Module 14. Aseptic Processing 

and Packaging Systems 

Thermal Processing for Meat and 

Poultry Products Training 

1 
Aseptic Processing Inspection 

2 
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 

3 
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 

4 
Scheduled Proces,ses 

 Product 

 Product “sterile zones” 

 hold tube downstream 

 Packaging system 

 Packaging materials 

5 
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6 
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 

7 
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 

8 
Direct Product Heating Systems 

Product Inlet 

Figure 2 - Steam Infusion 

 Steam Injection • Steam Infusion 

9 
Indirect Product Heating Systems 

Steam Inlet , 

~ -

"-~-- ~ - C ./ • • ·.:~• • • , 

., 

Product 

Inlet 

--::z:f:l 

--+ 

,1--.lL _ _..l,;l~~~ Steam 

Outlet 

Figure 4 - Tubular Heat Exchanger 

 Plate Heat 

Exchanger 

 Tubular Heat 

Exchanger 

 Scraped Surface 

Heat Exchanger 

10 
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) 

11 
Equipment and Controls 

TE 

 

 

 

 

 Temperature Indicating Device 

 Must meet requirements 

 Checked for accuracy 

• upon installation and at least once per 

year 

 Calibration records 

 Bulb in vicinity of recorder 

 Recorder 

 Accurate 

 If air actuated, clean air supply

(filter maintenance) 

 Bulb located at the exit end of the 

hold tube 

12 
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 

13 
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 

14 
 

 

Backpressure Device 

 Valves, orifices, or pumps may be used to 

assure that pressure prevents flashing of 

product in hold tube. 

15 
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 nonsterile product 

 Routinely challenge system to verify function 

 Review recent challenge and calibration records 

including testing method, frequency of testing, and 

who performs the test 

16 
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 

17 
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 

18 
Possible 1Process 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 

19 
Cleaning and Reprocessing 

Following a Deviation 

 

 

 

 

 Written procedures for cleaning and resterilizing 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. 

20 
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 

21 
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 

22 
Webfed Paperboard System 

23 
Webfed Paperboard System 1 

Fl" ,g. ,Pipe 

□□□□ !Finished Packages 

Web Slade: 

24 
Webfed Paperboard System 2 

FiJrng Piipe 

- ---

., 

Peroxide Bath D c:J 

Web Stack 

25 
Preformed Container System 

14 

26 
Thermoform Filler 

© 2007 Spinak Consulting 27 
Erca Filler 

© 2007 Spinak Consulting 28 
Pouch Filling System 

7-

29 
Pouches 

© 2007 Spinak Consulting 30 
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 

35 
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) 

36 
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) 

37 
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 

38 
Key Points 

 

 

 

 

 

 

 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. 

39