Tailin Biotechnology HTY-EMD01 Automatic Membrane Dispenser

Overview

The Tailin Biotechnology HTY-EMD01 Automatic Membrane Dispenser is an engineered solution for controlled, aseptic handling of sterile filter membranes in regulated laboratory and manufacturing environments. Designed specifically for integration into microbiological quality control workflows—including membrane filtration-based microbial enumeration (e.g., USP , EP 2.6.27, ISO 7218), sterility testing (USP , ISO 11737-1), and environmental monitoring—the HTY-EMD01 eliminates manual peeling of membrane strips from laminated packaging, thereby reducing operator-induced contamination risk, improving procedural consistency, and supporting GLP/GMP-aligned documentation practices. Its core operation relies on a precision dual-roller traction system actuated by independent DC motors, which applies calibrated shear force to separate the top and bottom layers of commercially supplied continuous-strip membrane packaging. The absence of direct tactile contact during dispensing ensures integrity preservation of pre-sterilized membranes—critical when working with low-bioburden or high-purity applications.

Key Features

• Dual-roller mechanical separation system with synchronized torque control, enabling reliable peel-force delivery across variable packaging thicknesses (e.g., PET/aluminum foil/laminated polymer composites)
• Non-contact infrared proximity sensor with adjustable sensitivity and 0.5 s response latency—optimized for glove-compatible operation in ISO Class 5 biosafety cabinets and laminar flow hoods
• Modular cassette design accommodating standard 150-sheet sterile membrane strips (47 mm or 50 mm diameter); cassettes are preloaded and sealed under ISO 11140-compliant conditions
• ABS polymer housing rated IP54 for dust resistance and incidental liquid splash protection; ergonomic footprint (250 × 170 × 260 mm) enables benchtop deployment without occupying critical cleanroom real estate
• Rechargeable 12 V lithium-ion battery providing ≥8 hours of continuous operation per charge (typical usage: 20–30 dispenses/hour); battery status indicated via LED interface
• Tool-free roller access and snap-fit cover mechanism—enabling full cassette replacement in <15 seconds without calibration recalibration

Sample Compatibility & Compliance

The HTY-EMD01 is validated for use with commercially available sterile membrane formats packaged in continuous-strip configuration, including mixed cellulose ester (MCE), polyethersulfone (PES), nylon 66, and polyvinylidene fluoride (PVDF) membranes—each certified to ISO 9001 and ISO 13485 manufacturing standards. It complies with mechanical safety requirements outlined in IEC 61000-6-2 (immunity) and IEC 61000-6-3 (emissions), and its non-invasive dispensing method supports adherence to FDA 21 CFR Part 11 data integrity principles when paired with electronic lab notebook (ELN) systems logging dispensing events. While not a medical device itself, the instrument facilitates compliance with pharmacopoeial membrane filtration methods referenced in USP , EP 5.1.1, and JP 4.05.

Software & Data Management

The HTY-EMD01 operates as a standalone electromechanical unit with no embedded firmware or network connectivity. All operational parameters—including motor duty cycle, sensor activation threshold, and battery voltage—are factory-set and non-user-adjustable to ensure repeatable performance across installations. For auditability, users may integrate external timestamped logging via USB-connected barcode scanners or footswitch-triggered ELN entries. No software validation package is provided; however, the device’s deterministic mechanical behavior permits straightforward IQ/OQ execution per ASTM E2500-13 guidelines for ancillary equipment in pharmaceutical QC labs.

Applications

• Routine membrane filtration in pharmaceutical water system monitoring (PW, WFI, Pure Steam condensate)
• Sterility testing of injectables, ophthalmic solutions, and biologics intermediates per USP
• Environmental monitoring of Grade A/B cleanrooms using settle plates or membrane filtration of air samples
• Microbial limit testing of non-sterile products (USP ) and raw materials
• Research-scale filtration in academic microbiology and bioprocess development labs requiring traceable, low-handling-risk membrane deployment

FAQ

Is the HTY-EMD01 compatible with non-standard membrane diameters or packaging formats?

No. It is mechanically calibrated exclusively for 47 mm and 50 mm round membranes supplied in industry-standard continuous-strip laminated packaging (typically 100–150 mm web width). Custom configurations require factory retrofitting and revalidation.
Does the device require periodic calibration or preventive maintenance?

Roller alignment and sensor sensitivity are factory-verified and do not drift under normal operating conditions. Annual visual inspection of roller surfaces and battery health assessment are recommended per internal SOPs.
Can the HTY-EMD01 be used in ISO Class 5 laminar airflow workstations?

Yes—its compact size, absence of particulate-generating components (e.g., fans, vents), and glove-compatible IR sensor make it suitable for placement inside certified laminar flow hoods and isolators.
What regulatory documentation is supplied with the instrument?

Each unit ships with a Certificate of Conformance, Factory Test Report (including roller torque verification and sensor response validation), and CE Declaration of Conformity (based on Machinery Directive 2006/42/EC and EMC Directive 2014/30/EU).