U.S. Code of Federal Regulations

Regulations most recently checked for updates: Jun 08, 2023

§ 109.2 - Sterilizers.

Steam and dry-heat sterilizers used in connection with the processing of biological products at licensed establishments shall be equipped with automatic temperature recording gauges: Provided, That other record keeping systems may be used when approved by the Administrator. When gauges are used, they shall be periodically standardized to assure accuracy. Charts and other temperature records made during production shall be available at all times charts and records shall be kept in accordance with part 116 of this chapter.

[35 FR 16039, Oct. 13, 1970, as amended at 56 FR 66783, Dec. 26, 1991]