Dairy Establishment Inspection Manual – Chapter 14 - Aseptic Processing and Packaging Systems
1.14.19 Packaging and Filling Controls

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The aseptic packaging stage is the most delicate operation of producing aseptic product, both in terms of control and preventative measures required. The processing plant must have well trained personnel to carry out the operations and to maintain the equipment.

For packaging and filling equipment, the critical controls which attain and maintain commercial sterility within the aseptic zone must be identified. These critical controls include sterile air supply systems and sterile product contact surfaces of the filler and packaging material. The packaging and filling critical controls become the basis of the scheduled process for aseptic packaging. Calibration of Controls

The packaging and filling critical controls must be calibrated on a regular basis. When they function properly they will be fail-safe. If the critical controls are not met, the machine must stop and preclude the packaging of sterile product into non-sterile containers. Records of calibration must be kept indicating the date of testing, method(s) used, and the name of the individual performing the calibrations. Setting of Controls

In order to have a commercially sterile finished product, the identified critical controls must be set and adhere to the specifications identified in the scheduled process during container formation and filling. These critical controls may include but are not limited to, for example:

  1. positive sterile air/inert gas pressure in the filling and sealing area of the machine
  2. hydrogen peroxide concentration and temperature
  3. drying section temperature

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. This manual over-ride must be protected from unauthorized personnel access. Setting Deviation

Acceptable variations from the specified setting of critical controls must be described in the scheduled process and in the operator's packaging and filling production log. In the event of a critical deviation from the setting, the packaging system shall be shut down, non-sterilized product must be segregated and the system must be re-sterilized before resuming operation.

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