U.S. Code of Federal Regulations

Regulations most recently checked for updates: Jun 08, 2023

§ 109.1 - Equipment and the like.

(a) All containers, instruments, and other apparatus and equipment, before being used in preparing, handling, or storing biological products, at a licensed establishment, except as otherwise prescribed herein, shall be thoroughly sterilized by live steam at a temperature of at least 120 °C. for not less than one-half hour, or by dry heat at a temperature of at least 160 °C. for not less than one hour. If for any reason such methods of sterilization are impracticable, then a process known to be equally efficacious in destroying microorganisms and their spores may be substituted after approval by the Administrator.

(b) Instruments which are found to be damaged by exposure to the degree of heat prescribed in this section, after having been thoroughly cleaned, may be sterilized by boiling for not less than 15 minutes.

[23 FR 10051, Dec. 23, 1958, as amended at 34 FR 18119, Nov. 11, 1969; 56 FR 66783, Dec. 26, 1991]