Before the start of packaging operations, both the container and closure sterilizing system and the product filling and closing system shall be brought to a condition of commercial sterility.
(B) Loss of sterility.
A system shall be provided to stop packaging operations, or alternatively to ensure segregation of any product packaged when the packaging conditions fall below scheduled processes. In the event product is packaged under conditions below those specified in the scheduled process, all such product shall be segregated and handled in accordance with rule 901:3-3-14(D) of the Administrative Code. In the event of loss of sterility, the system shall be returned to a condition of commercial sterility before resuming packaging operations.
Observations and measurements of operating conditions shall be made and recorded at intervals of sufficient frequency to ensure that commercial sterility of the food product is being achieved. Such measurements shall include the sterilization media flow rates, temperatures, the container and closure rates is applicable, through the sterilizing system, and the sterilization conditions if a batch system is used for container sterilization.
(D) Critical factors.
Critical factors specified in the scheduled process shall be measured and recorded on the processing record at intervals of sufficient frequency to ensure that the factors are within the limits specified in the scheduled process.