Freeze-drying technology is widely used in food production (for fruits, vegetables, meats, snacks, etc.) because it maximizes the retention of nutrients, texture, and appearance. For food-grade freeze-dryers, the core requirements are compliance with food hygiene standards, ease of cleaning and disinfection, and possession of relevant compliance certifications to ensure food safety at the source. While the freeze-dryer itself does not require a separate administrative license as a piece of production equipment, it must pass mandatory electrical safety certification (CCC) and compliance testing for food-contact materials; there are significant differences between certifications for domestic sales and those for export.
Certifications for Domestic Sales
Freeze-dryer manufacturers: Selling complete units domestically requires CCC certification (covering electrical safety); all food-contact components (such as trays) must have test reports confirming compliance with the GB 4806 series of standards for food-contact materials. Industrial Product Production License: Certain large-scale food machinery requires an "Industrial Product Production License" issued by the State Administration for Market Regulation, certifying that production capacity and quality control systems meet industry standards. Environmental and energy efficiency certifications: Equipment must pass environmental impact assessments by environmental protection authorities, and certain high-energy-consumption units must comply with the requirements of "Minimum Allowable Values of Energy Efficiency and Energy Efficiency Grades for Food Machinery" (GB 32154).
At the food production stage—for enterprises using freeze-dryers to produce freeze-dried foods: SC Food Production License: A core market-entry qualification; the scope of the license must cover the "freeze-dried food" category (e.g., "solid beverages," "convenience foods," or "foods for special dietary uses"), and the production environment must meet Class 100,000 cleanroom standards. GMP (Good Manufacturing Practice) Certification: A mandatory compliance requirement for food production processes; it necessitates comprehensive process control—including equipment validation (IQ/OQ/PQ stages), cleaning validation, and data traceability—to ensure parameter stability and product safety throughout the freeze-drying process (pre-freezing, sublimation, and desorption). ISO 22000/HACCP System Certification: Internationally recognized food safety management systems; HACCP requires the establishment of preventive monitoring procedures for critical control points of the freeze-dryer (such as vacuum level, temperature, and residual moisture) to prevent cross-contamination and microbial levels exceeding safety limits. Export Certifications
In addition to meeting domestic sales certifications, exports to the EU require CE certification and food-contact material certification; exports to the US require ASME and FDA certification; exports to Canada require CSA certification; exports to former Soviet republics require EAC certification; and other markets require compliance with local regulations (such as South Korea's KC certification).
Hygiene Standards: The core principles are "no residue, no contamination, and ease of cleaning."
For food freeze-dryers, all components in contact with food must comply with hygiene standards for food-contact materials. Three core requirements apply: First, material compliance—components such as the chamber, shelves, and cold trap should preferably be made of 304 or 316L stainless steel; materials must be odorless, free from impurity leaching, corrosion-resistant, and heat-resistant to withstand the cleaning and disinfection processes required in food production. Second, structural design—the inner chamber walls must be mirror-polished and free of sharp edges or "dead zones" to prevent food residue from harboring bacteria; sealing structures must utilize food-grade silicone rubber gaskets that are heat- and aging-resistant, preventing the entry of external impurities and bacteria to ensure food hygiene. Third, environmental adaptability—the equipment must feature dust-proof and moisture-proof designs and be installed in a cleanroom environment that meets hygiene standards for food production workshops.
Cleaning Requirements: Standardized procedures to eliminate residual contamination
Food production involves numerous batches and diverse product varieties; incomplete cleaning of the freeze-dryer can easily lead to cross-contamination and compromise product quality. Cleaning must follow a three-step process: "Rinsing – Disinfection – Drying." First, rinsing—using warm water and food-grade detergent to rinse the chamber walls, shelves, and accessories to remove food residue. Second, disinfection—employing high-temperature sterilization, UV sterilization, or soaking in food-grade disinfectant to thoroughly eliminate bacteria. Third, drying—thoroughly drying the equipment after cleaning to prevent moisture-induced bacterial growth, with a cleanliness check performed before the equipment is put back into service. Additionally, a regular cleaning schedule must be established, documenting the cleaning process, time, and responsible personnel to ensure traceability.
