Alabama Administrative Code › Title 420 - ALABAMA STATE BOARD OF HEALTH › Chapter 420-3-16 - PRODUCTION, PROCESSING, HANDLING OR DISTRIBUTION OF MILK, MILK PRODUCTS AND FROZEN DESSERTS › APPENDICES › Appendix H - PASTEURIZATION EQUIPMENT AND PROCEDURES AND OTHER EQUIPMENT

Current through Register Vol. 42, No. 9, June 28, 2024
I.
HIGH TEMPERATURE/SHORT TIME (HTST) PASTEURIZATION
				  OPERATION OF HTST PASTEURIZATION SYSTEMS
HTST pasteurization is important to the dairy industry
				  because of the operating efficiencies that it affords. Properly operated, these
				  units allow a high volume of production in a minimum of processing
				  space.
The ability of HTST pasteurizers to assure a safe, finished
				  milk and/or milk product hinges on the reliability of the
				  time-temperature-pressure relationships that must prevail whenever the system
				  is in operation. It is important that the milk plant operator understand the
				  HTST process in order to maintain proper surveillance over the equipment. The
				  basic flow pattern is described below:
1. Cold raw milk or milk product in a constant-level supply
				  tank is drawn into the regenerator section of the HTST pasteurizer.
Note:
Some operators prefer to bypass the
				  regenerator when starting. Under this system, cold milk is drawn directly
				  through the timing pump, step 3, and into the heater section. The remaining
				  steps are performed without exception. This bypass arrangement facilitates and
				  speeds up the starting operation. After forward-flow has been established at
				  the FDD, the bypass, which may be manually or automatically controlled, is not
				  used and the raw milk or milk product flows through the regenerator. A second
				  start-up technique involves the use of sanitizing solution at 77°C
				  (170°F). This is passed through the complete unit and followed immediately
				  by milk or milk product. Dilution of the first milk or milk product does occur;
				  however, care shall be taken to prevent this from being packaged.
2. In the regenerator section, the cold raw milk or milk
				  product is warmed by hot pasteurized milk or milk product flowing in a counter
				  current direction on the opposite sides of thin stainless steel
				  surfaces.
3. The raw milk or milk product still under suction passes
				  through a positive-displacement-timing pump that delivers it under pressure
				  through the rest of the HTST pasteurization system.
4. The raw milk or milk product is pumped through the heater
				  section where hot water or steam on opposite sides of thin stainless steel
				  surfaces heats the milk or milk product to a temperature of at 72°C
				  (161°F).
5. The milk or milk product at pasteurization temperature and
				  under pressure flows through the holding tube where it is held for at least
				  fifteen (15) seconds. The maximum velocity of the milk or milk product through
				  the holding tube is governed by the speed of the timing pump, the diameter and
				  length of the holding tube, and surface friction.
6. After passing the sensing bulbs of the indicating
				  thermometer and recorder/controller, the milk or milk product passes into the
				  FDD which automatically assumes a forward-flow position if the milk or milk
				  product passes the recorder/controller bulb at the preset cut-in temperature,
				  i.e., 72°C (161°F).
7. Improperly heated milk or milk product flows through the
				  diverted-flow line back to the constant-level tank.
8. Properly heated milk or milk product flows through the
				  forward-flow line to the pasteurized milk or milk product regenerator section
				  where it serves to warm the cold raw milk or milk product and, in turn, is
				  cooled.
9. The warm milk or milk product passes through the cooling
				  section where coolant on the sides of thin stainless steel surfaces opposite
				  the pasteurized milk or milk product reduces its temperature to 4.5°C
				  (40°F) and below.
10. The cold pasteurized milk or milk product then passes to
				  a storage tank or vat to await packaging.
HTST PASTEURIZERS EMPLOYING MILK OR MILK
				  PRODUCT-TO-MILK OR MILK PRODUCT REGENERATORS WITH BOTH SIDES CLOSED TO THE
				  ATMOSPHERE
Rule
				  420-3-16-.10(16)
				  establishes standards for regenerators. These standards ensure that the raw
				  milk or milk product will always be under less pressure than pasteurized milk
				  or milk product in order to prevent contamination of the pasteurized milk or
				  milk product in the event flaws should develop in the metal or joints
				  separating it from the raw milk or milk product. An explanation of regenerator
				  specifications is given below.
During normal operation, i.e., while the timing pump is
				  operating, raw milk or milk product will be drawn through the regenerator at
				  sub-atmospheric pressure. The pasteurized milk or milk product in the milk, or
				  milk product-to-milk or milk product regenerator will be above atmospheric
				  pressure. The required pressure differential will be assured when there is no
				  flow-promoting device downstream from the pasteurized milk or milk product side
				  of the regenerator to draw the pasteurized milk or milk product through the
				  regenerator, and the pasteurized milk or milk product downstream from the
				  regenerator rises to at least 30.5 centimeters (twelve [12] inches) elevation
				  above the highest raw milk or milk product level downstream from the
				  constant-level tank, and is open to the atmosphere at this or a higher
				  elevation, as required in Item 16p(C),
				  420-3-16-.10(16)(iv)
				  (refer to Administrative Procedures 2).
During a shutdown, i.e., when the timing pump stops, the raw
				  milk or milk product in the regenerator will be retained under suction, except
				  this suction may be gradually relieved by possible entrance of air drawn
				  through the regenerator plate gaskets from the higher outside atmospheric
				  pressure. With a free draining regenerator as required under Item 16p(C),
				  Administrative Procedures 8, the raw milk or milk product level in the
				  regenerator may drop slowly depending on the tightness of the gaskets
				  ultimately falling below the level of the plates to the milk or milk product
				  level in the constant-level tank. However, under these conditions, as long as
				  any raw milk or milk product remains in the regenerator, it will be at
				  sub-atmospheric pressure.
During shutdown, the pasteurized milk or milk product in the
				  regenerator is maintained at atmospheric pressure or above by meeting the
				  elevation requirement of Item 16p(C), (refer to Administrative Procedures 2).
				  Pressure greater than atmospheric is maintained when the level of pasteurized
				  milk or milk product is at or above the required elevation and loss of pressure
				  due to suction is prevented by prohibiting a downstream pump.
Any backflow of milk or milk product through the FDD would
				  lower the pasteurized milk or milk product level during pump shutdowns thus
				  tending to reduce the pressure on the pasteurized milk or milk product side of
				  the regenerator. An FDD cannot be relied upon to prevent backflow in such
				  instances because during the first few minutes following a pump shutdown, the
				  milk or milk product is still at a sufficiently high temperature to keep the
				  FDD in the forward flow position. Compliance with the provisions of Item
				  16p(C), Administrative Procedures 2 and 3; however, will ensure a proper
				  pressure differential in the regenerator.
At the beginning of a run, from the time raw milk or milk
				  product or water is drawn through the regenerator until the pasteurized milk or
				  milk product or water has risen to the elevation specified in Item 16p(C),
				  Administrative Procedures 2, the pasteurized milk or milk product side of the
				  regenerator is at atmospheric pressure or higher. Even if the timing pump
				  should stop during this period, the pressure on the pasteurized milk or milk
				  product side of the regenerator will be greater than the sub-atmospheric
				  pressure on the raw milk or milk product side. This will be assured by
				  compliance with Item 16p(C), Administrative Procedures 2 and 3, as long as any
				  raw milk or milk product remains in the regenerator.
When a raw milk or milk product booster pump is incorporated
				  into the HTST pasteurization system, Item 16p(C), Administrative Procedures 5
				  requires, in part, that automatic means shall be provided to assure, at all
				  times, the required pressure differential between raw and pasteurized milk or
				  milk product in the regenerator before the booster pump can operate.
THE USE OF SEPARATORS WITHIN HTST SYSTEMS
Separators in HTST pasteurization systems shall be installed
				  and operated in such a manner that they will not adversely affect the
				  regenerator pressures, create a negative pressure on the FDD during operation,
				  or cause milk or milk product flow through the holding tube during times when
				  such flow would compromise a required public health safe guard.
1. A separator may be located between the outlet of a raw
				  regenerator and the timing pump or between raw regenerator sections if the
				  separator is automatically valved-out of the system, and separator stuffing
				  pump(s) are de-energized, when:
a. The timing pump is not in operation; or
b. A dual stem FDD is in the inspect position; or
c. In a system with a dual stem FDD in which the separator is
				  located between sections of a raw regenerator, during the first ten (10)
				  minutes of a required ten (10) minute time delay in CIP mode and during any
				  period of diverted-flow; or
d. The pressures in any raw regenerator sections located
				  after the separator are out of compliance with the pressure requirements of
				  these rules.
Note:
The second section of a split raw
				  regenerator shall automatically drain freely to the constant-level tank or to
				  the floor in the event of a shut down.
2. A separator may not be located between the timing pump and
				  the FDD.
3. A separator may be located on the pasteurized side of the
				  FDD if:
a. A properly installed atmospheric break is located between
				  the FDD and the inlet of the separator.
b. All milk or milk product rises to at least 30.5
				  centimeters (twelve [12] inches) higher than the highest raw milk or milk
				  product in the system and is open to the
atmosphere at some point between the outlet of the separator
				  and the inlet of any pasteurized side regenerator.
c. All milk or milk product rises to at least 30.5
				  centimeters (twelve [12] inches) higher than the highest raw milk or milk
				  product in the system and is open to the atmosphere at some point between the
				  outlet of any pasteurized side regenerator and the inlet of a separator.
d. The separator is automatically valved-out of the system,
				  and the separator stuffing pump is de-energized.
(1) When a dual stem FDD is in the first ten (10) minutes of
				  a required ten (10) minute delay in CIP mode.
(2) When the FDD is diverted in product or inspect
				  mode.
(3) When the timing pump is not in operation.
(4) When the temperature is below the required pasteurization
				  temperature and the FDD is not in the fully diverted-position.
4. The following criteria apply to installations where a
				  separator shall be valved-out:
a. A valve shall be located to isolate the product supply
				  line from the separator.
b. A valve shall be located to prevent all flow exiting the
				  separator from being returned to the pasteurization system downstream of the
				  separator.
c. The valves are required to move in order to accomplish the
				  two (2) criteria listed above and shall move to the valved-out position, and
				  any separator stuffing pumps shall be de-energized upon loss of air or
				  power.
5. The following criteria applies to installations where a
				  separator is located on the raw side of a HTST system and a cream or skim
				  balance tank(s) is not being utilized for the collection of either the cream or
				  skim that exits the HTST system:
a. A fail-safe (spring-to-close upon loss of air or power),
				  block-and-bleed valve or valve arrangement shall be installed on the cream or
				  skim line downstream from the separator and prior to any pump(s) or cream or
				  skim storage tank(s), and shall be at least 30.5 centimeters (12 inches) below
				  the required opening to the atmosphere on the pasteurized side of the HTST
				  regenerator. This fail-safe valve or valve arrangement shall be closed whenever
				  the separator is required to be automatically valved-out of the system and the
				  separator stuffer pump is de-energized.
b. If a computer or programmable controller is used to
				  provide any of these required functions, it shall comply with the applicable
				  Section(s) of Appendix H, VI.
c. If not installed in compliance with a. and b. above, the
				  height of the cream or skim storage tank shall be considered when determining
				  the highest raw product in the HTST system.
THE USE OF LIQUID INGREDIENT INJECTION WITHIN HTST
				  SYSTEMS
Milk or milk product flavoring slurries, condensed milk or
				  milk products, and cream or skim milk for standardization and similar
				  ingredients may be injected at a point after the last regenerator and before
				  the timing pump, if all of the following conditions are met:
1. The slurry injection valve(s) is (are) closed and the
				  slurry pump is de-energized:
a. When the FDD is in the "Inspect" mode.
b. When the timing pump is not in operation.
c. When the temperature is below the required minimum legal
				  pasteurization temperature and the FDD is not in the fully diverted
				  position.
Note:
The slurry pump may remain energized
				  provided:
(1) A spring-to-close and air-to-open blocking valve is
				  located between the slurry injection pump and the slurry injection valve(s)
				  described in 2 below.
(2) All valves shall be inter-wired to assure they fully
				  isolate the slurry pump from the pasteurization system when the FDD is not in
				  the forward-flow position or whenever any flow-promoting device(s) which is
				  (are) upstream of the FDD and (are) capable of generating flow through the FDD
				  is (are) not in operation.
2. The slurry injection valve(s) is (are) of the fail-safe
				  type, spring-to-close and air-to-open, and are "block-and-bleed" design with a
				  full port open to the atmosphere between the HTST isolation seat and the slurry
				  pump when slurry is not being injected.
3. The slurry piping between the slurry pump and the
				  injection point may rise to a height that is higher than the overflow level of
				  the slurry supply tank(s), but is at least 30.5 centimeters (twelve [12]
				  inches) lower than the required opening to the atmosphere on the pasteurized
				  side.
4. The slurry supply tank has an overflow that is at least
				  twice the diameter of the largest inlet pipe, or all inlet pipes are
				  disconnected and the openings capped during operation of the slurry
				  pump.
5. There is a check-valve in the flow stream of the milk or
				  milk product line from the last regenerator, typically after the separator,
				  upstream of the injection point valve.
6. For a milk or milk product flavoring slurry that contains
				  milk and/or milk products, the tanks and/or vessels used to blend and hold the
				  slurry shall be completely emptied and cleaned after each four (4) hours of
				  operation or less, unless the slurry is stored at a temperature of 7°C
				  (45°F) or less, or at a temperature of 66°C (150°F) or greater, and
				  maintained thereat until the time of injection.
7. If computers or programmable controllers are used to
				  provide any of these required functions, they shall meet the applicable portion
				  of Appendix H, VI.
8. Appropriate test procedures shall be provided to evaluate
				  the required inter-wiring and function.
