Contamination of Bottled Beverages


Introduction

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Root Cause Analysis (RCA) and Failure Investigation are important tools in: 







“There are scores of Food and Beverage Safety violations terminated in the: 

  1. Hospitals before,
  2. Tribunals later, 
  3. Press, in the meantime”


  • Product Complaint, 
  • mitigation activities, 
  • Failure Investigation,  
  • non-conformance, 
  • Risk Management,
  • hazard analysis,

and the basic foundation of a satisfactory Corrective And/or Preventive Actions (CAPA) system.  Root Cause Analysis is required to verify and validate the issues including data outliers.  These are often improperly and arbitrarily dismissed.   RCA is required in order to close the logic loops existing on:

  • corrective actions,
  • preventive actions, 

thus allowing a proper impact analysis before to decide any action.  Meaning that Failure Investigation and Root Cause Analysis are an important element of Current Good Manufacturing Practice (cGMP) regulations compliance, enforced by the US Food and Drug Administration.  When non adequately performed it becomes a key source of problems with respect to the norms of the Regulatory Agencies (i.e., FDA in the US, EFSA in the EU, etc.).   Companies’ resources are frequently scarce exactly in those activities that have the greatest positive effect to the Quality and Safety of their Product.   RCA is meant to reduce fire fighting, thus minimizing compliance problems also.   The expectations for meaningful Corrective And/or Preventive Actions, supported by: 

  • Root Cause Analysis,
  • results-driven Failure Investigation, 











addressing and resolving the hidden product problems, are really growing among the Regulatory Agencies.   Significative examples are the FDA's QSIT, referred to equipments and the EU’s ISO 14971 thinked for the Device Risk Management.    A valid Corrective And/or Preventive Actions system requires defined failure investigation.  This includes a systemic Root Cause Analysis devoted to the true problem resolution.   There are scores of Food and Beverage Safety violations terminated in the: 

  1. hospitals before,
  2. tribunals later, 
  3. worldwide Press in the meantime. 

The Food and Beverage Contaminations deriving by such violations, as seen by a merely forensic point of view, are a subset of the wider field of the “Product Liability”   In terms of damage to the health of the people, they rarely reach the gravity of other cases of Product Liability, like e.g. the Customer who lose an eye because of glass fragments shattered by an exploded bottle.    But unfortunately, leveraging the Media in a matter of hours a localized contamination can be known worldwide, originating impressive levels of social alarm toward all Companies in a certain sector. Not only the one who produced the contaminated food or beverages. Issues of Food and Beverage poisoning have become increasingly complex, extending beyond traditional concerns regarding spoilage and contamination.    An excellent reference in this matter is the Center for Disease Control. Following their studies, unfortunately the majority of the people do not think at all about Food and Beverage Safety, until an illness affects them directly or one of their family members.   As an example valid for the USA, the Centre for Disease Control, estimates that each one year: 

  • 76 million of US-inhabitants get sick; 
  • over 300000 are being hospitalized;
  • 5000 inhabitants die, due to Food and Beverage-related illness.

That’s why preventing Food and Beverage-related illness, disease, and death remains a major public health challenge.    Consuming contaminated Foods or Beverages is the cause of these digits.    But, back of those numbers there are people, and not other numbers.   Several kinds of disease-causing pathogens can contaminate Food and Beverages.   Also, inorganic poisonous chemicals, toxins, or other harmful substances can cause diseases or illnesses.  


  Molecular arrangement of Sodium hydroxide NaOH, also known as lye or caustic soda, to form crystals (public domain image/CC 3.0)









  1. Pre-cleaning
  • Residual draining
  • High-pressure pre-jetting 
  • Pre-soak tank 
  • Pre-soak with label removal 
  • Pre-jetting
  • Recovery step


