(A) Recording device.
(1) The container and closure sterilization system and product filling and closing system shall be instrumented to demonstrate that the required sterilization is being accomplished continuously.
(2) Automatic recording devices shall be used to record, when applicable, the sterilization media flow rates, temperature, concentration, or other factors.
(3) When a batch system is used for container sterilization, the sterilization conditions shall be recorded.
(B) Timing methods.
(1) Methods shall be used either to give the retention time of containers, and closures if applicable, in the sterilizing environment specified in the scheduled process, or to control the sterilization cycle at the rate specified in the scheduled process.
(2) A means of preventing unauthorized speed changes shall be provided.