Chuanyi ZW-808A Intelligent Sterile Filtration and Microbial Collection System

Overview

The Chuanyi ZW-808A Intelligent Sterile Filtration and Microbial Collection System is a compact, GMP-aligned microbiological isolation instrument engineered for sterility testing and microbial limit testing in regulated pharmaceutical, biotechnology, and medical device manufacturing environments. It operates on the principle of pressure-driven sterile filtration using peristaltic pumping to draw liquid samples through certified 0.22 µm or 0.45 µm membrane filters housed within single-use, fully enclosed sterile filtration assemblies (e.g., Sartorius Minisart®, Merck Millipore Steritop®, or compatible ISO 11737-compliant units). The system enables quantitative retention of viable microorganisms—bacteria, yeasts, and molds—on the filter surface while removing inhibitory substances via controlled rinse cycles. Subsequent introduction of validated growth media into the same closed assembly ensures maintenance of sterility integrity throughout sample processing, eliminating risk of environmental contamination during transfer. Designed in accordance with ISO 13408-1 (Aseptic Processing of Health Care Products) and aligned with USP <71>, EP 2.6.1, and JP 4.07 sterility test requirements, the ZW-808A supports both membrane filtration and direct inoculation methods under Grade A/B cleanroom conditions.

Key Features

• Monolithic 304 stainless steel chassis with electropolished mirror finish—compliant with ASME BPE surface roughness standards (Ra ≤ 0.4 µm)—ensuring corrosion resistance, ease of disinfection (validated with 70% IPA, hydrogen peroxide vapor, or sodium hypochlorite), and zero crevice design to prevent biofilm accumulation.
• Low-speed, high-torque brushless DC motor directly coupled to the peristaltic pump mechanism—reducing thermal load, minimizing mechanical wear, and maintaining stable flow rates across variable viscosity ranges (e.g., viscous antibiotics, protein solutions, or lipid emulsions).
• Ergonomic eccentric cam pump head with tool-free tension adjustment—enabling rapid, repeatable tubing loading/unloading without torque calibration drift or roller misalignment.
• Intuitive rotary speed control interface with preset RPM buttons (30R, 60R, 100R, 160R, 220R) and continuous fine-tuning via UP/DOWN keys; retains last-used speed setting after power cycle (non-volatile memory).
• Integrated safety architecture: automatic pump shutdown upon pump head opening, low-voltage footswitch (<24 V DC) with IP67-rated aviation connector, and full perimeter sealing of all fluidic ports (IPX4 ingress protection).
• Modular drain tray configuration—available in detachable static or rotating integrated variants—to accommodate diverse lab layouts and workflow integration needs.
• Optional recoverable sample module—field-installable bracket system allows retrieval of unfiltered or partially filtered expensive APIs, cell therapies, or viral vectors without compromising sterility assurance.

Sample Compatibility & Compliance

The ZW-808A accommodates standard 47 mm diameter sterile filtration assemblies with either 0.22 µm (for sterility testing per USP <71>) or 0.45 µm (for microbial enumeration per USP <61>) track-etched or mixed-cellulose ester membranes. It supports aqueous solutions, isotonic saline, buffered preparations, and low-viscosity parenterals—including antibiotics with bacteriostatic agents, lyophilized reconstituted products, large-volume infusions (LVPs), ophthalmic solutions, and sterile water for injection (WFI). All wetted surfaces are non-leaching and extractables-tested per USP <661.1>. The system meets ISO 9001:2015 manufacturing quality standards and is documented for use in GLP and GMP environments requiring audit-ready traceability. Optional IQ/OQ documentation packages are available for validation against FDA 21 CFR Part 11 data integrity requirements, including electronic signature support and immutable audit trails.

Software & Data Management

While the ZW-808A operates as a standalone hardware platform without embedded software, its analog-digital hybrid control architecture provides RS-232 and optional USB-C output for external logging systems. RPM setpoint, runtime duration, and start/stop timestamps can be captured by third-party LIMS or ELN platforms (e.g., LabVantage, Benchling, or Thermo Fisher SampleManager) when integrated via Modbus RTU or ASCII protocol. All operational parameters—including total runtime per filter unit, cumulative pump revolutions, and manual intervention logs—are recordable for batch release documentation and regulatory inspection readiness. Calibration certificates for speed accuracy (±5 rpm tolerance at all setpoints) and electrical safety (IEC 61010-1) are supplied with each unit.

Applications

• Sterility testing of final drug products: injectables (vials, ampoules, prefilled syringes), biologics (monoclonal antibodies, vaccines), and sterile raw materials per USP <71>, Ph. Eur. 2.6.1, and JP 4.07.
• Microbial limit testing (MLT) of non-sterile pharmaceuticals, excipients, and packaging components per USP <61> and ISO 11737-1.
• Environmental monitoring support: filtration of compressed air, HVAC condensate, or purified water loop samples for subsequent membrane-based colony enumeration.
• Medical device sterility assurance: validation of sterilization processes for catheters, IV sets, surgical kits, and implantable devices per ISO 11737-2.
• Food & beverage QC: pathogen screening (e.g., E. coli, Salmonella) in beverages, dairy products, and ready-to-eat meals using AOAC-approved filtration protocols.

FAQ

Is the ZW-808A compliant with FDA 21 CFR Part 11 for electronic records?
Yes—when paired with validated third-party data acquisition software that implements role-based access control, audit trail generation, and electronic signatures, the ZW-808A meets Part 11 requirements for attributable, legible, contemporaneous, original, and accurate (ALCOA+) data capture.
Can it handle viscous or particulate-containing samples?
It supports samples with dynamic viscosities up to 25 cP and suspended solids <5 µm in diameter; pre-filtration through 5 µm depth filters is recommended for highly turbid or fiber-laden matrices.
What filter diameters and pore sizes are supported?
Standard 47 mm diameter filters only; compatible with 0.22 µm (sterility) and 0.45 µm (microbial limits) pore sizes per ISO 8573-7 and ASTM F838-22 specifications.
Does the system include validation documentation?
Factory-supplied IQ/OQ templates and calibration reports are provided; PQ execution requires user-defined test protocols aligned with pharmacopeial acceptance criteria.
Is remote monitoring or network connectivity available?
No native Ethernet or Wi-Fi capability exists; however, optional RS-232-to-Ethernet gateways enable integration into centralized facility monitoring systems (SCADA/HMS).