Chapter 11 - H.T.S.T.

Pasteurization Tasks
Dairy Establishment Inspection Manual
HTST System Flow Task 1.11.01.01 Up-To-Date and Accurate (HS=3) Inspection Criteria A. Flow schematic Available; easily accessible Complete o all HTST components Accurate; up-to-date A. HTST system free of cross-connections between: For acceptable segregation between raw and pasteurized products o refer to the specific requirements in Chapter 11 For other applications (i.e. washes or Amini-washes@ while connected to product lines) o refer to Appendix 19 - 10 for assessment of applications B. HTST actual piping verified with schematic

1.11.01.02 No CrossConnections (HS=1)

Critical Control Records 1 Task 1.11.02.01 Temperature and Time Requirements (HS=2) Inspection Criteria A. A representative sampling of plant's records must be assessed Complete records for all products processed Minimum holding time and minimum temperature required must be met. See text for pasteurization requirements

Critical Control Records 2 Task 1.11.02.02 Process Control Records (HS=2) Inspection Criteria A. A representative sampling of plant's records must be assessed STLR processing records provide the following permanent data on every 12 hour chart: o plant name and address or registration number o date, shift and batch number where applicable o STLR identification when more than one is used o product type and amount of product processed o identification of CIP cleaning cycles, including Amini-wash@ cycles o reading of indicating thermometer during processing. This reading must never be lower than recording thermometer reading o cut-in/cut-out temperatures at the beginning of production and when a new divert temperature is selected (for production runs of > 12 hours a new cut-in/cut-out is not required when the chart is changed) o record of time the flow diversion device is in the forward flow position o unusual occurrences (include reason and time of occurrence) o signature or initials of the operator Meter Based Timing System flow records provide the following information on every 12 hour record: (if applicable) o plant name and address or registration number o date o pasteurizer number o product processed o movement between forward and divert flow o synchronized time with STLR chart o frequency or event pen information o signature or initials of the operator o unusual occurrences No overlapping of recordings Record is replaced daily Satisfactory follow up for out of specification findings and documentation of actions taken A. Time-frame Minimum of one year period As determined by responsible regulatory agency; or Until the finished product has been consumed (if more than one year) Constant Level Tank 2

1.11.02.03 Retention of Process Control Records (HS=3)

Task 1.11.03.01 General Conditions (HS=3)

Inspection Criteria A. General Inspection Criteria for Dairy Plant Equipment B. Specific Areas of Interest Stainless steel construction Clean and good condition A. Requirements Air shall not be drawn in pasteurizer when operating at maximum capacity of FCD o Raw product to drain to the outlet before the outlet becomes uncovered. Could be accomplished by: o bottom of the tank sloped by at least 2% to the outlet o top of the outlet pipe is lower than the lowest point in the tank

1.11.03.02 Design (HS=2)

1.11.03.03 Cover (HS=3)

A. Requirements Removable o independent cover; or o inspection port All openings flanged upwards and covered Sanitary umbrella deflector on pipelines (excluding directly clamped lines) that enter through the cover Used during processing A. Overflow Point Lower than the lowest point of raw regenerator Satisfactory type o rim of the tank; or o top of outlet (below the rim) Diameter at least twice that of the largest raw product inlet pipe A. Leak detect, divert, CIP line/spray ball, water and milk recycle lines Terminate and break to atmosphere Break must be at least two pipe diameters of the largest return line above maximum overflow point A. Requirements Automatic device Sanitary design and construction

1.11.03.04 Overflow Point/Diameter (HS=2)

1.11.03.05 Airspace (HS=2)

1.11.03.06 Level Control Device (HS=3)

Booster Pump Task 1.11.04.01 General Conditions (HS=3) Inspection Criteria A. Requirements Clean and in good condition Centrifugal type Entrapment of the product in the by-pass line is precluded by: o close coupled by-pass connections, or o design of the valve permitting slight movement of the product through the bypass line, or o other equally effective system No interference of by-pass valve with free draining of raw regenerator to CLT o fail safe, normally open position during divert A. Requirements Located between the CLT and inlet of raw regenerator A. Requirements Only operates when o FCD is operating o proper pressure differential is achieved in the regeneration section o FDD is in forward flow (both divert and leak detect valve in forward flow) Tested upon installation and at least every 6 months thereafter, and when changes occur o appropriate records of testing on file