Note:
This section describes one (1) method that
				  has been reviewed and accepted for this purpose. It does not preclude other
				  methods that may be reviewed and found acceptable.
In order to help assure compliance with Section
				  2-Adulteration, the Health Officer may require that the milk plant close the
				  slurry valve and de-energize the slurry pump during times when the system is
				  recycling milk or milk product, such as in recycle mode, diverted-flow, or the
				  first ten (10) minutes of the CIP cycle. If a computer is used to accomplish
				  this, it does not need to meet Appendix H and VI.
PRESSURE RELIEF VALVES LOCATED DOWNSTREAM FROM THE
				  HOLDING TUBE WITHIN HTST PASTEURIZATION SYSTEMS
The pressures in the pasteurized side of the regenerator
				  shall be protected from falling within 6.9 kPa (1 psi) of the pressures in the
				  raw side of the regenerator at all times, including during shut down. A
				  pressure relief valve on the pasteurized side of the FDD will meet this
				  criterion if the pressure relief valve is fail-safe. A leaking pressure relief
				  valve can cause an unacceptable loss of pressure in the pasteurized side of the
				  regenerator during a shut down and is considered a violation of Item 16p(C)
				  420-3-16-.10(19).
				  Any leakage from this pressure relief valve shall be readily visible. This may
				  be accomplished by opening the pressure relief valve vent directly to the floor
				  or by providing sanitary piping from the pressure relief valve vent to the
				  constant-level tank. If the latter option is utilized, the piping shall be
				  properly sloped to assure drainage to the constant-level tank and shall be
				  provided with a properly located and installed sight-glass.
POSITION DETECTION DEVICES
Where the position detectability of FDDs and valve seats is
				  required this may be accomplished by mechanical or electronic means, such as
				  mechanical limit switches (micro-switches) or electronic proximity switches.
				  These switches shall be capable of providing an electrical signal when the
				  valve seat is in the fully closed position, provided further that the position
				  detection capability is fully testable.
Position detection devices (PDDs) shall be repeatable and
				  capable of detecting valve seat movement of less than 3.18 mm (1/8 [0.125] of
				  an inch) at all times.
MAGNETIC FLOW METER BASED TIMING SYSTEMS WITHIN
				  CONTINUOUS FLOW PASTEURIZATION SYSTEMS
Many pasteurization systems use magnetic flow meter based
				  timing systems (MFMBTS). The flow through these timing systems is developed by
				  a combination of flow promoting devices including booster and stuffer pumps,
				  separators and clarifiers, homogenizers, and positive displacement
				  pumps.
Item 16p.(B)2(f), Section 7 provides for their use, provided
				  they meet the following specifications for design, installation, and
				  use.
Components
- MFMBTS shall consist of the
				  following components:
A magnetic flow meter which has been reviewed by FDA or one
				  (1) which meets the following criteria for accuracy and reliability:
a. Self-diagnostic circuitry that provides constant
				  monitoring of all sensing, input, and conditioning circuits. The diagnostic
				  circuitry shall be capable of detecting "open" circuits, "short" circuits, poor
				  connections, and faulty components. Upon the detection of a failure of any
				  component, the magnetic flow meter read-out shall be blank or become
				  unreadable.
b. The electro-magnetic compatibility of the magnetic flow
				  meter shall be documented and available to the Health Officer. The magnetic
				  flow meter shall be tested to determine the effects of electrostatic discharge,
				  power fluctuation, conductive emission and susceptibility, and radiative
				  emission and susceptibility.
c. The effect of exposure to specific environmental
				  conditions shall be documented. The magnetic flow meter shall be tested to
				  determine the effects of low and high temperatures, thermal shock, humidity,
				  physical shock, and salt fog.
d. The magnetic flow meter converter or transmitter and flow
				  sensor, for those magnetic flow meters in which flow sensor sealing is
				  required, shall be constructed so that they can be sealed by the Health
				  Officer.
e. The calibration of the magnetic flow meter shall be
				  protected against unauthorized changes.
f. The magnetic flow meter shall be protected against
				  unauthorized converter or transmitter replacement. If flow tubes are replaced,
				  the Health Officer shall be notified and such replacement shall be regarded as
				  a replacement of the magnetic flow meter and subject to the Health Officer's
				  inspection and all applicable tests under Appendix I.
g. The flow tube shall be encased in appropriate material and
				  constructed in such a manner that the final assembly complies with the
				  conditions cited within Item 11p
				  420-3-16-.10(11).
Calibration
- The calibration shall be based on
				  multiple points for the entire range of the magnetic flow meter for MFMBTS
				  application. The magnetic flow meter shall be tested against a traceable
				  National Institute of Standards and Technology (NIST) standard. The
				  procedure(s) used for the magnetic flow meter calibration is documented and
				  available to the Health Officer.
Accuracy
- At mid-range, six (6) consecutive
				  flow measurements are taken at the same flow setting. From these six (6)
				  measurements, the standard deviation is calculated. The standard deviation for
				  these measurements shall be less than 0.5 percent. Compliance of the magnetic
				  flow meter would be determined through the actual installation field-testing of
				  the magnetic flow meter.
2. Suitable converters for conversion of electric and/or air
				  signals to the proper mode for the operation of the system.
3. A suitable flow recorder capable of recording flow at the
				  flow alarm set point and also at least nineteen (19) liters (five [5] gallons)
				  per minute higher than the flow alarm setting. The flow recorder shall have an
				  event pen that shall indicate the status of the flow alarm with respect to flow
				  rate.
4. A flow alarm, with an adjustable set point shall be
				  installed within the system which shall automatically cause the FDD to be moved
				  to the divert position whenever excessive flow rate causes the milk or milk
				  product holding time to be less than the legal holding time for the
				  pasteurization process being used. The flow alarm shall be tested by the Health
				  Officer in accordance with the procedures of Appendix I, Test 11, 2.A and B at
				  the frequency specified. The flow alarm adjustment shall be sealed.
Note:
Test 11, 2.A is not applicable to HHST
				  pasteurization systems.
5. A low-flow or loss-of-signal alarm shall be installed with
				  the system, which shall automatically cause the FDD to be moved to the divert
				  position whenever there is a low-flow or loss-of-signal from the magnetic flow
				  meter. The low-flow or loss-of-signal provision shall be tested by the Health
				  Officer in accordance with Appendix I, Test 11, 2.C at the frequency specified.
				  The low-flow or loss-of-signal provision shall be sealed.
6. For HTST systems, when the legal flow rate has been
				  reestablished following an excessive flow rate, a time delay shall be
				  instituted which shall prevent the FDD from assuming the forward-flow position
				  for at least a minimum of fifteen (15) or twenty-five (25) seconds depending
				  upon the product being pasteurized and the temperature being utilized. The time
				  delay shall be tested and sealed by the Health Officer.
For HHST systems, when the legal holding time has been
				  reestablished following an excessive flow rate, a time delay at least as long
				  as the legal flow rate shall be instituted which shall prevent the FDD from
				  assuming the forward-flow position until at least the legal holding time within
				  the holding tube has been reestablished. This time delay shall be built into
				  the sequencelogic that requires all conditions for legal pasteurization to be
				  satisfied and that legal pasteurization temperature exists from the holding
				  tube to the FDD, before the FDD can assume the forward-flow position.
7. For HTST systems, a sanitary check valve or normally
				  closed automatically controlled sanitary valve shall be installed with the
				  magnetic flow meter to prevent a positive pressure in the raw milk or milk
				  product side of the regenerator whenever a power failure, shutdown, or
				  flow-diversion occurs.
Note:
This provision is not applicable to HHST
				  pasteurization systems.
8. For HTST systems, when a regenerator is used with large
				  systems, it will be necessary to bypass the regenerator during start-up and
				  when the FDD is in the diverted-flow position. Care shall be taken in the
				  design of such bypass systems to assure that a dead-end does not exist. A
				  dead-end could allow milk or milk product to remain at ambient temperature for
				  long periods of time and allow bacterial growth in the milk or milk product.
				  Caution shall also be observed with such bypass systems and any valves used in
				  them so that raw milk or milk product will not be trapped under pressure in the
				  raw regenerator plates and not have free drainage back to the constant-level
				  tank when shutdown occurs.
Note:
This provision is not applicable to HHST
				  pasteurization systems.
9. When switching to the "CIP" position, the FDD shall move
				  to the divert position and shall remain in the diverted-flow position for at
				  least ten (10) minutes, regardless of temperature, and for HTST pasteurization
				  systems, the booster pump cannot run during this ten (10) minute time
				  delay.
10. All MFMBTS pasteurization systems shall be designed,
				  installed, and operated so that all applicable tests required by
				  420-3-16-.10(21),
				  Item 16p(D) can be performed by the Health Officer, at the frequency specified
				  (refer to Appendix I). Where adjustment or changes can be made to these devices
				  or controls, appropriate seals shall be applied by the Health Officer after
				  testing so that changes cannot be made without detection.
11. Except for those requirements directly related to the
				  physical presence of the timing pump, all other requirements of the most recent
				  edition of these rules are applicable.
Placement of Components
- Individual components
				  in an MFMBTS shall comply with the following placement conditions:
1. The timing system's flow promoting device(s) shall be
				  located upstream from the magnetic flow meter.
2. The magnetic flow meter shall be placed after the last raw
				  product regenerator outlet and upstream of the holding tube. There shall be no
				  intervening flow-promoting components between the magnetic flow meter and the
				  holding tube.
3. For HTST pasteurization systems, when a sanitary check
				  valve or normally closed automatically controlled sanitary valve, as described
				  in #7 above, is used with a variable or constant speed flow promoting device,
				  it shall be located downstream of the last regenerator outlet and upstream of
				  the holding tube.
Note:
This provision is not applicable to HHST
				  pasteurization systems.
4. All flow-promoting devices which are upstream of the FDD
				  and which are capable of generating flow through the FDD, shall be properly
				  interwired with the FDD so that they may run and produce flow through the
				  system at sub-legal temperatures only when the FDD is in the fully diverted
				  position and in "Product" run mode, or "CIP" mode after the ten (10) minute
				  time delay has timed out. Such flow promoting devices shall be de-energized in
				  "Inspect" mode. Separators or clarifiers that continue to run after they are
				  de-energized shall be automatically valved-out of the system with fail-safe
				  valves so that they are incapable of producing flow.
5. There shall not be any product entering or leaving the
				  pasteurization system, i.e., cream or skim milk from a separator or other
				  product components, between the magnetic flow meter and the holding
				  tube.
6. The magnetic flow meter shall be so installed that the
				  milk or milk product has contact with both electrodes at all times when there
				  is flow through the system. This is most easily accomplished by mounting the
				  flow tube of the magnetic flow meter in a vertical position with the direction
				  of flow from the bottom to the top. However, horizontal mounting is acceptable
				  when other precautions are taken to assure that both electrodes are in contact
				  with the product and the horizontal line shall remain full of liquid during
				  operation. Magnetic flow meters shall not be mounted on a horizontal line that
				  may be only partially full and thereby trap air.
7. The magnetic flow meter shall be piped in such a manner
				  that at least ten (10) pipe diameters of straight pipe exists, upstream and
				  downstream from the center of the magnetic flow meter, before any elbow or
				  change of direction takes place. Except that other piping configurations
				  upstream and downstream of the magnetic flow meter may also be used if they
				  have been reviewed and found acceptable to FDA and the Health Officer.
THE USE OF VACUUM BREAKERS ON HTST
				  SYSTEMS
Vacuum breakers are often used on HTST pasteurization systems
				  to help maintain proper pressure relationships in milk-to-milk regenerator
				  sections, or to prevent a negative pressure between the FDD and any downstream
				  flow-promoting device. The use of vacuum breakers on HTST pasteurization
				  systems is allowed provided the following conditions are met:
1. Vacuum breakers shall open to the atmosphere when subject
				  to a negative pressure.
2. The pasteurized milk and milk product between its outlet
				  from the regenerator and the nearest point downstream open to the atmosphere
				  shall rise to a vertical elevation of 30.5 centimeters (12 inches) above the
				  highest raw milk or milk product level, downstream from the constant- level
				  tank, and shall be open to the atmosphere at this or a higher elevation.
Spring-to-close vacuum breakers are not allowed.
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				  image
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Figure 31. HTST Pasteurizer with a Positive
				  Displacement Rotary Timing Pump
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Figure 32. HTST Pasteurizer with a Homogenizer Located
				  at the Outlet of the Heater Section and of a Larger Capacity than the Timing
				  Pump
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				  image
Figure 33. HTST Pasteurizer with a Booster Pump, Meter
				  Based Timing System and a Homogenizer with a Bypass Line
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				  image
Figure 34. HTST Pasteurizer with a Booster Pump, Timing
				  Pump, and a CIP-Type Separator Located Between Two Pasteurized Product
				  Regenerators with a Pre-Heater
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				  image
Figure 35. HTST Pasteurizer with a Booster Pump,
				  Homogenizer as a Timing Pump with an AC Variable Frequency Drive, CIP-Type
				  Separator Located Between Two Pasteurized Product Regenerators and an Air
				  Actuated Discharge Valve with an Air Blow
Click to view
				  image
Figure 36. HTST Pasteurizer with a Separator Between
				  the Raw Regenerator and the Heater Section with a Meter Based Timing System and
				  a Regenerator Bypass
Click to view
				  image
Figure 37. HTST Pasteurizer Utilizing Tubular Type Heat
				  Exchangers and a Homogenizer as the Timing Pump
Click to view
				  image
Figure 38. HTST Pasteurizer, without a Regenerator or
				  Cooler Section, with a Meter Based Timing System Located Upstream from an
				  Evaporator
Click to view
				  image
Figure 39. HTST Pasteurizer with a Regenerator,
				  Separator, Skim Surge Tank, and a Meter Based Timing System Located Upstream
				  from an Evaporator Pump
Click to view
				  image
Figure 40. HHST Pasteurizer with a Flow-Diversion
				  Device Located Downstream of the Cooling Section
Click to view
				  image
Figure 41. HHST Pasteurizer Utilizing Steam Injection
				  Heating, Vacuum Flash Cooling, and a Flow-Diversion Device Located Downstream
				  of the Cooler Section Pump
Click to view
				  image
Figure 42. HHST Pasteurizer Utilizing Direct Culinary
				  Steam Infusion and Vacuum Flash Cooling with a Homogenizer Located
				  Downstream
Click to view
				  image
Figure 43. HHST Pasteurizer with a Homogenizer as the
				  Timing Pump and Utilizing a Spiral Tubular Heat Exchanger with Indirect
				  Regeneration
II.