  1. Main treatment
  • Caustic bath
  • Recirculation system 
  • Label press 


  1. Post-treatment
  • Post-caustic tank 
  • Warm water 1
  • Warm water 2
  • Cold water
  • Fresh-water jetting unit




Caustic Soda

Sodium hydroxide, whose crystals' molecular shape is visible in the figure here above, also known as lye or caustic soda, is a compound with the chemical formula NaOH. It is a white solid and highly caustic metallic base and alkali salt. Some of the typical examples encountered in the Food and Beverage packaging Lines, are well documented and frequently occurring worldwide, in the Glass Returnable Bottling Lines. Here, caustic soda has to be added to the water of some of the inner tanks the Bottle Washer Machine, to nearly sterilise the incoming bottles, returning by the Market.    Caustic soda whose density typically ranges ~(1.5 - 3.5) % but that, due to other reasons, has also been frequently observed set at densities as high as 4.5 %.  Bottle Washers Machines include a serie of rinsing baths with freshwater, sequentially tilting the bottles upside down, to prevent caustic soda presence at the outfeed of the Machines. Also, there are pressured water jets to easy sticky soil removal.    A complete example of all the sequence in 3 steps (Pre-cleaning, Main treatment and Post-treatment) is:



                          High pressure jets in a Bottle Washer Machine


This long row of measures testifies the good intentions, technical skills and conscience of the Vendors’ designers.  Passing to the reality we discover that the process, however careful the Bottle Washer's Vendor was, cannot prevent 100 % of the caustic soda from reaching the outfeed of the Bottle Washer Machine.  And, it is not simply a matter of statistical fluctuations, preventing an absurd infinite efficiency for a process.  It is the superposed effect of an amount of highly practical issues whose occurrence is worldwide known. Events where little or nothing the Vendor can really do in terms of prevention.   As an example, after emptying the bottles many final Customers are accustomed to introduce into the bottles:

 A preventive maintenance of the Bottle Washer Machine simply delayed, may cause the worst possible consequences: contaminations with caustic soda of the beverage 

  • plastic foils, the cigarette one of the most common, 
  • bent metal caps;

In the Bottle Washer Machine, bottles are tilted upside down to let caustic soda, water and other small objects eventually present get out.     Plastic foils and bent metal caps are objects particularly prone to clog the bottle neck, keeping the dangerous fluid into the bottles.   Cases like these cannot be obviously reconducted as caused by unknown Final Customers. This results more clear when cosidering that one more contribution to the public statistics of people terminating in the Hospitals with pains to the stomach due to ingestion of caustic soda mixed to the bottled beverage, is strictly related to the Quality level of the Maintenance of the Machinery of the Food and Beverage Bottling Line.    



Inorganic Contaminations due to Delayed Maintenances







In the Bottle Washers, bottles “travels” through each one of the treatement phases listed above, hosted into open metal or plastic holders.  These holders need maintenance, meaning long stops to the Production of the Machine and of the Bottling Line.  Maintenance needed to manually remove plastics clogged into the openings existing in the holders to allow evacuation of the plastic foils and papers which get out of the bottles. Maintenance fully and clearly specified by the Bottle Washer Vendor as a condition  for the validity of other relevant Technical Guarantees of that Machine, like the relative percentage of labels out feeding the Washer, or the density of the caustic soda into the out feeding bottles.  

  Periodic maintenance of the Bottle Washer Machine is fundamental, starting by the very basic hourly cleaning of its filters. Showed a Bottle Washer “feeding” an EBI and the following Filler Machine, whose nominal production is 60000 bottles-per-hour.  A great pressure on the Bottle Washer Machine, to let it provide 1.1 millions of Bottles per day (image ScandinavianDesignLab®)











To stop a Bottle Washer to do this Maintenance, e.g. cleaning 20000 bottle holders, means days of Production lost.  So long because it is necessary before to cool the hot water into the Washer, water whose maximum  temperature frequently ranges over 70 ºC and the Washer itself.  More, it is necessary a small Team of Production Operators and Mechanics: we are speaking of Bottle Washers which may be as big as an 2-storey house. What you can expect by a Machine which has to wash until 160000 bottles-per-hour, along a cycle whose duration is nearly one hour.  In the end, it results necessary to wait for the reheating of tens of cubic meters of waters in the tanks.   The effects of the delayed Maintenances like these, are immediately observed in the counters of the Empty Bottle Inspectors (EBIs) interposed between the Bottle Washer Machines out feed and the Filler Machines. EBI High Frequency (HF) Residual Liquid Control's counters for the number of bottles with water into and with or without caustic soda, whose common relative averages should have to be minimised to < 0.03 %, peaking at ~0.20 %.  One bottle each five hundred with too much water into, potentially mixed to residuals of the Washer Machine caustic soda, infeeding the EBI.  Bottles now dangerously close to the Filler Machine infeed.


