TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION
PART 113 THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS
Subpart A--General Provisions
§ 113.3 - Definitions.
§ 113.5 - Current good manufacturing practice.
§ 113.10 - Personnel.
§ 113.40 - Equipment and procedures.
Subpart D--Control of Components, Food Product Containers, Closures, and In-Process Materials
§ 113.60 - Containers.
Subpart E--Production and Process Controls
§ 113.81 - Product preparation.
§ 113.83 - Establishing scheduled processes.
§ 113.87 - Operations in the thermal processing room.
§113.89 - Deviations in processing, venting, or control of critical factors.
Subpart F--Records and Reports
§ 113.100 - Processing and production records.
Subpart A--General Provisions
Sec. 113.3 Definitions.
For the purposes of this part, the following definitions apply:
(a)Aseptic processing and packaging means the filling of a commercially sterilized cooled product intopresterilized containers, followed by aseptic hermetical sealing, with a presterilized closure, in an atmosphere free of microorganisms.
(b)Bleeders means openings used to remove air that enters with steam from retorts and steam chambers and to promote circulation of steam in such retorts and steam chambers. Bleeders may serve as a means of removing condensate.
(c)Come-up-time means the time which elapsesbetween the introduction of steam into the closed retort and the time when the retort reaches the required processing temperature.
(d)Commercial processor includes any person engaged in commercial, custom, or institutional (church, school, penal, or other organization) processing of food, including pet food. Persons engaged in the production of foods that are to be used in market or consumer testsare also included.
(e)Commercial sterility: (1) "Commercial sterility" of thermally processed food means the condition achieved--
(i) By the application of heat which renders the food free of--
(a ) Microorganisms capable of reproducing in the food under normal nonrefrigerated conditions of storage and distribution; and
(b ) Viable microorganisms (including spores) of public healthsignificance; or
(ii) By the control of water activity and the application of heat, which renders the food free of microorganisms capable of reproducing in the food under normal nonrefrigerated conditions of storage and distribution.
(2) "Commercial sterility" of equipment and containers used for aseptic processing and packaging of food means the condition achieved by application of heat, chemicalsterilant(s), or other appropriate treatment that renders the equipment and containers free of viable microorganisms having public health significance, as well as microorganisms of nonhealth significance, capable of reproducing in the food under normal nonrefrigerated conditions of storage and distribution.
(f)Critical factor means any property, characteristic, condition, aspect, or other parameter,variation of which may affect the scheduled process and the attainment of commercial sterility.
(g)Flame sterilizer means an apparatus in which hermetically sealed containers are agitated at atmospheric pressure, by either continuous, discontinuous, or reciprocating movement, with impinging gas flames to achieve sterilization temperatures. A holding period in a heated section may follow the initialheating period.
(h)Headspace, gross is the vertical distance between the level of the product (generally the liquid surface) in an upright rigid container and the top edge of the container (the top of the double seam of a can or the top edge of a glass jar).
(i)Headspace, net of a container is the vertical distance between the level of the product (generally the liquid surface) in the upright...
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