AIR FOR DRYING EQUIPMENT AND AIR UNDER PRESSURE -
				  DIRECT CONTACT WITH MILK AND MILK PRODUCTS AND MILK PRODUCT-CONTACT
				  SURFACES
AIR FOR DRYING EQUIPMENT
Filter Media
- Intake air filter media shall
				  consist of fiberglass with a downstream backing dense enough to prevent
				  fiberglass break off from passing through cotton flannel, wool flannel, spun
				  metal, activated carbon, activated alumina, non-woven fabric, absorbent cotton
				  fiber, electrostatic, or other suitable materials which, under conditions of
				  intended use, are non-toxic and non-shedding and which do not release toxic
				  volatiles or other contaminants to the air, or volatiles which impart any
				  flavor or odor to the milk or milk product. Chemical bonding materials
				  contained in the media shall be non-toxic, non-volatile, and insoluble under
				  all conditions of use. Disposable media are not intended to be cleaned and
				  re-used. Electronic air cleaners using electrostatic precipitation principles
				  to collect particulate matter may be used in spray drying systems only as a
				  pre-filter.
Filter Performance
- The air supply system
				  and/or ducting shall be such that the air supply is caused to pass through
				  suitable air filters, properly installed, before coming in contact with milk
				  product-contact surfaces of the drying system. Supply air filters for air which
				  will be heated before it comes in contact with the milk or milk product shall
				  be of a design selected to operate at a face velocity, and installed in a
				  manner which will allow the filter manufacturer's rating to be 90 percent or
				  higher, when tested in accordance with the American Society of Heating,
				  Refrigerating and Air-Conditioning Engineers (ASHRAE) Synthetic Dust Arrestance
				  Test.1 Supply air filters for air which will not be
				  heated before it comes in contact with the milk or milk product shall be of a
				  design selected to operate at a face velocity, and installed in a manner which
				  will allow the filter manufacturer's rating to be 85 percent or higher when
				  tested in accordance with the ASHRAE Atmospheric Dust Spot
				  Method.2
AIR UNDER PRESSURE - MILK PRODUCT-CONTACT
				  SURFACES
Filter Media
- Air intake and pipeline filters
				  shall consist of fiberglass with a downstream backing dense enough to prevent
				  fiberglass break off from passing through cotton flannel, wool flannel, spun
				  metal, electrostatic material or other equally acceptable filtering media which
				  are non-shedding and which do not release to the air, toxic volatiles or
				  volatiles which may impart any flavor or odor to the milk or milk
				  product.
Filter Performance
- Intake air filter
				  efficiency shall be at least 98 percent SAE J7263,
				  June 19874 using Air Cleaner (AC) coarse test dust.
				  Final filter efficiency shall be at least 99 percent as measured by the
				  Dioctylphthalate Fog Method (DOP) test (with a mean particle diameter of 0.3
				  microns).5 When commercially sterile air is
				  required, the final filter efficiency shall be at least 99.99 percent as
				  measured by the DOP test.
FABRICATION AND INSTALLATION
1
Method of Testing Air
				  Cleaning Devices
, ASHRAE Standard 52 (available from the American
				  Society of Heating, Refrigerating and Air Conditioning Engineers
2
Method of Testing Air
				  Cleaning Devices
, ASHRAE Standard 52 (available from the American
				  Society of Heating, Refrigerating and Air Conditioning Engineers
3 Dill, R. S., A Test Method for
				  Air Filters. Transactions of the American Society of Heating and Ventilation
				  engineers. 44:379, 1938. Society of Automotive Engineers, 400 Commonwealth
				  Drive, Warrendale, Pennsylvania 15096-0001 (412) 776-4841.
4 DOP Smoke Penetration and Air
				  Resistance of filters. Military Standard No. 282. Section 102.91. Naval Supply
				  Depot, 5801 Tabor Avenue, Philadelphia, Pennsylvania 19120.
5 MIL-STD-282-Military Standard
				  282: Method 102.91: Dicoctyphthalate Fog Method (DOP). Standardization,
				  Document Order Desk (Department of Navy), 700 Robinson Avenue, Building 4,
				  Section D. Philadelphia, PA 1911-5094.
Air Supply Equipment
- The compressing equipment
				  shall be designed to preclude contamination of the air with lubricant vapors
				  and fumes. Oil-free air may be produced by one of the following methods or
				  their equivalent:
a. Use of a carbon ring piston compressor;
b. Use of oil-lubricated compressor with effective provision
				  for removal of any oil vapor by cooling the compressed air; or
c. Water-lubricated or non-lubricated blowers.
The air supply shall be taken from a clean space or from
				  relatively clean outer air and shall pass through a filter upstream from the
				  compressing equipment. This filter shall be located and constructed so that it
				  is easily accessible for examination and the filter media are easily removable
				  for cleaning or replacing. The filter shall be protected from weather,
				  drainage, water, product spillage, and physical damage.
Moisture Removal Equipment
- Air under pressure
				  systems in excess of one (1) bar, i.e., 103.5 kPa (15psi), shall be provided
				  with methods of moisture removal. The removal of moisture may be achieved by
				  condensation and coalescing filtration or absorption, or equivalent, to prevent
				  free water in the system. If it is necessary to cool the compressed air, an
				  after-cooler shall be installed between the compressor and the air storage tank
				  for the purpose of removing moisture from the compressed air.
Filters and Moisture Traps
- Filters shall be
				  constructed so as to assure effective passage of air through the filter media
				  only. The coalescing filter and associated traps shall be located in the air
				  pipeline downstream from the compressing equipment, and from the air tank, if
				  one is used. The filter shall be readily accessible for examination, cleaning,
				  and for replacing the filter media. The moisture trap shall be equipped with a
				  petcock or other means for draining accumulated water (refer to Figures 44, 45,
				  and 48).
When coalescing filters are used, a means shall be provided
				  to measure the differential pressure across the filter. The differential
				  pressure device is required to indicate the need for filter media
				  replacement.
All coalescing filter housings shall be provided with a means
				  of removing the condensed liquid from the filtration device. This can be
				  accomplished by an automatic or manual drain installed on the base of the
				  filter housing.
The final filter media shall be disposable. The filter media
				  shall be located in the air line upstream from, and as close as possible to,
				  the point of application (refer to Figures 44, 45 and 48). Except that a final
				  filter shall not be required where the compressing equipment is of a fan or
				  blower type and operating at a pressure of less than one (1) bar, i.e., 103.5
				  kPa (15psi) (refer to Figures 46 and 47).
Electronic air cleaners utilizing electrostatic precipitation
				  principles to collect particulate matter may be used. Disposable filter media
				  shall not be cleaned and reused.
Air Piping
- The air piping from the compressing
				  equipment to the filter and moisture trap shall be readily drainable.
A milk or milk product check-valve of sanitary design shall
				  be installed in the air piping downstream from the disposable media filter to
				  prevent backflow of milk or milk product into the air pipeline, except that a
				  check-valve shall not be required if the air piping enters the milk or milk
				  product zone from a point higher than the milk or milk product overflow level
				  which is open to the atmosphere or is for dry product applications or for other
				  dry application where liquids are not present.
When a check-valve is not required, plastic or rubber or
				  rubber-like tubing and suitable compatible fittings and connections made of
				  plastic or stainless steel may be used between the final filter and the point
				  of application.
Air distribution piping and fittings after the final filter
				  shall be of corrosion-resistant materials. Air distribution piping, fittings,
				  and gaskets between the discharge of the sanitary check-valve to the processing
				  equipment shall be sanitary piping that conforms to the requirements of Item
				  10p, Rule
				  420-3-16-.10(10),
				  except that:
When air under pressure is directed at product-contact
				  surfaces of containers, closures, and supplementary fitments, the air passage
				  from the final filter to the point of application shall be made of a non-toxic,
				  relatively nonabsorbent material. In this application, check-valves are not
				  required. The final filter shall be located as close as practical to the point
				  of application (refer to Figure 48).
When used for air agitation, tubing used to introduce air
				  into the product and/or product zone shall be sanitary piping that conforms to
				  the requirements of Item 10p, Rule
420-3-16-.10(10).
				  There shall be no threads on product-contact surfaces. When drilled or
				  perforated pipe is used, internal drilling burrs shall be removed and the
				  orifices shall be chambered on the outer surface of the pipe. If the volume of
				  the air from the compressing equipment is in excess of that required for
				  satisfactory agitation, suitable means shall be employed to eliminate the
				  excess volume.
Note:
For additional details, refer to the
3-A Accepted Practices for Supplying Air Under Pressure in Contact with
				  Milk, Milk Products and Product-Contact
Surfaces 604-## and 3-A
				  Accepted Practices for Spray Drying Systems 607##.
Click to view
				  image
Figure 44.
Individual Compression-Type Air
				  Supply
1. Compressing Equipment
2. Drain Valve
3. After-cooler (When Used)
4. Pressure Gauge (Optional)
5. Dryer (When Used)
6. Air Pipe Line Coalescing Filter and Moisture Trap
7. Final Filter
8. Product Contact Valve (Where Required)
9. Sanitary Piping Downstream From This Point
10. To Point of Application
11. Intake Air Filter
Click to view
				  image
Figure 45. Central Compression-Type Air
				  Supply
1. Compressing Equipment
2. Intake Air Filter
3. After-cooler
4. Sanitary Relief Valve
5. Air Pipe Line Coalescing Filter and
6. Moisture Trap Pressure Gauge (Optional)
7. Dryer (When Used)
8. Sanitary Piping Downstream From This Point
9. Product Check-Valve (Where Required)
10. Final Filter
11. To Point of Application
12. Drain Valve
13. Moisture Leg or Trap
14. Air Storage Tank
15. Air Gap
16. Trap and Drain Valve
17. Condensate Pipe
Click to view
				  image
Figure 46. Individual Blower-Type Air
				  Supply
1. Blower or Fan, 34.5-103.5 kPa (5-15 psi)
2. Air Line or Duct
3. Pressure Gauge (When Used)
4. To Point of Application
5. Final Filter (When Used)
6. Intake Air Filter
Click to view
				  image
Figure 47. Individual Fan-Type Air Supply
1. Blower or Fan, Below 34.5 kPa (5 psi)
2. Intake Air Filter
3. To Point of Application
Click to view
				  image
Figure 48. Rotating Mandrel Assembly
1. Compressing Equipment
2. Aftercooler (When Used)
3. Pressure Gauge (When Used)
4. Air Pipeline Coalescing Filter and Moisture Trap
5. Drain Valve
6. Dryer (When Used)
7. Final Filter
8. Intake Air Filter
9. Fixed Air Passage
10. Rotating Mandrel Assembly
III.
CULINARY STEAM - MILK AND MILK
				  PRODUCTS
The following methods and procedures will provide steam of
				  culinary quality for use in the processing of milk and milk products.
SOURCE OF BOILER FEED WATER
Potable water or water supplies acceptable to the Health
				  Officer shall be used.
FEED WATER TREATMENT
Feed water may be treated, if necessary, for proper boiler
				  care and operation. Boiler feed water treatment and control shall be under the
				  supervision of trained personnel or a firm specializing in industrial water
				  conditioning. Such personnel shall be informed that the steam is to be used for
				  culinary purposes. Pretreatment of feed waters for boilers or steam generating
				  systems to reduce water hardness before entering the boiler or steam generator
				  by ion exchange or other acceptable procedures is preferable to the addition of
				  conditioning compounds to boiler waters. Only compounds complying with
				  21 CFR
				  173.310 may be used to prevent corrosion and
				  scale in boilers or to facilitate sludge removal. Greater amounts shall not be
				  used of the boiler water treatment compounds than the minimum necessary for
				  controlling boiler scale or other boiler water treatment purposes. No greater
				  amount of steam shall be used for the treatment and/or pasteurization of milk
				  and milk products than necessary.
It should be noted that tannin, which is also frequently
				  added to boiler water to facilitate sludge removal during boiler blow-down, has
				  been reported to give rise to odor problems and should be used with
				  caution.
Boiler compounds containing cyclohexylmine, morpholine,
				  octadecylamine, diethylamino-ethanol, trisodium nitrilotriacetae, and hydrazine
				  shall not be permitted for use in steam in contact with milk and milk
				  products.
BOILER OPERATION
A supply of clean, dry saturated steam is necessary for
				  proper equipment operation. Boilers and steam generation equipment shall be
				  operated in such a manner as to prevent foaming, priming, carryover, and
				  excessive entrainment of boiler water into the steam. Carryover of boiler water
				  additives can result in the production of milk or milk product off-flavors.
				  Manufacturers' instructions regarding recommended water level and blow-down
				  should be consulted and rigorously followed. The blow-down of the boiler should
				  be carefully watched so that an over- concentration of the boiler water solids
				  and foaming is avoided. It is recommended that periodic analyses be made of
				  condensate samples. Such samples should be taken from the line between the
				  final steam separating equipment and the point of the introduction of steam
				  into the milk or milk product.
