Chemistry - Overall Migration - 1 simulant - single use

Different food types extract substances differently - aqueous foods mobilize hydrophilic compounds, acidic foods enhance metal extraction, alcoholic beverages solubilize specific additives requiring simulant selection matching intended use. Single-use overall migration testing in liquid simulants (A, B, C, D1) evaluates total substance transfer under conditions representing different food types following EU 10/2011 requirements. Simulant selection matches intended food contact - aqueous simulant A for water-based foods, acidic simulant B for foods below pH 4.5, alcoholic simulant C for beverages containing alcohol, and D1 for general fatty or oily foods. Gravimetric determination provides definitive measurement of migration levels ensuring compliance with regulatory limits of 10 mg/dm² or 60 mg/kg regardless of migrated substance identity. Critical for medical devices contacting various food types during clinical nutrition where simulant selection represents actual use, enteral feeding applications where nutritional formulations vary from aqueous to fatty compositions, and regulatory submissions requiring demonstrated compliance with food type-specific conditions. For devices contacting acidic nutritional formulations, simulant B testing reveals enhanced metal extraction that neutral simulants miss, while alcoholic simulant testing proves relevant for medical devices used with alcohol-containing medications or disinfectants. The multi-simulant approach ensures comprehensive assessment across intended uses, identifies worst-case migration conditions guiding material selection and specification setting, and supports risk assessment demonstrating safety regardless of food type variability. Manufacturing validation confirms materials achieve acceptable migration across relevant simulants, processing doesn't differentially affect migration in specific simulants suggesting material changes, and specifications account for simulant-dependent migration variations preventing surprises during regulatory testing.

No.
1007019
Method
Conditions per customer in simulant, gravimetric analysis
Analyses category
Sample type
Finished device, Primary container, Secondary packaging, Bulk material
Sample requirement (type)
Sterile or non sterile
Sample quantities
2 product, 200 cm2, 20 gram
Equipment
Weighting
Lead Time Standard (Days)
unavailable
Lead Time Express (Days)
unavailable
Lead Time Super Express (Days)
unavailable
Test facility
In House
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