Built to Meet Global Compliance — Especially US FDA

If you're in the business of ready-to-eat or shelf-stable foods, regulatory compliance isn't optional — it's your ticket to market access and consumer trust.

Among all regulations, US FDA compliance stands out as one of the most important and demanding. Whether you export to the U.S. now or plan to in the future, meeting FDA's 21 CFR Part 113 and 114 for thermally processed low-acid and acidified foods gives your business a solid foundation for growth and acceptance in global markets.

ITECT PRIME Retorts: Designed for Confidence

At ITECT, we understand the pressure food processors face to comply with complex regulations. That's why our PRIME series retorts are engineered from the ground up to meet all key requirements — especially those set by the U.S. FDA.

What Makes Our Systems Stand Out

• FDA-Compliant by Design
  Our retorts are tailor-made to meet the FDA 21 CFR Part 113 and 114 standards — covering everything from temperature control and pressure to documentation and safety interlocks. When a Process Authority creates your scheduled process, our machines execute it accurately and consistently, every time.
• Built-in Process Integrity
  Each batch is processed with precise time-temperature control, with optional Fo/Po monitoring and alarms for any deviation. This ensures your products reach commercial sterility without overprocessing — maintaining both food safety and quality.
• Complete Traceability
  ITECT PRIME retorts log every step of the process — temperature, pressure, time, and alarms. These records can be easily reviewed, exported, and submitted during audits or FDA inspections.
• Deviation Detection & Safety Lockouts
  If a process deviation occurs (for example, if temperature doesn't reach the required level), the system flags it and holds the batch until reviewed — exactly how FDA expects it to work.
• We Speak the Language of Your Process Authority
  ITECT works closely with your Process Authority to make sure the retort is ready for validation and easy to operate within your scheduled process. We also help ensure you're equipped for FCE/SID filing if you're exporting to the U.S.

Why This Matters for You

• Avoid shipment delays and rejections at U.S. ports
• Pass audits with ease — from FDA, third-party certifiers, or your buyers
• Build trust with partners and retailers who require FDA compliance
• Future-proof your business by having a retort system that's ready for international markets