 

Contaminations due to Technical limits of the 

Inspection Systems




NaOH



We’d expect that the High Frequency (HF) Residual Liquid control is there to do its job, preventing a bottle with e.g. 20 ml of water and 3.8 % of caustic soda from reaching the Filler Machine.  But, all of the HF Residual Liquid Controls operate in difficult conditions because their own level of humidity is made variable by the phase and efficiency of the productive process.  It depends on other external factors, themselves variable.   We are introducing an issue which is unrelated to the technological quality of the design by the different Vendors of Electronic Inspection systems.  Referring ourselves to the effects of factors external to the Electronic Inspector, however giving effects into the Electronic Inspector.  Factors out of any control or automatic regulation.  Some of the factors random, superimposed to other showing on the opposite a marked periodicity.  All High Frequency systems are highly sensible to the dielectric permittivity of the medium (e.g., the air), as we have thoroughly explained elsewhere, until the last causes at the atomic level.  

    The single adjustment of sensitivity of the High Frequency Residual Liquid inspection, one of the most important Beverage Safety controls, cannot linearise the wide range of the dielectric permittivities of the medium. Permittivities depending on the changing environmental conditions of humidity and temperature. Because of this reason, a sensitivity adjustment optimised for an EBI running since over one hour, results definitely too sensible in the initial 20 minutes. As a consequence, huge false rejects (hour average > 0.5 %) whose instantaneous peaks can be so high ( > 10 %) as to stop completely the Filler Machine. To prevent these stops, production losses and false rejects, the sensitivity is then forcedly limited to a single value. A value which let the device operate not as sensible as it’d be necessary to reduce the risks of ingestion of caustic soda



“...a single sensitivity adjustment, optimised for an EBI running since over one hour, results definitely too sensible in the initial 20 minutes. As a consequence, huge false rejects (hourly average > 0.5 %) whose instantaneous peaks can be so high ( > 10 %) as to stop completely the Filler Machine.  

To prevent these stops, production losses and false rejects, the sensitivity is then forcedly limited to a lower value. A value which let the device operate not as sensible as it’d be necessary to reduce the risks of ingestion of caustic soda.


Because of this main reason, the single adjustment of sensitivity for this important Beverage Safety control cannot at all linearise all the wide range of dielectric permittivities of the medium.   A range as wide as that which can be expected comprised between the superposed effect of completely dry: 


HF trasmitter + HF receiver + bottle + interposed air + other metal parts 


and the superposed effect of the same elements, all of them heavily damped.  Because of this reason, a single sensitivity adjustment, optimised for an EBI running since over one hour, results definitely too sensible in the initial 20 minutes. As a consequence, huge false rejects (hour average > 0.5 %) whose instantaneous peaks can be so high ( > 10 %) as to stop completely the Filler Machine.    To prevent these stops, production losses and false rejects, the sensitivity is then forcedly limited to a lower value.  A value which let the device operate not as sensible as it’d be necessary to reduce the risks of ingestion of caustic soda.    To have two consecutive HF residual liquid inspections in a single Empty Bottle Inspector (EBI) is the minimum which can be done to counter this unfortunate technical limit of the devices.  But, ask yourself what is the worldwide relative porcentage of the EBIs equipped with the double HF residual liquid control. The answer is a number far from the desired 100 % and lower than 50 %.    




