Dairy Establishment Inspection Manual – Chapter 14 - Aseptic Processing and Packaging Systems
1.14.02 Scheduled Process

This page is part of the Guidance Document Repository (GDR).

Looking for related documents?
Search for related documents in the Guidance Document Repository

The scheduled process means all the conditions needed to achieve and maintain commercial sterility of equipment (processing and packaging), containers and products.

1.14.02.01 Scheduled Process

The scheduled process is developed and documented by a qualified Process Authority who has scientific knowledge and experience in this field. The documentation required to validate the process covers the scientific basis for selecting certain specifications and requirements, calculations used to derive numerical values for the specifications, a review of applicable regulations and guidelines, and a descriptive commentary on what equipment and controls are being used and why. The combinations of variations encountered in commercial production are to be accounted for in the process, and critical factors that may affect the achievement of commercial sterility need to be specified. To achieve commercial sterility, Health Canada requires that the process be designed to meet a Fo = 3.0 as a minimum. See Appendix 19 - 14 for an explanation of Fo value.

If the process is designed to meet commercial sterility as per the Food and Drug Regulations B.27.001 but does not meet a minimum Fo = 3.0, a submission must be made to Health Canada to request an evaluation of the process to determine its acceptability.

Testing procedures and operator instructions are to be included in the process documentation.

Upon initial commissioning of the processing unit or after significant alterations have been made to the system or scheduled process, incubation trials and analysis must be used to confirm that the process is valid.

Any changes to an aseptic processing and packaging system must be assessed by the qualified authority as to the potential impact they will have on the system, so as to maintain the safety of the product.

1.14.02.02 Operating Instructions

Detailed operating instructions are to be made available to the operator, to ensure that the process is operated according to the design of the scheduled process. These instructions must include procedures for monitoring for critical factors during pre-sterilizing at start-up, and during production, and what to do if the critical factor limits are not met (process deviation procedures).

A process deviation occurs whenever any process is less than the scheduled process or when critical factors are outside of specified limits.

1.14.02.03 Critical Factor Adherence

The critical factors are those factors specified in the scheduled process as being necessary for the achievement of commercial sterility in the product. The inspector must review the scheduled process to see what critical factors were established. If during on-site observation, any of these critical factors are not within the limits documented in the schedule process, this is a process deviation and the product cannot be considered commercially sterile. The affected product must be placed under detention pending a thorough and documented investigation. The results of the investigation must be reviewed by a competent process authority. Prior to the release of any affected product, the process authority must authorize in writing that the results of the investigation scientifically demonstrate that the product is commercially sterile.

The process authority must be able to provide the appropriate evidence obtained through documented sterility trials that the product is commercially sterile. If the scientifically derived evidence to support the out-of-limit critical factor does not exist, the process authority cannot authorize the release of the product until such evidence is obtained. The lack of spoilage in incubated samples is not, by itself, indicative of commercially sterility but rather only indicates that other problems do not exist (e.g. low level container closure failure).

1.14.02.04 Critical Factor Records

The processing records must contain all the required information and indicate if the products were processed within the acceptable limits for the critical factors (no process deviations). Process deviations require detailed documentation in the plant's deviation log book and/or a separate file for follow up by the plant management 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.

Process deviation records must 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 (e.g. equipment breakdown, power failure, low temperature at outlet of holding tube), the action taken (e.g. line cleared, repairs performed, system re-sterilized) and review by appropriate company personnel.

Recording charts are part of the critical factor records. This information must be recorded in ink to provide a permanent record. Since this information provides a processing record, it will assist the plant in tracking down quality and safety problems and help prevent recall of their products. All production records must be reviewed on a timely basis by a member of plant management. Any operator's notes concerning unusual occurrences must be evaluated by plant management to ensure that a critical process parameter was not violated (i.e. that an unusual occurrence was not in fact a process deviation requiring product quarantine).

  1. All recording charts for aseptic processing and packaging systems shall provide the following data on every chart. (If operations extend beyond 12 hours, a 24-hour chart can be used if it can provide an equivalent level of accuracy and clarity to a 12-hour chart):
    1. Plant name and address or registration number
    2. Date, shift and batch number where applicable
    3. Recorder unit identification when more than one is used
    4. Product type and amount of product processed (may be recorded in production records)
    5. Identification of sterilization cycles (e.g. indicate when water or product being run)
    6. Identification of Clean in place (CIP), mini-wash (if used)
    7. Unusual occurrences and operator comments
    8. Signature or initials of the operators
    9. No overlapping of chart pen markings
  2. For the Safety Thermal Limit Recorder (STLR):
    1. Reading of the official indicating thermometer during processing. This reading must never be lower than the recording thermometer reading
    2. Record of time the flow diversion device (FDD) is in the forward flow position, as indicated by the event pen
    3. Recording thermometer tracing
    4. Set point tracing, when multiple set points are used
    5. All of 1. above
  3. For systems equipped with a Meter Based Timing System (MBTS):
    1. Synchronized time with STLR chart
    2. Record of time the flow alarm is activated, as indicated by an event pen
    3. Flow rate tracing
    4. All of 1. above
  4. For the pressure differential controller-recorder:
    1. Synchronized time with STLR chart; Electronic data collection, storage and reporting of pressure differentials, with or without hard copy printouts, may be acceptable provided the electronically generated records are readily available at the establishment for review by the regulatory agency and meet minimum criteria required for STLR charts
    2. Raw product or media side pressure tracing
    3. Sterilized product side pressure tracing
    4. In lieu of b) and c) above, the pressure differential recording between b) and c)
    5. All of 1. above
  5. For the pressure limit recorder:
    1. Synchronized time with STLR chart; Electronic data collection, storage and reporting of pressure limit in the holding tube, with or without hard copy printouts, may be acceptable provided the electronically generated records are readily available at the establishment for review by the regulatory agency and meet minimum criteria required for STLR charts
    2. Holding tube operation pressure
    3. All of 1. above
  6. For the aseptic surge tank(s):
    1. Record of the tank sterilization cycle (time and temperature); as determined by the process authority in the scheduled process
    2. Record of pressure applied to the sterile surge tank during aseptic filling operations as determined by the process authority in the scheduled process
    3. All of 1. above; Electronic data collection, storage and reporting of the surge tank's sterilization cycle (time and temperature) and pressure during aseptic filling of product, with or without hard copy printouts, may be acceptable provided the electronically generated records are readily available at the establishment for review by the regulatory agency and meet minimum criteria required for STLR charts.
  7. For optional additional temperature recorders/controllers on the system:
    1. Synchronized time with STLR chart
    2. Recording thermometer tracing
    3. All of 1. above; note especially the identification of sterilization cycles
  8. All pertinent processing records should be retained as part of the quality assurance program. These records will assist the plant and regulatory agencies to determine if the products are considered commercially sterile. The time-frame for retention is as follows:
    1. Three years minimum, or the shelf life of the product (if more than 3 years)
    2. As determined by the responsible regulatory agency
Date modified: