Tailin HTY-EMD02 / HTY-EMD02W Automated Membrane Dispenser

Overview

The Tailin HTY-EMD02 and HTY-EMD02W Automated Membrane Dispensers are precision-engineered laboratory instruments designed to eliminate manual handling during the aseptic transfer of microporous filter membranes in pharmaceutical, biotechnology, and quality control laboratories. These devices operate on a non-contact infrared proximity sensing principle—detecting operator hand presence within a configurable 0–150 mm range—to trigger controlled, single-membrane advancement from pre-loaded sterile cassettes or reels. Alternatively, tactile activation via the top-mounted momentary push button provides deterministic, low-latency dispensing for applications requiring procedural repeatability under glovebox or laminar flow hood conditions. The core mechanism employs a rare-earth permanent magnet DC motor coupled to a precision-ground 316L stainless steel drive roller, ensuring consistent torque delivery, micron-level positional fidelity, and resistance to repeated autoclave cycles, alcohol wipes, and hydrogen peroxide vapor (HPV) decontamination protocols. Engineered specifically for integration into sterility testing workflows (e.g., USP , EP 2.6.1), microbial enumeration (ISO 11133, ISO 8583), and environmental monitoring programs, the HTY-EMD02 series supports seamless alignment with GLP and GMP documentation requirements through its repeatable mechanical actuation and absence of software-based user inputs.

Key Features

• Two-mode operation: Hands-free infrared proximity sensing (adjustable detection range) and tactile button-actuated dispensing for protocol-specific flexibility
• High-reliability drive system: Rare-earth DC motor delivering stable rotational velocity and sub-millimeter positioning accuracy across >40,000 operational cycles
• Chemically inert and sterilization-compatible drivetrain: 316L stainless steel roller surface rated for repeated exposure to 70% isopropyl alcohol, 1.0 N NaOH, and saturated vapor-phase H₂O₂
• Extended battery autonomy: Integrated rechargeable Li-ion pack enables uninterrupted operation for up to 35 hours or ~40,000 membrane dispenses per charge
• Compact footprint (125 × 85 × 110 mm): Optimized for placement inside Class II biosafety cabinets, isolators, and Grade A laminar airflow workstations without compromising ergonomic access
• Patented cassette interface: Accommodates standard sterile membrane packaging formats—including double-bagged polypropylene trays and individually foil-wrapped discs—without adapter modification

Sample Compatibility & Compliance

The HTY-EMD02/W is validated for use with commercially available sterile filter membranes ranging from 25 mm to 47 mm in diameter and thicknesses between 100 µm and 250 µm, including mixed cellulose ester (MCE), polycarbonate (PC), polyethersulfone (PES), and nylon variants. It complies with mechanical safety requirements outlined in IEC 61010-1:2010 for laboratory equipment and meets electromagnetic compatibility (EMC) standards per CISPR 11 Group 1, Class B. While not a medical device itself, the instrument is manufactured under an ISO 13485:2016-certified quality management system, supporting traceability of materials, assembly records, and calibration logs required for FDA 21 CFR Part 820 audits. Its design facilitates alignment with EU Annex 1 (2022) expectations for minimizing human intervention in Grade A environments.

Software & Data Management

The HTY-EMD02/W operates as a standalone electromechanical device with no embedded firmware, network connectivity, or data logging capability—intentionally eliminating cybersecurity risks and validation overhead associated with software-driven instrumentation. All operational parameters (e.g., sensing threshold, motor dwell time) are fixed at factory calibration and cannot be modified by end users. This architecture ensures regulatory compliance in settings where ALCOA+ data integrity principles apply: attributable (via unique serial number engraved on housing), legible (mechanical action is directly observable), contemporaneous (dispensing occurs only upon verified physical stimulus), original (no electronic record generation), accurate (mechanical repeatability ±0.2 mm), complete (no missing events due to power loss or memory corruption), consistent (identical performance across units), enduring (no firmware decay), and available (full service history accessible via Tailin’s technical support portal). Audit trails rely on external documentation—such as logbooks or LIMS entries—linked to batch numbers and operator IDs.

Applications

• Sterility testing per USP and Ph. Eur. 2.6.1 using membrane filtration methodology
• Microbial recovery studies evaluating filter retention efficiency and extractables profiles
• Environmental monitoring in aseptic manufacturing suites (ISO 14644-1 Class 5/ISO 5)
• Preparation of membrane filters for colony-forming unit (CFU) enumeration in water and pharmaceutical product testing
• Quality control release testing of parenteral solutions, ophthalmic preparations, and biologicals
• Research applications requiring high-throughput, contamination-minimized membrane handling in cell culture and virology labs

FAQ

Does the HTY-EMD02/W require connection to a computer or network?
No. It is a fully autonomous electromechanical dispenser with no USB, Bluetooth, or Wi-Fi interfaces.
Can it accommodate non-standard membrane diameters or custom packaging?
Only standard 25 mm, 37 mm, 47 mm, and 50 mm sterile membranes in industry-accepted trays or reels are supported; custom configurations require prior engineering review.
What maintenance is required beyond routine surface disinfection?
Annual inspection of roller surface finish and motor torque output is recommended; no lubrication or recalibration is needed under normal operating conditions.
Is the device suitable for use inside a VHP (vaporized hydrogen peroxide) decontaminated isolator?
Yes—the 316L roller and ABS housing have been verified for ≥100 VHP cycles without dimensional or functional degradation.
How is device performance verified during qualification?
Through mechanical challenge testing: 100 consecutive dispenses measured for positional repeatability (±0.3 mm tolerance), followed by 1,000-cycle endurance validation under simulated worst-case humidity (60% RH) and temperature (25°C) conditions.