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U.S. Department of Health and Human Services

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Teat Preparation Protocol GEA Farms Technologies, Incorporated MIone USA Robotic Milking System

September 21, 2011

TO: All Regional Food and Drug Directors 
Attn: Regional Milk Specialists 
FROM:Dairy and Egg Branch (HFS-316)
SUBJECT:Teat Preparation Protocol GEA Farms Technologies, Incorporated MIone USA Robotic Milking System
 

ITEM 13r. MILKING – FLANKS, UDDERS AND TEATS

The Teat Preparation Protocol for the GEA Farms Technologies, Incorporated MIone USA Robotic Milking System has been submitted and evaluated by FDA’s Central Region Milk Specialists and CFSAN’s Dairy and Egg Branch/Milk Safety Team and has been determined to be in compliance with Item 13r-Milking-Flanks, Udders and Teats of Section 7-Standards for Grade “A” Raw Milk for Pasteurization, Ultra-Pasteurization or Aseptic Processing and Item 13r-Milking-Flanks, Udders and Teats of Appendix Q-Operation of Automatic Milking Installations for the Production of Grade “A” Raw Milk for Pasteurization.  Item 13r within Appendix Q of the PMO states:

“AMI manufacturers shall submit data to FDA to show that the teat prepping system employed in their system is equivalent to Item 13r., Administrative Procedures #4: “Teats shall be treated with a sanitizing solution just prior to the time of milking and shall be dry before milking.” Each installer shall provide the producer and the Regulatory Agency with a copy of this approval, including a detailed description of the approved procedure. Each producer shall keep a copy on file at the farm.”

Compliance with Item 13r of the PMO was based upon the following guidance, provided by GEA Farms Technologies, Incorporated MIone USA (July 10, 2011) for the Teat Preparation Protocol: 

NOTE: While this protocol is specified for use with the GEA Farms Technologies, Incorporated MIone USA Robotic Milking System, its acceptance will remain in effect with future versions (models) of this equipment as long as this accepted Teat Preparation Protocol can be applied as written.  If the Protocol has not been changed, the manufacturer shall provide this accepted protocol with future versions (models) of their automated milking installations.  Only MIone US liners (model MIone US plus part number molded into the head) may be used for this process.  This liner will have 1 inlet port.  The prep, air chase and then liner head vent all come in the same port.

 

Teat Preparation Protocol for MIone U.S.A.  


GEA Farm Technologies, Inc.


July 10, 2011


The serial number will be the Julian date at the start of building a particular unit. The part number will be 7802-6100-000.  It is the same part number whether it is a 1, 2, 3, 4, or 5 box system.

 A view of the outside of the main control enclosure box of the MIone USA Robotic Milking system for decal attachment.  This decal will contain the model, serial number, date code, and power input rating for the system.


Index

 

  1. Summary

  2. Teat Preparation Procedure
    1. ID cow and attach teat cups
    2. Default prep configuration
    3. Prep solution input
    4. Teat cleaning and sanitizing
    5. Teat drying
    6. Purging prep and foremilk
    7. Milk mode
    8. Backflush
  3. Controller Logic

    Milk Flow Monitoring and Transition from Prep Receiver to Good Milk Receiver Control

    Note:  Software versions are subject to change as programs and sensors evolve to improve performance.  

  1. Summary

    The teat preparation process is part of a milking operation layout that resembles a traditional parlor.  Milking boxes are arranged in a line, allowing for milk to be collected in a single location and efficiently moved to the cooling process.  The box furthest from the PSU main control is referred to as box #1.

     Schematic layout of a basic milking center with the robotic milk system site in a single location.

    The teat cleaning process takes place within the milking teat cups.  All four teats are located and attached to the cups. A double block valve arrangement isolates the milk during the teat preparation process. Teat sanitizer is introduced onto the entire teat surface through a passage within the head of the milking liner. Only MIone US liners (model MIone US plus part number molded into the head) may be used for this process. This liner will have 1 inlet port.  The prep, air chase and then liner head vent all come in the same port. Clean oil-free filtered air is used to disperse sanitizer over entire teat and purge any excess. The teat prepping supply line is completely isolated through a double block arrangement of valves. Vented air continues to be admitted to dry the teat.  Initial milk flow is used to rinse teat sanitizer and foremilk from the system, then valves isolating the teat cups from the good milk system are switched and milk is allowed to flow to the good milk receiver. Because this is a single attachment process, teats do not have to be located again, therefore dirt on the underside of the cow is not introduced into the system following the teat sanitizing process.

  2. Teat Preparation Procedure
    1. Once cow is identified in the box as being a cow acceptable for milking, the robot travels to the box and removes the milking cluster from its cleaning station.  The cluster is moved under the cow, teats are located and all teat cups are attached to teats.  Vacuum with pulsation is applied when searching for a teat.  If teat is located, vacuum and pulsation remain on throughout prep process.  If teat is not located, vacuum is shut off and teat location is attempted again. 

