Inspections, Compliance, Enforcement, and Criminal Investigations

Low Acid Canned Food Manufacturers Part 2 - Processes/Procedures

Manufacturers - 2

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Table of Contents

Page Title Page Number
Introduction Pg. 1
Investigator Role Pg. 2
lacf Inspection Equipment for Investigators Pg. 2
Critical Factors Pg. 3
Raw Materials Pg. 4
Product Formulation Pg. 6
Packing Medium Pg. 7
Filling of Containers-Critical Factors Pg. 8
Exhausting of Containers Pg. 9
Incipient Spoilage Pg. 10
Operations in the Thermal Processing Area Pg. 10
Area Pg. 10
Pg. 10
Pg. 11
Pg. 11
Pg. 12
Pg. 12
Pg. 12
Thermal Processing Systems Installation and Instrumentation Pg. 13
Pg. 14
Pg. 14
Pg. 15
Pg. 15
Pg. 15
Pg. 15
Pg. 16
Pg. 17
Pg. 18
Pg. 20
Temperature Distribution Pg. 21
Process Establishment Pg. 22
Stacking Equipment Pg. 23
Retort Systems Pg. 23
Pg. 23
Pg. 23
Pg. 26
Pg. 28
Pg. 31
Pg. 32
Pg. 34
Pg. 36
Pg. 38
Pg. 39
Pg. 39
Thermal Processing Records Pg. 41
Computer Generated Records Pg. 43
Post Process Container Handling Pg. 44
Pg. 44
Pg. 45
Coding of Containers Pg. 46

Field Exams/Sample Collections

Pg. 46
References Pg. 47
Summary Guidelines for lacf Processes Pg. 49
List of Forms/ Attachments Pg. 51


The Guide to Inspection of Low-Acid Canned Foods consists of three separate documents; Part 1 covers Administrative Procedures\Scheduled Processes; Part 2 covers Manufacturing Processes\Procedures and Part 3 covers Container/Closures (Part 3 of the manual is still in process, and will issue at a later date). In addition to providing guidance for inspections of low acid canned foods (lacf) manufacturers, the guide(s) also contains background and general information on lacf regulations and procedures.In addition to the information and instructions provided in IOM Subchapter 530, 21CFR 108 and 113, and applicable compliance programs, direct attention to areas covered in this Guide when covering lacf manufacturers. Another good reference is the Food Processors Institute 'Canned Foods' manual, which should be available from anyone in your district who has attended a Better Process Control School.The Division of Emergency and Investigational Operations (DEIO), HFC-132, has available, for loan only, the following National Food Processor Association (NFPA manuals):

1.Thermal Processes For Low-Acid Foods in Metal

------------------------------------------------------ reference materials for investigators and other FDA personnel. The document does not bind FDA, and does not confer any rights, privileges, benefits, or immunities for or on any person(s).

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