MeFoam-FG (Food-Grade Silicone Defoamer, USP / FDA-Compliant Dimethicone): The Compliance-Critical Defoamer for Fermentation, Food Processing, and Pharmaceutical Applications
SEMITECH MeFoam-FG is the food-grade silicone defoamer formulated to USP and FDA 21 CFR 173.340 specifications — FCC-grade dimethicone + USP-grade hydrophobic silica + food-additive-class emulsifier. Used in fermentation, food processing, beverage, dairy, and pharmaceutical processes where the defoamer enters the food/drug stream. 25 kg HDPE pail with full compliance documentation packet.
Contents
| USP / FDA / FCC | 10 ppm max | 25 kg |
|---|---|---|
| Compliance | Carry-over limit | MOQ (HDPE) |
Chemistry & Compliance Specifications
FCC-grade dimethicone + USP-grade hydrophobic silica + food-additive emulsifier; FDA 21 CFR 173.340 compliant.
Three regulated components: (1) FCC-grade dimethicone with low cyclic siloxane content (D4/D5/D6 below FCC limits); (2) USP-grade hydrophobic silica; (3) GRAS-status emulsifier. Compliance documentation includes FDA 21 CFR 173.340 letter, USP-NF certificate, EU E900 listing, halal/kosher on request. 10 ppm maximum carry-over in finished food product; 100 ppm maximum process-water dose.
Defoaming Mechanism: FCC-PDMS Spreading + USP-Silica Nucleation
Same fundamental mechanism as MeFoam-S, but FCC/USP component certification meets food-process toxicology requirements.
FCC-grade dimethicone spreads on foam bubbles, displaces surfactant and proteins, USP-grade silica nucleates rupture. Knockdown 10–30 seconds, persistence 4–12 hours.
- Dosing 5–50 ppm — fermentation reactor foam control (penicillin, citric acid, SCP)
- Dosing 10–100 ppm — food-processing wastewater (dairy, brewery, beverage)
- Dosing 5–50 ppm — pharmaceutical bioreactor foam suppression
- Dosing 5–30 ppm — direct food-contact processes (sugar refining, fruit juice, edible oil)
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Applications & Formulation Guidance
Fermentation (largest), food processing, dairy, beverage, pharmaceutical bioreactor, edible-oil processing.
Industrial fermentation (largest) — penicillin, amino acid, organic acid, ethanol at 5–50 ppm continuous dosing. Food and beverage — dairy CIP, brewery wort, fruit juice, sugar refining at 5–50 ppm. Pharmaceutical bioreactor — CHO cells, E. coli, yeast at 5–50 ppm with full cGMP documentation. Direct food-contact — 5–30 ppm with engineering controls ensuring carry-over stays below 10 ppm.
Procurement, Compliance Documentation, Storage and Quality Control
CoA + full compliance documentation packet per shipment; 25 kg HDPE pail; 12-month sealed shelf life.
CoA per batch: FCC dimethicone (≥85%), silica (5–8%), cyclic siloxane (D4/D5 ≤500 ppm, D6 ≤300 ppm), heavy metals (Pb ≤1 ppm, Hg ≤0.1 ppm), microbial limits (TAMC ≤100 cfu/g). Compliance packet: FDA 21 CFR 173.340, USP-NF, EU E900, GRAS, halal/kosher on request. MOQ 25 kg. Lead time 2–3 weeks Asia, 4–6 weeks Europe/North America. Shelf life 12 months sealed; 6 months for opened pails.
MeFoam-FG Specification Sheet
SEMITECH stocked grade; CoA + compliance packet per batch.
| Property | Specification | Test Method |
|---|---|---|
| Chemistry | FCC-grade dimethicone + USP-grade hydrophobic silica + food-additive emulsifier | — |
| Form | Self-emulsifying liquid | — |
| Dimethicone content | ≥85% | USP-NF method |
| Hydrophobic silica content | 5–8% | Gravimetric |
| Cyclic siloxane (D4) | ≤500 ppm | GC-MS |
| Cyclic siloxane (D5) | ≤500 ppm | GC-MS |
| Cyclic siloxane (D6) | ≤300 ppm | GC-MS |
| Lead (Pb) | ≤1 ppm | ICP-MS |
| Tin (Sn) | ≤1 ppm | ICP-MS |
| Mercury (Hg) | ≤0.1 ppm | ICP-MS |
| Microbial limits (TAMC) | ≤100 cfu/g | USP-NF |
| Microbial limits (TYMC) | ≤10 cfu/g | USP-NF |
| Pathogens | Absent | USP-NF |
| Appearance | Translucent off-white liquid | Visual |
| Density (25°C) | 0.97–1.00 g/cm³ | ASTM D1475 |
| Viscosity (25°C) | 200–500 cP | Brookfield |
| Compliance | FDA 21 CFR 173.340 / USP-NF / EU E900 / FCC / GRAS / Halal / Kosher | — |
| Packaging | 25 kg HDPE pail (tamper-evident) / 200 kg drum / 1 t IBC | — |
| Shelf life | 12 months sealed below 30°C | — |
FAQ
+Is MeFoam-FG approved for direct addition to beverage and dairy production?
Yes, within regulated limits. FDA 21 CFR 173.340 permits dimethicone-silica defoamer with 10 ppm max carry-over in finished product. Typical dosing 5–30 ppm in process water.
+What compliance documents come with each shipment?
CoA, FDA 21 CFR 173.340 letter, USP-NF certificate, EU E900 listing, GRAS reference, cGMP audit summary. Halal/kosher on request (1–2 week lead time).
+Can I substitute MeFoam-S or MeFoam-MO for MeFoam-FG in fermentation?
No. MeFoam-S and MeFoam-MO lack FCC/USP compliance. Using either in pharmaceutical or food production would fail USP-NF residual-impurity testing and FDA audit.