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 (food-chemicals-codex compliant PDMS) + USP-grade hydrophobic silica + food-additive-class emulsifier blend. Used in fermentation reactors, food processing, beverage manufacturing, dairy, and pharmaceutical processes where the defoamer enters the food/drug stream and toxicology compliance is mandatory. 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.
MeFoam-FG is the food-grade silicone defoamer compound built from three regulated-compliance components: (1) FCC-grade (Food Chemicals Codex) dimethicone — purified PDMS with low cyclic siloxane content (D4, D5, D6 below FCC limits), low metal residue (Pt, Sn, Pb below ICP-MS limits), and certified manufacturing under cGMP-equivalent quality systems; (2) USP-grade hydrophobic silica nucleator — pharmaceutical-grade fumed silica surface-treated with HMDS and tested to USP-NF specifications for food-additive use; (3) food-additive-class emulsifier blend (typically polyethylene glycol or sorbitan ester at 1–3%) certified to GRAS (Generally Recognised As Safe) status under FDA 21 CFR 184/186.
SEMITECH supplies MeFoam-FG with a full compliance documentation packet: FDA 21 CFR 173.340 letter (defoaming agents in food processing); USP-NF dimethicone monograph compliance certificate; EU Regulation 1333/2008 E900 dimethylpolysiloxane food-additive listing; halal and kosher certification (Halal-MUI Indonesia, Kosher Star-K USA) on request; cGMP manufacturing audit summary. The compound conforms to a 10 ppm maximum carry-over limit in finished food product (FDA 21 CFR 173.340 specification) and a 100 ppm maximum dose in process water (food-processing application limit). Applications above these thresholds require regulatory pre-approval.
Defoaming Mechanism: FCC-PDMS Spreading + USP-Silica Nucleation
Same fundamental mechanism as MeFoam-S, but FCC/USP component certification meets food-process toxicology requirements.
MeFoam-FG operates by the standard silicone-defoamer spreading-rupture mechanism: FCC-grade dimethicone partitions to the air-water interface of foam bubbles via its low surface tension (~20 mN/m), spreads aggressively across the bubble film displacing surfactant and food-derived foam-stabilising proteins, and the USP-grade hydrophobic silica nucleator punctures the thinning bubble wall to complete rupture. Defoaming kinetics are similar to MeFoam-S: 10–30 second foam knockdown in standard surfactant test, 4–12 hour persistence at typical dosing levels.
- Dosing 5–50 ppm — fermentation reactor foam control (penicillin, citric acid, single-cell-protein)
- Dosing 10–100 ppm — food-processing wastewater (dairy, brewery, beverage)
- Dosing 5–50 ppm — pharmaceutical bioreactor and downstream-processing foam suppression
- Dosing 5–30 ppm — direct food-contact processes (sugar refining, fruit juice, edible-oil processing)
The compliance-driven application differentiates MeFoam-FG from the lower-cost MeFoam-S even though the chemistry is mechanically similar. Pharmaceutical fermentation (penicillin biosynthesis, monoclonal-antibody production, vaccine adjuvant manufacture) requires defoamer with full cGMP and USP-NF compliance documentation chain. Food-processing wastewater regulated under FDA 21 CFR 173.340 requires the defoamer to comply with the 10 ppm carry-over limit. Dairy and beverage process foam control requires E900 EU listing for European-market product. Choose MeFoam-FG specifically when these compliance pathways apply.
Applications & Formulation Guidance
Fermentation (largest), food processing, dairy, beverage, pharmaceutical bioreactor, edible-oil processing.
Industrial fermentation is the largest single application — penicillin and antibiotic fermentation, citric acid and amino acid bioprocessing, single-cell-protein production, ethanol fermentation. MeFoam-FG at 5–50 ppm continuous dosing into the fermentation reactor controls the foam load generated by protein and surfactant by-products of microbial metabolism. The FCC/USP compliance is mandatory because the finished product (antibiotic, organic acid, protein) is downstream of the fermentation broth and any defoamer carry-over is subject to USP-NF residual-impurity limits.
Food and beverage processing uses MeFoam-FG at 5–50 ppm in dairy CIP/SIP cleaning systems, brewery wort handling, fruit juice and edible-oil processing, sugar refining, and beverage carbonation systems. Pharmaceutical bioreactor and downstream processing uses MeFoam-FG at 5–50 ppm for cell-culture bioreactor foam control (CHO cells for monoclonal antibody, E. coli for recombinant protein, yeast for vaccine adjuvant) — the cGMP and USP-NF compliance documentation chain is mandatory for pharmaceutical regulatory approvals. Direct food-contact processes (sugar crystallisation, fruit juice deaeration, edible oil refining) use MeFoam-FG at 5–30 ppm — the lower dosing levels reflect the strict 10 ppm carry-over limit in finished food product.