1.11.04.02 Location (HS=2) 1.11.04.03 Interwiring (HS=2)

Regeneration Task 1.11.05.01 General Conditions (HS=2) Inspection Criteria A. Heat Transfer Plates Stainless steel or other corrosion resistant material Sanitary design Clean and good condition o no visible pinholes o equipped with leakage grooves o gaskets in good condition (not compressed or show signs of wear) o no leaks at plate gaskets during operation o no milk remnants, milkstone or foreign particles Plant records to indicate annual pinhole testing or more often if required to ensure integrity o document the cause of failure (e.g. age compression, metal fatigue), action taken to correct failure, plate replacement A. Design Raw product inlet at the lowest point of regenerator o second regenerators of dual regenerator systems many hae inlet at top or bottom Drain holes (at least 1.59 mm or 0.0625") drilled in deflector plates (if present). o If deflector plates are back to back the upstream drain hole is large enough to allow for CIP cleaning Free draining to CLT o no valves or pumps that block the flow to CLT o provision for free draining pathway from the second stage regenerator during shutdown (applicable to two stage regenerators) A. Operation (System with booster pump) Pressure on the raw side of the regenerator must always be lower by 14 kPa (2 p.s.i.) than pasteurized side as confirmed by PDC B. System without booster pump Appopriate system layout C. Milk-to-heat transfer medium-to-milk type regenerators Pressure on the raw side/media side of the regenerator must always be lower by 14 kPa (2 p.s.i.) than the pasteurized side as confirmed by a PDC

1.11.05.02 Shutdown Capability (HS=2)

1.11.05.03 Pressure Differentials (HS=2)

Flow Control Device (FCD) Task 1.11.06.01 General Conditions (HS=2) Inspection Criteria A. Design Proper type of system o positive pump or o homogenizer or o Meter Based Timing System B. Condition Stainless steel or other corrosion resistant material Clean and in good condition C. Location Upstream from holding tube D. Operation Cannot be excluded from the system during operation No back-flow through FCD in the event of a system shutdown Mechanical wear will not increase capacity (flow rate) 1.11.06.02 Set and Sealed (HS=1) A. Procedure Set at legal holding time obtained at the fastest flow rate with no back pressure i.e. o all appropriate components sealed, ie. pumps, belts o at the maximum operating capacity o with separators by-passed o zero-valve pressure on the homogenizer o vacuum equipment operating at maximum vacuum if it is downstream of Flow Diversion Device (FDD) Sealed at fastest flow rate giving legal hold time Checked upon installation and annually thereafter o appropriate records of testing on file Re-evaluated and re-sealed (if necessary) after any alterations or repairs. Refer to the written text for the exception for when belts are replaced. B. Records Accurate and complete o include information of all alterations or repairs Available

Flow Control Device (FCD) Task 1.11.06.03 Fail Safe (Operation) Capability (HS=2) Inspection Criteria A. General Conditions Inter-wired properly with FDD and Safety Thermal Limit Recorder (STLR) micro-switches o FCD only operates when FDD is in safe forward or fully diverted position Time delay relay (if present) o not more than 1 sec No by-pass line during processing Evaluated upon installation, at least every 6 months thereafter and whenever micro-switch is re-set or replaced o appropriate records of testing on file B. Homogenizer Used as FCD No by-pass line during processing C. Meter Based Timing System used as FCD Must have appropriate controls (See Appendix 19 - 4) o High flow alarm: divert flow occurs when flow rate is higher than the value at which holding time was measured o Low flow/Signal loss alarm: divert flow occurs upon low flow or signal loss o Flow cut-in and cut-out checked and recorded o Alarm pen tracks with flow recorder pen o Interwired with FDD to diver during alarm conditions Evaluated upon installation, at least every 6 months thereafter and when alterations occur o appropriate records of testing on file

