Is SILICONE STAR/SD Suction & Pressure Silicone Hose suitable for sterile pharmaceutical transfer and compliant with FDA, USP Class VI, and EU 1935/2004?

Yes. SILICONE STAR/SD Suction & Pressure Silicone Hose is suitable for sterile pharmaceutical transfer and compliant with relevant standards. Its extruded translucent silicone inner layer meets FDA 21 CFR 177.2600, USP Class VI, European Pharmacopoeia 3.1.9, BfR XV, Journal Officiel Brochure 1227, and CE Directive 1935/2004, making it appropriate for hygienic, sterile pharmaceutical, biotechnological, food and beverage applications. The hose’s platinum-cured construction, AISI 316 stainless steel spiral, four polyester braids, and wide operating temperature range (-60°C to +180°C) provide mechanical strength, pressure/vacuum resistance (up to 736.6 mm Hg / 0.98 bar) and flexibility required for demanding sterile transfer processes.

Can SILICONE STAR/SD Suction & Pressure Silicone Hose be safely used for high-temperature sterilization cycles (e.g., autoclaving) without compromising its compliance with FDA, USP Class VI, and EU 1935/2004?

Yes. SILICONE STAR/SD Suction & Pressure Silicone Hose can be safely autoclaved and used in high-temperature sterilization cycles without compromising its stated regulatory compliance—provided the cycles remain within the hose’s specified temperature and pressure limits. The hose’s platinum-cured, extruded translucent silicone inner layer meets FDA 21 CFR 177.2600, USP Class VI, European Pharmacopoeia 3.1.9, BfR XV and EU 1935/2004, indicating suitability for sanitary and medical-grade applications. Its operating range of -60°C to +180°C covers standard autoclave temperatures (typically 121°C–134°C). Note the manufacturer’s statement that working pressure must be adjusted above +100°C; therefore ensure autoclave pressure/temperature profiles do not exceed the hose’s maximum allowable pressure at sterilization temperatures and avoid prolonged exposure beyond rated limits. Follow manufacturer installation, inspection and replacement guidance after repeated sterilization cycles to maintain performance and compliance.

SILICONE STAR/SD Suction & Pressure Silicone Hose

All products, Silicone hoses, Star series/

The suction and pressure hose, manufactured with advanced platinum-cured technology, is designed to meet the highest standards of safety and performance in demanding applications. Its extruded inner layer of translucent silicone ensures exceptional purity and compliance with FDA 21 CFR 177.2600, USP Class VI, European Pharmacopoeia 3.1.9, BfR XV, Journal Officiel Brochure 1227, and CE Directive 1935/2004, making it ideal for industries where hygiene and reliability are crucial. Reinforced with four durable polyester braids and a robust AISI 316 stainless steel spiral, the hose guarantees outstanding resistance to pressure and vacuum, withstanding up to 736.6 mm Hg (0.98 bar). The outer translucent silicone layer provides additional protection while maintaining flexibility and transparency. Engineered to operate in extreme conditions, it performs reliably within a wide temperature range from -60°C to +180°C, with a precise adjustment of working pressure above +100°C to ensure maximum safety. This combination of durability, compliance, and versatility makes it the perfect solution for pharmaceutical, biotechnological, food, and beverage processes where uncompromising quality is essential.

List of product variants

Article number	Product variant name	Nominal inner diameter	Working pressure [bar]
SO-SILICONESTAR-SD-10	SILICONE STAR/SD hose 9.5 mm	10	7.5
SO-SILICONESTAR-SD-13	SILICONE STAR/SD hose 12.7 mm	12	7.5
SO-SILICONESTAR-SD-19	SILICONE STAR/SD hose 19.05 mm	20	7.5
SO-SILICONESTAR-SD-25	SILICONE STAR/SD hose 25.4 mm	25	7.5
SO-SILICONESTAR-SD-32	SILICONE HOSE STAR/SD 31.8 mm	32	7.5
SO-SILICONESTAR-SD-38	SILICONE STAR/SD hose 38.1 mm	38	7.5
SO-SILICONESTAR-SD-51	SILICONE STAR/SD hose 50.8 mm	50	7.5

The suction and pressure hose, manufactured with advanced platinum-cured technology, is designed to meet the highest standards of safety and performance in demanding applications. Its extruded inner layer of translucent silicone ensures exceptional purity and compliance with FDA 21 CFR 177.2600, USP Class VI, European Pharmacopoeia 3.1.9, BfR XV, Journal Officiel Brochure 1227, and CE Directive 1935/2004, making it ideal for industries where hygiene and reliability are crucial. Reinforced with four durable polyester braids and a robust AISI 316 stainless steel spiral, the hose guarantees outstanding resistance to pressure and vacuum, withstanding up to 736.6 mm Hg (0.98 bar). The outer translucent silicone layer provides additional protection while maintaining flexibility and transparency. Engineered to operate in extreme conditions, it performs reliably within a wide temperature range from -60°C to +180°C, with a precise adjustment of working pressure above +100°C to ensure maximum safety. This combination of durability, compliance, and versatility makes it the perfect solution for pharmaceutical, biotechnological, food, and beverage processes where uncompromising quality is essential.