Procurement, Compliance Documentation, Storage and Quality Control
CoA + full compliance documentation packet per shipment; 25 kg HDPE pail; 12-month sealed shelf life.
SEMITECH issues a CoA and compliance documentation packet on every batch with: viscosity at 25°C (Brookfield, target 200–500 cP), FCC dimethicone content (USP-NF method, target ≥85%), USP-grade silica content (gravimetric, target 5–8%), cyclic siloxane content (GC-MS, target D4 ≤500 ppm, D5 ≤500 ppm, D6 ≤300 ppm — well within FCC limits), heavy metal residue (ICP-MS, target Pb ≤1 ppm, Sn ≤1 ppm, Hg ≤0.1 ppm), microbial limits (USP-NF method, target TAMC ≤100 cfu/g, TYMC ≤10 cfu/g, absence of pathogens). Compliance packet includes FDA 21 CFR 173.340 letter, USP-NF monograph compliance certificate, EU E900 listing, GRAS notification reference, halal and kosher certificates (on request), cGMP manufacturing audit summary.
Standard packing 25 kg HDPE pails with food-contact-compliant tamper-evident seals; 200 kg HDPE drums for bulk fermentation plants; 1 t IBC totes for pharmaceutical-scale bioreactor customers (with full chain-of-custody documentation). MOQ 25 kg per grade. Lead time 2–3 weeks ex-Zhejiang to Asia ports, 4–6 weeks to Europe and North America after sea freight (compliance-document review at customs clearance can add 1–2 days). Air freight available for laboratory and qualification quantities (1–5 kg) within 5 working days of CoA approval. Storage: stable under ambient conditions; protect from microbial contamination by maintaining sealed packaging and using clean transfer equipment dedicated to food-grade applications. Shelf life 12 months sealed; 6 months for opened pails (microbial-limit re-test recommended for opened material beyond 6 months). REACH and regulatory: all standard food-additive regulatory pathways supported (FDA 21 CFR 173.340, USP-NF, EU 1333/2008 E900, GRAS, halal, kosher); FCC 13th Edition compliant.
MeFoam-FG is the compliance-critical food-grade defoamer — FCC-grade dimethicone + USP-grade silica, fully documented to FDA 21 CFR 173.340 / USP-NF / EU E900 specifications. Mandatory choice for fermentation, pharmaceutical bioreactor, food processing, dairy, beverage, and direct food-contact applications. 10 ppm finished-product carry-over limit; 100 ppm process-water dose limit.
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 dosing limits. FDA 21 CFR 173.340 specifies dimethicone-silica defoamer is permitted in food processing with a 10 ppm maximum carry-over limit in the finished food product. SEMITECH MeFoam-FG is FCC dimethicone + USP-grade silica, fully compliant with this regulation. Practical dosing for direct food-contact processes (sugar crystallisation, fruit juice deaeration, edible oil refining) is typically 5–30 ppm in process water, with engineering controls (filtration, separation) ensuring carry-over to finished product stays well below the 10 ppm threshold. Submit your specific process flow to SEMITECH technical service for application-specific compliance review before scaling.
+What compliance documents come with each MeFoam-FG shipment?
Full compliance documentation packet on every shipment: (1) Certificate of Analysis with quantitative results for dimethicone content, silica content, cyclic siloxane (D4/D5/D6), heavy metal residue (Pb/Sn/Hg), and microbial limits; (2) FDA 21 CFR 173.340 compliance letter; (3) USP-NF dimethicone monograph compliance certificate; (4) EU Regulation 1333/2008 E900 food-additive listing; (5) GRAS notification reference; (6) cGMP manufacturing audit summary. On request: halal certification (Halal-MUI Indonesia or equivalent), kosher certification (Star-K USA or equivalent), and customer-specific compliance letters for downstream regulatory submissions. Allow 1–2 weeks lead time for customer-specific compliance letter preparation.
+Can I substitute MeFoam-S or MeFoam-MO for MeFoam-FG in a fermentation application?
No. MeFoam-S and MeFoam-MO are industrial-grade silicone and mineral-oil defoamers without FCC-grade dimethicone certification or USP-NF compliance documentation chain. Using either in a fermentation reactor producing pharmaceutical product or food ingredient would: (1) fail USP-NF residual-impurity testing on the finished product; (2) fail FDA 21 CFR audit on the manufacturing record; (3) require regulatory re-submission of the manufacturing pathway with significant cost and delay. The cost premium of MeFoam-FG over MeFoam-S (typically USD 4–8/kg vs USD 1.7–2.5/kg) is fully justified by the avoided regulatory risk for pharmaceutical and food-contact applications. Use MeFoam-S/MO only in clearly non-food-contact industrial process applications where compliance is not required.
