Vitsab User Manual 2011
Contents
1. The key phrase here is adequate temperature control monitoring but what does this term actually mean in practice In reply to this question consider an excerpt from another document produced in January 1998 by the U S Food and Drug Administration Center for Food Safety and Applied Nutrition FISH AND FISHERY PRODUCTS HAZARDS AND CONTROLS GUIDE Chapter 13 CLOSTRIDIUM BOTULINUM TOXIN FORMATION If you intend to vacuum package or use modified atmosphere packaging or hermetically sealed packaging for these products or pack them in oil or a similar oxygen excluding media you will need to evaluate the effectiveness of other preventive measures either singularly or in combination Such evaluation will usually necessitate the performance of inoculated pack studies under moderate abuse conditions An example of another preventive measure to consider is strict temperature controls throughout distribution and retail sale such as the use of recorder thermometer charts or digital time temperature data loggers during distribution and retail storage and sales or time temperature integrators on individual packages It is not cost effective to employ recorder thermometer charts or digital time temperature data loggers for the entire distribution scheme from processor to consumer for seafood packaged under reduced oxygen conditions Time temperature integrators are recognized as being the most Vitsab International AB Krossve2. L5 8 label has a transparent window that displays the color of the chemical reaction taking place inside the label Before the labels are activated the window appears white in color This is because the window is showing the contents of only one of the two pouches containing the reactants that make up the pre activated label Activation causes the reactants to combine together see diagrams below Vitsab International AB Krossverksgatan 5 H SE 216 16 Limhamn 46 40 555 470 www vitsab com Page 2 ie b Vitsab User Manual 2011 The sign of freshness Unless instructions indicate otherwise Vitsab L5 8 labels are activated by applying top down pressure to the white window side of the label or to the arrow side of the label top figure After activation of the label the window that originally showed white before activation will show green This is because the two pouches one containing green component and one containing the white components are mixed together the result is a lighter green color of the combined reactants eventually an endpoint orange red colour develops Apply pressure here Or apply pressure here Color Change at Endpoint f White Side of Label wil Activation Step E eu CN Green Side of Label Contents of Green and White Mixed Activated Label label is running Mixing of the contents is achieved by massaging the label so that the fluid contents slosh back and forth a
3. factors that make Clostridium botulinum a hazard that is reasonably likely to occur in a fishery product Answer Some factors which contribute to the likelihood of a Clostridium botulinum hazard include packing the product under vacuum in a deliberately modified atmosphere in a hermetically sealed container inside a package with a film covering that restricts inward oxygen diffusion or in oil Historically the hazard been controlled by applying a moderate heat treatment in combination with salt at less that 10 or other reduced water activity methods This type of processing is not currently in widespread use due to consumer preferences for minimally processed fresh products For additional information consult FDA s Fish and Fishery Products Hazards and Controls Guide Guide Edition Two p 154 Question Is Clostridium botulinum C bot a hazard in vacuum packaged raw seafood products that are stored and distributed refrigerated Answer Yes the Guide states that FDA is not aware of any suitable controls for C bot in vacuum packaged raw fish i e such a product would not contain any known barriers to the growth of C bot Refrigeration alone is not a suitable barrier without adequate temperature control monitoring from processor to consumer If a processor intends to pack raw fish in a vacuum package he will need to establish adequate safety controls The most likely procedure would be to carry out inoculated pack studies
4. few times to ensure proper combination This mixing process can be performed by hand or by activation applicator machinery Details of an appropriate tool for this step are available from Vitsab The label adhesives are specially designed to operate successfully at low temperatures However adhesion may be weakened if the surface is wet dirty or waxy Instructions for Use Detecting Endpoints Vitsab L5 8 labels show a defined and consistently reproducible sequence of color development during time temperature monitoring The green colour denoting activation becomes a clear yellow near the endpoint finally showing as a defined orange red at the endpoint see figure Endpoints can also be quantitatively validated using an appropriate colour measuring laboratory instrument Vitsab International AB Krossverksgatan 5 H SE 216 16 Limhamn 46 40 555 470 www vitsab com Page 3 Vitsab Vitsab User Manual 2011 The sign of freshness Standby or non running label The white central window means that the label has not yet been activated Running activated label with green central window This is how the label looks immediately after activation and for most of the time temperature monitoring period Just before the endpoint the central window changes to a yellowish color Intermediate steps manifest as a yellowish green The endpoint is reached when the central window first turns orange re