      Verification cow status good/bad – go to robot system computer and access the individual cow record screen.

    2. Valves to and from the teat cup begin in a configuration to divert all flow to the waste line
      • Valves 6, 8, 10 closed
      • Valves 7, 9, 11 open

      All prep process and switching from bad milk to good milk are done on an individual teat basis.

      Diagram of a block-bleed valve used during cow udder prep.  Multiple valves are identified, and valves' 4, 6, 8 and the vent/drain are closed.
      Verification of proper valve function and position –

      • Visually monitor each valve (all valves are transparent with LED indication position sensing – LED on indicates valve is in safe position for milking into good milk tank.)
      • Go to robot system computer and access box monitoring screen to observe valve status and position sensor status in real-time.
      • The following screen shows where all valves, block-bleed-block sensors, blood and conductivity sensors can be monitored.  Valves can also be operated from here by pressing the key symbol near the bottom and then selecting any valve for manual operation and sensor function.

       

       

       Image of the computer screen of the monitoring program used with the robotic milking system during the udder prep process.

       

    3. Valves 1, 2, and 3 which provide the teat prep solutions are enabled by closing valve 4 and opening valve 5.  Valves 6, 7, and 8 provide the double block protection from good milk and are position confirmed.  35 psi prep solution is dispensed for 120 milliseconds to delivery 5-8 ml of sanitizer into the delivery hose.

      Verification –

      • Valve function and position monitored in the same manner as above.
      • Prep solution pressure monitored by checking pressure gage located at solution air pump next to solution supply drum.
      • Valve on-time value can be confirmed on the robot system computer by accessing the expert parameters page 1 screen.
      • Volume can be individually verified by
        • Plugging the teat cup and removing the sanitizer delivery hose from the teat cup, pointing it into a graduated cylinder.
        • Initiate the prep cycle by using a cow ID responder that is entered in the system to fake the robot into thinking that cow has entered.
        • Wait for the sanitizer to be dispensed into the graduated cylinder and observe volume.
    4. Valve 3 provides 5-10 psi oil-free clean filtered air to push the sanitizer to the teats and distribute it all around the teat.  Teat cleaning is accomplished by flowing liquids past the teat while pulsation is operating.  Air flows for 10 seconds to get the sanitizer to the teat, distribute it onto the teat and remove excess.  The liquid solutions flow into the head of the liner from valves 1 and 2 and are directed all around the teat by geometry inside the liner head.  Pulsation continues throughout the entire process to enhance movement of solution onto all teat surfaces, to aid in loosening and removal of dirt from the teat and to strip fore-milk.  Valves 1-5 return to a safe position, creating a double isolation of the teat sanitizer delivery system.

      Verification –

      • Valve function and position monitored in the same manner as above.
      • The set value for teat sanitizer delivery and air purge time can be verified on the Milk Safety (shown as the FDA tab in this draft version) P6 = 12 which is 120 ms of time.  P7 = 1000 is the air chase or purge time which is calculated to 10 seconds or air valve on-time.
      • Pressure of filtered air can be confirmed by looking at the pressure gage in the PSU next to the coalescing filter. 
      • Check teat sanitizer delivery pressure by looking at the pressure gage located at the air operated pump next to the OxyCide® AMS ready-to-use product supply drum.

       Image of the computer screen of the monitoring program's teat sanitizer delivery pressure gauge.

       

    5. Teat drying and kill-time take place by allowing air to be drawn into the liner from an air bleed located in the sanitizer delivery system.  This air flow provides a constant drying process during the kill-time and throughout the milking process.  Based on laboratory tests, OxyCide has a 95% + kill of Staph. and Strep. organisms within 5 seconds, so the necessary kill-time elapses during the previous 10 second distribution and excess purging process.  Teat drying takes place until milk flow begins.

      Verification –

      • Air bleed vent can be located on the bottom end of the prep safety valve.  To verify it is admitting air, place finger over bleed during milking or when applying vacuum with teat cup plugged.

      Process:

      Cycle 1 – Dispense teat sanitizer

      Cycle 2 – Apply teat sanitizer and remove excess

      Cycle 3 – Kill-time and teat drying

      Approved sanitizer = OxyCide® AMS  
      (low-foaming 1%      hydrogen peroxide)
      Qty = 5-8ml delivered at 35psi for 120ms.

      5-10 psi clean filtered air is applied for approximately 10 seconds to move sanitizer to teat, distribute onto all surfaces of teat and remove excess.

      Oxycide is tested to provide over a 95% kill rate within 5 seconds.  Therefore, the kill-time is complete by the end of Cycle 2.  Air bleed into liner provides for continuous teat drying.

      Illustration of the automatic teat sanitizing and drying spray below a table addressing the three cycles of the sanitizing process.