PIPING ASSEMBLIES
Refer to Figures 49 and 50 for suggested piping assemblies
				  for steam infusion or injection. Other assemblies that will assure a clean, dry
				  saturated steam are acceptable.
Click to view
				  image
Figure 49 - Culinary Steam Piping Assembly for Steam
				  Infusion or Injection
1. Steam Main Device
2. Stop Valve
3. Strainer
4. *Entrainment Separator
5. *Condensate Trap (from this point)
6. Pressure Gauge
7. Steam Pressure Regulating
8. Steam Throttling Valve (automatic or manual) or
				  Orifice
9. *Differential Pressure Measuring Device
10. *Filtering Device
11. *Stainless Steel (from this point)
12. *Sanitary Piping and Fittings
13. *Spring-loaded Sanitary Check Valve
14. *Sanitary Piping To Process Equipment (reducing)
				  Valve
15. *Sampling Means
*Required Equipment
Click to view
				  image
Figure 50 - Culinary Steam Piping Assembly for Steam
				  Infusion or Injection (Optional Configuration)
Click to view
				  image
Figure 51 - Culinary Steam Piping Assembly for Airspace
				  Heating or Defoaming
1. Steam Main
2. Strainer
3. *Entrainment Strainer
4. Steam Trap
5. Filtering Device
5a. *Stainless Steel (from this point)
6. *Control Needle Valve
7. *Steam Gauge
8. *Cap With Drain Hole
9. *Cap With Orifice
10. *Sanitary Piping (from this point) Sanitary piping
				  should rise prior to entering the vat pasteurizer.
11. *To Equipment
*Required Equipment
IV.
THERMOMETER SPECIFICATIONS INDICATING THERMOMETERS
				  FOR BATCH PASTEURIZERS
Type
1.
Mercury Actuated Direct Reading
a. Contained in a corrosion-resistant case which protects
				  against breakage and permits easy observation of the column and scale.
b. Filling above mercury-nitrogen or other suitable
				  gas.
c. The mercury column shall be magnified to an apparent width
				  of not less than 1.6 millimeters (0.0625 of an inch).
2. Digital Stand Alone
a. No more than 0.2°C (0.5°F) drift over three (3)
				  months use on a batch pasteurizer compared to a certified temperature
				  source.
b. Self-diagnostic circuitry which provides constant
				  monitoring of all sensing, input, and conditioning circuits. The diagnostic
				  circuitry should be capable of detecting "open" circuits, "short" circuits,
				  poor connections, and faulty components. Upon detection of failure of any
				  component, the device shall be blank or become unreadable.
c. The electromagnetic compatibility of this device for this
				  use shall be documented and available to the Health Officer. The device shall
				  be tested to determine the effects of electrostatic discharge, power
				  fluctuation, conductive emission and susceptibility, and radiative emission and
				  susceptibility. The device shall comply with the requirements for performance
				  level characteristics of industrial devices.
d. The effect of exposure to specific environmental
				  conditions shall be documented. The device shall be tested to determine the
				  effects of low and high temperatures, thermal shock, humidity, physical shock,
				  and salt fog.
e. Both the probe and the display case shall be constructed
				  so that they may be sealed by the Health Officer.
f. Calibration of the device shall be protected against
				  unauthorized changes.
g. The device shall be protected against unauthorized
				  component or sensing element replacement. Replacement of any component or
				  sensing element shall be regarded as a replacement of the indicating
				  thermometer and subject to the Health Officer's inspection and all application
				  tests under Appendix I.
h. The sensing element shall be encased in appropriate
				  material constructed in such a way that the final assembly meets the conditions
				  of Item 11p
				  420-3-16-.10(11).
i. The device shall be tested from the sensing probe through
				  the final output.
3.
Digital Combination
a. No more than 0.2°C (0.5°F) drift over three (3)
				  months use on a batch pasteurizer compared to a certified temperature
				  source.
b. Self-diagnostic circuitry which provides constant
				  monitoring of all sensing, input, and conditioning circuits. The diagnostic
				  circuitry should be capable of detecting "open" circuits, "short" circuits,
				  poor connections, and faulty components. Upon detection of failure of any
				  component, the temperature sensors output signal and indicating display shall
				  go visibly out of range.
c. The electromagnetic compatibility of this device for this
				  use shall be documented and available to the Health Officer. The device shall
				  be tested to determine the effects of electrostatic discharge, power
				  fluctuation, conductive emission and susceptibility, and radiative emission and
				  susceptibility. The device shall comply with the requirements for performance
				  level characteristics of industrial devices.
d. The effect of exposure to specific environmental
				  conditions shall be documented. The device shall be tested to determine the
				  effects of low and high temperatures, thermal shock, humidity, physical shock,
				  and salt fog.
e. Both the probe and the display case shall be constructed
				  so that they may be sealed by the Health Officer.
f. Calibration of the device shall be protected against
				  unauthorized changes.
g. The device shall be protected against unauthorized
				  component or sensing element replacement. Replacement of any component or
				  sensing element shall be regarded as a replacement of the indicating
				  thermometer and subject to the Health Officer's inspection and all application
				  tests under Appendix I.
h. The sensing element shall be encased in appropriate
				  material constructed in such a way that the final assembly meets the conditions
				  of Item 11p.
i. The device shall be tested from the sensing probe through
				  the final output.
Scale
- Shall have a span of not less than
				  14° (25°F), including the pasteurization temperature, ±
				  2.5°C (± 5°F); graduated in 0.5°C (1ºF) divisions, with
				  not more than 9°C (16°F) per 2.54 centimeters (1 inch) of span; and
				  protected against damage at 105°C (220°F). Provided, that on batch
				  pasteurizers used solely for thirty (30) minute pasteurization of milk and milk
				  products at temperatures above 71°C (160°F), indicating thermometers
				  with 1°C (2°F) scale graduations, with not more than 6°C (28°F)
				  per 2.54 centimeters (1 inch) of scale, may be used.
Accuracy
- Within ± 0.2°C (±
				  0.5°F), through the specified scale span. Provided, that on batch
				  pasteurizers used solely for thirty (30) minute pasteurization of milk and milk
				  products at temperatures above 71°C (160°F), indicating thermometers
				  shall be accurate to within ±.5°C (± 1°F) (refer to
				  Appendix I, Test 1).
Submerged Stem Fitting
- A pressure-tight seat
				  against the inside wall of the holder; no threads exposed to milk or milk
				  products; and the location of this seat to conform to the 3-A Sanitary Standard
				  for a wall-type fitting or other equivalent sanitary fitting.
Bulb
- Corning normal or equally suitable
				  thermometric glass.
INDICATING THERMOMETERS LOCATED ON PASTEURIZATION
				  PIPELINES
Type
1.
Mercury Actuated Direct Reading
a. Contained in a corrosion-resistant case which protects
				  against breakage and permits easy observation of the column and scale.
b. Filling above mercury - nitrogen or other suitable
				  gas.
c. The mercury column shall be magnified to an apparent width
				  of not less than 1.6 millimeters (0.0625 of an inch).
2.
Digital
a. No more than 0.2°C (0.5°F) drift over three (3)
				  months use on a HTST system compared to a certified temperature source.
b. Self-diagnostic circuitry which provides constant
				  monitoring of all sensing, input, and conditioning circuits. The diagnostic
				  circuitry should be capable of detecting "open" circuits, "short" circuits,
				  poor connections and faulty components. Upon detection of failure of any
				  component, the device shall blank or become unreadable.
c. The electromagnetic compatibility of this device for this
				  use shall be documented and available to the Health Officer. The device shall
				  be tested to determine the effects of electrostatic discharge, power
				  fluctuation, conductive emission and susceptibility, and radiative emission and
				  susceptibility. The device shall comply with the requirements for performance
				  level characteristics of industrial devices.
d. The effect of exposure to specific environmental
				  conditions shall be documented. The device shall be tested to determine the
				  effects of low and high temperatures, thermal shock, humidity, physical shock,
				  and salt fog.
e. Both the probe and the display case shall be constructed
				  so that they may be sealed by the Health Officer.
f. Calibration of the device shall be protected against
				  unauthorized changes.
g. The device shall be protected against unauthorized
				  component or sensing element replacement. Replacement of any component or
				  sensing element shall be regarded as a replacement of the indicating
				  thermometer and subject to the Health Officer's inspection and all applicable
				  tests under Appendix I.
h. The sensing element shall be encased in appropriate
				  material constructed in such a way that the final assembly meets the conditions
				  of Item 11p.
i. The device shall be tested from the sensing probe through
				  the final output.
Scale:
Shall have a span of not less than
				  14°C (25°F), including the pasteurization temperature, ±
				  2.5°C (± 5°F); and protected against damage at 105°C
				  (220°F), and in the case of thermometers used on HHST pasteurization
				  systems protected against damage at 149°C (300°F). Mercury actuated
				  thermometers shall be graduated in 0.2°C (0.5°F) divisions with not
				  more than 4°C (8°F) per 2.54 centimeters (one [1] inch) of scale. The
				  digital thermometer readout shall display in units no greater than of
				  0.05°C (0.1°F).
Accuracy:
Within ± 0.2°C (±
				  0.5°F), throughout the specified scale span (refer to Appendix I, Test
				  1).
Stem Fittings:
A pressure-tight seat against the
				  inside wall of the fittings; no threads exposed to milk or milk products. The
				  probe is to be designed so that the sensitive area is discernible from the
				  remainder of the stem. The overall probe length to be such that the sensitive
				  area is positioned in the milk or milk product flow path when properly
				  installed.
Thermometric Response:
When the thermometer is
				  at room temperature and then is immersed in a well-stirred water bath 11°C
				  (19°F) or less above the pasteurization temperature, the time required for
				  the reading to increase from water bath temperature, minus 11°C (19°F),
				  to water bath temperature, minus 4°C (7°F), shall not exceed four (4)
				  seconds. The digital thermometer displays shall change at a rate that can be
				  noted by the operator or Health Officer during the thermometric lag test (refer
				  to Appendix I, Test 7).
Bulb:
Corning normal or equally suitable
				  thermometric glass.
AIRSPACE INDICATING THERMOMETER FOR BATCH
				  PASTEURIZERS
Type
1.
Mercury Actuated Direct Reading
a. Contained in a corrosion-resistant case which protects
				  against breakage and permits easy observation of the column and scale.
b. The bottom of the bulb chamber shall not be less than
				  fifty-one (51) millimeters (two [2] inches) and not more than eighty-nine (89)
				  millimeters (3.5 inches), below the underside of the cover.
c. Filling above mercury-nitrogen or other suitable
				  gas.
d. The mercury column shall be magnified to an apparent width
				  of not less than 1.6 millimeters (0.0625 of an inch).
2. Digital Stand Alone
a. No more than 0.2°C (0.5°F) drift over three (3)
				  months use on a batch pasteurizer compared to a certified temperature
				  source.
b. Self-diagnostic circuitry which provides constant
				  monitoring of all sensing, input, and conditioning circuits. The diagnostic
				  circuitry should be capable of detecting "open" circuits, "short" circuits,
				  poor connections, and faulty components. Upon detection of failure of any
				  component, the device shall be blank or become unreadable.
c. The electromagnetic compatibility of this device for this
				  use shall be documented and available to the Health Officer. The device shall
				  be tested to determine the effects of electrostatic discharge, power
				  fluctuation, conductive emission and susceptibility, and radiative emission and
				  susceptibility. The device shall comply with the requirements for performance
				  level characteristics of industrial devices.
d. The effect of exposure to specific environmental
				  conditions shall be documented. The device shall be tested to determine the
				  effects of low and high temperatures, thermal shock, humidity, physical shock,
				  and salt fog.
e. Both the probe and the display case shall be constructed
				  so that they may be sealed by the Health Officer.
f. Calibration of the device shall be protected against
				  unauthorized changes.
g. The device shall be protected against unauthorized
				  component or sensing element replacement. Replacement of any component or
				  sensing element shall be regarded as a replacement of the indicating
				  thermometer and subject to the Health Officer's inspection and all application
				  tests under Appendix I.
h. The sensing element shall be encased in appropriate
				  material constructed in such a way that the final assembly meets the conditions
				  of Item 11p Rule
				  420-3-16-.10(11).
i. The device shall be tested from the sensing probe through
				  the final output.
j. The bottom of the bulb chamber is not less than fifty-one
				  (51) millimeters (two [2] inches) and not more than eight-nine (89) millimeters
				  [3.5 inches], below the underside of the cover.
3. Digital Combination:
a. No more than 0.2°C (0.5ºF) drift over three (3)
				  months use on a batch pasteurizer compared to a certified temperature
				  source.
b. Self-diagnostic circuitry which provides constant
				  monitoring of all sensing, input, and conditioning circuits. The diagnostic
				  circuitry should be capable of detecting "open" circuits, "short" circuits,
				  poor connections, and faulty components. Upon detection of failure of any
				  component, the temperature sensors output signal and indicating display shall
				  go visibly out of range.
c. The electromagnetic compatibility of this device for this
				  use shall be documented and available to the Health Officer. The device shall
				  be tested to determine the effects of electrostatic discharge, power
				  fluctuation, conductive emission and susceptibility, and radiative emission and
				  susceptibility. The device shall comply with the requirements for performance
				  level characteristics of industrial devices.
d. The effect of exposure to specific environmental
				  conditions shall be documented. The device shall be tested to determine the
				  effects of low and high temperatures, thermal shock, humidity, physical shock,
				  and salt fog.
e. Both the probe and the display case shall be constructed
				  so that they may be sealed by the Health Officer.
f. Calibration of the device shall be protected against
				  unauthorized changes.
g. The device shall be protected against unauthorized
				  component or sensing element replacement. Replacement of any component or
				  sensing element shall be regarded as a replacement of the indicating
				  thermometer and subject to the Health Officer's inspection and all application
				  tests under Appendix I.
h. The sensing element shall be encased in appropriate
				  material constructed in such a way that the final assembly meets the conditions
				  of Item 11p.
i. The device shall be tested from the sensing probe through
				  the final output.
j. The bottom of the bulb chamber is not less than fifty-one
				  (51) millimeters (two [2] inches) and not more than eighty-nine (89)
				  millimeters (3.5 inches), below the underside of the cover.
