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Dairy processing: Aseptic processing and packaging systems
Packaging and filling controls

The aseptic packaging stage is the most delicate operation of producing aseptic product, both in terms of control and preventive measures required.

Calibration of controls

  • Calibrate the packaging and filling critical controls on a regular basis
    • keep records of calibration including the date of testing, method(s) used, and the name of the person performing the calibration

Setting of controls

In order to have a commercially sterile finished product, set the identified critical controls and adhere to the specifications identified in the scheduled process during container formation and filling.

  • Critical controls may include:
    • positive sterile air/inert gas pressure in the filling and sealing area of the machine
    • hydrogen peroxide concentration and temperature
    • drying section temperature

If the critical controls are not met, the equipment stops and precludes the packaging of sterile product into non-sterile containers.

Although these systems usually operate in an automatic mode, most, if not all, will be equipped with a capability of manual over-ride of the automatic controls.

  • Protect the manual over-ride from unauthorized personnel access

Setting deviation

Acceptable variations from the specified setting of critical controls are described in the scheduled process.

  • Describe the acceptable variations in the operator's packaging and filling production log
    • in the event of a critical deviation from the setting, shut down the packaging system, segregate non-sterilized product and re-sterilize the system before resuming operation
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