Heating/Cooling Task 1.11.07.01 General Conditions - Heating (HS=2) Inspection Criteria A. Heat Transfer Plates Stainless steel or other corrosion resistant material Sanitary Design Clean and good condition o no visible pinholes o gaskets equipped with leakage grooves and in good condition (not compressed or show signs of wear) o no leaks at plate gaskets during operation o no excessive mineral scale on "medium" side o no gasket particles and other foreign debris Plant records to indicate annual pinhole testing or more often if required to ensure integrity o document the cause of failure (e.g. age, compression, metal fatigue), action taken to correct failure, plate replacement A. Quality Culinary steam/hot water Boiler chemicals/additives must be dairy safe and approved Appropriate follow-up documented A. Heat Transfer Plates Stainless steel or other corrosion resistant material Sanitary Design Clean and good condition o no visible pinholes o gaskets equipped with leakage grooves and in good condition (not compressed or show signs of wear) o no leaks at plate gaskets during operation o no excessive mineral scale on "medium" side o no gasket particles and other foreign debris Plant records to indicate annual pinhole testing or more often if required to ensure integrity o document the cause of failure (e.g. age, compression, metal fatigue), action taken to correct failure, plate replacement A. Cooling Medium Pressure Monitored Must be at least 14 kPa (2 p.s.i.) less than product pressure during forward flow. During diverted flow and shut down conditions, higher pressure is maintained on the pasteurized product side Checked daily and recorded 8

1.11.07.02 Heating Medium HS=3)

1.11.07.03 General Conditions - Cooling (HS=2)

1.11.07.04 Pressure Differentials Cooling (HS=2)

Task

Inspection Criteria Requires either an automated mechanism or written program If automated mechanism must meet the following: o cooling medium stopped or diverted and the cooling medium side vented to atmosphere: during forward flow, when the product pressure on the pasteurized product side drops to within 2 psi of the cooling medium side of the plates and during diverted flow and shutdown conditions. o If product vacuum breaker is in use, venting of medium side shall be at an elevation below that of the product vacuum breaker o demonstrate to regulatory authority If there is no automated mechanism, establishment has a written program which includes the following: o person responsible, what is done, how it is done, frequency, records to be kept and results of monitoring, verification procedures, actions taken for deviant situations, parameters of acceptability/unacceptability, preventative measures. o records of pressures recorded a minimum of twice a day during production (at beginning and end of run). o microbial cooling media checks of at least once per week per week o pH testing of cooling media at least once a week o visual cooling media checks at least once per week o pinhole testing and plate teardowns once every six months o plate replacement program.

1.11.07.05 Cooling Medium (HS=3)

A. Quality Cooling media checked at least monthly for microorganisms (e.g. psychrotrophs, coliforms (or at least once per week depending upon establishment controls) Cooling medium chemicals/additives must be dairy safe and approved Records of cooling water additives and cooling media products used and microbial testing results Appropriate follow-up documented

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Holding Task 1.11.08.01 General Conditions (HS=3) Inspection Criteria A. Holding Tube and Sensing Chamber Clean and in good condition Installed in correct location o after FCD with no intervening flow promoters o after heating section o prior to FDD No portion of tube can be left out Free of external heat source If insulated, insulation must be easily removed to allow for proper inspection of the holding tubes A. Holding Tube Continuous 2% upwards slope (including elbows) Permanent support A. Fitting(s) Equipped with necessary fitting(s) for checking Holding time by salt conductivity test or acceptable alternative Fittings located at: o the beginning (at the lowest point) of holding tube and sensing chamber or an alternate fitting(s) upstream of FDD A. Records Evidence of holding time by salt conductivity test Test conducted in both divert and forward flow (except when magnetic flow meter systems are used) Test results converted to holding time for all products processed B. Frequency Upon installation, annually or after any change made to system Refer to the written text for the exception for when belts are replaced. 1.11.08.05 Sensing Chamber (HS=3) A. Requirements Maintains slope of holding tube Indicator thermometer sensor and STLR hot milk temperature sensor in close proximity

1.11.08.02 Slope and Support (HS=2) 1.11.08.03 Holding Time Provisions (HS=3)

1.11.08.04 Holding Verification and Records (HS=2)

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Task 1.11.08.06 Extended Hold (HS=2)

Inspection Criteria A. Conditions Extension connection be close coupled Extended hold line cleaned and sanitized regularly o records available Extended hold cycle scheduled at the end of production day or system rinsed before production run on short hold cycle If upstream of FDD: o records available o hold must have a continuous upward slope of at least 2% o if a two speed FCD used and extended hold used as legal hold, interwiring must ensure legal hold met (see explanation)

