YG-2000 Cylindrical Pressure Filtration Unit
| Key | Material: 304 or 316L stainless steel |
|---|---|
| Capacity | 2000 mL |
| Filter Disc Diameter | Φ150 mm |
| Inlet Port Diameter | 6 mm |
| Outlet Port Diameter | 9 mm |
| Outlet Height Options | 19 cm or 28 cm (from work surface) |
| Total Height | 46 cm |
| Water Flow Rate | 2.2 L/min (at 0.2 MPa, with 0.22 µm membrane) |
| Maximum Operating Pressure | 0.6 MPa |
| Compliance | Designed for sterile filtration per ISO 8573-1 (compressed air quality), compatible with USP <788> particulate matter testing workflows |
Overview
The YG-2000 Cylindrical Pressure Filtration Unit is a precision-engineered, benchtop sterile filtration system designed for reliable, high-integrity removal of microorganisms and particulates from heat-labile liquids in regulated life science environments. Utilizing positive-pressure-driven crossflow through vertically mounted, disposable membrane filters, the unit operates on fundamental principles of depth and surface retention—optimized for bacterial retention (≥ log 7 reduction of Brevundimonas diminuta) when paired with certified 0.22 µm pore-rated membranes. Its cylindrical pressure vessel architecture ensures uniform flow distribution, minimal dead volume, and full drainability—critical attributes for Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) compliance in pharmaceutical, biotech, and clinical research settings.
Key Features
- Robust 304 or electropolished 316L stainless steel construction—resistant to corrosion from organic solvents, acids, alkalis, and sterilants including hydrogen peroxide vapor (HPV) and saturated steam (up to 121°C, 20 min autoclave cycles)
- Smooth, Ra ≤ 0.8 µm internal surface finish—reducing biofilm adhesion and enabling validated cleaning-in-place (CIP) protocols
- Modular inlet/outlet configuration with standardized 6 mm (¼″ NPT) gas inlet and 9 mm (⅜″ NPT) liquid outlet ports—compatible with common lab-grade pressure regulators, sterile tubing, and vacuum/pressure manifolds
- Two fixed outlet height options (19 cm and 28 cm)—allowing ergonomic integration beneath laminar flow hoods or into collection flask stands without repositioning
- Maximum working pressure rating of 0.6 MPa (6 bar)—validated for sustained operation at 0.2–0.4 MPa typical process range, ensuring consistent flux and membrane integrity under load
- No internal gaskets or O-rings in fluid path—eliminating leachable contaminants and simplifying validation of extractables and leachables (E&L) per ICH Q5C and USP
Sample Compatibility & Compliance
The YG-2000 supports filtration of aqueous and low-viscosity organic solutions—including cell culture media, serum-free formulations, buffer stocks, IV admixtures, and diagnostic reagents—without compromising sterility or protein stability. It accommodates standard Φ150 mm disc membranes (e.g., PVDF, PES, nylon, or mixed cellulose ester) and is routinely deployed in pre-filtration steps prior to final 0.22 µm sterilizing grade filtration per ISO 13408-1. The unit meets mechanical design requirements outlined in ASME BPE-2022 for single-use and reusable systems and is suitable for use in environments requiring adherence to FDA 21 CFR Part 11 (when integrated with compliant digital pressure logging), EU Annex 1 (sterile processing), and ISO 14644-1 Class 5 cleanroom operations.
Software & Data Management
As a standalone mechanical filtration device, the YG-2000 does not incorporate embedded electronics or firmware. However, it is fully compatible with external pressure monitoring systems (e.g., digital gauges with 0.01 MPa resolution and ±0.005 MPa accuracy) and data acquisition platforms supporting CSV export and audit-trail generation. When used within validated processes, operators record critical parameters—including applied pressure, filtration time, temperature, and membrane lot number—in paper-based or electronic batch records aligned with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available).
Applications
- Sterile filtration of microbial growth media prior to dispensing into Petri dishes or bioreactor bags
- Clarification and endotoxin-reduction of monoclonal antibody harvest streams during downstream purification development
- Pre-sterilization filtration of radiopharmaceutical eluates in nuclear medicine departments
- Particulate control in ophthalmic solution manufacturing per USP light obscuration testing protocols
- Routine quality control of injectable excipients—including polysorbate 80, glycerol, and sodium chloride solutions—in QC laboratories
- Process validation studies for filter compatibility, extractables screening, and bubble point testing per ASTM F838-22
FAQ
What membrane types are validated for use with the YG-2000?
The unit is compatible with all commercially available Φ150 mm disc membranes rated for sterilizing-grade filtration (0.1 µm, 0.22 µm, and 0.45 µm), including hydrophilic PES, low-protein-binding PVDF, and sterilizing-grade nylon.
Can the YG-2000 be autoclaved?
Yes—units constructed from 316L stainless steel with electropolished surfaces may undergo repeated autoclaving at 121°C for 20 minutes; verify seal integrity and pressure rating after each cycle.
Is the YG-2000 suitable for GMP production environments?
It is qualified for use in GMP manufacturing as a non-product-contact auxiliary system when included in equipment qualification (IQ/OQ/PQ) documentation and operated within defined pressure and temperature limits.
How is integrity testing performed post-filtration?
Standard forward-flow, bubble point, or diffusion test methods per ASTM F316-21 may be conducted using an external integrity tester connected via the inlet port; the unit’s sealed chamber design ensures reliable test execution.
Does the YG-2000 support tangential flow filtration (TFF)?
No—it is configured exclusively for normal-flow (dead-end) filtration; TFF applications require dedicated hollow-fiber or cassette-based systems with recirculation manifolds.
