Dairy processing: Aseptic processing and packaging systems
Scheduled process

Operating instructions

• Provide detailed operating instructions to the APPS operator to ensure that the process is operated according to the design of the scheduled process
  • include procedures for monitoring critical factors during pre-sterilizing at start-up, during production, and what to do if the critical factor limits are not met (process deviation procedures)

Critical factor adherence

Critical factors are those factors specified in the scheduled process as being necessary for the achievement of commercial sterility in the product. If any of these critical factors are not within the limits documented in the scheduled process, it is a process deviation and the product cannot be considered commercially sterile.

• Place the affected product on hold pending a thorough and documented investigation
• Have a competent person review the results of the investigation
  • this person obtains the appropriate evidence through documented sterility trials that the product is commercially sterile
    • the lack of spoilage in incubated samples is not, by itself, indicative of commercial sterility but rather only indicates that other problems do not exist (for example, low level container closure failure)
  • if this person authorizes in writing that the results of the investigation scientifically demonstrate that the product is commercially sterile, the affected product can be released

Critical factor records

Processing records are part of the preventive control plan. They indicate whether the products were processed within the acceptable limits for the critical factors (no process deviations). Detailed documentation of process deviations permit follow up to determine the cause and corrective action for the deviation and to ensure any compromised product is properly identified and handled to prevent distribution or sale.

Recording charts are part of the critical factor records. These records can be in either a hard copy or electronic format but are to provide a permanent record. Refer to Record keeping for your preventive control plan for additional guidance on best practices for recording information.

• Review all production records on a timely basis
  • evaluate all operator notes on unusual occurrences to ensure that a critical process parameter was not violated (that is, that an unusual occurrence was not in fact a process deviation requiring product quarantine)

1. Recording charts for aseptic processing and packaging systems provide the following data on every chart. (If operations extend beyond 12 hours, use a 24-hour chart if it can provide an equivalent level of accuracy and clarity to a 12-hour chart):

• plant name and address or licence number
• date, shift and batch number where applicable
• recorder unit identification when more than one is used
• product type and amount of product processed (may be recorded in production records)
• identification of sterilization cycles (for example, indicate when water or product being run)
• identification of Clean in place (CIP) mini-wash (if used)
• unusual occurrences and operator comments
• signature or initials of the operators
• chart pen markings (Note: they should not overlap)

2. For the Safety Thermal Limit Recorder (STLR):

• reading of the official indicating thermometer during processing
  • ensure this reading is not lower than the recording thermometer reading
• record of time the flow diversion device is in the forward flow position, as indicated by the event pen
• recording thermometer tracing
• set point tracing, when multiple set points are used
• all of number 1 above

3. For systems equipped with a Meter Based Timing System (MBTS):

• synchronized time with safety thermal limit recorder chart
• record of time the flow alarm is activated, as indicated by an event pen
• flow rate tracing
• all of number 1 above

4. For the pressure differential controller-recorder:

• synchronized time with safety thermal limit recorder chart
• raw product or media side pressure tracing
• sterilized product side pressure tracing
• in lieu of raw product or media side pressure tracing and sterilized product side pressure tracing, the pressure differential recording between them
• all of number 1 above

5. For the pressure limit recorder:

• synchronized time with safety thermal limit recorder chart
• holding tube operation pressure
• all of number 1 above

6. For the aseptic surge tank(s):

• record of the tank sterilization cycle (time and temperature) as determined in the scheduled process
• record of the pressure applied to the sterile surge tank during aseptic filling operations as determined in the scheduled process
• all of number 1 above

7. For optional additional temperature recorders/controllers on the system:

• synchronized time with safety thermal limit recorder chart
• recording thermometer tracing
• all of number 1 above; note especially the identification of sterilization cycles

8. Process deviation records include:

• date and time of the process deviation
• amount of product involved
• product quarantine and release of affected product
• investigation into the cause of the process deviation (for example, equipment breakdown, power failure, low temperature at outlet of holding tube)
• action taken (for example, line cleared, repairs performed, system re-sterilized)
• review by competent personnel

Retain all pertinent processing records as part of the preventive control plan. These records will assist in determining if the products are considered commercially sterile.