Scale
- Shall have a span of not less than
				  14°C (25°F), including the pasteurization temperature of 66°C
				  (150°F), ± 2.5°C (± 5°F); graduated in not more than
				  1°C (2°F) divisions, with not more than 9°C (16°F) per 2.54
				  centimeters (1 inch) of scale; and protected against damage at (105°C)
				  220°F.
Accuracy
- Within ± 0.5°C (±
				  1°F), throughout the specified scale span (refer to Appendix I, Test
				  1).
Stem Fittings
- A pressure-tight seat or other
				  suitable sanitary fitting with no threads exposed.
TEMPERATURE-RECORDING DEVICES FOR BATCH
				  PASTEURIZERS
1.
UTILIZING TEMPERATURES LESS THAN 71°C
				  (160°F)
Case
- Moisture proof under normal operating
				  conditions in milk plants.
Chart Scale
- Shall have a span of not less than
				  11°C (20°F), including pasteurization temperature, ± 2.5°C
				  (± 5°F); and graduated in temperature-scale divisions of 0.5°C
				  (1°F), spaced not less than 1.6 millimeter (0.0625 of an inch) apart
				  between 60°C (140°F) and 69°C (155°F). Provided, that
				  temperature-scale divisions of 0.5°C (1°F), spaced not less than 1
				  millimeter (0.040 of an inch) apart, are permitted when the ink line is thin
				  enough to be easily distinguished from the printed line; graduated in
				  time-scale divisions of not more than ten (10) minutes; and having a chord of
				  straight-line length of not less than 6.3 millimeters (0.25 of an inch),
				  between 63°C (145°F) and 66°C (150°F).
Temperature Accuracy
- Within ± 0.5°C
				  (± 1° F), between 60°C (140°F) and 69°C (155°F)
				  (refer to Appendix I, Test 2).
Time Accuracy
- The recorded elapsed time as
				  indicated by the chart rotation shall not exceed the true elapsed time, as
				  compared to an accurate watch, over a period of at least thirty (30) minutes at
				  pasteurization temperature. Temperature-recording devices for batch
				  pasteurizers may be equipped with spring operated or electrically operated
				  clocks (refer to Appendix I, Test 3).
Pen-Arm Setting Device
- Easily accessible and
				  simple to adjust for mercury-actuated recording thermometer (refer to Appendix
				  I, Test 4).
Temperature Sensing Device
1.
Mercury Actuated
- Bulb, tube, and spring
				  protected against damage at a temperature of 105°C (220°F).
2. Digital
a. No more than 0.5°C (1.0° F) drift over three (3)
				  months use on a batch pasteurizer compared to a certified temperature
				  source.
b. Self-diagnostic circuitry which provides constant
				  monitoring of all sensing, input and conditioning circuits. The diagnostic
				  circuitry should be capable of detecting "open" circuits, "short" circuits,
				  poor connections, and faulty components. Upon detection of failure of any
				  component, the device shall be blank, become unreadable or go visibly out of
				  range.
c. The electromagnetic compatibility of this device for this
				  use shall be documented and available to the Health Officer. The device shall
				  be tested to determine the effects of electrostatic discharge, power
				  fluctuation, conductive emission and susceptibility, and radiative emission and
				  susceptibility. The device shall comply with the requirements for performance
				  level characteristics of industrial devices.
d. The effect of exposure to specific environmental
				  conditions shall be documented. The device shall be tested to determine the
				  effects of low and high temperatures, thermal shock, humidity, physical shock,
				  and salt fog.
e. Both the probe and the display case shall be constructed
				  so that they may be sealed by the Health Officer.
f. Calibration of the device shall be protected against
				  unauthorized changes.
g. The device shall be protected against unauthorized
				  component or sensing element replacement. Replacement of any component or
				  sensing element shall be regarded as a replacement of the indicating
				  thermometer and subject to the Health Officer's inspection and all application
				  tests under Appendix I.
h. The sensing element shall be encased in appropriate
				  material constructed in such a way that the final assembly meets the conditions
				  of Item 11p Rule
				  420-3-16-.10(11).
Submerged Stem Fitting
- A pressure-tight seat
				  against the inside wall of the holder; no threads exposed to milk or milk
				  products; and the distance from the underside of the ferrule to the sensitive
				  portion of the bulb to be not less than seventy-six (76) millimeters (three [3]
				  inches).
Chart Speed
- A circular chart shall make one
				  (1) revolution in not more than twelve (12) hours. Two (2) charts shall be used
				  if operations extend beyond twelve (12) hours in one (1) day. Circular charts
				  shall be graduated for a maximum record of twelve (12) hours. Strip-charts may
				  show a continuous recording over a twenty-four (24) hour period.
Chart Support Drive
- The rotating chart support
				  drive shall be provided with a pin to puncture the chart in a manner to prevent
				  its fraudulent rotation.
2.
UTILIZING TEMPERATURES GREATER THAN 71°C
				  (160°F)
Batch pasteurizers used solely for thirty (30) minute
				  pasteurization of milk and milk products at temperature above 71°C
				  (160°F) may use temperature-recording devices that comply with 1. with the
				  following options:
Chart Scale
- Graduated in temperature scale
				  divisions of 1°C (2°F), spaced not less than 1 millimeter (.040 of an
				  inch) apart between 65°C (150°F) and 77°C (170°F); graduated in
				  time-scale divisions of not more than fifteen (15) minutes; and having a chord
				  of straight-line length of not less than 6.3 millimeters (0.25 of an inch)
				  between 71°C (160°F) and 77°C (170°F).
Temperature Accuracy
- Within ± 1°C
				  (± 2° F), between 71°C (160°F) and 77°C
				  (170°F).
Digital Temperature Sensing Device
- No more
				  than 1°C (2°F) drift over three (3) months use on a batch pasteurizer
				  compared to a certified temperature source.
Chart Speed
- A circular chart shall make one
				  (1) revolution in not more than twenty-four (24) hours and shall be graduated
				  for a maximum record of twenty-four (24) hours.
RECORDER/CONTROLLERS FOR CONTINUOUS
				  PASTEURIZERS
Case
- Moisture proof under normal operating
				  conditions in milk pasteurization plants.
Chart Scale
- Shall have a span of not less than
				  17°C (30°F), including the temperature at which diversion is set,
				  ± 7°C (± 12°F); graduated in temperature scale divisions
				  of 0.5°C (1°F), spaced not less than 1.6 millimeter (0.0625 of an inch)
				  apart at the diversion temperature, ± 0.5°C (± 1°F).
				  Provided, that temperature-scale divisions of 0.5°C (1°F), spaced not
				  less than 1 millimeter (0.040 of an inch) apart, are permitted when the ink
				  line is thin enough to be easily distinguished from the printed line; graduated
				  in time-scale divisions of not more than fifteen (15) minutes; and having an
				  equivalent fifteen (15) minute chord or straight-line length of not less than
				  6.3 millimeters (0.25 of an inch) at the diversion temperature, ±
				  0.5°C (± 1°F).
Temperature Accuracy
- Within ± 0.5°C
				  (± 1°F), at the temperature, ± 3°C (± 5°F), at
				  which the controller is set to divert (refer to Appendix I, Test 2).
Power Operated
- All recorder/controllers for
				  continuous pasteurization shall be electrically operated.
Pen-Arm Setting Device
- Easily accessible and
				  simple to adjust for mercury-actuated recording thermometer (refer to Appendix
				  I, Test 4).
Pen and Chart Paper
- Pen designed to give a
				  line not over .07 millimeters (0.025 of an inch) wide and easy to
				  maintain.
Temperature Sensing Device
1.
Mercury Actuated
- Bulb, tube, and spring
				  protected against damage at a temperature of 105°C (220°F). Provided,
				  that the recorder/controller temperature sensing devices used on HHST systems
				  shall be protected against damage at temperatures of 149°C
				  (300°F).
2. Digital
a. No more than 0.5°C (1.0°F) drift over three (3)
				  months use on a HTST pasteurization system compared to a certified temperature
				  source.
b. Self-diagnostic circuitry which provides constant
				  monitoring of all sensing, input, and conditioning circuits. The diagnostic
				  circuitry should be capable of detecting "open" circuits, "short" circuits,
				  poor connections, and faulty components. Upon detection of failure of any
				  component, the device shall be blank or become unreadable.
c. The electromagnetic compatibility of this device for this
				  use shall be documented and available to the Health Officer. The device shall
				  be tested to determine the effects of electrostatic discharge, power
				  fluctuation, conductive emission and susceptibility, and radiative emission and
				  susceptibility. The device shall comply with the requirements for performance
				  level characteristics of industrial devices.
d. The effect of exposure to specific environmental
				  conditions shall be documented. The device shall be tested to determine the
				  effects of low and high temperatures, thermal shock, humidity, physical shock,
				  and salt fog.
e. Both the probe and the display case shall be constructed
				  so that they may be sealed by the Health Officer.
f. Calibration of the device shall be protected against
				  unauthorized changes.
g. The device shall be protected against unauthorized
				  component or sensing element replacement. Replacement of any component or
				  sensing element shall be regarded as a replacement of the indicating
				  thermometer and subject to the Health Officer's inspection and all applicable
				  tests under Appendix I.
h. The sensing element shall be encased in appropriate
				  material constructed in such a way that the final assembly meets the conditions
				  of Item 11p.
i. The device shall be tested from the sensing probe through
				  the final output.
Stem Fitting
- A pressure-tight seat against the
				  inside wall of the pipe; no threads exposed to milk or milk products; and the
				  distance from the underside of the ferrule to the sensitive portion of the bulb
				  is to be not less than 76 millimeters (3 inches).
Chart Speed
- A circular chart shall make one
				  (1) revolution in not more than twelve (12) hours. Two (2) charts shall be used
				  if operations extend beyond twelve (12) hours in one (1) day. Circular charts
				  shall be graduated for a maximum record of twelve (12) hours. Strip-charts may
				  show a continuous recording over a twenty-four (24) hour period.
Frequency Pen
- The recorder/controller shall be
				  provided with an additional pen-arm located on the outer edge of the chart, for
				  recording the time at which the FDD is in the forward or diverted-flow
				  position. The chart time line shall correspond with the reference arc and the
				  recording pen shall rest upon the time line matching the reference arc.
Controller
- Actuated by the same sensor as the
				  recorder pen; however, the cut-in and cut-out response shall be independent of
				  pen-arm movement.
Controller Adjustment
- A mechanism for the
				  adjustment of the response temperature. It shall be designed so that the
				  temperature setting cannot be altered or the controller manipulated without
				  detection.
Thermometric Response
- With the
				  recorder/controller bulb at room temperature and then immersed in sufficiently
				  agitated water or oil bath at 4ºC (7ºF) above the cut-in point, the
				  interval between the moment when the recording thermometer reads 7ºC
				  (12ºF) below the cut-in temperature and the moment of power cut-in shall
				  be not more than five (5) seconds (refer to Appendix I).
Chart Support Drive
- The rotating chart support
				  drive shall be provided with a pin to puncture the chart in a manner to prevent
				  its fraudulent rotation.
INDICATING THERMOMETERS USED IN STORAGE
				  TANKS
Scale Range
- Shall have a span not less than
				  28°C (50°F) Fahrenheit, including normal storage temperatures, ±
				  3°C (± 5°F), with an extension of scale on either side
				  permitted, and graduated in not more than 1°C (2°F) divisions.
Temperature Scale Division
- Spaced not less
				  than 1.6 millimeters (0.0625 of an inch) apart between 2°C (35°F) and
				  13°C (55°F).
Accuracy
- Within ± 1°C (±
				  2°F) throughout the specified scale range.
Stem Fitting
- A pressure-tight seat or other
				  suitable sanitary fittings with no threads exposed.
TEMPERATURE-RECORDING DEVICES USED IN STORAGE
				  TANKS
Case
- Moisture proof under operating conditions
				  in milk plants.
Chart Scale
- Shall have a scale span of not
				  less than 28°C (50°F) including normal storage temperature, ±
				  3°C (± 5°F), graduated in not more than 1°C (2°F)
				  divisions. Lines spaced not less than 1 millimeter (0.040 of an inch) apart are
				  permitted when the ink line is thin enough to be easily distinguished from the
				  printed line. They shall be graduated in time scale divisions of not more than
				  one (1) hour, having a chord of straight-line length of not less than 3.2
				  millimeters (0.125 of an inch) at 5°C (41°F). These charts shall be
				  capable of recording temperatures up to 83°C (180°F). Span
				  specifications do not apply to extensions beyond 38°C (100°F).
Temperature Accuracy
- Within ± 1°C
				  (± 2°F), between the specified range limits.
Pen-Arm Setting Device
- Easily accessible and
				  simple to adjust.
Pen and Chart Paper
- Designed to make a line
				  not over .635 millimeters (0.025 of an inch) wide when in proper adjustment and
				  easy to maintain.
Temperature Sensor
- Protected against damage at
				  100°C (212°F).
Stem Fittings
- A pressure-tight seat or other
				  suitable sanitary fitting with no threads exposed.
Chart Speed
- The circular chart shall make one
				  (1) revolution in not more than seven (7) days and shall be graduated for a
				  maximum record of seven (7) days. Strip chart shall move not less than 2.54
				  centimeters (1 inch) per hour and may be used continuously for one (1) calendar
				  month.
TEMPERATURE-RECORDING DEVICES ON MECHANICAL CLEANING
				  SYSTEMS
Location
- Temperature sensor is in the return
				  solution line downstream from the process.
