Supercritical Fluid Botanical Toll Extraction Agreement
FDA 21 CFR Β§ 111 cGMP Cleanroom Standards & USP <467> Solventless Quality Warranty
FDA cGMP / USP <467>
1. Supercritical Carbon Dioxide Extraction & Purity Warranty
Processor agrees to extract Customerβs botanical, nutraceutical, or pharmaceutical biomass using food-grade supercritical carbon dioxide (SC-CO2) at pressures between 2,500 PSI and 7,500 PSI. Processor warrants that the primary extraction process uses zero petrochemical or flammable hydrocarbon solvents (e.g., butane, propane, hexane), guaranteeing a 100% solvent-free crude extract per USP <467> guidelines.
2. Biomass Ingestion Quality, Moisture & Pre-Processing Specifications
Customer warrants that all delivered biomass is dried to between 8.0% and 11.0% moisture content by weight, milled to a consistent 20β40 mesh particle size, and accompanied by a certified third-party lab certificate verifying absence of heavy metals, mycotoxins, and non-approved agricultural pesticides.
3. FDA 21 CFR Part 111 / ISO Class 7 Cleanroom cGMP Protocols
Processing occurs within positive-pressure ISO Class 7 / Class 8 cleanrooms with full HEPA air filtration and stainless steel sanitary fluid paths. Processor maintains complete electronic batch production records (eBPR), chain of custody manifests, and cleaning validation logs pursuant to FDA dietary supplement cGMP standards.
4. Secondary Winterization, Decarboxylation & Refined Yield Target
When ordered, crude oleoresin undergoes sub-zero cryogenic ethanol winterization to remove plant waxes and lipids, followed by gentle solvent recovery and vacuum degassing to < 500 ppm ethanol. Minimum active ingredient extraction recovery yield is guaranteed at ≥ 90.0% of assayed feedstock potency.
5. Toll Processing Fees, Batch Release Testing & Payment Terms
Services are invoiced based on gross kilograms of raw biomass processed plus optional secondary refining fees per liter. Every finished production lot includes a certified third-party Certificate of Analysis (CoA). Processor maintains $10,000,000 Ingestion Product Liability and Errors & Omissions coverage. Payment terms are Net 30 days.
CUSTOMER / BIOMASS CULTIVATOR:
Authorized Signature & Date
CERTIFIED SUPERCRITICAL PROCESSOR:
Authorized Signature & Date