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Flow Diversion Device (FDD) Task 1.11.09.01 General Conditions (HS=2) Inspection Criteria A. Flow Diversion Device and Return Lines Appropriate design Clean and in good condition o plunger seals o valves and "O" rings o valve stem moves with ease Clean and unrestricted air supply Proper control panel o free of any device or switches that may jeopardize the safety of the pasteurized product Non-adjustable valve stem length o locking pin present, if necessary No quick release couplings on air lines if external solenoids Evaluated upon installation and at least every 6 months thereafter with appropriate records kept A. Requirements Separate free draining divert line to the CLT o free of any valves o identifiable and cleanable restrictor permitted to ensure sufficient holding in divert flow

1.11.09.02 Divert Line (HS=2)

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Task 1.11.09.03 Leak Detect Capabilities (HS=2)

Inspection Criteria A. Single Stem FDD Properly functioning and unobstructed leak detect ports B. Dual stem FDD Separate unrestricted free draining leak detect line to CLT or acceptable receptacle Sight "glass" on leak detect line o vertical position o clear (no etching or cloudy)

1.11.09.04 Location (HS=2) 1.11.09.05 Fail Safe Divert Capability (HS=1)

A. Requirements Installed at highest point (end) of holding tube after the sensing chamber A. Divert Conditions Valve response time from forward flow to divert not exceed 1 sec Assumes divert at sub-legal temperature Assumes divert at loss of electrical power, or air supply B. Inter-wiring Interwired with FCD. FCD and flow promoters to operate only when FDD is in safe forward flow or fully diverted position. C. Records Available; easily accessible Tests performed upon installation and at least every 6 months thereafter or as required o appropriate records kept Satisfactory follow up on out of specification findings and documentation of actions taken

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Task 1.11.09.06 Time Delay Relays (HS=2)

Inspection Criteria A. Dual Stem FDD 1) General 1 second minimum flush time between the two valve stems (maximum 3 seconds where applicable) Tests performed upon installation, at least once every 6 months and when seal on the time delay relays are broken and records kept 2) From PRODUCT to INSPECT Mode FDD immediately diverts and all flow promoters (includes FCD) run down or are valved out. 3) From PRODUCT to CIP Mode For a system where flow promoters (includes FCD) not operating during CIP o FDD immediately diverts and remains diverted until flow promoters (includes FCD) have stopped or are valved out o FDD then controlled by CIP mode For a system where flow promoters (includes FCD) are operating during CIP o FDD immediately diverts at least 10 minutes o no pressure on regeneration during divert (e.g. booster pump stopped) o FDD then controlled by CIP mode o refer to Appendix 19 - 10 for prevention of chemical contamination during miniwash B. Meter Based Timing System as FCD Diverts on high flow or low flow (above high set point or below low set point) After safe flow established, minimum legal hold time delay before forward flow Tests performed upon installation, at least once every 6 months, whenever seal on the flow alarm is broken and if changes occur and records are kept

1.11.09.07 Device Sealed (HS=2)

A. Requirements Device must be sealed appropriately o solenoids, time delay relays and critical microswitches

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Task 1.11.10.01 General Conditions (HS=2)

Inspection Criteria A. Requirements Clean and in good condition 1) Mercury Type Direct reading No column splitting Easy to read Contained in corrosion resistant case 2) Resistance Temperature Devices (RTD) Utilizing two separate RTD and verifying each other Meets the design requirements in Appendix 19 -13 A. Requirements Located in the temperature sensing chamber Easily accessible A. Requirements Column width magnified to an apparent width of at least 1.6 mm (0.0625") Scale span of at least 14C (25F) including pasteurization temperature +/- 3C (5F) Graduated in 0.25C (0.5F) divisions with not more than 4C (8F) per 25 mm (1") span Protected against damage at 105C (220F) No stem fitting threads exposed to product At least 76 mm (3") from product contact surface of ferrule to sensing area of bulb same unit of measure as the recording thermometer A. Calibration Temperature accuracy Thermometric response Frequency of calibration (upon installation and at least once every 6 months) Tests completed according to required methods and standards B. Records Available; easily accessible Satisfactory follow up on out of specification findings and documentation of actions taken o product safety assessment required

