Module 14.

Aseptic Processing
and Packaging Systems
Thermal Processing for Meat and
Poultry Products Training

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Aseptic Processing Inspection

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Different from Traditional Canning
PA must ensure commercial sterility not only for
product but also:
 Product sterilization system (hold tube) and all
downstream equipment including the filler
 Packaging equipment; and
 Packaging materials

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System Pre-Sterilization
 Processing Equipment
 Steam or hot water under pressure
 Packaging Equipment and Materials
 Saturated Steam
 Superheated Steam
 Hydrogen peroxide and heat
 Other treatments
 Validated by placing resistant microbial spores on
adhesive strips

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Scheduled Proces,ses

 Product
 Product “sterile zones”
 hold tube downstream
 Packaging system
 Packaging materials

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Equipment and Controls
 Formulation controls
 Starches, particle size, rehydration
 Metering (timing) pump
 Fixed or variable speed
 Flow meter (flow control must be validated)
 Flow rate affects residence time in hold tube
 System design, pumping rates, and product
characteristics (formulation) affect flow rate

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Equipment and Controls
 Process Authority determines and calculates
residence time of the fastest moving particle
 Processor monitors specified flow rate
 Pump speed correlated to flow rate (indirect)
 Count pump strokes per time period
 Tachometer
 Flow meters (direct)
 Gallons per minute
 Containers per set time interval

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Direct Product Heating Systems

 Steam Injection • Steam Infusion

Product Inlet

Figure 2 - Steam Infusion

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Indirect Product Heating Systems

 Plate Heat
Exchanger
~-
"-~-- ~ - C . / • • ·.:~• • • ,

.,

 Tubular Heat Product

-
Exchanger
Inlet
Steam Inlet ,
-::z:f:l
--+
, 1 - - . l L_ _..l,;l~~~ Steam
Outlet

Figure 4 - Tubular Heat Exchanger

 Scraped Surface
Heat Exchanger

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Equipment and Controls

 Hold tube
 Sloped upward at least
0.25”/foot
 Diameter, length, and
slope conform to tested
 No portion of the tube
is heated (can be
insulated)

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Equipment and Controls

 Temperature Indicating Device

 Must meet requirements
 Checked for accuracy
• upon installation and at least once per
year
 Calibration records
 Bulb in vicinity of recorder
TE
 Recorder
 Accurate
 If air actuated, clean air supply
(filter maintenance)
 Bulb located at the exit end of the
hold tube

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Equipment and Controls
 Flow diversion system
 Location
 Automatic flow diversion parameters
• Temperature drop
• Pressure drop in product to product regenerator
 Manual flow diversion notification system

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Equipment and Controls
 Product to product regenerators
 Pressure of sterilized product greater than the
pressure on any unsterilized product
 Differential Pressure Recorder-Controller Sensors
• Sterilized product outlet (highest pressure)
• Unsterilized product inlet (lowest pressure)
• Tested for accuracy

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 Backpressure Device

 Valves, orifices, or pumps may be used to

assure that pressure prevents flashing of
product in hold tube.

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Product Heating Control Systems
 Manually operated systems rely on review of
production logs and recording charts to verify
process schedule was delivered
 Automated systems prevent packaging non-
sterile product
 Routinely challenge system to verify function
 Review recent challenge and calibration records
including testing method, frequency of testing, and
who performs the test

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Verifying Operations
 Start-Up Verification
 Follow scheduled process
 Monitor temperature at coldest point downstream
of the hold tube
 Determine how the establishment prevents
deviations during switch-over from water to
product

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Verifying Operations
 Operating Records
 Temperature Indicating Device at end of hold tube
 Temperature Recording Device at end of hold tube
 Temperature Recorder-Controller at final heater outlet
 Regenerator differential pressure record
 Product flow rate
 Surge tank sterile air overpressure
 Performance of steam seals
 Pre-sterilization records

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Possible 1
Process Deviations
 Temperature drop in hold tube
 Loss of differential pressure in regenerator
 Loss of sterile air pressure or other protection
in the surge tank
 Loss of sterile air/gas to sterile zones
 Critical factors in PS outside specification
 Speed of variable speed pump too high

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Cleaning and Reprocessing
Following a Deviation
 Written procedures for cleaning and re-
sterilizing the system
 If re-sterilization procedure differs from
startup, verify the procedure is from a PA
 Verify

 Establishment documents clean-up

 System is returned to commercial sterility
 Disposition of suspect product already filled into
containers.

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Reprocessing
 Previously processed product may exhibit
different flow characteristics (starch/binders)
 Verify whether affected lots are to be
reprocessed separately, together, or blended
with new product

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Package Sterilization Systems
 Cans and lids: super heated steam
 Webfed paperboard: H2O2 and heat
 Preformed or partially formed paperboard:
H2O2 and heat
 Preformed plastic cups: H2O2 and heat
 Thermoform-fill-seal: H2O2 and heat or heat
of co-extrusion
 Bag-in-box: gamma irradiated bags
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Webfed Paperboard System

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Webfed Paperboard System 1

Fl" ,g.,Pipe

□□□□
!Finished Packages

Web Slade:
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Webfed Paperboard System 2

FiJrng Piipe
- ---

.,
Peroxide Bath D c:J
Web Stack

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Preformed Container System

14

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Thermoform Filler

© 2007 Spinak Consulting

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Erca Filler

© 2007 Spinak Consulting

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Pouch Filling System

7 -

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Pouches

© 2007 Spinak Consulting

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Pouch and Bag Materials

© 2007 Spinak Consulting 31

Bag Filler

© 2007 Spinak Consulting 32

Bulk Filler

© 2007 Spinak Consulting 33

Bulk Filler

© 2007 Spinak Consulting 34

Possible Packaging Critical Factors
 Sterile air temperature (or incinerated air,
subsequently cooled and used to provide over-
pressure in a sterile zone)
 Sterile air filters
 Sterile air over-pressure in sterile zone
 Gas flush - nitrogen or other sterile gases used to
flush equipment or container headspace must be
sterilized and maintained in a sterile condition
 Hold time after temperatures have reached that
specified for thermoform, fill, and seal containers

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Paperboard and Plastic Container Critical
Factors
 Peroxide consumption rate
 Peroxide concentration
 Peroxide level (immersion) or deposition
(roller or fog)
 Temperature of warming air to transport
chemical sterilants
 Air or heating element temperature (to
remove H2O2 and complete sterilization)
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Packaging Process Deviations
 Many systems automatically stop the machine
and preclude packaging into non-sterile
containers
 Determine who calibrates and checks controls
 Review calibration methods and recent results
 Determine how system is challenged
 Review procedure and recent results
 Can manual override be initiated, by whom, and
how is it recorded
 How is residual H2O2 on packaging tested for
compliance with 21 CFR 178.1005(d)
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Packaging System Records
 Observations/measurements must be made at
frequency to ensure the product is
commercially sterile
 Recommended frequency for critical factors
and operating conditions should not exceed
one hour

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Key Po in ts
 Aseptic systems target the same microorganisms as a typical
commercial sterile low acid canned product.
 Aseptic systems consist of a means to heat the food, a timing
pump, a hold tube, and a cooling system.
 Downstream from the hold tube must be brought to
commercial sterility before filling.
 The thermal process of the food is performed in the hold tube
by controlling flow rate, residence time, and temperatures.
 Aseptic zones of machines create and maintain a sterile zone
for filling and sealing.
 Sterilizing agents such as heat, chemicals, irradiation, or a
combination of treatments are used to treat packing materials
or machine surfaces.

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