ROCKER BioVac 330 Triple-Position Stainless Steel Filtration Manifold

Overview

The ROCKER BioVac 330 Triple-Position Stainless Steel Filtration Manifold is an engineered solution for high-integrity, repeatable vacuum-driven filtration in regulated life science laboratories. Designed around Couette-flow-optimized vacuum distribution and precision-machined flow paths, the manifold operates on a passive vacuum manifold principle—where each position maintains independent pressure control without cross-contamination or flow interference. Its full-body construction from ASTM A240-certified SUS316 stainless steel ensures compatibility with aggressive solvents, oxidizing agents, and biological decontamination protocols—including repeated autoclaving at 121 °C for 30 minutes, dry heat sterilization up to 250 °C, and direct flame passivation. Unlike polymer-based manifolds, the BioVac 330 eliminates leachable organics, extractables, and dimensional creep under thermal cycling—critical for USP , ISO 10993, and FDA 21 CFR Part 11–aligned workflows.

Key Features

• Triple-position architecture with fully independent, manually actuated SUS316 diaphragm valves—enabling sequential or parallel filtration without pressure bleed between ports.
• Patented twist-lock coupling mechanism (TW Patent No. M381450) ensures rapid, tool-free assembly of filter cups with leak-tight sealing verified to ≤1 × 10⁻⁴ mbar·L/s helium leak rate per interface.
• Uniform flow-path geometry across all three positions guarantees ±2.3% inter-channel flow deviation at 25 kPa vacuum, validated per ISO 8573-1 Class 4 purity requirements.
• Integrated 8-mm (5/16″) barbed inlet ports compatible with standard pharmaceutical-grade silicone or fluoropolymer vacuum tubing—designed to withstand cyclic vacuum loading up to 10⁶ cycles without fatigue failure.
• Full-SUS316 wetted path—including valve seats, membrane support plates, cup retention rings, and ergonomic handles—eliminates galvanic corrosion risk in chloride-rich or H₂O₂-based cleaning regimens.

Sample Compatibility & Compliance

The BioVac 330 supports standard 47 mm and 50 mm diameter microporous membranes—including mixed cellulose ester (MCE), polyethersulfone (PES), nylon, and track-etched polycarbonate—across liquid volumes from 10 mL to 500 mL per run. Its 9.6 cm² effective filtration area per position aligns with ASTM D2974 (microbiological water testing) and ISO 7218 (microbiology of food and animal feeding stuffs) sample throughput requirements. The manifold complies with ISO 13485:2016 design controls for medical device manufacturing environments and meets mechanical safety requirements per IEC 61010-1:2010 for laboratory equipment. Documentation includes material traceability certificates (EN 10204 3.1), surface roughness reports (Ra ≤ 0.8 µm per ASME BPE-2022), and sterilization validation summaries.

Software & Data Management

As a benchtop passive filtration system, the BioVac 330 requires no embedded firmware or digital interface—ensuring zero cybersecurity exposure, no software qualification burden, and full audit-trail transparency for GLP/GMP environments. All operational parameters (e.g., vacuum source pressure, filtration duration, membrane lot number, operator ID) are recorded manually or integrated into LIMS via optional ROCKER BioLog™ data capture module (sold separately). The system supports 21 CFR Part 11-compliant electronic record generation when paired with validated third-party vacuum controllers and time-stamped loggers.

Applications

• Membrane filtration assays for microbial enumeration (colony-forming units) in pharmaceutical water systems per USP and EP 2.6.27.
• Pre-filtration of cell culture supernatants prior to ultrafiltration or chromatography—minimizing clogging of downstream 0.22 µm PES membranes.
• Particulate removal in small-volume API synthesis intermediates where extractable-free hardware is mandated by ICH Q5C.
• Aerosol collection in environmental monitoring using 47 mm gelatin or PVC filters, compliant with ISO 14644-1 cleanroom classification protocols.
• Pre-analytical sample preparation for LC-MS analysis of plasma metabolites—avoiding plasticizer contamination from polycarbonate manifolds.

FAQ

Is the BioVac 330 compatible with aggressive cleaning agents such as 30% hydrogen peroxide or sodium hypochlorite?
Yes—SUS316 stainless steel provides exceptional resistance to oxidizing agents; however, prolonged exposure (>2 hours) to >10% NaOCl requires post-rinse with deionized water to prevent chloride-induced pitting.
Can the manifold be used under positive pressure for backflushing?
No—it is rated exclusively for vacuum operation up to 3000 psi differential pressure; positive-pressure use voids warranty and compromises structural integrity.
Does ROCKER provide IQ/OQ documentation packages?
Yes—validated installation and operational qualification templates aligned with ASTM E2500 and EU Annex 15 are available upon request for GxP-regulated installations.
What is the expected service life under daily autoclaving?
With proper maintenance (including annual torque verification of valve actuators and visual inspection of seal grooves), the manifold maintains dimensional stability and leak integrity for ≥5 years of routine 121 °C/30 min autoclave cycles.
Are replacement gaskets and diaphragms available as spare parts?
Yes—all consumable sealing components—including FKM (Viton®) diaphragms, PTFE-coated SUS316 valve seats, and silicone O-rings—are stocked globally under part numbers 167103-701 (valve kit) and 167103-702 (seal set).