1.11.10.02 Location/ Accessibility (HS=2) 1.11.10.03 Specifications (HS=2)

1.11.10.04 Calibration/ Records (HS=1)

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Safety Thermal Limit Recorder (STLR) Task 1.11.11.01 General Conditions (HS=3) Inspection Criteria A. Requirements Good mechanical and sanitary condition Proper design o meets requirements of appropriate agency or 3A requirements o moisture proof case o electrically operated Records and frequency of servicing (at least once a year) Absence of unidentified/unauthorized switches or devices that may jeopardize the safety of product Covers in place Flow indicating lights (green for forward and red for divert) operating Cut in/cut out independent of temperature recording arm movement. Probe o protected against damage at 105oC (220oF) o no stem fitting threads exposed to product o at least 76 mm (3 inches) from product contact surface of ferrule to sensing area of bulb A. Set Points Single set point o At the highest product temperature Multiple set points o diversion control capability for all products run (tested upon installation and once every 6 months thereafter) o set point indicator B. Pasteurized and Unpasteurized Products Dual temperature divert switch Pasteurized product processed first Entire HTST system washed and sanitized prior to pasteurized product processing A. Requirements Legal cut-in/cut-out temperature set Inaccessible mechanism for altering cut-in/cut-out temperature B. Operation Cut-in and cut-out checked and recorded daily at 17

1.11.11.02 Diversion Capabilities (HS=2)

1.11.11.03 Cut In/Cut Out (HS=1)

Task

Inspection Criteria start up and when new set-point selected (see the left page written text for definition of additional scenarios when cut-in and cut-out is required)

1.11.11.04 Pens (HS=2)

A. Temperature Recording Pen Easily accessible adjustment screw Functional (checked daily) Thickness of pen not > 0.7 mm (0.025") B. Frequency Pen Functional (checked daily) Thickness of pen not > 0.7 mm (0.025") Tracks with temperature recording pen or follow the same time line C. Third Pen Present on dual/multiple diversion STLR includes pasteurized/heat treated milk STLR Different colour ink

1.11.11.05 Charts (HS=3)

A. Design Positive drive mechanism equipped with a system to prevent slippage Proper charts o correspond with chart # displayed on identification plate of STLR o circular charts graduated for 12 hours maximum Appropriate chart scale span, graduations and time scale divisions o chart span at least 17C (30F), including diversion set point +/- 7C (12F) o graduated in 0.5C (1F) scale divisions spaced at least 1.6 mm (0.0625) apart at the diversion temperature +/- 0.5C (1F), unless ink line is thin enough to distinguish from chart line, then spacing can be 1 mm (0.040 inch) apart o time scale divisions not more than 15 minutes, spaced at least 6.3 mm (0.25") apart at the diversion temperature +/- 0.5C (1F) Same unit of measure as the indication thermometer Tests performed upon installation and once a year thereafter and appropriate records kept B. Chart speed Circular chart to rotate one revolution in not more 18

Task

Inspection Criteria than 12 hours

1.11.11.06 Accuracy (HS=2)

A. Records 1) General Available; easily accessible Tests performed upon installation, at least annually or as required Satisfactory follow up on out of specification findings and documentation of actions taken 2) Required Tests and Accuracy Temperature accuracy o shall be accurate within +/- 0.5C (1F) at divert temperature set point +/- 3C (5F) Time accuracy o recorded time shall not exceed true elapsed time Recording thermometer check against indicating thermometer o recording thermometer not higher than indicating thermometer Thermometric response o shall not exceed 5 seconds A. Requirements Must be sealed o including electrical contact point type A. Installation Micro-processor controlled outputs o shall not circumvent any operation of Public Health Controls (e.g. booster pump, FCD, FDD etc.) when FDD mode switch is in process position o maybe implemented to operate Public Health Controls (e.g. booster pump, FCD, FDD, etc) when FDD mode switch is at CIP position after the 10 minute time delay. o maybe implemented to operate other components (e.g. regenerator by-pass valves, pasteurized product regenerator back pressure valves, hot water set controls, recycle valves, CLT controls, cold milk temperature controls, MBTS product flow controls, heating and cooling medium controls etc.) under all operating conditions B. Testing 19

1.11.11.07 Sealed (HS=2) 1.11.11.08 Programmable Logic Controllers and Computers (HS=1)

Task

Inspection Criteria Test procedures used to confirm proper operation of all required public health controls shall be available. An example of test procedure is outlined in Appendix 19 - 5