5. timing by less than 5 if left in 100 CO z for more than 24 hours Lower CO concentrations produce negligible effects on label time to endpoint characteristics Evidence indicates that acceleration effects are completely reversible if the time run of a specific label is long enough for outward diffusion to reset the chemical reaction of endpoint color production Sunlight UV No effect when parallel sample groups are tested Radiation Carbon monoxide No effect when parallel sample groups are tested lonizing Radiation No effect when parallel sample groups are tested by exposure to soft beta radiation Not susceptible to normal food irradiation levels Anaerobic No effect when parallel sample groups are tested Conditions Storage Refer to shipping and storage guideline information above Temperature Vitsab International has performed exhaustive validation testing of its L 5 8 formulation A number of labels were tested according to the type of time temperature function described for Clostridium Vitsab International AB Krossverksgatan 5 H SE 216 16 Limhamn 46 40 555 470 www vitsab com Page 7 b Vitsab User Manual 2011 The sign of freshness botulinum thresholds for toxin formation as previously indicated Please refer to Vitsab Scientific Supplement Sep 2008 for more information Process Controls Used in Vitsab Manufacturing All materials used in the manufacture of L5 8 labels ar
6. a for any purchaser s use The data on the Material Data Safety Sheet relates only to this product and does not relate to use with other material or in any process All chemical products should be used only by or under the direction of technically qualified personnel who are aware of the hazards involved and the necessity for reasonable care in handling Hazard communication regulations USA Occupational Safety and Health Act OSHA and Canada Workplace Hazardous Materials Information System WHMIS require that employees must be trained on the use of Material Safety Data Sheets as a source of hazardous information Vitsab International AB Krossverksgatan 5 H SE 216 16 Limhamn 46 40 555 470 www vitsab com Page 11
7. d in color Once established the label has passed the endpoint For practical purposes we have set the endpoint at the start of the yellow to orange red color transition that is as shown between panels 3 and 4 above when users are alerted by a notification on the label such as Do not use or Expired the exact message depends on the requirements of the customer who purchases labels for specific product applications Stages 3 and 4 occur rapidly comprising only a small fraction of the label s total running time The above images bracket the subjective endpoint required by the user Smart Labels and Food Safety Our smart labels are widely used for monitoring the chill chain condition of for example seafood products They are formulated to produce a response that conforms to the established guidelines for HACCP regulations for packaging seafood under reduced oxygen and modified atmosphere conditions Vitsab International AB Krossverksgatan 5 H SE 216 16 Limhamn 46 40 555 470 www vitsab com Page 4 Vitsab Vitsab User Manual 2011 oO The sign of freshness Using Smart Labels for Clostridium botulinum Control The following is an excerpt from a document produced in January 1999 by the U S Food and Drug Administration Center for Food Safety and Applied Nutrition Office of Seafood HACCP REGULATION FOR FISH AND FISHERY PRODUCTS QUESTIONS AND ANSWERS Question What are the
8. ds on biochemical components so labels are normally delivered by courier to ensure that their temperature is controlled during shipment They are packaged 2 by Vitsab in insulated boxes with cooled and thermally active gel packs together with a temperature logger to keep track of any variations in temperature during transit Temperature C The enclosed figure shows an example of a temperature profile solid red line recorded by a logger during of a smart label shipment In this case the transport lasted 64 Hours Vitsab International AB Krossverksgatan 5 H SE 216 16 Limhamn 46 40 555 470 www vitsab com Page 1 b Vitsab User Manual 2011 The sign of freshness hours from Vitsab in Sweden to a customer in Japan S represents the logger s start time and temperature when the labels were packed for shipment F represents the point when package was opened by the customer at its destination The effective temperature Ter dashed line or weighted average temperature inside the package is calculated by the logger as 9 C Note that even though the temperature during the last 8 10 hours of shipment rose to between 10 20 C Terr was still no more than 9 C for the full duration of the shipment On arrival to the end user a marker on the logger is pressed and the logger is returned to Vitsab in the included addressed envelope so that time and temperature conditions during shipm
9. e red line and red circles represent the Skinner Larkin borderline function for incipient Clostridium botulinum toxin formation The blue line represents an exact Arrhenius curve fitted to the experimental L5 8 data blue squares It can be seen that the response of the L5 8 label corresponds well to the Skinner Larkin boundary and thus to the contour of no Clostridium botulinum toxin formation as described by Skinner and Vitsab International AB Krossverksgatan 5 H SE 216 16 Limhamn 46 40 555 470 www vitsab com Page 6 Vitsab Vitsab User Manual 2011 The sign of freshness Larkin Vitsab L5 8 labels are thus an appropriate application as a smart label control instrument since the endpoint of the label response creates a warning signal prior to approaching Skinner and Larkin boundary time temperature values through a change to an orange red color In conclusion the L5 8 label therefore acts as a functional HACCP control that encompasses the lower threshold limits for the toxin effect Validation of the Vitsab L5 8 label L 5 8 Time Temperature Response Prior testing has established the information shown in the table about the vulnerability of the labels to environmental factors We periodically repeat all of these tests for L5 8 labels and other formulations for environmental susceptibility and conformity to manufacturing specifications Environmental Susceptibility Factor Carbon dioxide Acceleration of
