Tubing, gaskets, valves, profiles and LSR parts in silicone tested under FDA 21 CFR 177.2600, CE 1935/2004 and BfR IX/XV for cold rooms, stainless steel tanks, fermenters, bakery ovens, packaging lines and thermoformers. Resistance to steam, oils, fats and CIP/SIP agents in ISO 8 cleanroom under ISO 9001.
Elastomeric components in food production and packaging are in direct contact with product, refrigerated environment or wide thermal cycles (cold room at −25 °C, fermenter at 30 °C, bakery oven at 250 °C). European regulation CE 1935/2004 and EU Regulation 10/2011 set the general framework; FDA 21 CFR 177.2600 covers the United States; BfR IX/XV adds the German control. Each formulation undergoes migration testing before series approval, and each batch ships with a unique number and CoA on file.
Migration testing of the formulation under FDA 21 CFR 177.2600 (USA), CE 1935/2004 + EU Regulation 10/2011 (Europe), BfR IX and XV (Germany) and Arrêté of 25/11/1992 (France). Progress catalogue series with full coverage are S01, S02, S07, S09, S10, S12, S14, S15, S20, S22 and S30.
Operation between −25 °C in cold room, 30-40 °C in fermenter, 80-95 °C in pasteurisation, 121-134 °C in autoclave and up to +230 °C in bakery oven (+315 °C transient peaks). Series S09 and S20 cover the high range; S14 is optimised for autoclave steam; S12 covers the intermediate all-purpose range.
Resistance to alkaline agents (NaOH 2-5 %), acids (HNO₃ 0.5-2 %), chlorinated agents, hydrogen peroxide and saturated steam in repeated cycles. Series S14 in the Progress catalogue is specifically qualified for autoclave and steam without loss of mechanical properties.
Pigments certified for food contact under FDA / CE / BfR. Colour matching against RAL chart or customer reference. Each batch ships with a unique number, compound mechanical data sheet, ISO 3302-1 E1 / M2 dimensional control plan and certificate of conformity archived as per the sanitary audit protocol.
The Apt plant (France) runs extrusion and moulding of food-grade compounds under ISO 9001 in an ISO 8 cleanroom compliant with ISO 14644-1. Top Tech Silicones (Italy) provides food-grade LSR injection with six dedicated presses. Each batch ships with the compound CoA, mechanical data sheet and certificate of conformity referencing the applicable FDA / CE / BfR migration matrix.
European, US and French regulatory framework for elastomeric components in direct contact with food, beverages and dairy products. The specific coverage of each series depends on colourants and additives · always verified before series approval.
| Standard | Scope of application |
|---|---|
| FDA 21 CFR 177.2600 | Migration tests for rubber in contact with food · USA |
| CE 1935/2004 | European regulation on materials in contact with food · Europe |
| EU Regulation 10/2011 | Plastic materials and articles intended to come into contact with food |
| BfR IX | German recommendation · silicone rubber in contact with food |
| BfR XV | German recommendation · silicone seals for food use |
| Arrêté 25/11/1992 | French regulation · silicone in contact with food and beverages |
| Arrêté 5/08/2020 | French regulation · rubber for teats, soothers and breastfeeding articles |
| ISO 9001 | Quality management system |
| ISO 13485 | QMS for components in contact with regulated sectors (associated medical/pharma) |
| ISO 14644-1 | Cleanroom classes · ISO 8 room for hygienic production |
| ISO 17665 / 11135 / 11137 | Sterilisation by steam, ethylene oxide and gamma radiation |
| REACH (CE 1907/2006) | Registration, evaluation and restriction of chemical substances |
| RoHS (2015/863) | Restriction of hazardous substances in associated electrical equipment |
Four series in the Progress catalogue cover virtually all sector applications: all-purpose contact, high mechanical tear strength, steam and CIP/SIP resistance, and peristaltic pumping with added biocompatibility. The choice is driven by temperature, chemical exposure and type of contact (solid, liquid, steam).
Platinum-cure VMQ · Shore A 20-90 (widest range in the platinum-cure catalogue) · range −60 / +200 °C (+300 °C transient). Translucent version for visual obstruction detection. FDA + CE 1935 + BfR + ISO 10993 + USP VI coverage when the colourant allows. Main application of the catalogue.
Platinum-cure VMQ · Shore A 40-80 · high tear (33-55 kN/m) · no volatile by-products. FDA + CE 1935 + BfR + USP VI coverage. For tubing, gaskets and moulded parts with added mechanical demands — stainless steel tanks, transfer lines, fermenter sealing.
Peroxide-cure VMQ · Shore A 60-70 · range −60 / +200 °C. Optimised for saturated steam, coolant and oils in repeated CIP/SIP cleaning cycles. FDA + BfR IX/XV. For autoclave gaskets, fermenters, pasteurisation lines and equipment with in-line sterilisation.
Platinum-cure VMQ · Shore A 50-65 · range −60 / +180 °C (+215 °C transient). Resistance to repeated deformation (controlled CSR) for peristaltic transfer pumps, dosing and aseptic filling. FDA + USP VI + ISO 10993 — suitable for dual regulated markets (food and biotech).
The base polymer arrives with the supplier CoA and declaration of compliance FDA 21 CFR 177.2600, CE 1935/2004, BfR IX and XV. Each banbury assigns a unique batch number maintained from formulation through to final packaging — mixing, calendering, extrusion or injection, post-curing in a sealed stainless steel oven, dimensional control and packaging under hygienic conditions.
Each shipment ships with a certificate of conformity referencing the applicable migration matrix, the compound mechanical data sheet (tensile NF ISO 37, Shore A hardness NF ISO 7619-1, compression set NF ISO 815-1), the ISO 3302-1 E1 (extrusion) or M2 (moulding) dimensional control plan, and REACH / RoHS records. The file is archived as per the sanitary audit protocol.
Reference catalogue with the most requested families: cold rooms, beer and wine fermenters, bakery ovens, packaging lines and thermoformers, dairy equipment, coffee machines and milk dispensers, stainless steel tanks and hygienic hatches.
| Product | Typical application in the sector | Data sheet |
|---|---|---|
| Food-grade hoses | Liquid transfer, filling and dosing on packaging lines | View details |
| Peristaltic hoses | Peristaltic transfer pumps, dosing of juice, milk and beverages | View details |
| High-temperature hoses | Bakery ovens 230-250 °C, pasteurisation and sterilisation ducts | View details |
| Reinforced hoses | Pressurised lines, tank-to-tank transfer, pumping of solid product | View details |
| Food-grade LSR injection | Valves, connectors, coffee machine components, milk dispensers | View details |
| Vulcanised seals | Cold-room door, beer fermenters, bakery ovens | View details |
| Platinum-cured O-rings | Stainless steel wine tanks, flanged connections, hygienic closure systems | View details |
| Flat gaskets | Sealing of thermoformers, packaging equipment and hygienic hatches | View details |
| Inflatable seals | Cold-room doors and entry of process cleanrooms | View details |
Send us the process context (packaging, dosing, preservation, fermentation, baking), thermal demands, CIP/SIP cleaning frequency, type of contact (liquid, solid, steam) and applicable standards (FDA, CE 1935, BfR, EU Regulation 10/2011, French Arrêté). We confirm the applicable series (S12, S10, S14 or S30), available migration coverage, group plant and lead time for tested samples. No order commitment.
