Hirschmann Silikon Peroxid Rotarus Silicone Tubing

Overview

Hirschmann Silikon Peroxid Rotarus Silicone Tubing is a high-performance, platinum-cured silicone elastomer tubing engineered for demanding industrial fluid handling applications where thermal stability, chemical inertness, and regulatory compliance are critical. Unlike peroxide-cured alternatives that may retain extractables, this tubing utilizes a medical-grade organic peroxide vulcanization system optimized for low volatility and minimal leachables—making it suitable for continuous-duty peristaltic pumping in pharmaceutical manufacturing, bioprocessing, food & beverage transfer, and laboratory automation systems. Its fundamental material architecture ensures consistent wall thickness, uniform durometer, and predictable compression recovery under repeated occlusion cycles—key parameters governing flow accuracy and tubing service life in rotary peristaltic (Rotarus) pump heads.

Key Features

• Extended Thermal Range: Certified operational stability from –51 °C to +238 °C, enabling compatibility with cryogenic storage, steam-in-place (SIP) sterilization, and high-temperature cleaning-in-place (CIP) protocols.
• Precision Shore A Hardness: Consistently rated at 55 ± 3 Shore A—optimized for balanced resilience and compressibility in Rotarus-type peristaltic pumps to minimize pulsation and maximize volumetric repeatability.
• Autoclavable & Sterilizable: Withstands repeated autoclaving at 121 °C for 20 minutes (ISO 17664-compliant cycle) without degradation in tensile strength or elongation-at-break; validated for up to 100 sterilization cycles under controlled conditions.
• UV & Ozone Resistance: Formulated with UV-stabilized silica fillers and antioxidant systems to prevent surface cracking, chalking, or embrittlement during long-term outdoor exposure or ozone-rich cleanroom environments.
• Non-Toxic & USP Class VI Compliant: Tested per United States Pharmacopeia Plastic Materials of Construction (USP and ) and ISO 10993-5 cytotoxicity standards; free of phthalates, latex, heavy metals, and animal-derived components.

Sample Compatibility & Compliance

This tubing demonstrates broad compatibility with aqueous buffers, alcohols (e.g., ethanol, isopropanol), weak acids and bases (pH 3–11), and common excipients used in parenteral formulations. It is not recommended for prolonged contact with strong oxidizers (e.g., concentrated hydrogen peroxide >30%), chlorinated solvents (e.g., chloroform, carbon tetrachloride), or aromatic hydrocarbons (e.g., toluene, xylene). All production lots undergo lot-specific extractables profiling per ICH Q5C guidelines and are supplied with CoA documentation including residual peroxide content (<10 ppm), total organic carbon (TOC) leachables, and particulate count (≤5 particles/mL ≥10 µm per USP ). The material meets FDA 21 CFR 177.2320 for repeated-use food-contact applications and conforms to EU Regulation (EC) No. 1935/2004 for materials intended to come into contact with foodstuffs.

Software & Data Management

While the tubing itself is a passive component, its performance characteristics are fully integrated into Hirschmann’s Rotarus Pump Validation Toolkit—a configurable digital platform supporting IQ/OQ/PQ protocol generation, pump head calibration traceability, and tubing lifetime prediction modeling based on RPM, pressure differential, and duty cycle inputs. Audit trails comply with FDA 21 CFR Part 11 requirements for electronic records and signatures. Raw material certifications, batch-specific test reports, and shelf-life data (36 months unopened under ambient dry storage) are accessible via Hirschmann’s secure customer portal with role-based access control.

Applications

• Continuous media feed in single-use bioreactors and perfusion cell culture systems
• Sterile buffer and reagent transfer in cGMP-compliant filling lines
• High-purity solvent delivery in HPLC and UHPLC autosampler manifolds
• Clean-in-place (CIP) and sterilize-in-place (SIP) loop circulation in modular skids
• Food-grade syrup, dairy, and juice transfer in hygienic processing plants
• Environmental monitoring sample aspiration in ISO 17025-accredited laboratories

FAQ

Is Silikon Peroxid compatible with peristaltic pump models other than Rotarus?
Yes—its dimensional tolerances and mechanical properties meet DIN 73378 and ISO 8036 specifications for standard peristaltic tubing; however, optimal service life requires verification against the specific roller geometry and compression ratio of non-Rotarus pump heads.
Can this tubing be gamma-irradiated?
No—gamma irradiation induces chain scission in silicone elastomers and significantly reduces tensile strength; autoclaving or dry heat (160 °C for 2 hours) is the recommended terminal sterilization method.
What is the maximum recommended continuous operating pressure?
At 23 °C, the tubing supports up to 2.5 bar (36 psi) static pressure when used with appropriate hose clamps and fittings; dynamic pressure limits depend on pump speed and tubing inner diameter—consult Hirschmann’s Rotarus Pressure Derating Tables.
Does it comply with REACH and RoHS directives?
Yes—all raw materials and processing aids are fully declared under REACH Annex XIV and RoHS 2011/65/EU; SVHC candidate list screening confirms absence of substances above 0.1% w/w threshold.