Is the Reinforced silicone hose PHARMATECH compatible with repeated steam sterilization at +135Â°C without affecting its hydrophobic properties or safety certifications?

Yes. Reinforced silicone hose PHARMATECH is compatible with repeated steam sterilization at +135Â°C. Its specification explicitly lists sterilization by steam at +135Â°C, and the hose is manufactured from platinum-cured (platinum-enhanced) silicone with a smooth, hydrophobic inner layer that resists contamination adhesion. The material and construction (translucent silicone inner and outer layers with polyester braid reinforcement) support high-temperature sterilization within the stated operating range (â60Â°C to +200Â°C). Additionally, compliance with FDA requirements, USP Class VI, European Pharmacopoeia 3.1.9, and EC 1935/2004 and EC 2023/2006 (GMP) indicates retained biocompatibility and safety credentials under validated sterilization processes. The provided safety factor (3:1) and suitability for alternative sterilization methods (argon, cobalt) further support its robustness.

Can Reinforced silicone hose PHARMATECH be safely sterilized using argon or cobalt without compromising its hydrophobic surface or certifications?

Reinforced silicone hose PHARMATECH can be safely sterilized using argon or cobalt as alternative methods according to its specification. The hose is described as high-quality hydrophobic pressure hose manufactured with platinum-enhanced technology, with a smooth, non-contaminant-adhesive surface and explicit allowance for sterilization by steam at +135Â°C or alternatively by argon, cobalt. Its materials and certifications (FDA, USP Class VI, European Pharmacopoeia 3.1.9, EC 1935/2004 and EC 2023/2006 GMP) indicate biocompatibility and process control consistent with these sterilization methods. The platinum-cured silicone construction, polyester braid reinforcement and operating range (-60Â°C to +200Â°C) support resistance to such sterilization without compromising hydrophobic surface or stated certifications, provided recommended parameters and validation protocols are followed.

Does Reinforced silicone hose PHARMATECH maintain FDA, USP VI and EP compliance after repeated sterilization cycles?

Reinforced silicone hose PHARMATECH Format is manufactured and certified to meet FDA, USP Class VI and European Pharmacopoeia (EP 3.1.9) requirements and is specified as sterilizable by steam at +135Â°C (also by argon or cobalt). These certifications and the stated sterilization method indicate the hose is designed to retain compliance when subjected to validated sterilization cycles compatible with its materials and construction (platinum-cured silicone inner and outer layers, polyester braid reinforcement). However, continued compliance after repeated sterilizations depends on following validated sterilization parameters and routine verification. Key points: - The hoseâs operating temperature range (â60Â°C to +200Â°C) and specified steam sterilization at +135Â°C show material suitability for standard autoclave cycles. - Platinum-cured silicone and smooth hydrophobic surface reduce degradation and contamination adhesion, supporting durability through multiple cycles. - Reinforcement with a polyester braid provides a safety factor of 3:1 but may limit long-term exposure to repeated high-temperature/chemical sterilization compared with fully metallic reinforcements. - To ensure ongoing FDA/USP/EP compliance in your application, perform and document a validation protocol: repeated-cycle aging/sterilization tests, material extraction/biocompatibility re-testing if required by USP VI, and physical integrity/leakage/permeation assessments after the intended number of cycles. Conclusion: Reinforced silicone hose PHARMATECH Format is designed to maintain compliance through sterilization at +135Â°C when used and sterilized according to validated procedures, but confirmation for ârepeatedâ cycles requires application-specific validation and periodic re-testing to document continued conformity.

Reinforced silicone hose PHARMATECH

All products, Silicone hoses/

Additional information

Material	VMQ – silicone
Maximum operating temperature [°C]	200
Minimum operating temperature [°C]	-60
Vacuum resistance	check
Standard length [m]	10, 25, 40, 50

High-quality hydrophobic pressure hose manufactured using platinum-enhanced technology. Odorless and tasteless. Smooth surface prevents contamination adhesion. Sterilization by steam at +135°C, alternatively by argon, cobalt. Compliant with FDA requirements, USP Class VI, European Pharmacopoeia 3.1.9, and directives EC 1935/2004 and EC 2023/2006 (GMP). Safety factor 3:1. Inner layer: translucent silicone. Reinforcement: polyester braid. Outer layer: translucent silicone. Operating temperature: from -60°C to +200°C.

List of product variants

Article number	Product variant name	Nominal inner diameter	Working pressure [bar]
MT-PHARMATECH-05	PHARMATECH hose 4.76x11.3 mm	5	15
MT-PHARMATECH-06	PHARMATECH hose 6.35x13.2 mm	6	14
MT-PHARMATECH-08	PHARMATECH hose 7.93x15 mm	8	12
MT-PHARMATECH-10	PHARMATECH hose 9.52x16.6 mm	10	11
MT-PHARMATECH-13	PHARMATECH hose 12.7x20.3 mm	12	9
MT-PHARMATECH-16	PHARMATECH hose 15.87x24.5 mm	16	8
MT-PHARMATECH-19	PHARMATECH hose 19.05x27.9 mm	20	6
MT-PHARMATECH-22	PHARMATECH hose 22.2x31.3 mm	22	5
MT-PHARMATECH-25	PHARMATECH hose 25.4x34.5 mm	25	5
MT-PHARMATECH-32	PHARMATECH hose 31.75x40.8 mm	32	4

High-quality hydrophobic pressure hose manufactured using platinum-enhanced technology. Odorless and tasteless. Smooth surface prevents contamination adhesion. Sterilization by steam at +135°C, alternatively by argon, cobalt. Compliant with FDA requirements, USP Class VI, European Pharmacopoeia 3.1.9, and directives EC 1935/2004 and EC 2023/2006 (GMP). Safety factor 3:1. Inner layer: translucent silicone. Reinforcement: polyester braid. Outer layer: translucent silicone. Operating temperature: from -60°C to +200°C.

Additional information

Material	VMQ – silicone
Maximum operating temperature [°C]	200
Minimum operating temperature [°C]	-60
Vacuum resistance	check
Standard length [m]	10, 25, 40, 50