Ensuring food safety and regulatory compliance has never been easier. At Thermosoft Technologies, we provide expert Autoclave Validation, sterilization, and food safety consulting to help businesses meet FDA, FSMA, HACCP, and GMP standards seamlessly. With our proven expertise and tailored solutions, we optimize your thermal processes for efficiency, compliance, and product safety, giving you confidence in every step of production.
We are proud to be the trusted partner for businesses across various industries, ensuring compliance, safety, and efficiency in food processing.
At TST Field Services and Consulting, we are committed to ensuring the highest standards of food safety and quality. With expertise in thermal processing and validation, we offer tailored solutions that help food manufacturers optimize their processes, navigate regulatory requirements, and achieve global compliance. Trust us to be your dedicated partner in delivering safe, high-quality food products.
Our specialists bring decades of experience in thermal validation processes, ensuring your food products meet the highest safety standards.
We help you navigate complex regulations and standards, ensuring your operations remain compliant across global markets.
Our tailored solutions help you optimize production processes, improving efficiency without compromising on quality.
We work alongside your team as true partners, committed to your success and the safety of your products.
Whatever you require for your qualification, validation or process standardisation, we’ve got you covered. With TST, you get a dedicated and experienced partner for even the most challenging GMP-level projects.
At TST Field Services and Consulting, we offer a comprehensive range of specialized services to meet the needs of food manufacturers and ensure compliance with industry standards. Our expertise spans across thermal processing, regulatory support, and more.
We take a hands-on approach to every project, offering tailored solutions that align with your specific production needs. From process validation to regulatory guidance, our expertise ensures that your food products meet the strictest safety and quality standards. Whether you’re optimizing sterilization methods, navigating FDA filings, or improving thermal processing efficiency, we are here to support you at every step.
Ensuring the safety and quality of your food products through accurate thermal process validation.
We develop and validate thermal processes for LACF, acid, and acidified foods in various containers.
We assist with FDA filings, facility registration, compliance, and resolving detention issues for seamless exports. FDA process validation guidance
We support FSMA, FSVP, HACCP, GMP/SSOP, allergen management, sanitation, and label compliance, including third-party audits.
Need assistance with thermal process validation, sterilization, or regulatory compliance? Our team at Thermosoft Technologies is here to help!
Our vast experience with different types of retorts and processing methods helps clients produce and export food products without concerns from international regulatory agencies.
We develop unique and innovative solutions based on close interactions with our customers, tailored to specific needs and challenges.
Deep knowledge of FDA requirements and international food safety regulations ensures smooth export processes and compliance.
From initial consultation to implementation and documentation, we provide end-to-end support for all validation and compliance needs.
We pride ourselves on rapid response times and efficient service delivery, helping you meet tight production schedules and market deadlines.
With numerous successful validations across various food products and packaging types, our methods are proven to be reliable and effective.
Thermal Process Validation is the scientific process of proving that a specific heating method (like retorting or pasteurization) consistently kills target pathogens. It is mandatory under global regulations (like FDA 21 CFR 113/114) to ensure that shelf-stable foods are safe from life-threatening bacteria like Clostridium botulinum.
Temperature Distribution study ensures the sterilizer heats uniformly and identifies the “cold spot” in the equipment. A Heat Penetration study measures how fast heat reaches the “slowest heating point” inside the food container itself. Both are required for a complete validation.
No. The high-heat sterilization process effectively eliminates microorganisms and enzymes that cause spoilage. When combined with a hermetically sealed container, the food remains shelf-stable for 1–2 years without any added chemical preservatives.
FCE (Food Canning Establishment) is a unique registration number for the manufacturing facility. SID (Submission Identifier) is a unique number for each specific product and process. You cannot legally export Low-Acid or Acidified foods to the U.S. without these.
Low-Acid (LACF): Any food (except alcoholic beverages) with a finished equilibrium pH greater than 4.6 and water activity (a_w) greater than 0.85.
Acidified (AF): Low-acid foods to which acid(s) or acid food(s) are added to result in a finished equilibrium pH of 4.6 or below and a_w greater than 0.85.
It is a formal document issued by a recognized thermal process expert that establishes the “Scheduled Process.” It outlines the specific time, temperature, and critical factors (like pouch thickness or initial temp) required to achieve commercial sterility.
Re-validation should occur if you change the product formulation, change the packaging material/size, modify the processing equipment, or if it has been more than a year since the last validation (as per many GFSI standards).
These are variables that, if changed, could affect the safety of the product. Common examples include:
Initial temperature of the product.
Container dimensions and material.
Residual air in a pouch.
Solid-to-liquid ratio.
Yes. We specialize in resolving FDA detentions by reviewing your process filings, identifying discrepancies, and providing the necessary technical data or corrected SID filings to satisfy FDA requirements.
While the physical data collection (Heat Penetration and Distribution) usually takes 2–4 days on-site, the data analysis and final Process Authority report typically take 1–2 weeks. We prioritize accuracy to ensure your “Scheduled Process” is bulletproof under audit.
Many companies “over-process” their food to be safe, which results in loss of texture, flavor, and color—not to mention wasted energy. Thermosoft uses precise lethality calculation and world class instruments (Fo and Po values) to find the “sweet spot”: a process that is 100% safe but preserves the premium quality of your food.
At TST, we offer advanced process authority and validation services in support of thermally processed shelf-stable food products. Our teams are industry experts and come well-equipped with industry-leading thermal validation equipment