10. e subject to inspection and testing These tests are summarized in our scientific supplement Vitsab L5 8 Sci 808 which is available on request All production runs are indexed with a batch number giving full traceability Post production label batches are kept in frozen storage for all shipped product for up to a year after shipment Periodic tests of TT performance are made to verify proper function Data based records are kept for all verification and quality control tests which are performed in house The manufacturer of the label s supporting film also maintains records of film production tests Vitsab recommendations With the analysis of logger data Vitsab validate each individual shipment to customers Thus for shipments to customers Vitsab advise the following Effective temperature Teff Duration of shipment Shipment status Less than 15 C Shorter than 10 days OK 15 20 C Shorter than 96 hours OK 20 25 C Shorter than 48 hours OK 25 35 C Shorter than 12 hours OK The effective temperature is a weighted average of temperature for the duration of the shipment in literature also referred to as mean kinetic temperature MKT As have been pointed out previously L5 8 labels should be stored either chilled or frozen the reason being that label function is based on an enzyme reaction and as most biological material should be stored chilled or frozen to maintain its set activity Vitsab advise t
11. ent can be evaluated and calculate Ter and the corresponding Mean Kinetic Temperature for the complete shipment Vitsab instructions are that labels must not be used until Certificate of Approved Delivery has been issued by Vitsab For further information regarding temperature tolerance of Vitsab L5 8 labels prior to activation and how their response might be affected at elevated and extreme temperatures please refer to Vitsab s Scientific Supplement 2008 which is available on request Storage of Smart Labels Vitsab specify storage temperatures for Vitsab L5 8 labels within the normal refrigerated and freezer ranges For storage temperatures between 0 5 C the specified TTI function is guaranteed for up to 2 months and if the labels are kept frozen below 15 C up to 6 months as indicated in the Certificate of Conformance included with each shipment Once removed from the specified storage conditions labels should be used immediately I nstructions for Use Activation and Application Vitsab smart labels are supplied in a non running mode so they must be activated prior to use according to the following simple sequence Immediately apply labels to product to be monitored by using adhesive backing Remove labels Warm labels by putting Activate labels from frozen them in storage at 18 by hand or storage to 22 C for 2 4 hours machine Labels are now running Every Vitsab
12. he following Storage temperature Storage time 20 to 15 C 6 months 0 to 5 C 2 months If customers after an extended time of storage need to verify the preset function of the label a simple validation test can be carried out A label or a set of 5 10 labels are brought out of storage allowed to temperature equilibrate to room temperature around 20 C e g overnight then activated and put in a constant temperature and monitor the response time The response time should be within the given range in the table below Vitsab International AB Krossverksgatan 5 H SE 216 16 Limhamn 46 40 555 470 www vitsab com Page 8 ie b Vitsab User Manual 2011 The sign of freshness Constant temperature Response time 10 C 2 5 days 10 15 C 24 hours 10 20 C 8 5 hours 10 The variation in response time can be due to how well activation has been accomplished i e mixing or massaging the contents of the two pouches during the activation procedure Using the above recommended procedures customers will be sure of fully viable L5 8 labels when put to use Appendices Appendix A Endpoint Setting Processes Subjective Reading Vitsab L5 8 labels indicate a defined process endpoint for perishables of different kinds And it can be based on the time temperature characteristics of that process The endpoint is signaled by a change in color of the target dot of the label Personnel inte
13. ide as well as water and Hydrogen Chloride Vitsab International AB Krossverksgatan 5 H SE 216 16 Limhamn 46 40 555 470 www vitsab com Page 10 Vitsab Vitsab User Manual 2011 The sign of freshness Section 5 Reactivity Data The plastic laminate as well as the pouch content is stable i e the whole product is stable Incompatibility materials to avoid Strong Oxidizing Compounds Strong Acids and Strong Bases Hazardous Polymerization Will Not Occur Hazardous Decomposition Products When exposed to intense heat resulting in decomposition the product may release toxic fumes such as Acrolein Carbon Monoxide Carbon Dioxide and Hydrogen Chloride Section 6 Health Hazards Threshold Limit Value TLV NA Effects of Overexposure None Emergency First Aid Procedures Skin and Eyes In the event of rupture of the pouch flush immediately with copious amounts of water Get medical attention for eyes Wash skin with soap and water Initial pH of pouch content is 8 9 after activation of TTI while TTI color is green This drops to about 5 5 when TTI has changed color to red orange NA Not Applicable ND Not Determined The information contained herein is based on data considered accurate and is offered solely for information consideration and investigation Vitsab Inc extends no warranties make no representations and assumes no responsibility as to the accuracy completeness or suitability of this dat
