Processing Authority Partnership

We will work in partnership with our clients to provide all aspects of the process authority roles mandated by the state and Federal Regulations that pertain to the processing of shelf-stable foods packed in hermetically sealed containers as mandated in Title 21 CFR, parts 108, 110, 113, and 114, and the USDA Canning Regulations as published in parts 318.300-311 and 381.300-311. According to these federal regulations, it is mandatory that all process schedules, for all low-acid and acidified foods covered by these regulations originate from a “process authority”, a group or individual having expert knowledge in thermal processing systems and the related sciences. While many processors have in-house process authorities, many others do not. The IEH staff of process authorities is a World Class group that is ready to assist you in all aspects of process design and implementation. The following are brief descriptions of the process authority services that we offer along with a rationale of the regulatory need for the service:

• Heat penetration testing.

• Processing vessel temperature distribution testing and development of operating guidelines documentation.

• Thermal and Aseptic process recommendations.

• Evaluate deviations from thermal and aseptic processes and provide disposition recommendations for the affected product lots.

• Assist with preparation of FDA process filing documents and responses to FDA inquiries and inspectional observations.

• Aseptic Processing and Packaging Services.

• Consult with processors on 21 CFR part 11 compliance of electronic control and recordation systems for aseptic and thermal processing systems.

• Consult with processors on validation of automated control systems for retorts and aseptic processing and packaging systems.
  
• Planning for and Conducting Product Recalls

• Consultations