  Virus Bacteriophagus T4










The cap is the Achilles’ heel of all sensitive beverages, whatever the technology adopted during their filling   

Introduction

Quite incredibly but true, over 250 different food- and beverage-borne diseases have been described.   Most of these are infections, caused by a variety of:

  • bacteria, 
  • viruses, 
  • parasites.

 These different diseases have many different symptoms, so there is no one syndrome named Food or Beverage-borne illness.  The microbe or toxin enters the body through the gastro- intestinal tract.    Some of the most commonly visible initial symptoms are: 

  • nausea, 
  • vomiting, 
  • abdominal cramps,
  • diarrhea.

There are particular difficulties when trying to fully identify as Food or Beverage-borne a disease.  This because many microbes can spread in more than one way. The distinction really does matter, because Public Health Authorities need to know how a particular disease is spreading, to have the possibility to take the appropriate steps to stop it.    They need because, as an example, Escherichia coli O157:H7 infections can spread through any or more of these ways:

  • contaminated drinking water,
  • contaminated food, 
  • contaminated swimming water,
  • toddler to toddler at a day care center.

In the following, we'll briefly outline two different Case Histories, having in common the extreme sensitivity of the beverages, milk and milk with fruit, and the ignored Achilles’ heel: the cap.




When full accountability results the winning strategy

 Both cases hinted before in the Case studies, about two Aseptic Beverage Bottling Line, compelled to produce sensitive dairy products with only a Cap “Presence” Inspection, is nearly opposite than the installation depicted above.  Here, similar dairy bottled products are controlled by a couple of cameras, assuring a full 360º coverage of the cap and of the tamper evident ring. The electromagnetic-only measurement approach is not the optimal solution. But, in the case here presented each individual cap results independently controlled in the Capper by mean of mechanic systems sensible to the torque. All of the measurements correlated to a uniquely identified bottle (in-the-Machine operation mode). Imaged one of the Bottling Lines of Nestle’-Yinlu at Jinan, China, installed by our staff

After a Food and Beverage Safety violations, one of the best ways to know the Truth about what it really happened, a Truth defending all parts, and first of all the Bottler, implies keeping a careful and well organized register of all the variables of the process. Those Empty Bottle Inspector counters are a legal evidence in case of illnesses to Customers due to bottles tagged with that shift.   Also, the Vendors of the Electronic Inspectors shape these functions in such a way that counters cannot be falsified nor cleared, without leaving a permanent register in the device’s FlashPROM memory.  All EBIs’ counters' have to be kept archived along a period of time.  Period longer than the maximum period these bottles shall be made available on the Market for sale and consumption.    

Then, if the beverage is guaranteed by the Bottler adapt for consumption along 12 months counted by their production (BBD, Best-Before-Date), these counters are better kept along a period superior to the sum of the BBD and of the period that the local Legislation of the Bottler’s Country allows, after an offence is known, for the Civil or Penal claims.  In general, to keep these records at least 18 months is enough.  Sufficient to have ready at hand independent evidences with full juridical value after a claim.  Data registered before we become aware of the Event.     

On printed data sheets later stamped and signed by who in the Factory is responsible for such records, commonly the Shift Leader or Production Supervisor.  Records whose relevance is frequently over sighted, can make the difference between a Food and Beverage Packaging Plant in full production and another long time blocked by Authorities’ investigations, after having received claims. And all this, not naming the negative effects over our greatest value: the brand.   We are here openly suggesting the Beverage Bottlers to consider as a Minimum Requirement the fact that complete, detailed and falsification-safe Counter menus exist in the Electronic Inspectors they are planning to acquire.  

A suggestion vital when the Beverage:

  • lies in a returnable glass or PRB bottle;
  • is filled in an aseptic ambient (e.g., hot filling), then not including preservative substances.
18 Beverage Bottling Factories filling sensitive beverage in aseptic conditions, in Germany, France, Greece, USA, Russia and China run our solutions to assure the safety of their beverages

  18 Beverage Bottling Factories filling sensitive beverage in aseptic conditions, in Germany, France, Greece, USA, Russia and China run our solutions to assure the safety of their beverages




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