Flange Clamp Fitting for Peristaltic Pump Tubing Systems

Overview

The Flange Clamp Fitting (Model 31805-01) is a precision-engineered mechanical coupling component designed specifically for secure, leak-tight integration of peristaltic pump tubing into fluid handling systems within regulated laboratory and pilot-scale process environments. Unlike threaded or barbed connectors, this flange-style clamp utilizes radial compression force applied via stainless steel clamping bands to uniformly compress an elastomeric gasket between two mating flanged surfaces—ensuring consistent sealing performance across repeated assembly/disassembly cycles. Its design conforms to standard DIN 11851 and ISO 2852 sanitary interface geometries, enabling interoperability with peristaltic pump heads, bioreactor manifolds, and single-use fluid path assemblies. The fitting supports continuous operation under pressures up to 6 bar (87 psi) at ambient temperatures and is rated for repeated autoclaving (121 °C, 20 min, saturated steam), making it suitable for applications requiring sterility assurance in pharmaceutical QC labs and cell culture workflows.

Key Features

• Stainless steel 316 body and clamp band for corrosion resistance and cleanability in aggressive solvents and cleaning agents
• EPDM or silicone gasket options available—certified compliant with USP Class VI and FDA 21 CFR 177.2600 for food-contact and pharmaceutical use
• Tool-free installation using integrated lever-actuated cam mechanism; achieves full seal in ≤3 seconds
• Zero dead-leg design minimizes hold-up volume (<0.15 mL per joint) and facilitates complete system drainage and CIP/SIP validation
• Reusability validated for ≥200 thermal cycles (autoclave) and ≥500 mechanical engagement cycles without gasket extrusion or clamp fatigue

Sample Compatibility & Compliance

This flange clamp fitting is compatible with standard peristaltic pump tubing sizes ranging from 1/4″ to 3/8″ (6.4–9.5 mm) ID, including Pharmapure® silicone, Tygon® LFL, and Viton®-lined reinforced elastomers. It maintains dimensional stability when mated with pump heads from Watson-Marlow, Masterflex®, and Cole-Parmer peristaltic systems. All materials comply with ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation/sensitization), and EU Regulation (EC) No. 1935/2004 for materials intended to come into contact with medicinal products. Documentation includes material traceability certificates, RoHS 2011/65/EU declaration, and REACH SVHC screening reports.

Software & Data Management

While the Flange Clamp Fitting itself is a passive mechanical component, its integration into automated peristaltic pump systems enables full traceability when paired with controllers supporting IEC 62443-compliant communication protocols (Modbus TCP, EtherNet/IP). When used in GMP environments, the fitting’s batch-specific serial numbering allows linkage to electronic batch records (EBRs) and audit trails in validated LIMS or MES platforms. Installation events—including torque verification logs and gasket replacement timestamps—can be captured via digital torque wrench interfaces and synchronized with 21 CFR Part 11–compliant electronic signatures where required.

Applications

• Continuous media feeding in mammalian cell culture bioreactors (per USP guidance)
• Buffer delivery in chromatography skids during purification process development
• Sanitary transfer of sterile filtrates in aseptic filling line pre-validation studies
• Integration into single-use bioprocessing assemblies per ASTM F3073 standards
• High-integrity connections in analytical sample introduction lines for HPLC and ICP-MS systems

FAQ

Is this fitting compatible with both fixed-speed and variable-frequency drive (VFD) peristaltic pumps?
Yes—mechanical integrity is independent of pump motor control strategy; however, vibration damping characteristics should be verified when operating above 120 rpm in high-flow configurations.
Can the gasket be replaced in situ without disassembling adjacent tubing sections?
Yes—the clamp design permits partial loosening to extract and replace the gasket while retaining flange alignment and tubing positioning.
Does the model number 31805-01 indicate a specific pressure or temperature rating?
No—the suffix denotes configuration variant (e.g., gasket material, flange thickness); full pressure/temperature ratings are defined in the certified test report accompanying each shipment.
Are calibration certificates provided with each unit?
Not applicable—this is a passive mechanical fitting; dimensional conformity is verified per ASME B16.5 Annex F and documented in the Certificate of Conformance.
What documentation is included for regulatory submissions (e.g., FDA IND/BLA filings)?
Material declarations, biocompatibility summaries, and manufacturing process flow diagrams are supplied upon request for inclusion in Device Master Records (DMRs) or Quality Agreements.