Temperature-Recording Device - TRD (21 CFR 113.40)

21 CFR 113.40 Equipment and procedures.

(a) … in steam in still retorts
(b) … in water in still retorts
(c) … in steam in continuous agitating retorts
(d) … in discontinuous agitating retorts
(e) … in water in discontinuous agitating retorts

(2) Temperature-recording device.  Each retort shall have an accurate temperature-recording device. Each temperature-recording device shall have a sensor and a mechanism for recording temperatures to a permanent record, such as a temperature-recording chart. 

(i) Analog or graphical recordings. Temperature-recording devices that create analog or graphical recordings may be used. Temperature-recording devices that record to charts shall be used only with the appropriate chart. Each chart shall have a working scale of not more than 55 °F per inch (12 °C per centimeter) within a range of 20 °F (10 °C) of the process temperature. Chart graduations shall not exceed 2 °F (1 °C) within a range of 10 °F (5 °C) of the process temperature. Temperature- recording devices that create multipoint plottings of temperature readings shall record the temperature at intervals that will assure that the parameters of the process time and process temperature have been met.

(ii) Digital recordings. Temperature- recording devices, such as data loggers, that record numbers or create other digital records may be used. Such a device shall record the temperature at intervals that will assure that the parameters of the process time and process temperature have been met. 

NOTE what is stated in 21 CFR 113.100… Processing and production records. (h) Records of this part may be maintained electronically, provided they are in compliance with part 11 of this chapter (Electronic records; Electronic signatures).

(iii) Adjustments. The temperature- recording device shall be adjusted with sufficient frequency to ensure agreement as nearly as possible with, but to be in no event higher than, the temperature- indicating device during processing. A means of preventing unauthorized changes in adjustment shall be provided. A lock or a notice from management posted at or near the temperature-recording device that provides a warning that only authorized persons are permitted to make adjustments is a satisfactory means of preventing unauthorized changes.

(iv) Temperature controller. The temperature-recording device may be combined with the steam controller and may be a combination recorder- controller. For a vertical retort equipped with a combination recorder-controller, the temperature recorder-controller sensor shall be located at the bottom of the retort below the lowest crate rest in such a position that the steam does not strike it directly. For a horizontal retort equipped with a combination recorder- controller, the temperature recorder- controller sensor shall be located between the water surface and the horizontal plane passing through the center of the retort so that there is no opportunity for direct steam impingement on the sensor. For all still retort systems that pressure process in water and are equipped with combination recorder-controllers, the temperature recorder-controller sensors shall be located where the recorded temperature is an accurate measurement of the scheduled process temperature and is not affected by the heating media.


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