Tailin HTY-610 ISO Integrated Isolator Bacterial Collection System

Overview

The Tailin HTY-610 ISO Integrated Isolator Bacterial Collection System is a purpose-engineered filtration unit designed for seamless integration into Class A/B isolator environments used in pharmaceutical aseptic processing and sterility testing. Unlike standalone microbial collection devices, the HTY-610 ISO is mechanically and spatially optimized to mount directly within the isolator’s internal frame—eliminating external tubing penetrations, minimizing operator intervention, and preserving the integrity of the ISO 14644-1 Class 5 (ISO Class 5) laminar airflow zone. Its operation relies on positive-pressure-driven vacuum filtration through sterile, single-use filter assemblies (e.g., 0.45 µm or 0.22 µm pore-rated membranes), enabling quantitative recovery of viable microorganisms from liquid pharmaceutical products, raw materials, or process solutions per USP , Ph. Eur. 5.1.1, and JP 4.07 sterility test protocols.

Key Features

• Constant-torque brushless motor system engineered for consistent rotational output across the full 0–300 rpm range—critical for maintaining uniform membrane shear stress during low-flow or high-viscosity sample filtration.
• Digital pulse-width modulation (PWM) control architecture ensures precise speed regulation with ±2 rpm repeatability under variable load conditions, supporting method transfer between isolator-integrated and benchtop workflows.
• Tempered glass capacitive touch interface with haptic feedback provides glove-compatible operation inside isolators; screen layout complies with IEC 62366-1 usability engineering requirements for medical device interfaces.
• Manual clamp actuation mechanism eliminates solenoid valves or pneumatic components—reducing failure points, simplifying validation, and avoiding potential particulate generation in Grade A environments.
• Integrated pump head safety logic monitors current draw and rotational stall events in real time, automatically halting operation if tubing occlusion or membrane clogging exceeds predefined thresholds—ensuring filter integrity and preventing backflow.
• Last-setting memory function retains the most recently configured speed value upon power cycle, reducing procedural variability during multi-batch sterility testing campaigns.

Sample Compatibility & Compliance

The HTY-610 ISO accommodates standard 47 mm or 50 mm diameter sterile filter discs mounted in reusable or disposable filter holders compatible with common aseptic test assemblies (e.g., Millipore Steritop®, Sartorius Minisart® NML). It supports aqueous, oily, and low-surface-tension formulations—including suspensions, ophthalmic solutions, and lyophilized reconstitutes—provided viscosity remains below 25 cP at filtration temperature. Device design conforms to ISO 13485:2016 quality management system requirements for in vitro diagnostic-related equipment. All electrical components meet IEC 61010-1 safety standards for laboratory equipment. When deployed within a validated isolator environment, the system supports compliance with EU GMP Annex 1 (2022), FDA Aseptic Processing Guidance (2004), and WHO Technical Report Series No. 961, Annex 2.

Software & Data Management

The HTY-610 ISO operates as a hardware-controlled analog device with no embedded firmware or network connectivity—intentionally minimizing cybersecurity exposure and qualification burden in regulated settings. All operational parameters (speed setpoint, runtime, start/stop timestamps) are recorded manually in paper-based or electronic batch records per ALCOA+ principles. For facilities requiring electronic data capture, optional analog output (0–10 V DC) enables integration with SCADA or MES systems for trend monitoring. Audit trail functionality is implemented externally via the host LIMS or ELN platform, satisfying FDA 21 CFR Part 11 requirements when paired with appropriate access controls and electronic signatures.

Applications

• Sterility testing of finished injectables, ophthalmic preparations, and parenteral nutrition solutions under ISO 14644-1 Class 5 conditions.
• Environmental monitoring sample concentration (e.g., isolator surface rinse fluids, compressed gas condensates).
• Media fill simulation filtration verification during aseptic process validation.
• Bioburden assessment of non-sterile APIs and excipients prior to terminal sterilization.
• Validation of filter compatibility and flow rate consistency across multiple lots of sterile-grade membranes.

FAQ

Is the HTY-610 ISO suitable for use with aggressive solvents such as acetone or IPA?
No—the device’s wetted materials (silicone tubing clamps, stainless-steel mounting brackets) are not chemically rated for prolonged exposure to halogenated or highly polar organic solvents. Use only with aqueous-based or pharmaceutically approved vehicles.
Can the unit be calibrated or qualified independently of the isolator?
Yes—mechanical speed accuracy may be verified using a traceable handheld tachometer; torque consistency can be assessed via gravimetric flow rate testing with reference standards. Full IQ/OQ must include isolator-integrated installation checks per ASTM E2500.
Does Tailin provide 21 CFR Part 11-compliant software for this instrument?
No—the HTY-610 ISO contains no onboard software or data storage. Compliance with electronic record requirements is achieved through external systems (LIMS/ELN) interfaced via analog signal or manual entry.
What maintenance intervals are recommended for the motor and control electronics?
Brushless motor requires no scheduled maintenance; annual visual inspection of touch panel responsiveness, clamp actuation smoothness, and mounting bracket integrity is advised per manufacturer’s preventive maintenance guide.
Is third-party validation support available from Tailin?
Tailin provides URS templates, FAT/SAT protocols, and raw test data packages for IQ/OQ execution but does not perform on-site commissioning or regulatory audits—these remain the responsibility of the end-user’s qualified validation team.