Case
- Moisture proof under operation
				  conditions.
Chart Scale
- Shall have a range from 16°C
				  (60°F) to 83°C (180°F), with extensions of scale on either side
				  permissible and graduated in time-scale divisions of not more than fifteen (15)
				  minutes. The chart is to be graduated in temperature divisions of not more than
				  1°C (2°F), spaced not less than 1.6 millimeters (0.0625 of an inch)
				  apart, above 44°C (110°F). Provided, that temperature-scale divisions
				  of 1°C (2°F), spaced not less than 1 millimeter (0.040 of an inch)
				  apart, are permitted when the ink line is thin enough to be easily
				  distinguished from the printed line.
Temperature Accuracy
- Within ± 1°C
				  (± 2°F), above 44°C (110°F).
Pen-Arm Setting Device
- Easily accessible and
				  simple to adjust.
Pen and Chart Paper
- Designed to make a line
				  not over .635 millimeters (0.025 of an inch) wide and easy to maintain.
Temperature Sensor
- Protected against damage at
				  100°C (212°F).
Stem Fitting
- A pressure-tight seat against the
				  inside wall of the pipe with no threads exposed to solution.
Chart Speed
- Circular charts shall make one (1)
				  revolution in not more than twenty-four (24) hours. Strip charts shall not move
				  less than 25 millimeters (1 inch) per hour. More than one (1) record of the
				  cleaning operation shall not overlap on the same section of the chart for
				  either circular or strip-type charts.
INDICATING THERMOMETERS USED IN REFRIGERATED ROOMS
				  WHERE MILK AND MILK PRODUCTS ARE STORED SHALL MEET THE FOLLOWING
				  SPECIFICATIONS:
Scale Range
- Shall have a span not less than
				  28°C (50°F), including normal storage temperatures, ± 3°C
				  (± 5°F), with extensions of scale on either side permitted if
				  graduated in not more than 1°C (2°F) divisions.
Temperature Scale Divisions
- Spaced not less
				  than 1.6 millimeters (0.0625 of an inch) apart between 0°C (32°F) and
				  13°C (55°F).
Accuracy
- Within ± 1°C (±
				  2°F), throughout the specified scale ranges.
SPECIFICATIONS FOR RECORDING pH METER FOR USE ON
				  AUTOMATED CIP CLEANING SYSTEMS FOR EVAPORATORS
Location
- pH sensor shall be located in the
				  return line downstream from processing equipment and all lines included in the
				  CIP cleaning circuit.
Case:
Moisture proof under operating
				  conditions.
Chart Scale
- It shall have a range of pH value
				  from two (2) to twelve (12), with extensions of scale on either side
				  permissible, and graduated in time scale divisions of not more than fifteen
				  (15) minutes. The chart is to be graduated in pH divisions of not more than 0.5
				  pH values and spaced not less than 1.6mm (0.0625 of an inch) apart.
pH Accuracy
- Within 0.5, plus or minus pH
				  values.
Pen-Arm Setting Device
- Easily accessible;
				  simple to adjust.
Pen and Chart Paper
- Designed to mark a line
				  not over 0.635mm (0.025 of an inch) wide; easy to maintain.
pH Sensor
- Protected against damage at 83°C
				  (180°F).
Chart Speed
- Circular charts shall make one (1)
				  revolution in not more than twenty-four (24) hours. Strip charts shall not move
				  slower than 25mm (1 inch) per hour. More than one (1) record of the cleaning
				  operation shall not overlap on the same section of the chart for either
				  circular or strip-type charts.
V.
CRITERIA FOR THE EVALUATION OF ELECTRONIC DATA
				  COLLECTION, STORAGE, AND REPORTING
BACKGROUND
Electronically collecting data storing data and reporting
				  information with computers can be a beneficial replacement for circular chart
				  recorders and/or hand-written records. This method of presenting
Grade
				  "A" PMO
required information should essentially replace and duplicate
				  the purpose and functionality of their manual or chart recorder counterparts.
				  These would include CIP records, pasteurization records, raw and heat-treated
				  product storage tank's temperature and cleaning requirements, and temperature
				  monitors for membrane filtration. This criteria for the evaluation addresses
				  the difference between manual records or chart recorders and electronic or
				  computer record keeping. These differences are identified in the criteria below
				  that address the verification of system reliability, security and
				  dependability, and what information is available and accurate for assuring
				  public health safety and inspection.
Following are some of the differences between manual records
				  and chart recorders as compared to electronically collecting data, storing
				  data, and reporting information using computers:
1.
Manual Records and Chart Recorders are Visual in
				  Nature
- Milk plant employees and regulatory personnel can see and
				  physically hold the records and place them in files for safe keeping. Whereas
				  computerized data collection systems are not so, they need to have methods in
				  place to assure that the information is reliably placed and safe.
2.
Manual Records and Chart Recorders are Physical in
				  Nature
- Milk plant employees and regulatory personnel can physically
				  record on and actually sign the records and; therefore, become responsible for
				  the required public health activity. Also, the quality assurance manager is
				  typically responsible for the integrity of the stored records. Whereas,
				  computerized data collection and reporting systems need to collect the identity
				  of the person performing the function and they also need to have someone at
				  each milk plant responsible for the integrity of the stored records.
3.
Manual Records and Chart Recorders are Typically
				  Hard Wired Directly to Dedicated Instrumentation
- Very little
				  complexity exists between the sensor, such as a temperature or flow sensor, and
				  the final recording device. This allows routine maintenance and compliance
				  monitoring and inspection of manual records and chart recorders to be
				  relatively simple. Whereas the computerized data collection, storage, and
				  reporting systems need to have documented procedures in place to assure that
				  system changes, upgrades, and normal operating procedures do not compromise the
				  integrity of the public health safety information and reports.
CRITERIA
- The following criteria are to be used
				  for the evaluation of electronic collection, storage, and recording or
				  reporting of any information required within Items 12p and 16p(D), Rules
				  420-3-16-.10(12)
				  and 420-3-16-.10(21).
Note:
These criteria do not address computer
				  instrumentation or the electronic control of pasteurization for public health
				  safety.
All computer-generated records and reports shall contain the
				  information required in these rules that is applicable. The computerized data
				  collection, storage, and reporting system shall have an assigned and identified
				  representative from the milk plant that is responsible for the system. This
				  person's name shall be available to the Health Officer and the FDA.
1. Any computer required in the making of a public health
				  safety report, including data collection computers, data storage computers, or
				  report servers shall be powered with an Uninterruptible Power Supply (UPS)
				  capable of maintaining power to the computerized data collection, storage, and
				  reporting system for twenty (20) minutes.
2. A written user's guide of the computerized data
				  collection, storage and reporting system shall be provided and will explain the
				  system's architecture, the software used, and the sensors or instruments
				  monitored. This overview may be presented in text or in a graphical
				  representation. A copy of this overview shall be maintained at the discretion
				  of the Health Officer. This document shall bear the name of the identified
				  representative from the milk plant assigned to administrate this procedure and
				  be available for review at the milk plant by the Health Officer and the FDA.
				  This documentation shall explain:
a. System's architecture, the software used, and the sensors
				  or instruments monitored.
b. Reporting interface of the computerized data collection,
				  storage, and reporting system.
c. Backup procedure for ensuring the safe storage of the
				  public health safety data of all reports.
d. Procedure for any changes or maintenance to the
				  instrumentation, sensors, hardware, or computers. This procedure will explain
				  how the plant will ensure that when a physical change occurs, the information
				  affected has been checked for accuracy.
e. Listing and explanation of the reports available on the
				  system, instructions on how to access the reports, and examples of each report
				  with a description of their content.
3. A written record shall be maintained by the milk plant
				  identifying any changes or updates to the computerized data collection, storage
				  and reporting system, software, drivers, networking, or servers in order to
				  assure the collection, storage, or reporting of any data needed for compliance
				  has not been compromised. This document shall bear the name of the
				  representative from the milk plant assigned to administer this procedure and be
				  available for review at the milk plant by the Health Officer and the
				  FDA.
4. In the case of CIP and raw and heat-treated storage tank
				  records, data shall be stored at a rate to provide a reasonable account of the
				  process being recorded. This shall never exceed a maximum of fifteen (15)
				  minutes between data records. The data for the reporting system shall be backed
				  up at least once every twenty-four (24) hours. Alternatively, the final reports
				  may be stored and backed up at least once every twenty-four (24) hours.
5. In the case of pasteurization records, data shall be
				  stored no less than every five (5) seconds for each required variable. Any
				  event required to be recorded in manual reporting, such as a divert condition,
				  shall be recorded no matter how short the duration. Provisions shall be made to
				  allow operators to report additional events electronically, such as a record of
				  unusual occurrences. The data for the reporting system shall be backed up at
				  least once every twenty-four (24) hours. Alternatively, the final reports may
				  be stored and backed up at least once every twenty-four (24) hours.
6. Upon the initial installation, computer generated reports
				  shall be verified visually for accuracy for seven (7) consecutive days and be
				  found to be accurate and error free in actual service in the milk plant where
				  installed. These seven (7) days of reports shall be printed out and shall bear
				  the signature of both the vendor of the system and the identified
				  representative from the milk plant, or they shall be accompanied by a cover
				  letter signed by the vendor and the identified representative from the milk
				  plant. If the milk plant develops the computerized data collection, storage,
				  and reporting system, the programmer and the identified representative from the
				  milk plant shall be two (2) different individuals. This seven (7) day report
				  verification period shall only be required at initial installation and one (1)
				  time only whenever a chart recorder and/or hand-written record is being
				  replaced by electronic data collection, storage, and reporting. These seven (7)
				  days of reports shall be kept on file at the milk plant and a copy shall be
				  provided to the Health Officer when requested.
7. Whenever changes, updates, or observed anomalies that
				  affect the reliability or accuracy of the reporting system occur following the
				  initial installation of the system, these changes, updates, or observed
				  anomalies shall be evaluated and investigated and if corrections are warranted
				  shall be addressed. The records of each evaluation and corrections made shall
				  bear the signature of the vendor or the identified representative from the milk
				  plant. The records shall be maintained and be available for the Health Officer
				  when requested.
8. The electronic computerized data collection, storage, and
				  reporting system shall provide for any signatures or initials required by these
				  rules. Acceptable operator signatures or initials captured electronically may
				  be any combination of alpha and/or numeric characters that identify the
				  individual performing the test or operation. Input of this signature or
				  initials may be done by any means, including but not limited to, a biometric
				  reader, a card or radio frequency device, or by simple direct entry that
				  provides a unique identifier directly associated with a specific person. Input
				  of this signature or initials shall occur each time it is required by these
				  rules. Except, that in the case of pasteurization records, the operator's
				  signature or initials shall occur whenever an operator changes and at a minimum
				  frequency of once every twenty-four (24) hours.
9. The data supporting electronic reports shall be stored in
				  a database or data archival system in a Write Once, Read Many (WORM).
10. The system shall provide an anomalies report indicating
				  any system or communication failure that could have affected the validity of
				  the required reports. This anomalies report shall be automatically attached to
				  any report that may have been affected by the system anomaly. A separate error
				  log or system log shall not suffice for meeting this requirement, since any
				  anomaly requires an evaluation and investigation to correlate the
				  anomaly.
Note:
While electronic and computerized systems
				  can furnish a wide range of process validation and anomaly reporting, these
				  criteria only require appended reporting of data loss that affects the reports
				  that are required to comply with this Appendix and Items 12p and 16p(D) or
				  other required reporting contained in Rules
				  420-3-16-.10(12)
				  and 420-3-16-.10(21).
11. When a report is viewed on a computer screen, this format
				  is exempt from the graduated temperature divisions, temperature-scale
				  divisions, and line spacing requirements of this appendix.
12. Printed reports shall present data in a form that is
				  compatible with the applicable requirements of these rules.
VI.
CRITERIA FOR THE EVALUATION OF COMPUTERIZED SYSTEMS
				  FOR GRADE "A" PUBLIC HEALTH CONTROLS
BACKGROUND
Computer systems are commonly used to manage the functions of
				  public health control devices (valves, pumps, etc.) that operate milk
				  pasteurization systems. These computer systems may be programmed for monitoring
				  and controlling the instrumentation of HTST and HHST pasteurizers. They may
				  also control the operational state of devices such as the FDDs, booster pumps,
				  etc. While this technology can furnish numerous advantages throughout the
				  manufacturing process, the public health computer system should essentially
				  just replace its hard-wired counterpart. These computer systems are evaluated
				  similar to hard-wired systems and all of the required public health controls
				  shall meet the established criteria. Computers are different from hard-wired
				  controls in three (3) major categories. To provide adequate public health
				  protection, the design of computerized public health controls shall address
				  these three (3) major differences.
First, unlike conventional hard-wired systems which provide
				  full-time monitoring of the public health controls, the computer performs its
				  tasks sequentially, and the computer may be in real time contact with the FDD
				  for only one (1) millisecond. During the next one hundred (100) milliseconds,
				  or however long it takes the computer to cycle one (1) time through its tasks,
				  the FDD remains in forward-flow, independent of temperature in the holding
				  tube. Normally, this is not a problem because most computers can cycle through
				  one hundred (100) steps in their program, many times during one (1) second. The
				  problem occurs when the public health computer is directed away from its tasks
				  by another computer; or the computer program is changed; or a seldom used JUMP,
				  BRANCH, or GOTO Instruction diverts the public health computer away from its
				  tasks.
Second, in a computerized system, the control logic is easily
				  changed because the computer program is easily changed. A few keystrokes at the
				  keyboard will completely change the control logic of the computer program.
				  Sealing the access to the public health computer's programming function can
				  solve the problem addressed above. A procedure is needed to ensure that the
				  public health computer has the correct program when the Health Officer reseals
				  the public health computer.
