GroundRules
9 CFR 109.1: Equipment and the like.
Where this section sits in the code
- Title 9—Animals and Animal Products
- CHAPTER I—ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE
- SUBCHAPTER E—VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS
- PART 109—STERILIZATION AND PASTEURIZATION AT LICENSED ESTABLISHMENTS
(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.
Collected 2026-08-27T02:24:03Z. Source file · JSON