Tailin HTY-ESIC97 Enzyme Substrate-Based Automated Microbial Incubation and Enumeration System
| Brand | Tailin |
|---|---|
| Origin | Zhejiang, China |
| Manufacturer Type | Manufacturer |
| Origin Category | Domestic |
| Model | HTY-ESIC97 |
| Pricing | Upon Request |
| Power Supply | AC 220 V / 50 Hz |
| Dimensions (W × D × H) | 1320 × 835 × 1890 mm |
| Weight | ≤ 100 kg |
| Total Power Consumption | 5 kW |
| Operating Noise Level | ≤ 60 dB(A) |
| Target Microorganisms | Total Coliforms, Escherichia coli |
| Incubation Temperatures | 37 °C and 44.5 °C |
| Temperature Control Accuracy | ±0.4 °C |
| Quantification Plate Formats | 97-well and 51-well |
| Maximum Concurrent Plates | 100 |
| Integrated UV Observation Chamber | Yes |
| Data Integrity Features | Audit Trail, Electronic Signature, Role-Based Access Control (3-Tier), Automatic Archiving, LIMS Compatibility, Customizable Report Templates, Cloud/Network Reporting |
Overview
The Tailin HTY-ESIC97 is a fully integrated, automated microbial enumeration system engineered for regulatory-compliant water quality testing using the standardized enzyme substrate method (e.g., defined in EPA Method 1603, ISO 9308-1, and APHA Standard Methods 9223B). It implements a dual-temperature incubation strategy—37 °C for total coliform detection and 44.5 °C for thermotolerant Escherichia coli confirmation—within a single instrument architecture. Unlike conventional benchtop incubators paired with manual colony counting, the HTY-ESIC97 embeds precise thermal control, real-time fluorescence-based colony enumeration, and end-to-end digital data handling into one unified platform. Its design adheres to principles of ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available) and supports compliance with FDA 21 CFR Part 11, EU Annex 11, and GMP Annex 11 requirements for electronic records and signatures.
Key Features
- Simultaneous incubation and automated optical enumeration of up to 100 enzyme substrate quantification plates (97-well or 51-well format) per cycle
- Dual-zone temperature control with ±0.4 °C stability at both 37 °C and 44.5 °C, validated per ISO/IEC 17025 calibration protocols
- Integrated UV observation chamber with adjustable intensity and safety interlock for real-time fluorescent signal verification without plate removal
- High-resolution CCD imaging system coupled with proprietary image analysis algorithms for reliable, operator-independent colony identification and MPN calculation
- Touchscreen HMI powered by industrial-grade embedded CPU; supports multi-language UI, customizable workflows, and offline operation with local data caching
- Full audit trail with timestamped user actions, electronic signature capture (role-authenticated), and immutable log export in CSV/PDF formats
- Three-tier permission management (Administrator, Supervisor, Analyst) enforcing separation of duties and preventing unauthorized data modification
- Network-enabled reporting: automatic result transmission via email, SMS gateway, or secure API endpoints; optional integration with enterprise LIMS or ELN systems
Sample Compatibility & Compliance
The HTY-ESIC97 is validated for use with commercially available, AOAC-PTM-verified enzyme substrate reagents (e.g., Colilert®, Enterolert®) in standard 97-well or 51-well Quanti-Tray® formats. It meets performance criteria outlined in US EPA Method 1603 for E. coli and total coliforms in drinking water, surface water, and wastewater effluents. The system’s hardware and firmware architecture support GLP/GMP-aligned validation documentation packages—including IQ/OQ/PQ protocols—and is designed to withstand routine environmental monitoring laboratory conditions (ISO 17025-accredited labs). All software modules comply with ICH GCP and 21 CFR Part 11 requirements for electronic records, including mandatory electronic signatures, audit trail retention (>10 years), and system access logs.
Software & Data Management
The embedded operating system provides native support for structured data export (CSV, XML, PDF), batch-level traceability, and date-range filtered retrieval of historical runs. Users may define report templates compliant with internal SOPs or external regulatory submissions (e.g., state DEP portals, EPA eNOA). All raw images, enumeration logs, environmental sensor readings (temperature, humidity), and user metadata are archived automatically with SHA-256 hash integrity verification. Optional cloud synchronization enables remote monitoring and centralized oversight across multi-site laboratories. The system supports TLS 1.2+ encrypted communications and integrates with LDAP/Active Directory for enterprise identity management.
Applications
- Regulatory compliance testing of potable water distribution systems per US Safe Drinking Water Act (SDWA) and EU Directive 98/83/EC
- Routine monitoring of treated wastewater discharge points under NPDES permits
- Validation and routine surveillance of membrane filtration and UV disinfection units
- Pharmaceutical water system qualification (PW, WFI) per USP , EP 2.6.12, and JP 17
- Environmental surveillance in cleanrooms and aseptic manufacturing facilities (ISO 14644-1 Class 5–8)
- Field-deployable operation in mobile labs or regional water testing centers with limited technical staffing
FAQ
Does the HTY-ESIC97 require external calibration or annual certification?
No—built-in NIST-traceable temperature sensors and self-diagnostic routines eliminate the need for third-party recalibration; however, users may perform periodic verification using certified reference standards per their internal SOP.
Can the system be validated for use in GMP environments?
Yes—the platform includes prequalified IQ/OQ documentation templates, configurable electronic signature workflows, and full audit trail export capability required for FDA and EMA inspections.
Is remote software update supported?
Yes—firmware updates can be deployed over secure HTTPS with version rollback capability and change-log documentation.
What happens if network connectivity is lost during a run?
All incubation parameters, imaging data, and enumeration results are stored locally on redundant SSD storage; synchronization resumes automatically upon connection restoration.
Are consumables other than standard quantification plates required?
No—no proprietary reagents or cartridges are needed; compatibility extends to all major enzyme substrate assay kits meeting ASTM D6162 and ISO 9308-1 specifications.