Finally, for public health controls, the public health
				  computer program shall and can be made error-free since the programs required
				  for public health control are relatively brief. This is accomplished by
				  attempting to keep the public health computer program simple and of limited
				  control scope.
GLOSSARY
Address
- A numerical label on each memory
				  location of the computer. The computer uses this address when communicating
				  with the input or output.
Computer
- A very large number of on-off
				  switches arranged in a manner to sequentially perform logical and numerical
				  functions.
Default Mode
- The pre-described position of
				  some memory locations during start-up and standby operations of the
				  computer.
EAPROM
- An Electrically Alterable,
				  Programmable, Read-Only Memory. Individual memory locations may be altered
				  without erasing the remaining memory.
EEPROM
- An Electrically Erasable Programmable,
				  Read-Only Memory. The entire memory is erased with one (1) electrical
				  signal.
EPROM
- An Erasable, Programmable, Read-Only
				  Memory. The entire memory is erased by exposure to ultra-violet light.
Fail-Safe
- Design considerations that cause the
				  instrument or system to move to the safe position upon failure of electricity,
				  air, or other support systems.
Field Alterable
- A device having a specific
				  design or function that is readily changed by the user and/or the maintenance
				  personnel.
FDD
- The common acronym used for flow-diversion
				  valves or devices on pasteurization systems.
Force Off
- A programmable computer instruction
				  that places any input or output in the "off" state, independently of any other
				  program instructions.
Force On
- A programmable computer instruction
				  that places any input or output in the "on" state, independently of any other
				  program instructions.
Human Machine Interface
- Often referred to as
				  operator interface, this computer station allows personnel monitoring and
				  control of the computer system normally by use of a touch screen or
				  keyboard.
Input
- Electrical signals applied to the
				  computer and used by the computer to make logical decisions on whether or not
				  to activate one or more outputs. Input consists of data from temperature and
				  pressure instruments, liquid level controls, PDDs, and operator-controlled
				  panel switches.
Input/Output Terminals
- The input/output
				  terminals are the electrical panels that provide for connection of all the
				  inputs and outputs to the computer. The input/output address labels are found
				  on this panel. Indicator lights showing the status, "on" or "off," of all
				  inputs and outputs may be available on this panel. This terminal is typically
				  located on the computer and is commonly known as a "bus."
Ladder Logic Diagram
- A programming language
				  typically used for industrial computers commonly used and applied to milk
				  pasteurization systems.
Last State Switch
- A manually operated switch
				  or software setting that instructs the computer to place all outputs in the
				  "on," "off," or "last state" condition during a start-up. The "last state"
				  position instructs the computer to place the outputs in whatever state, on or
				  off, occurred during the last loss of power.
Operator Override Switch
- A manually operated
				  switch that permits the operator to place any input or output in the "on" or
				  "off" position, independently of any program instructions.
Output
- Electrical signals from the computer
				  that turn on or off valves, motors, lights, horns, and other devices being
				  controlled by the computer. Outputs may also consist of messages and data to
				  the operator.
Position Detecting Device (PDD)
- Mechanical
				  limit switches (micro-switches) or electronic proximity switches capable of
				  providing an electrical signal.
Programmable Logic Controller (PLC)
- Also known
				  as PLCs, this is a computer commonly used to control industrial machines,
				  instruments, and processes.
RAM
- Random Access Memory is memory used by the
				  computer to run programs; store data; read input and control outputs. The
				  computer may either read data from the memory or write data into the
				  memory.
ROM
- Read-Only Memory is memory used by the
				  computer to run its own internal unchangeable programs. The computer may only
				  read from the memory. It cannot write into the memory or alter the memory in
				  any way.
RTD
- Resistance Temperature Detector
Standby Status
- The computer is turned on,
				  running, and waiting for instructions to start processing input data. A
				  manually operated switch usually accomplishes this instruction.
Status Printing
- Some computers are programmed
				  to interrupt printing of the chart record and print the status of key set
				  points and conditions such as: cold milk temperature, holding tube temperature,
				  diversion temperature setting, and chart speed.
WORM
- Write Once, Read Many is a data storage
				  technology that allows information to be written to a device a single time and
				  prevents the device from erasing the data.
CRITERIA
The following listed criteria shall be complied with for all
				  computers when applied to HTST and HHST pasteurization systems used for Grade
				  "A" milk and/or milk products. In addition, all systems shall conform to all
				  other existing requirements of these rules.
1. A computer or a PLC used for the public health control of
				  a pasteurizer shall be dedicated only to the public health control of that
				  individual pasteurizer. The public health computer shall have no other
				  assignments involving the routine operation of the milk plant. Computer
				  functions peripheral to the public health controls, such as CIP valve cycling,
				  may be acceptable; provided, it does not compromise the public health
				  functionality of the public health computer or pasteurization system and all
				  rule requirements and safeguards are not compromised.
2. The public health computer and its outputs shall not be
				  under the command or control of any other computer system or Human Machine
				  Interface. It shall not have an address that is addressable by any other
				  computer system. A host computer cannot override its commands or place it on
				  standby status. All addresses of the public health computer shall be ready to
				  process data at any time.
3. A separate public health computer shall be used on each
				  HTST and HHST pasteurization system. Only the public health computer may
				  provide control over the public health devices and functions of the HTST and
				  HHST pasteurization system. Any other computer or Human Machine Interface may
				  request a function of a device (valve, pump, etc.) within the HTST or HHST
				  pasteurization system through a hard-wired input; however, this request would
				  be granted or denied by the logic in the public health computer depending on
				  the current status of the computer program and public health rule
				  requirements.
4. The status of the inputs and outputs of the public health
				  computer may be provided as inputs only to other computer systems and all
				  public health outputs or devices shall be controlled by direct hard-wiring from
				  the output terminal bus of the computer to the device. This includes solenoids,
				  motor speed controls, such as frequency drives, and motors located within the
				  HTST or HHST pasteurization system. The wiring connections shall be provided
				  with isolation protection such as relays, diodes, or optical-coupling devices
				  to prevent the public health outputs from being driven by the other computer
				  system. Digital outputs from another computer may be connected to an input of
				  the public health computer in order to request the operation of a device
				  controlled by the public health computer. This section shall not be interpreted
				  to prohibit control of the motor speed controls, such as frequency drives, by
				  non-public health computer systems provided that the regulatory limits cannot
				  be altered or disabled.
5. Upon loss of power to the public health computer all
				  public health controls shall assume the fail-safe position. Most computers can
				  be placed in standby status by either a program instruction or manual switches.
				  When the public health computer is in standby status, all public health
				  controls shall assume the fail-safe position. Some computers have internal
				  diagnostic checks that are performed automatically during start-up. During this
				  time, the public health computer places all outputs in default mode. In this
				  default mode, all public health controls shall be in the fail-safe position.
				  The status of outputs or inputs of the public health computer may provide
				  status to another computer for informational purposes. This shall only be
				  accomplished through a hard-wired output (separate from any control output)
				  from the public health computer to an input on another computer system. No
				  other communication from the public health computer is allowed.
6. Some computers and/or PLCs have Input/Output terminals
				  (buses) with "last state switches" that permit the designer to decide what
				  state the output bus will take on power-up, after a shutdown, or loss of power.
				  The choices are "on," "off," or "last state" occurring when the computer lost
				  power. These "last state switches" shall be placed in the "fail-safe" or "off"
				  position. Upon loss of power to the computer, all public health controls shall
				  assume the fail safe position. Most computers can be placed in standby status
				  by either a program instruction or manual switches. The public health computer
				  shall have its manual switch in the position that maintains all outputs in the
				  "off" state during any operations except normal program execution.
7. A computer performs its tasks sequentially, and for most
				  of real time the computer outputs are locked in the "ON" or "OFF" position,
				  while waiting for the computer to come back through the cycle. Consequently,
				  the public health computer program shall be written so that it monitors all
				  inputs and updates all outputs on a precise schedule, at least once every
				  second. Most computers will be capable of performing this function many times
				  in one (1) second. Program instructions may not exist within the public health
				  computer program that are capable of altering the scan order of the logic, or
				  distract focus from this order. These would include "JUMP" or "GOTO" type
				  instructions.
8. The computer program used to control the required public
				  health functions of HTST or HHST pasteurizers shall be stored in some form of
				  ROM and be available when the public health computer is turned on. The use of
				  tapes or disks are not acceptable.
9. The public health computer program access shall be sealed.
				  Any telephone modem accesses shall also be sealed. If the Input/Output
				  terminals contain "last state switches," the Input/Output terminals shall be
				  sealed. The vendor shall supply the Health Officer with test procedures and
				  instructions to verify that the program currently in use by the public health
				  computer is the correct program. Typically this is made available by providing
				  a copy of the program that controls the public health computer of the HTST or
				  HHST pasteurizer. The Health Officer shall use this test procedure to confirm
				  that the correct program is in use during a start-up, normal operation, and
				  whenever the seal is broken. Challenging the system during normal operation
				  could involve challenging the inter-wiring requirements through the CIP
				  computer. One (1) method could include attempting access to the booster pump
				  through the CIP computer. With the FDD mode selector in "PROCESS" or "PRODUCT"
				  position, attempt to access the booster pump using the CIP computer. Public
				  health controls in pasteurizers that may be compromised by such a challenge,
				  shall be altered or re-programmed so this compromise is prevented and the
				  access to this computer program shall be sealed by the Health Officer. Similar
				  challenges may be performed on other required public health functions that are
				  computer controlled.
10. If the public health computer contains FORCE-ON,
				  FORCE-OFF functions, the public health computer shall provide indicator lights
				  showing the status of the FORCE-ON, FORCE-OFF function. The vendor's
				  instructions shall remind the Health Officer that all FORCE-ON, FORCE-OFF
				  functions shall be cleared before the public health computer is sealed by the
				  Health Officer.
11. The Input/Output terminals of the public health computer
				  shall contain no operator override switches that are accessible without
				  compromising a regulatory seal.
12. Computerized systems that provide for printing the
				  pasteurizer recording chart by the public health computer shall ensure that the
				  required calibration is maintained. During chart printing, the public health
				  computer shall not be diverted from its tasks for more than one (1) second.
				  Upon returning to public health control tasks, the public health computer shall
				  complete at least one (1) full cycle of its public health tasks before
				  returning to chart printing.
13. When printing a chart, some systems may provide status
				  reports on the chart paper of selected Input/Output conditions. This is usually
				  done by interrupting the printing of the chart and printing the Input/Output
				  conditions. Such interruptions for status printing are permitted only when a
				  continuous record is recorded on the chart. When an interruption is initiated
				  the time of the start of the interruption shall be printed on the chart, at the
				  beginning of the interruption, and at the end of the interruption. The time
				  interval during which the public health computer is diverted from its public
				  health tasks for status printing shall not exceed one (1) second. Upon
				  returning to public health tasks, the public health computer shall complete at
				  least one (1) full cycle of its public health tasks before returning to status
				  printing.
14. When the public health computer prints the holding tube
				  temperature trace at specific intervals rather than a continuously changing
				  line, temperature readings shall be printed not less than once every five (5)
				  seconds. In addition, during the recorder/controller thermometric response
				  test, the temperature shall be printed or indicated at a time rate sufficient
				  to allow the Health Officer to measure the 7°C (12°F) rise in
				  temperature as described in Test 8. Recorder/Controller-Thermometric Response
				  of these rules.
15. When the public health computer prints the event pen
				  position, the position of the FDD, either forward or divert at specific
				  intervals, rather than continuously, all changes of position shall be
				  recognized by the public health computer and printed on the chart. In addition,
				  the event pen position and temperature in the holding tube shall be printed on
				  the chart in a manner that the temperature in the holding tube can be
				  determined at the moment of a change in position of the FDD.
16. The vendor shall provide a built-in program for test
				  procedures or a protocol shall be provided so that all applicable public health
				  tests, contained within Appendix I, can be performed by the Health Officer for
				  each instrument, i.e.:
a. Recording Thermometers: Temperature accuracy; time
				  accuracy; check against indicating thermometer and thermometric
				  response.
b. FDD - Valve seat leakage; operation of valve stem(s);
				  device assembly; manual diversion; response time and time delay intervals if
				  used.
c. Booster Pumps - Proper wiring and proper pressure control
				  settings.
d. Flow-Promoting Devices Capable of Generating Flow Through
				  the Holding Tube - Are installed with proper wiring interlocks.
17. Computers require high quality, clean, well-regulated
				  power supplies to operate reliably and safely. Spurious voltage spikes can
				  cause unwanted changes in public health computer RAM. To assure the public
				  health computer will execute its functions error free the following items
				  parameters shall be considered:
a. A "clean" power source that is relatively free of spikes,
				  interference, and other irregularities shall be supplied to the public health
				  computer.
b. The correct program should be confirmed at the time of
				  sealing (refer to the criteria cited within #9 of this section).
c. The output bus "last state" switch should be in the "off"
				  or "fail-safe" position which shall stop all functions of the HTST or HHST
				  pasteurizer in case of a spurious program error.
d. All public health computer outputs shall not have any
				  operator override switches and shall be wired in a manner that only allows the
				  public health PLC complete control.
It is necessary that the installer or designer for the public
				  health PLC ensure that the proper program is in the public health computer
				  memory before the Health Officer seals the computer. It is also necessary that
				  any program changes be written to the public health computer's back-up chip if
				  one exists.
18. Computer programs used for public health controls on
				  pasteurizers shall conform to the attached logic diagrams. Minor modifications
				  to these diagrams are permissible to accommodate or delete items that are
				  unique to a specific HTST or HHST pasteurization system. For example on meter
				  based timing systems when the FDD selector switch is placed in the CIP
				  position:
a. A minimum ten (10) minute time delay is required for the
				  FDD to remain in diverted flow.
b. During this time delay the booster pump shall shut down
				  and remain off for ten (10) minutes and then the Programmed CIP Operation is
				  allowed to fully perform all the cleaning functions for the HTST or HHST
				  pasteurization system, including allowing the timing pump, the separator, and
				  the booster/stuffer pump to run during cleaning operations and the FDD to pulse
				  or cycle.
