Is the Dynamic Cleanroom-Platinum suction and pressure silicone hose compatible with steam sterilization at +135Â°C and compliant with FDA, USP Class VI, and EC 1935/2004?

Yes. The Dynamic Cleanroom-Platinum suction and pressure silicone hose is compatible with steam sterilization at +135Â°C (validated for steam sterilization up to +135Â°C at 3.5 bar for 30 minutes) and is compliant with FDA, USP Class VI, and EC 1935/2004. The hoseâs inner PFA layer meets FDA and USP Class VI requirements (also D.M. 21/03/73 and EU Regulation No. 10/2011), the outer silicone layer meets USP Class VI, FDA, and European Pharmacopoeia standards, and the assembly is declared compliant with EC 1935/2004 and Commission Regulation (EU) 2023/2006 (GMP). It is free from animal-derived substances, phthalates, adipates and REACHârestricted materials.

Can the Dynamic Cleanroom-Platinum suction and pressure silicone hose be used with food-contact applications under EU and FDA regulations?

Yes. The Dynamic Cleanroom-Platinum suction and pressure silicone hose is suitable for food-contact applications under both EU and FDA frameworks: its inner layer meets FDA and EU Regulation No. 10/2011 requirements and USP Class VI/Italian D.M. 21/03/73; the outer layer meets USP Class VI, FDA and European Pharmacopoeia standards. The hose is compliant with EC 1935/2004 and manufactured under GMP (2023/2006/EC), free from animal-derived substances, phthalates, adipates and REACH-restricted materials. Note operating limits (steam sterilization up to +135Â°C), working pressures and bend radius apply; confirm specific food type and conditions (temperature, pressure, contact time) with supplier for final validation.

Does the Dynamic Cleanroom-Platinum suction and pressure silicone hose contain any animal-derived or REACH-restricted materials?

Dynamic Cleanroom-Platinum suction and pressure silicone hose does not contain animal-derived substances and is free from phthalates, adipates, and materials subject to restrictions under Directive EC 1907/2006 (REACH). The hose complies with EC 1935/2004 and 2023/2006/EC (GMP) and its inner and outer layers meet FDA, USP Class VI, D.M. 21/03/73, EU Regulation No. 10/2011 and European Pharmacopoeia requirements.

Dynamic Cleanroom-Platinum suction and pressure silicone hose

All products, Silicone hoses/

Additional information

Material	PFA/MFA/FEP – fluoropolymer
Maximum operating temperature [°C]	150
Minimum operating temperature [°C]	-30
Vacuum resistance	yes
Standard length [m]	15

Suction and pressure hose made according to platinum-enhanced technology. Steam sterilization (max. +135°C at 3.5 bar pressure for 30 min.). The inner layer meets FDA, USP Class VI, D.M. 21/03/73, and EU Regulation No. 10/2011 requirements. The outer layer meets USP Class VI, FDA, and European Pharmacopoeia standards. Hose compliant with EC 1935/2004 and 2023/2006/EC (GMP). Free from animal-derived substances, phthalates, adipates, and materials subject to restrictions of Directive EC 1907/2006 (REACH). Safety factor 3:1. The specified bend radius applies to static pressure. Working pressure (20°C): from 4 bar to 10 bar, depending on hose diameter. Inner layer: white smooth fluoropolymer PFA. Dynamic. Reinforcement: polyester braiding, AISI 302 steel spiral. Outer layer: transparent silicone. Operating temperature: from -30°C to +150°C.

List of product variants

Article number	Product variant name	Nominal inner diameter	Working pressure [bar]
MT-DYNAMIC-CP-13	DYNAMIC Cleanroom-Platinum hose 13x23 mm	12	10
MT-DYNAMIC-CP-19	DYNAMIC Cleanroom-Platinum hose 19x31 mm	20	10
MT-DYNAMIC-CP-25	DYNAMIC Cleanroom-Platinum hose 25x37 mm	25	9
MT-DYNAMIC-CP-38	DYNAMIC Cleanroom-Platinum hose 38x51 mm	38	7
MT-DYNAMIC-CP-51	DYNAMIC Cleanroom-Platinum hose 51x67 mm	50	6

Suction and pressure hose made according to platinum-enhanced technology. Steam sterilization (max. +135°C at 3.5 bar pressure for 30 min.). The inner layer meets FDA, USP Class VI, D.M. 21/03/73, and EU Regulation No. 10/2011 requirements. The outer layer meets USP Class VI, FDA, and European Pharmacopoeia standards. Hose compliant with EC 1935/2004 and 2023/2006/EC (GMP). Free from animal-derived substances, phthalates, adipates, and materials subject to restrictions of Directive EC 1907/2006 (REACH). Safety factor 3:1. The specified bend radius applies to static pressure. Working pressure (20°C): from 4 bar to 10 bar, depending on hose diameter. Inner layer: white smooth fluoropolymer PFA. Dynamic. Reinforcement: polyester braiding, AISI 302 steel spiral. Outer layer: transparent silicone. Operating temperature: from -30°C to +150°C.

Additional information

Material	PFA/MFA/FEP – fluoropolymer
Maximum operating temperature [°C]	150
Minimum operating temperature [°C]	-30
Vacuum resistance	yes
Standard length [m]	15