C. Documentation Complete and accurate documentation of interconnecting wiring, air piping and applicable programs must be available Microprocessor logic defined by program listings and descriptive narrative text D. Access sealed (All) Microprocessor access ports, modem ports and input/output terminals must be sealed to prevent unauthorized changes or tampering. The control panel holding the solenoids for the divert valves must be sealed A reliable third party may connect remotely to the PLC to repair something in the system providing it is not a permanent connection and there is documentation showing date of entry, purpose of reprogramming, who did it, who verified repair, seal breakage, re-sealing and new seal number

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Pressure Differential Controllers (PDC) /Gauges Task 1.11.12.01 General Conditions (HS=3) Inspection Criteria A. Pressure Differential Controllers Sensors clean and in good mechanical condition Proper design o easy dismantling of sensors for inspection o indicating section housed in appropriate control panel o it is considered acceptable to use a legal PLC to control the pressure differential. B. Gauges Clean and in good condition Accurate and calibrated Only applicable between raw and pasteurized product when no booster pump used 1.11.12.02 Location (HS=2) A. Regenerator - HTST System With Booster Pump Requires PDC Interwired with booster pump Raw product sensor between the booster pump and the raw product inlet to the regenerator Pasteurized product sensor at, or downstream from, pasteurized product outlet of regenerator Split regenerator o each section is monitored and controlled by its own pressure differential controller B. Cooling Sensors at the cooled milk outlet and cooling fluid inlet or other acceptable location A. Pressure Differential Controller Procedures established to regularly test (upon installation and at least once every 6 months) B. Gauges Checked for accuracy at least every 6 months A. Pressure Differential Controller Must be sealed A. Accuracy Available; easily accessible Satisfactory follow up on out of specification findings and documentation of action taken

1.11.12.03 Accuracy (HS=2)

1.11.12.04 Sealed (HS=2) 1.11.12.05 Records (HS=2)

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Recording Thermometer Task 1.11.13.01 General Conditions (HS=3) Inspection Criteria A. Requirements Clean and in good condition Protected against damage at 105C (220F) Moisture proof Positive drive mechanism equipped with a system to prevent slippage of chart Equipped to produce a continuous permanent record of all pertinent information (i.e. time of day and temperature) Thermometer scale graduated in units not greater than 1C (2F) Accuracy +/- 0.5C (1F) Records and frequency of servicing (at least once a year) Pasteurized Product Discharge Task 1.11.14.01 Elevation (HS=2) 1.11.14.02 Vacuum Break (HS=2) 1.11.14.03 Vacuum Breaker (HS=2) Inspection Criteria A. Pasteurized Product Discharge Piping At least 30 cm (12") above the highest potential raw product elevation A. At end of discharge piping at highest point, a break to atmosphere No restrictions (e.g. valves, pumps etc.) A. Equipment Clean and in good condition Functions in operation o plunger or core moves freely Installed in a manner so that the air intake is not a source of contamination (See text for further explanation).

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Homogenizer Task 1.11.15.01 General Conditions (HS=3) Inspection Criteria A. General Inspection Criteria for Dairy Plant Equipment B. Specific Areas of Interest Stainless steel product contact surfaces Clean and in good condition o filters o homogenizer valves o pistons o seat valves o pressure gauges Appropriate gauges A. Homogenizer Downstream of FCD; Greater Capacity Recirculation line o unrestricted o between inlet and outlet of homogenizer o no shut-off valve o check-valve allowed o diameter greater or equal to supply A. Homogenizer Downstream of FCD; Less Capacity Installed upstream of FDD Sanitary pressure relief line o runs from inlet side of homogenizer back to CLT o have a pressure relief valve A. Homogenizer of Lesser Capacity than FCD: Operates only when FCD engaged Equipped with a time delay relay of 1 sec Tests performed upon installation, at least once every 6 months or when micro-switch re-set or replaced and records kept

1.11.15.02 Recirculation Line (HS=2)

1.11.15.03 Relief Line (HS=3)

1.11.15.04 Interwiring (HS=2)

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Separator/Clarifier Task 1.11.16.01 General Conditions (HS=3) Inspection Criteria A. General Inspection Criteria for Dairy Plant Equipment B. Specific Areas of Interest Clean and in good condition o bowl o discs o disc covers A. Options Upstream of FDD o upstream of any FCD Downstream of FDD A. Conditions Non-flow promoting device whenever FCD is not operating o could be achieved by fail safe valving out o (by-passing) the separator o normally closed valve located downstream of product o Test performed upon installation, at least once every 6 months and when micro-switch is reset or replaced and records kept A. Separator/Clarifier Downstream from FDD Vacuum breaker at the inlet to the separator o no restrictions (e.g. valves, pumps etc.)

