Thermal Processing Services

Retort Validation & FDA Compliance

seated man working at Allpax retort processing equipment

Expert Retort Processing Authority Solutions by Allpax & TechniCAL

At Allpax we understand that helping customers select the right retort processing equipment equipment, and then partnering with them to best utilize, operate and maintain that equipment, is mission critical.

We work hand in hand with customer’s in-house thermal process authority personnel and/or their outside thermal process services consultants to ensure our retorts are operated in the safest and most effective and efficient manner possible.

For those customers who do not have such resources and/or need help with establishing a relationship with a recognized thermal process authority, Allpax has a solution.

Allpax proudly partners with the premier recognized thermal processing authority organization in the world, TechniCAL. TechniCAL has been serving the food processing industry since 1972, offering its services to processors of Low Acid Canned Foods (LACF) and Acidified Foods to help them establish processes and procedures for producing safe food products that are regulatory compliant. The experienced, collective team of Allpax and TechniCAL provides for the most comprehensive range of thermal processing solutions and services to both existing and new retort processing customers around the globe.

Process Establishment

The USDA and FDA low-acid canned foods regulations are centered around the premise that the processor must have scientific data to support the delivery of commercial sterility to their products. Whether your product is packaged in steel, aluminum or fiber cans; glass jars or bottles; fiber boxes; plastic bottles, cups, bowls, trays, pouches or chubs; etc., TechniCAL can conduct heat penetration tests and design the required/validated thermal processes to meet all federal regulations. Calculations are conducted using either General Method, Ball Formula, or other mathematical modeling methods. All work and reports are FDA/USDA compliant.

FDA Process Filing

The FDA requires that processors of all low-acid and acidified food products manufactured or sold in the USA must register the food processing facility and the applicable food products manufactured in those facilities. Whether you are a domestic or foreign processor, TechniCAL can assist your firm with these tasks, and then follow-up with the FDA to ensure delays are minimized. Let TechniCAL help you do the process filing correctly the first time.

retort 14 process record

Retort Validation / Temperature Distribution Studies

Regardless of the type of retort process employed (i.e.: horizontal or vertical steam, water immersion, steam/air, water spray or water cascade……agitating or non-agitating), we have the experience to document its performance to make sure it meets or exceeds all regulatory requirements. Allpax and TechniCAL can validate your retort to ensure it operates properly, delivering the required uniform temperatures to your product. Temperature distribution testing is conducted to evaluate the retort's performance during the come-up, cook, and cooling phases. A complete retort audit is also provided along with all temperature distribution testing. All work and reports generated are FDA/USDA compliant.

Deviation Analysis and Process Evaluation

Deviated product means that your money is tied up in inventory holds. TechniCAL uses advanced evaluation tools to assist processors in evaluating the deviations and moving the product along. Process deviations are analyzed to determine if a commercially sterile process was achieved. They occur when a process time, temperature, or other critical factor is not achieved during the thermal process as specified in the scheduled process. All documentation surrounding the deviation event can be submitted for review. Upon completion of the evaluation, a complete report of the findings is issued. All work and reports generated by are FDA/USDA compliant.

Regulatory Specialty Services

One of the keys to dealing with the government regulatory agencies is understanding the intent of the regulations. There isn't a low-acid or acidified foods question that we haven't addressed, so let TechniCAL act as your intermediary with these agencies when questions arise. TechniCAL's team of Regulatory Specialists has the experience and ability to handle any food safety regulatory issue. When FDA or USDA takes regulatory action against a food processor (foreign or domestic), it is important to understand how to properly react to the situation. TechniCAL’s knowledge of the regulations, law, and enforcement actions is a valuable resource during regulatory action. We can assist with Product Recalls, FDA or USDA inspections, FDA 483 reports and/or warning letters, FDA automatic detention, FDA emergency permit, or Import detentions.

retort overview screen

Thermal Process / Compliance Audits

TechniCAL can provide proactive, on-site assessments of your compliance with FDA/USDA canning regulations (US Code of Federal Regulations- Titles 9 and 21, HACCP, GMP, etc.). Assessments/audits are based on the most critical parts of these regulatory requirements, including product process source documentation, retort validation documentation, process delivery, and process deviations. A complete report of the findings is provided upon completion, along with suggestions on how to address any issues that are out of compliance.

Control System Validation Services - “Part 11” Compliance

The team of Allpax and TechniCAL can provide expert level software and services when it comes to Validating your new or existing control system to ensure compliance with FDA’s 21 CFR 11 which regulates the use of electronic records and electronic signatures. We follow the guidelines laid out in NFPA Bulletin 43L to validate the retort/control system, and then confirm that the system complies with all requirements of Part 11 such as user security/access, change control and audit trails, and data integrity. Upon completion, a complete Validation Report will be issued, documenting your systems compliance with 21 CFR Part 11.