product.• Determine the need for spray dryer to be decontaminated.• Investigate the cause of the problem and take appropriate action.• Staff retraining• Review of wand and nozzle decontamination procedures• Dryer intervention record including correct observation ofremoval and insertion procedure• Post-decontamination ATP and microbiological records• Tamperproof identity tag numberTable 3: Operational prerequisite program (OPRP) managementtable as adapted from classical CCP management.acceptable level, for example, cooking of a meat patty, coolingof a sauce or running a liquid product through a screen of definedparticle size. On the other hand, OPRPs are generally describedfor procedures or programs that address some aspect ofthe processing environment or the interaction of the processingenvironment with the process, for example, the manual removal,cleaning and reinsertion of milk spray nozzles into thespray dryer during a production run.A Developing StudyThe concept of identifying sources and vectors of cross-contamination,assessing their risk and managing their risk throughOPRPs in a fashion similar as CCPs is a developing study.Elevating the control of sources and vectors to the level ofOPRPs and managing them similar to CCPs focuses attentionon the control of what is thought to be the highest risk of crosscontaminationfrom the processing environment to the product.Controlling sources and vectors by developing and documentingOPRPs as discussed in this article may provide a means todemonstrate increased confidence in product safety should apathogen be found in the manufacturing environment.Taken beyond microbiological hazards,the same source-and-vector approach may beused to evaluate and control nonmicrobiologicalhazards, such as allergens or foreignmaterial. As these are developing concepts,comments are welcomed as to how they canbe improved.nJohn Holah, Ph.D., is an applied microbiologist workingboth in food factories and the laboratory and is responsiblefor food hygiene at Campden BRI.Edyta Margas is a hygiene and novel technologiesspecialist at Campden BRI.Robert Hagberg is the director of QA technical servicesat Land O’Lakes, Inc.Benjamin Warren, Ph.D., is the director of productsafety & regulatory affairs at Land O’Lakes, Inc.Judy Fraser-Heaps is the senior manager of QA, microbiology& food safety at Land O’Lakes, Inc.Sara Mortimore is the vice president of quality & regulatoryaffairs at Land O’Lakes, Inc.References1. www.cdc.gov/print.do?url=http%3A//www.cdc.gov/salmonella/agona.2. Jackson, K.A., M. Biggerstaff, M. Tobin-D’Angelo,D. Sweat, R. Klos, J. Nosari, O. Garrison, E. Boothe, L.Saathoff-Huber, L. Hainstock and R.P. Fagan. 2011.Multistate outbreak of Listeria monocytogenes associatedwith Mexican-style cheese made from pasteurizedmilk among pregnant, Hispanic women. J <strong>Food</strong>Prot 74: 949–953.3. Gaze, R. 2009. HACCP: A practical guide (fourth edition). Campden BRI,Chipping Campden, Gloucestershire, UK.4. www.codexalimentarius.net.5. www.mygfsi.com.6. Middleton, K.E. and J.T. Holah. 2008. Cleaning and disinfection of foodfactories: A practical guide. Campden BRI, Chipping Campden, Gloucestershire,UK.7. George, R.M. 2004. Foreign bodies in foods: Guidelines for their prevention,control and detection (second edition). Campden BRI, Chipping Campden,Gloucestershire, UK.8. Smith, D. 2009. Hand hygiene: Guidelines for best practice. CampdenBRI, Chipping Campden, Gloucestershire, UK.9. www.bcas.org.uk.10. www.cieh.org.11. Anon. 2005. ISO 22000:2005 <strong>Food</strong> <strong>Safety</strong> management systems —Requirements for any organization in the food chain.12. Smith, D. 2007. Ranking of cross-contamination vectors of ready-to-eatfoods: A practical approach. Campden BRI, Chipping Campden, Gloucestershire,UK.13. Lamb, H. 1994. Hydrodynamics (6th edition). Cambridge UniversityPress.F E B R U A R Y n M A R C H 2 0 1 2 61
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