NiuYin PG16300 Benchtop Flat-Plate Filtration System

Overview

The NiuYin PG16300 Benchtop Flat-Plate Filtration System is an engineered solution for sterile, scalable, and chemically robust tangential or dead-end filtration in life science laboratories and pilot-scale bioprocessing environments. Designed around a modular flat-plate architecture, it operates on positive-pressure driven flow—compatible with both pressurized vessels and peristaltic pump sources—to achieve high-efficiency clarification, sterilizing-grade removal of microorganisms (≥0.22 µm), and particulate retention across diverse liquid streams. Its construction adheres to core principles of pharmaceutical process equipment design: full traceability of wetted materials, surface finish compliance with ASME BPE-2022 (electropolished 316L SS, Ra ≤ 0.4 µm), and geometric configuration enabling complete drainage and minimal hold-up volume. The system supports both single- and double-layer membrane configurations, allowing users to configure for either high-throughput prefiltration or final sterile filtration stages under controlled pressure regimes up to 0.8 MPa.

Key Features

• Wetted components fabricated from ASTM A240 UNS S31603 stainless steel, electropolished to ASME BPE-2022 specifications (Ra ≤ 0.4 µm) for corrosion resistance and cleanability.
• PTFE (polytetrafluoroethylene) coating applied to all internal surfaces in contact with process fluid—eliminating metal ion leaching and extending chemical compatibility to aggressive solvents including acetone, THF, concentrated acids, and alkaline buffers.
• Hygienic clamp-type quick-release inlet/outlet connections conforming to DIN 11851 and ISO 2852 standards—enabling tool-free assembly, rapid membrane exchange, and full visual inspection of gasket seating.
• Four standard filter area options (63.5–572.2 cm²) accommodate scalable testing—from small-volume cell culture media screening (Φ100 mm) to pilot-scale buffer clarification (Φ300 mm).
• Double O-ring silicone gasket design ensures leak-tight sealing under thermal cycling; gaskets meet USP Class VI biocompatibility and FDA 21 CFR 177.2600 requirements.
• Fully autoclavable: validated for repeated steam sterilization at 121°C for 30 minutes without dimensional drift or surface degradation.

Sample Compatibility & Compliance

The PG16300 is routinely deployed in applications requiring strict adherence to current Good Manufacturing Practice (cGMP) and Good Laboratory Practice (GLP) frameworks. It supports filtration of aqueous and organic-phase solutions—including cell culture supernatants, protein formulations, ophthalmic solutions, vitamin suspensions, photoresists, and cosmetic emulsions—without compromising membrane integrity or introducing extractables. All material certifications (EN 10204 3.1, RoHS, REACH) are provided upon request. The system satisfies critical regulatory expectations for sterilizing filtration validation per ISO 13408-1 and USP , and its design facilitates filter integrity testing via forward flow or bubble point methods post-use. Surface finish and weld documentation comply with EU Annex 1 (2022) requirements for sterile processing equipment.

Software & Data Management

While the PG16300 is a manually operated, non-electronic filtration platform, its mechanical design integrates seamlessly into digitally governed workflows. Pressure transducers (optional add-on) interface with LabVIEW™, DeltaV™, or SCADA systems via 4–20 mA output for real-time monitoring of differential pressure across the membrane—enabling automated endpoint detection and batch record generation. All hardware components support audit trail-ready documentation under FDA 21 CFR Part 11 when paired with validated electronic lab notebooks (ELNs) or MES platforms. Calibration records, sterilization logs, and membrane lot traceability are maintained per ISO 9001:2015 and ICH Q5A(R2).

Applications

• Sterile filtration of cell culture media, buffers, and final drug product intermediates in biomanufacturing R&D labs.
• Clarification of fermentation broths and lysates prior to chromatographic purification.
• Pre-filtration of ophthalmic solutions (e.g., artificial tears, antibiotic eye drops) meeting USP particulate limits.
• Removal of catalyst residues and particulates from photoresist formulations used in semiconductor lithography.
• Stabilization and purification of cosmetic actives (vitamins, peptides, botanical extracts) in aqueous/alcoholic matrices.
• GMP-compliant filtration validation studies supporting ANDA, BLA, or MAA submissions.

FAQ

Is the PG16300 suitable for use with organic solvents such as DMF or DMSO?

Yes—the PTFE-coated wetted surfaces and silicone gaskets provide broad compatibility with polar aprotic solvents; consult the chemical resistance matrix for exposure duration limits.

Can the unit be integrated into a closed-system bioprocess train?

Yes—hygienic clamp interfaces allow direct connection to tubing manifolds, peristaltic pumps, and stainless-steel holding bags per ISO 5600 and ASTM F2755 standards.

Does the system support integrity testing per ASTM F838-22?

Yes—flat-plate geometry enables reliable forward flow and bubble point measurements using standard test fixtures and certified reference filters.

What documentation is supplied with each unit?

Material Certificates (EN 10204 3.1), surface finish reports, weld maps, sterilization validation summaries, and USP Class VI gasket certification.

Is replacement membrane holder geometry standardized across models?

Yes—all PG-series holders follow ISO 8536-4 dimensions for Φ100–Φ300 mm membranes, ensuring cross-model interchangeability and third-party filter compatibility.