    6. To purge the milk hoses of prep solution and foremilk, a minimum of 1 slug of milk is used to purge remaining prep solution and foremilk from the milk hose.  The slug is routed to waste milk through valves 9, 10 and 11.

      Only MIone US liners (model MIone US plus part number molded into the head) may be used for this process.  This liner will have 1 inlet port.  The prep, air chase and then liner head vent all come in the same port.

      Slugging of milk is enhanced through the use of pulsation and liner manipulation/stimulation (sometimes known as Stimopulse).  At the start of attach, the liner pulsation rate is greatly increased.  This causes the liner to stay mostly collapsed on the teat and helps to close the teat canal, while providing a stimulating message.  Good stimulation is sometimes important for up to 90 seconds to ensure fast and complete milking.  Therefore, the liner stimulation process continues for up to 90 seconds, then transitions to a normal pulsation rate.  Flow sensors monitor the flow and prevent switching from pre-milk to good milk until a required level of flow is achieved.

      Slow let-down cows:

      Some cows may be nervous or in general are slow initial flow milkers.  Their initial milk flow rate needs to be enhanced to provide good efficient rinsing of prep solution from the system.  The liner manipulation/stimulation helps to promote oxytocin release while helping to minimize flow.  Milk from slow let-down cows collects in the teat cistern and udder pressure builds.  After up to 90 seconds of stimulation and transition to normal pulsation, milk flow typically is improved, resulting in more efficient rinsing of prep solution from milk hoses.  As milk flow begins, the flow sensors continue to monitor until the minimum flow rate has been achieved for a short period of time to rinse prep solution from the system.  Then the decision valves switch the milk flow from pre-milk to good milk. 

      Easy let-down cows:

      Some cows come into the milking box with high udder pressure and a tendency of easy milk let-down.  In this case, good slugging and purging of prep solution can happen without the typical 90 second stimulation time.  If milk flow is sufficient during the stimulation time, indicating good pressure and milk flow for proper prep purging, the decision valves switch from pre-milk to good milk.  In this case, milk flow cannot be held back for up to 90 seconds and wasting additional milk is avoided by monitoring the flow sensors throughout the prep process.

      Verification – 
      • Valve function and position monitored in the same manner as above
        • Visually watch valves and sensor LED on valve, or
        • Go to robot system computer and access web visu box monitoring screen
      • Milk slug prior to valve switching can be visibly monitored through clear milk hoses and clear valve bodies.
      • The following screen capture shows the Web Visualization address for the per-teat level information.  Then click on the Expert Page 1 in the lower right of the display to monitor the milk flow sensors and quarterly transition to good milk information.

       Image of the computer screen of the verification of valve function and valve position monitoring.

    7. The teat cup is put into milking mode and milk is allowed to flow to the good milk line through the switching of various block-bleed valve arrangements on a teat-by-teat basis.
      • Valves 1, 2, 3, 5, 7, 9, 11 close
      • Valves 4, 6, 8, 10 open

       

       Diagram of a block-bleed valve used during the milking process.  Multiple valves are identified, and valves' 1, 2, 3, 5, 9, 11, and the vent/drain are closed.

      Verification of proper valve function and position –

      • Visually monitor each valve (all valves are transparent with LED indication position sensing – LED on indicates valve is in safe position for milking into good milk tank).
      • Go to robot system computer and access box monitoring screen to observe valve status and position sensor status in real-time.
      • The following screen is where blood monitoring is done as well as other milking information.

       Image of the computer screen of the verification of proper valve function and the teat cup assembly returns to a jetter rack and the cups are sanitized.

    8. After each cow milking is completed and the teat cups have been removed, the teat cup assembly returns to a jetter rack where all cups are sanitized and back flushed into the prep receiver.  The prep receiver is drained to waste. 

      Verification of proper valve function –

      • Visually monitor operation.  Waste draining can be viewed by observing end of hose at bottom of prep receiver.
  3. Controller Logic

    The following screen shows were the software version can be verified.

     

     Image of a computer screen for the verification of the software version.

    Milk Flow Monitoring and Transition from Prep Receiver to Good Milk Receiver Control

    Notice—No parameters can be accessed or changed that have anything to do with the prep process.  All parameters that control the prep delivery, valve switching from prep milk to good milk, or the decision making parameters of the robot related to purging prep solution cannot be changed by the customer or technician.  They can only be accessed by GEA programmers.

    An electronic version of this memorandum is available for distribution to Regional Milk Specialist, State Milk Regulatory Agencies and State Rating Officers in your region. The electronic version should be widely distributed to representatives of the FDA Web Site at http://www.fda.gov at a later date.

    If you would like an electronic version of this document prior to it being available on the FDA Web Site, please e-mail your request to Robert.Hennes@fda.hhs.gov.

                        
    Donald Signature
    Donald R. Goldsmith
    Regional Milk Specialist
    Robert Hennes Signature
    Robert Hennes, RS, MPH
    CAPT, U.S. Public Health Service
    Dairy and Egg Branch