1.11.16.02 Location (HS=2)

1.11.16.03 Non-Flow Promoting (HS=2)

1.11.16.04 Vacuum Break (HS=2)

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Flavour Adjusting Equipment (FAE) Task 1.11.17.01 General Conditions (HS=3) Inspection Criteria A. General Inspection Criteria for Dairy Plant Equipment B. Specific Areas of Interest Installed and operated in conjunction with HTST provided FAE will not o interfere with the detection of, or stoppage of, the forward flow of unpasteurized milk o influence the proper pressure relationship within the regenerator o reduce the holding time below required minimum o contaminate and adulterate the product A. Culinary Steam Used Downstream from the FDD Steam added only when FDD is in forward flow automatic steam control valve, or automatic solenoid shut off valve B. Water Feed Line Used No back-up and overflow of water and/or condensate from vacuum condenser into product vacuum chamber o automatic safety shut off valve and o high level sensing device in condenser C. FAE Downstream from FDD No back-up and overflow of water and/or condensate from vacuum condenser into product vacuum chamber No negative pressure A normally closed shut-of valve o downstream from vacuum breaker Both installed in line between FDD and inlet to vacuum chamber o directly downstream from FDD No lowering of pasteurized milk level in the regenerator during divert or shut down Automatic check valve or positive type shut-off valve and Vacuum breaker o downstream from valve Both installed in line between outlet from downstream vacuum chamber and pasteurized milk inlet to regenerator

1.11.17.02 Properly Valved Out (HS=2)

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Task 1.11.17.03 Steam Ratio Control (HS=3)

Inspection Criteria A. Culinary Steam Introduced into Product 1) Automatic Ratio Controller Sensors o outlet of FDD (prior to steam addition) o in vacuum chamber or its exit Automatically adjusts operating vacuum in vacuum chamber 2) Any other system which precludes adulteration

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Stuffing Pump/Flow Promoting Devices Task Inspection Criteria

1.11.18.01 General Conditions (HS=3)

A. General Inspection Criteria for Dairy Plant Equipment B. Specific Areas of Interest Clean and in good condition o impellers o back plates Painted exterior o clean o free of flaking paint and rust A. Requirements No interference with the draining of the system when the system shuts down Interwired so that the pump or devices shut(s) off when system shuts down or when FDD causes the FCD to shut down o Test performed upon installation, at least once every 6 months and when micro-switch is reset or replaced and records kept Not influence the proper pressure relationship within the regeneration section Not reduce the holding time below the required minimum

1.11.18.02 Proper Installation/ Operation (HS=2)

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Supplementary Milk Solids/Milk Fat Injection System (In-Line Standardization) Task 1.11.19.01 General Conditions (HS=3) Inspection Criteria A. General Inspection Criteria for Dairy Plant Equipment B. Specific Areas of Interest Clean and in good condition Stainless steel product contact surfaces Positive displacement pump or centrifugal pump with a MBTS A. Requirements Pasteurization holding time is not reduced below the required minimum. Composition (fat, solids) cheesemilk does not affect the minimum pasteurization time and temperature requirement as per 1.11.02.02 Proper pressure differential maintained within the regeneration section. System freely drains should the system shut down. Not interfere with the detection, or stoppage of forward flow of unpasteurized milk. B. Injection Location Directly into CLT, or Between CLT and FCD o injection point between outlet of last raw regeneration section and FCD o proper check valve installed upstream of injection point o flow rate not greater than FCD o proper design of injection valve: fail safe, springto-close, air-to-open, block and bleed design with full port open to atmosphere between the HTST isolation seat and pump when solids/milk fat not being injected C. Interwired or equivalent system to not operate when: FCD is not in operation FDD is in divert mode or the system is in recycle mode FDD is in inspect mode If the system is controlled by computers or programmable logic controllers they must meet the requirements of 1.11.11.08. Tests performed upon installation, at least once every 6 months and when micro-switch is re-set or replaced and records kept

1.11.19.02 Proper Installation/ Operation (HS=2)

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