USFDA Canned Food Regulations Thermal Processing Deviations Registration and Process Filing. William W. Deckert Jr. Low-acid canned foods Acidified foods. A compilation of title 21 code of federal regulations, parts 108, 113, and 114. Part 108 - Emergency permit control.
USFDA Canned Food RegulationsThermal Processing DeviationsRegistration and Process Filing
William W. Deckert Jr.
a) Aseptic processing and packaging
d) Commercial processor
e) Commercial sterility
f) Critical factor
g) Flame sterilizer
h) Headspace, gross
I) Headspace, net
j) Hermetically sealed containers
l) Initial temperature
n) Low-acid foods
o) Minimum thermal process
p) Operating process
r) Scheduled process
u) Vacuum-packed products
w) Water activity (aw)
(figure page 220, 221, 224)
b) Cooling water
d) Post process handling
(figure page 236)
A) Acid foods
b) Acidified foods
d) Low-acid foods
e) Scheduled process
h) Water activity (aw)
Thermal Processing DeviationsRegulatory ReviewFDA
(Thermal processing deviations (LACF))
(Thermal processing deviations (Acidified Foods)
21CFR$114.89 Deviations from scheduled processes
Title 21Food and DrugsChapter IFood and Drug AdministrationDepartment of Health and Human ServicesPart 108- Emergency Permit ControlTable of contents Subpart B- Specific Requirements and Conditions for Exemption From or Compliance With an Emergency Permit
Table of Contents Subpart B - Specific Requirements and Conditions for Exemption From or Compliance With an Emergency Permit
Sec.108.35 Thermal processing of low-acid foods packaged in hermetically sealed containers
Foreign and Domestic Low-acid Canned Food (LACF) and Acidified Food Establishment Inspection Report (EIR)Regulatory Review Considerations for Detention Without PhysicalExamination (DWPE) or Emergency PermitControl by FDA Compliance Officersin Order of Importance
1- How are process deviations handled ?
2- Are scheduled processes properly delivered?
3- Were schedule processes properly developed?
4- Does documentation exist to confirm that uniform heat distribution is achieved in the firm’s processing system?
5- Does the firm follow its established schedule process?
6- Does the firm have necessary procedures in place to ensure container integrity?
Guide to inspections of low acid canned food manufacturers
Part 1- Administrative procedures/scheduled process
Detection and correction in-process
Isolation of affected prodution
Sumissions to process authorities
Issues pertaining to evaluation
Reporting evaluation results to the processor
FDA 2541 Registration form
FDA 2541(A) Food process filing for all methods except low-acid aseptic
FDA CFSAN WEB SITE
AW, Ph List, Container conversion chart
Acidified and Low Acid Canned Foods
Imports and Exports