Junray ZR-1140 Microbial Limit Tester

Overview

The Junray ZR-1140 Microbial Limit Tester is an automated, four-channel vacuum filtration system engineered for precise, reproducible microbial enumeration in compliance with pharmacopoeial standards—including Chinese Pharmacopoeia (ChP), United States Pharmacopeia (USP and ), European Pharmacopoeia (Ph. Eur. 2.6.12), and ISO 8573-7 for compressed air monitoring. It implements the membrane filtration method: liquid samples are drawn through a sterile 0.45 µm pore-size filter membrane under controlled vacuum pressure; retained microorganisms are then transferred onto appropriate solid culture media (e.g., Soybean–Casein Digest Agar or Tryptic Soy Agar) and incubated for colony-forming unit (CFU) enumeration. Designed for high-integrity environmental and product testing, the ZR-1140 eliminates manual variability in filtration timing, pressure consistency, and membrane handling—critical parameters affecting recovery efficiency and regulatory audit readiness.

Key Features

• Four independent filtration channels with dedicated high-efficiency diaphragm pumps—ensuring true parallel processing without cross-channel interference or pressure drop.
• Quick-release, autoclavable filter heads (121 °C, 30 min) compatible with 47 mm standard membranes; optional 50 mm and 60 mm configurations support broader sample volume or viscous matrices.
• Real-time programmable timer per channel: users define exact filtration duration (0–99 min 59 s) to optimize retention of stressed or slow-growing organisms while avoiding membrane clogging.
• SIP (Steam-in-Place) functionality enables on-system sterilization of fluid pathways without disassembly—supporting GMP-aligned cleanroom operations and reducing validation burden.
• Integrated one-way check valves on each channel prevent reverse flow during pump shutdown or pressure fluctuations—preserving membrane integrity and eliminating contamination risk from back-suction.
• 304 stainless steel chassis with electropolished surface finish ensures corrosion resistance, ease of disinfection (e.g., 70% IPA, hydrogen peroxide vapor), and compatibility with ISO Class 5–8 environments.
• Intuitive 7-inch color LCD touchscreen interface with multilingual support (English default); stores up to 10,000 test records locally with timestamp, operator ID, channel status, and duration logs.

Sample Compatibility & Compliance

The ZR-1140 accommodates aqueous and low-viscosity non-aggressive liquids including purified water, water for injection (WFI), saline solutions, buffer preparations, and diluted pharmaceutical intermediates. It is validated for use with standard 0.45 µm mixed-cellulose ester (MCE) or polyethersulfone (PES) membranes meeting ASTM E2994 requirements for microbial retention. The system supports full traceability per FDA 21 CFR Part 11 when paired with Junray’s optional audit-trail-enabled software module—recording user actions, parameter changes, and electronic signatures. Its design conforms to ISO/IEC 17025:2017 clause 6.4.3 (equipment suitability) and aligns with EU GMP Annex 1 (2022) requirements for aseptic process simulation and environmental monitoring equipment qualification.

Software & Data Management

Onboard firmware enables secure data logging with automatic time/date stamping, operator code input, and session-based record grouping. Test results—including start/stop times, total filtered volume (calculated from duration and calibrated flow rate), and pass/fail flags—are exportable via USB flash drive in CSV format for LIMS integration. Optional Bluetooth thermal printer provides immediate hard-copy documentation compliant with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate). For enterprise deployment, Junray’s LabLink™ PC software (sold separately) adds role-based access control, trend analysis, deviation alerts, and electronic batch record (EBR) generation aligned with ICH Q7 and PIC/S PI 007-6.

Applications

• Pharmaceutical QC labs: microbial limit testing of raw materials, excipients, active pharmaceutical ingredients (APIs), and final dosage forms per USP .
• Water system monitoring: routine bioburden assessment of purified water (PW), WFI, and clean steam condensate in HVAC and process water loops.
• Healthcare & public health: bacterial enumeration in hospital cooling tower water, dialysis fluid, and municipal drinking water per GB/T 5750.12–2023.
• Contract testing organizations (CTOs): high-throughput environmental monitoring of Grade A–D cleanrooms using settle plates, contact plates, and air samplers—where rapid, standardized filtration of rinse fluids is essential.
• Biotechnology upstream processes: verification of sterile filtration integrity for buffer and media preparation lines prior to bioreactor inoculation.

FAQ

Is the ZR-1140 compliant with USP and for microbial enumeration?
Yes—the system’s controlled vacuum profile, membrane compatibility, and documented recovery validation protocols meet the apparatus requirements specified in USP chapters for membrane filtration-based microbial limit testing.
Can the filter heads be sterilized in an autoclave without disassembly?
Yes—each filter head is fully autoclavable at 121 °C for 30 minutes with all components assembled, per ISO 17665-1 validation guidelines.
Does the system support 21 CFR Part 11-compliant electronic records?
With the optional LabLink™ software package and configured user authentication, full Part 11 compliance—including audit trails, electronic signatures, and secure data archiving—is achievable.
What maintenance is required for long-term reliability?
Routine maintenance includes monthly inspection of diaphragm pump integrity, quarterly calibration of timer accuracy against NIST-traceable stopwatch, and annual verification of vacuum stability per ISO 8573-1 Class 2 requirements.
Is technical support available outside China?
Junray provides global remote diagnostics and application engineering support via ISO 9001-certified service centers in Germany, Singapore, and the United States—with spare parts logistics under 72-hour air freight commitment.