19. The ladder logic diagrams for the FDD and the booster
				  pump show a programmed CIP cleaning cycle operation as part of the computerized
				  system. Some milk plant operators may wish to use another computer for CIP
				  cleaning operations so that milk plant personnel may change CIP cleaning
				  programs. When using this method, the connections between the FDD, booster
				  pump, and milk plant computer shall be provided with solenoid relays or similar
				  devices for the FDD and booster pump outputs. This prevents them from being
				  operated by the milk plant computer except when the mode switch of the FDD is
				  in the "CIP" position and all applicable requirements have been
				  satisfied.
20. The vendor shall provide to the Health Officer a protocol
				  and documentation as follows:
a. Wiring diagrams of those controllers, instruments, and
				  devices pertaining to the public health computer.
b. The computer ladder logic printout and/or storage device
				  (programmed ROM chip, etc.) identical to the public health computer that
				  controls the pasteurizer. This is usually in the form of ladder line logic for
				  each component of the pasteurization system(s) and may include programming for
				  CIP and other functions.
c. A user manual including testing procedures and
				  instructions as required in Criteria #9 of this section.
COMPUTERIZED SYSTEMS LOGIC DIAGRAMS
LEGEND
t=Time
T=Temperature
PDD=Position Detecting Device
FDD= Flow-Diversion Device
LOSA = Loss of Signal/Low Flow Alarm
HFA=High Flow Alarm
STLR=Safety Thermal Limit Recorder/Controller
Click to view
				  image
Figure 52. Logic Diagram: HTST Flow Diversion Device,
				  Divert Valve Stem
Click to view
				  image
Figure 53. Logic Diagram; HTST Flow-Diversion,
				  Leak-Detect Valve Stem
Click to view
				  image
Figure 54. Logic Diagram: HTST Safety Thermal Limit
				  Recorder-Controller
Click to view
				  image
Figure 55. Logic Diagram: HTST Timing
				  Pump
Click to view
				  image
Figure 56. Logic Diagram: HTST Booster
				  Pump
VII.
CRITERIA FOR STEAM-BLOCK TYPE FDD
				  SYSTEMS
1. Steam-Block Type FDD Systems shall have two (2)
				  steam-block zones between the pasteurizer and the surge tank(s)/filler(s).
				  There shall be a continuous visible bleed of steam or condensate to the drain
				  from each steam-block zone.
2. The steam-block zones shall be temperature monitored and
				  shall alarm when temperature falls below 121°C (250°F).
3. The Primary Divert Valve and other critical valves shall
				  be position detectable and fail-safe and be alarmed to provide protection when
				  needed.
Note:
For the detection of the FDD and valve
				  seat positions (refer to Appendix H, and I, Position Detection Devices).
4. The Steam-Block Type FDD System shall not move to the
				  forward-flow position until all conditions required of the HHST pasteurizing
				  system are met and shall divert under the same conditions as a standard
				  FDD.
5. When the Steam-Block Type FDD System is in a divert
				  condition, a loss of temperature alarm in a steam-block zone shall cause a full
				  port opening to drain in that steam-block zone.
6. Should both steam-block zones fail when the Steam-Block
				  Type FDD is in diverted flow, the resulting compromised milk or milk product
				  shall not be distributed for sale.
7. Computer controls shall meet the requirements of this
				  appendix.
Click to view
				  image
VIII.
MILK AND MILK PRODUCTS HACCP CCP MODELS FOR
				  PASTEURIZATION EQUIPMENT
Milk plants regulated under the NCIMS voluntary HACCP Program
				  shall manage pasteurization under the HACCP Plan as a CCP. Following are
				  examples of acceptable models (HACCP Plan Summary Tables) that may be used.
				  Other HACCP Plan Summary Tables that appropriately manage pasteurization as a
				  CCP may also be used.
MILK AND MILK PRODUCT CONTINUOUS-FLOW (HTST AND HHST)
				  PASTEURIZATION -- CCP MODEL HACCP PLAN SUMMARY
(refer to the example on
				  H-69).
The essential elements of HTST and HHST pasteurization
				  are:
1. Time.
2. Temperature.
3. Pressure.
Each of these elements shall be addressed under the HACCP
				  Plan.
1. In continuous-flow pasteurizers with sealed timing pumps,
				  the minimum holding time at pasteurization temperature shall be addressed in
				  the HACCP Plan as a CCP verification. Continuous-flow pasteurizers with
				  magnetic flow meter based timing systems timed at minimum pasteurization
				  temperature and shall be addressed as a Critical Limit (CL).
2. Temperature shall always be addressed in the HACCP Plan as
				  a CL.
3. Pressures in the regenerator of continuous-flow
				  pasteurizers, and in the case of HHST pasteurizers as required in the holding
				  tubes, across steam injectors, and within infusion chambers shall be addressed
				  in the HACCP Plan and managed as CCP verification(s).
MILK AND MILK PRODUCT VAT (BATCH) PASTEURIZATION---CCP
				  MODEL HACCP PLAN SUMMARY (refer to the example on page H-70).
The essential elements of vat (batch) pasteurization
				  are:
1. Time.
2. Temperature.
Both of these elements shall be addressed under the HACCP
				  Plan as a CL.
MILK AND MILK PRODUCT CONTINUOUS-FLOW (HTST AND HHST)
				  PASTEURIZATION---CCP Model HACCP Plan Summary
Critical Control Point
								(CCP)
Hazard(s)
Critical Limits
Monitoring
Corrective
								Action(s)*
CCP Verification**
								and
***
Records
What
How
Frequency
Who
Milk and Milk Products Pasteurization (HTST and
								HHST)
Biological-Vegetative Pathogens (non-spore
								formers)
Time and Temperature
NOTE
:
Assuring that the minimum holding times are met in systems which use a
								sealed timing pump would be as CCP verification during required equipment
								calibration.
Temperature at the exit of the holding tube
Flow rate in forward flow in the holding tube (to
								verify minimum holding time) in continuous flow pasteurizers with magnetic flow
								meter based timing systems.
Temp. Recorder Chart
Flow Recorder Chart
Continuous during Operation
Continuous during Operation
Pasteurizer Operator
Pasteurizer Operator
Manually divert flow of product
Isolate the affected product
Evaluate and determine disposition of the product
								(reprocess or disposal)
Document actions
Record Review:
Pasteurizer charts verified
Equipment Function Checks:
Operator performs required daily tests and record
								on the temperature charts.
Authorized plant person (supervised by regulatory
								when required) conducts checks listed in the
Milk Plant Equipment Test
								Report
(FDA Form 2359b).
Seals:
Verify required regulatory seals daily
Pasteurizer Charts
Corrective Action Records
CCP Verification - Records, including
								equipment testing records
* A properly operating HTST or HHST pasteurization system
				  shall divert raw product to the constant-level tank when predetermined set
				  points are not met.
**Every particle of milk or milk product is heated, in a
				  properly designed, calibrated and operated pasteurizer, to one of the
				  temperature and time combinations specified in the current
Grade "A"
				  PMO
.
*** Pressures in the regenerator of continuous-flow
				  pasteurizers, and in the case of HHST pasteurizers as required in the holding
				  tubes, across steam injectors, and within infusion chambers shall be addressed
				  in the HACCP Plan and managed as CCP verification(s).
Product Description:
___________________________________
Intended Use and Consumer: ____________________________
				  Signature: _____________________________
Method of Storage and Distribution: _________________________
				  Date:
MILK AND MILK PRODUCT VAT (BATCH) PASTEURIZATION---CCP
				  MODEL HACCP PLAN SUMMARY
Critical Control Point
								(CCP)
Hazard(s)
Critical Limits
Monitoring
Corrective
								Action(s)
CCP
								Verification*
Records
What
How
Frequency
Who
Milk and Milk Products Pasteurization (Vat)
Biological-Vegetative Pathogens (non-spore
								formers)
Time and Temperature
Time and temperatures (in a vat that is
								continuously agitated to assure that there is no more than 1°F (0.5°C)
								difference between the warmest and the coldest product in the vat during
								processing) including minimum required time, product temperature and air space
								temperatures.
Temp. Recorder Chart
Continuous during Operation
Pasteurizer Operator
During Pasteurization:
Continue pasteurization until the time/ temperature
								criteria have been met. If the time/ temperature criteria cannot be met in two
								(2) hours, an evaluation needs to be made as to the disposition of the
								product.
After Pasteurization (i.e., during the record
								review):
If the product is found not to have met the critical
								time/temperature, place all affected finished product on hold, and evaluate to
								determine product distribution, i.e., reprocess or destroy.
Record Review:
Pasteurizer charts verified
Equipment Function Checks:
Operator performs required observation of
								indicating and airspace thermometers for each batch (air space checked at both
								the beginning and the end of the holding time) and recorded on the
								chart.
Authorized plant person (supervised by regulatory
								when required) conducts checks listed in the
Milk Plant Equipment Test
								Report
(FDA Form 2359b).
Seals:
Verify required regulatory
								seals daily if applicable
Pasteurizer Charts
Corrective Action Records
CCP Verification Records, including equipment
								testing records
*Every particle of milk or milk product is heated, in a
				  properly designed, calibrated and operated pasteurizer, to one of the
				  temperature and time combinations specified in the current
Grade "A"
				  PMO
.
Product Description:
_______________________
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IX.
ACCEPTED PROCESS FOR THE CREATION OF PASTEURIZED
				  EQUIVALENT WATER
UV LIGHT DISINFECTION OF WATER BACKGROUND
UV light between 2000-4000 Angstrom (200-400 nanometers) is
				  well known for inactivating pathogenic microorganisms in water via several
				  mechanisms, including the formation of deoxyribonucleic acid (DNA) bonds
				  (dimers) that inhibit reproduction and infectivity. Different microbes have
				  different responses to specific wavelengths which also can account for
				  differences in overall dose requirements. Some microbes can use their own
				  enzymes and mechanisms, or take advantage of host cell enzymes to repair the
				  damaged DNA, requiring higher doses of UV to cause irrevocable damage and
				  effective pasteurization-level disinfection.
Three (3) critical factors determine a UV unit's ability to
				  reliably achieve the necessary dose at any point in time: The tranmissivity of
				  the water to UV light, the performance of the lamps, and the hydraulics and
				  rate of the flow in the disinfection chamber. Color, turbidity, particles, and
				  organic impurities can interfere with the transmission of UV energy and lower
				  the disinfection efficiency below levels required to ensure destruction of
				  pathogenic organisms. Similarly, lamps can age unevenly and water can foul the
				  protective sleeves and prevent light from reaching some pathogens. Hydraulic
				  patterns or flow that is too high or too low can cause uneven distribution of
				  the dose and leave some areas without adequate disinfection.
Other important factors include the geometric configuration
				  of the reactor, the power, wavelength, and physical arrangement of the UV
				  lamps, and the UV path length. Longer path lengths provide more opportunities
				  for UV photon-microbe interaction and inactivation.
UV lamps treat water instantaneously while it is flowing
				  through the disinfection chamber but do not provide residual bactericidal
				  action. Using UV light for pasteurized equivalent water is not a substitute for
				  appropriate maintenance, periodic flushing, and sanitizing of the water
				  distribution system inside the plant.
CRITERIA
The following is a list of criteria that is required to
				  accept water treated with UV light to be considered equivalent to pasteurized
				  water:
1. UV light shall be applied so that the entire volume of
				  water receives at least the following dose when used as pasteurized
				  water.
a. Low pressure UV at 2,537 Angstrom (254 nanometers) at
				  186,000 microwatt-seconds per square centimeter or a 4-log adenovirus
				  equivalent.
b. Medium pressure UV at 120,000 microwatt-seconds per square
				  centimeter or a 4-log adenovirus equivalent.
2. A flow or time delay mechanism shall be provided so that
				  all water moving past the flow stop or divert valve receives the minimum dose
				  required above.
3. The unit shall be designed to permit the frequent cleaning
				  of the system without disassembly of the unit and shall be cleaned often enough
				  to ensure that the system will provide the required dose at all times.
4. An automatic flow control valve accurate within the
				  expected pressure range shall be installed to restrict flow to the maximum
				  design flow of the treatment unit so that all particles receive the minimum
				  dose listed above.
5. An accurately calibrated UV intensity sensor properly
				  filtered to restrict its sensitivity to the 2,500-2,800 Angstrom (250-280
				  nanometers) germicidal spectrum shall measure the UV energy from the
				  lamps.
6. There shall be one (1) sensor for each UV lamp.
7. The light shall adjust based on water quality measured
				  with a real time UVT analyzer to assure that the dose is always calculated
				  accurately and provided reliably.
8. A flow diversion valve or automatic shut-off valve shall
				  be installed which shall permit flow into the pasteurized product lines only
				  when at least the required UV dosage is applied. When power is not being
				  supplied to the unit, the valve should be in a closed (fail-safe) position
				  which prevents the flow of water into the pasteurized product lines.
9. The materials of construction shall not impart toxic
				  materials into the water either as a result of the presence of toxic
				  constituents in materials of construction or as a result of physical or
				  chemical changes resulting from exposure to UV energy.
10. The unit shall record the operating parameters (flow,
				  UVT, and dose) on a real time basis. These records shall be accessible to the
				  Health Officer for inspection. Electronically generated records, if used, shall
				  meet the criteria specified in Appendix H and V.
Author:
G. M. Gallaspy, Jr.
Statutory Authority:
Code of Ala. 1975, §
											22-2-2 and §
											22-20-7.