14. il b Vitsab User Manual 2011 The sign of freshness Vitsab User Manual 2011 L5 8 Smart Labels for Time Temperature I ndication Introduction Handling and Storage Instructions for Use Food Safety Validation Introduction Vitsab L5 8 Smart Labels Smart labels are time temperature indicators TTIs that have long been recognized by the scientific community as a simple and highly efficient tool for monitoring temperatures during distribution of perishable items This simple low cost biotechnology integrates temperature logging and alarm functions TTIs monitor the cold chain temperatures of food products for example as they leave the controlled environment of the production processing plant Once activated smart labels respond to temperature changes in real time and so give an accurate indication of the overall temperature exposure of such products over a set period a significant advance over the general guidelines from food and health authorities to monitor the time the product spends above a specified maximum temperature The label s visual appearance informs food industry workers and end users whether proper refrigeration has been maintained throughout the distribution chain by reflecting the actual temperature history and most important whether the product is safe to eat Handling and Storage Monitoring of Smart Labels during Shipment The TTI technology of Vitsab L5 8 Logged temperature profile labels depen
15. le Foods Single dot Section 2 Information on Ingredients Chemical Name CAS No Albumin Bovine 9048 46 8 CHES Buffer 103 47 9 Glycerol 56 81 5 PVC 9002 86 2 Trilaurin 37318 95 9 Methyl Myristate 124 10 7 Xanthan Gum 11138 66 2 Polypropylene Plastic film Distilled Water Lipase pH range 8 9 5 5 Section 3 Physical and Chemical Characteristics Appearance Plastic film with mini pouches containing partly water soluble components Properties of the plastic film Boiling point ND Solubility in Water None Specific gravity ND Reactivity in Water None Melting point 130 C Vapor Pressure mm Hg ND Properties of the contents of mini pouches Boiling point ND Solubility in Water 99 Specific gravity 1 11 at 68 F 20 C Reactivity in Water None Melting point lt 13 F 25 C Vapor Pressure mm Hg lt 1 at 68 F 20 C Section 4 Fire and Explosion Data The plastic laminate will burn under the right conditions of heat and oxygen supply Fires can be extinguished by conventional means with water fog preferred As with any fire use self contained breathing apparatus with facial mask to avoid inhalation of hazardous combustion fumes Fumes may contain hydrocarbons and oxides of carbon such as carbon monoxide carbon dioxide as well as water The content of the aqueous solution in the pouch can also generate fumes containing hydrocarbons and oxides of carbon such as Carbon Monoxide Carbon Diox
16. rksgatan 5 H SE 216 16 Limhamn 46 40 555 470 www vitsab com Page 5 Vitsab Vitsab User Manual 2011 B The sign of freshness effective and cost effective tool for guarding against the production of botulinum toxin in food products for a scientific rationale see G E Skinner and J W Larkin s paper Conservative prediction of time to Clostridium botulinum toxin formation for use with time temperature indicators to ensure safety of foods in Journal of Food Protection 61 1154 1160 1998 The Vitsab L5 8 label s TTI formulation has been developed to conform to the Skinner Larkin model see Vitsab s Scientific Supplement Sep 2008 for details and the FDA s HACCP regulations The figure below shows the time to endpoint color development as a function of temperature for a Smart Label TTI blue line The red line shows the Skinner Larkin boundary curve which describes the threshold of toxin formation as a function of temperature The implications of the diagram are that sets of time and temperature conditions below and to the left of the Skinner Larkin boundary line there is no toxin formed L5 8 response and Skinner and Larkin boundary curve Skinner and Larkin boundary A pe Time days Area of toxin formation Response of L5 8 formulation No toxin formed Test labels were run in controlled temperature cabinets to determine the time temperature TT response of the L5 8 label formulation Th
17. rpreting the label use a subjective judgment of color to determine if the endpoint of the defined process has been reached This color decision is then used in product handling acceptance or rejection or for other purposes The current color system of the labels will be transitioning from an initial green to a yellow gt greenish orange gt orange red color Some panelists see the final color transition to red others see it a transition to orange This final transition comprises only a small fraction of the entire run time of a L5 8 label Panellists were asked to determine endpoints based on first appearance of orange red color The panel participants were shown a graded series of color development stages of the labels anda specific color endpoint was determined by the preponderance of selections of endpoint Panel results were almost unanimous in the selection Appendix B General Validation of Vitsab L5 8 Labels A thorough validation review for Vitsab technology can be found in our scientific supplement Vitsab Scientific Supplement Sep 2008 which is available on request Vitsab International AB Krossverksgatan 5 H SE 216 16 Limhamn 46 40 555 470 www vitsab com Page 9 Vitsab Vitsab User Manual 2011 The sign of freshness Appendix C Material Safety Data Sheet for Vitsab L5 8 Labels Section 1 Product Identification Product number Application Product Type L Series Labels Perishab
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